Sustiva patent
Commercial Insight: HIV
Change of guard
Publication Date December 2006
Publisher Datamonitor
Product Type Strategic Report
Pages 157
ISBN Number not applicable
Product Code DAT199
Tuesday, February 12, 2008
Sustiva price
The report on new patented medicines - Sustiva
Sustiva price
Brands (total): SUSTIVA (efavirenz)
DIN: 02239886 50 mg capsules
02239887 100mg capsule
02239888 200 mg capsules
Patent: Bristol-Myers Squibb Pharmaceutical Group (formerly DuPont Pharma)
Indication (per product monograph): For the treatment of HIV-1 infection in combination with other antiretroviral drugs. This indication is based on analyses of plasma HIV-RNA levels of CD4 cells, and counts in controlled studies of up to 24 weeks.
Notification of Compliance: March 19,1999
Date of first sale: March 1999
In most cases, the patents issued to the drug to come to market. In this case, the first patent on Sustiva has been published August 28, 2001, and was under the PMPRB jurisdiction at the time.
ATC class: J05AG03
Antiretrovirals for systemic use:
non-nucleoside reverse transcriptase inhibitors (NNRTI)
Application Guidelines
Sustiva price
Summary:
Introductory price of Sustiva at the date of the first sale, were within the guidelines, because the cost of treatment is not greater than the cost of treating existing drugs for therapeutic class comparison, and the price does not exceed the price range in other comparator countries Sustiva, which was sold. These prices are still within the guidelines in 2001, when Sustiva came under the jurisdiction PMPRB.
Scientific review:
In PMPRB Rights Drug Advisory Panel (HDAP), recommended that Sustiva be considered as a category 3 new drugs (provide moderate, little or no therapeutic advantage over comparable medicines).
Sustiva price
In comparison therapeutic class (TCC) to test the guidelines stipulate that the price of a category 3 new drug product may not exceed the price of other drugs that treat the same disease or condition. Comparators are generally selected from among the existing drug products in the same level of the Anatomical 4th, therapeutic, chemical (ATC) systems, which are clinically equivalent in the decision approved indication. The guidelines stipulate that she may, however, be appropriate to include products from other classes ATC if they are clinically equivalent for the indication of drug product under consideration. See PMPRB in the compilation of guidelines, policies and procedures to better describe the guidelines and policies on troops.
Members of the same level ATC 4th grade include Sustiva as Rescriptor (delavirdine) and Viramune (nevirapine).
Like other drugs for HIV-infected people, Sustiva is usually used in combination with other drugs. Guidance on the use of antiretroviral drugs in HIV-infected adults and adolescents supported HIV / AIDS Treatment Information Service (ATIS), the United States (available on the Internet: # http://www.hivatis.org/trtgdlns.html adults) include Sustiva, in combination with other drugs to the list "strongly recommended" drugs, including non-nucleoside reverse transcriptase inhibitors (NNRTIs) and protease inhibitors (PIs). British HIV Association (BHIVA) guidelines for the treatment of HIV-infected adults receiving antiretroviral therapy (July 2001) to identify Sustiva, PX and NNRTIs, which will be used in conjunction with dual nucleoside reverse transcriptase inhibitors (NRTIs) background therapy.
In light of the evidence that Sustiva is used in combination with two NRTIs as an alternative to the PI-based treatment, the other scheme or NNRTI-based treatment Ziagen in patients with HIV HDAP recommended NNRTIs and PV if necessary troops comparators for Sustiva.
In PMPRB Guidelines provide that the dose recommended for comparison purposes, as a rule, should not exceed the maximum of the usual recommended dosage. Maintaining adult daily dose identified in the individual product monographs and supported by clinical literature was recommended for comparison purposes. See table below prices test section.
Price Review:
The Guidelines, the introductory price of the new drug product category 3 will be deemed excessive if it exceeds the cost of comparable drug products based on the test of troops, and if it exceeds the price of the same drugs in the seven countries listed in the Patented Medicine Rules , 1994.
Sustiva price
Next troops has been set up to Sustiva 200 mg capsule. It should be noted that, although Rescriptor and Agenerase would be appropriate comparators troops from a scientific point of view, they were not included, as these products were drugs in the field of view during Sustiva review. The exclusion of these products does not affect the outcome of the price review.
Sustiva price
Brands (total): SUSTIVA (efavirenz)
DIN: 02239886 50 mg capsules
02239887 100mg capsule
02239888 200 mg capsules
Patent: Bristol-Myers Squibb Pharmaceutical Group (formerly DuPont Pharma)
Indication (per product monograph): For the treatment of HIV-1 infection in combination with other antiretroviral drugs. This indication is based on analyses of plasma HIV-RNA levels of CD4 cells, and counts in controlled studies of up to 24 weeks.
Notification of Compliance: March 19,1999
Date of first sale: March 1999
In most cases, the patents issued to the drug to come to market. In this case, the first patent on Sustiva has been published August 28, 2001, and was under the PMPRB jurisdiction at the time.
ATC class: J05AG03
Antiretrovirals for systemic use:
non-nucleoside reverse transcriptase inhibitors (NNRTI)
Application Guidelines
Sustiva price
Summary:
Introductory price of Sustiva at the date of the first sale, were within the guidelines, because the cost of treatment is not greater than the cost of treating existing drugs for therapeutic class comparison, and the price does not exceed the price range in other comparator countries Sustiva, which was sold. These prices are still within the guidelines in 2001, when Sustiva came under the jurisdiction PMPRB.
Scientific review:
In PMPRB Rights Drug Advisory Panel (HDAP), recommended that Sustiva be considered as a category 3 new drugs (provide moderate, little or no therapeutic advantage over comparable medicines).
Sustiva price
In comparison therapeutic class (TCC) to test the guidelines stipulate that the price of a category 3 new drug product may not exceed the price of other drugs that treat the same disease or condition. Comparators are generally selected from among the existing drug products in the same level of the Anatomical 4th, therapeutic, chemical (ATC) systems, which are clinically equivalent in the decision approved indication. The guidelines stipulate that she may, however, be appropriate to include products from other classes ATC if they are clinically equivalent for the indication of drug product under consideration. See PMPRB in the compilation of guidelines, policies and procedures to better describe the guidelines and policies on troops.
Members of the same level ATC 4th grade include Sustiva as Rescriptor (delavirdine) and Viramune (nevirapine).
Like other drugs for HIV-infected people, Sustiva is usually used in combination with other drugs. Guidance on the use of antiretroviral drugs in HIV-infected adults and adolescents supported HIV / AIDS Treatment Information Service (ATIS), the United States (available on the Internet: # http://www.hivatis.org/trtgdlns.html adults) include Sustiva, in combination with other drugs to the list "strongly recommended" drugs, including non-nucleoside reverse transcriptase inhibitors (NNRTIs) and protease inhibitors (PIs). British HIV Association (BHIVA) guidelines for the treatment of HIV-infected adults receiving antiretroviral therapy (July 2001) to identify Sustiva, PX and NNRTIs, which will be used in conjunction with dual nucleoside reverse transcriptase inhibitors (NRTIs) background therapy.
In light of the evidence that Sustiva is used in combination with two NRTIs as an alternative to the PI-based treatment, the other scheme or NNRTI-based treatment Ziagen in patients with HIV HDAP recommended NNRTIs and PV if necessary troops comparators for Sustiva.
In PMPRB Guidelines provide that the dose recommended for comparison purposes, as a rule, should not exceed the maximum of the usual recommended dosage. Maintaining adult daily dose identified in the individual product monographs and supported by clinical literature was recommended for comparison purposes. See table below prices test section.
Price Review:
The Guidelines, the introductory price of the new drug product category 3 will be deemed excessive if it exceeds the cost of comparable drug products based on the test of troops, and if it exceeds the price of the same drugs in the seven countries listed in the Patented Medicine Rules , 1994.
Sustiva price
Next troops has been set up to Sustiva 200 mg capsule. It should be noted that, although Rescriptor and Agenerase would be appropriate comparators troops from a scientific point of view, they were not included, as these products were drugs in the field of view during Sustiva review. The exclusion of these products does not affect the outcome of the price review.
Generic Sustiva
EFAVIR ( Generic Sustiva, Efavirenz )
Manufacturer: Cipla Limited manufactures EFAVIR ( Generic Sustiva, Efavirenz ).
Uses: The uses of EFAVIR ( Generic Sustiva, Efavirenz ) include:
Efavir is one of the growing number of drugs used to fight HIV infection. HIV, the human immunodeficiency virus, weakens the immune system until it can no longer fight off infections, leading to the fatal disease known as AIDS (acquired immune deficiency syndrome).
Generic Sustiva
Like other drugs for HIV, Efavir works by impairing the virus's ability to multiply. However, when taken alone it may prompt the virus to become resistant. Efavir is therefore always taken with at least one other HIV medication, such as Retrovir or Crixivan. Even when used properly, it may remain effective for only a limited time.
Manufacturer: Cipla Limited manufactures EFAVIR ( Generic Sustiva, Efavirenz ).
Uses: The uses of EFAVIR ( Generic Sustiva, Efavirenz ) include:
Efavir is one of the growing number of drugs used to fight HIV infection. HIV, the human immunodeficiency virus, weakens the immune system until it can no longer fight off infections, leading to the fatal disease known as AIDS (acquired immune deficiency syndrome).
Generic Sustiva
Like other drugs for HIV, Efavir works by impairing the virus's ability to multiply. However, when taken alone it may prompt the virus to become resistant. Efavir is therefore always taken with at least one other HIV medication, such as Retrovir or Crixivan. Even when used properly, it may remain effective for only a limited time.
Sustiva cost
Low cost international AIDS drugs reduced prices
Sustiva cost
HIV is not treated here becomes AIDS. AIDS is 100% fatal However, prolonging the life of anti-retroviral drugs began to transform HIV from a death sentence to the inevitable acceptable condition for those who, first of all, living in developed countries in a position to acquire them. We help people with HIV / AIDS at the "confidential" to get more affordable drugs from international sources tested drugs. Call now for more information (888) 380-6337.
HIV / AIDS medicine price list
Price Update (5/11/07)
HIV threat to the very fabric of human society as no disease in human history before. By 2010, an estimated mortality from pandemic opponent will be one of those with bubonic plague, which killed 93 million people. The numbers may be impressive, but we can not allow that they become numbing. Evidence of success in reducing the incidence of infections in countries such as Thailand and Uganda show that HIV / AIDS is not hopeless. A single and a global commitment to turning the tide on this disease is needed and the building. This would require efficient use of resources for research, prevention, care and treatment for those infected and affected by the disease.
By the end of 2003 there were 37.8 million people living with HIV / AIDS, including 17 million women and 2.1 million Children under the age of 15. 4.8 million people were newly infected with HIV in 2003, including 630000 children. In 2003 alone, a total of 2.9 million people who died of HIV / AIDS-related causes. UNAIDS predicts that an additional 45 million people will be infected with HIV in 126 low - and middle-income countries by 2010, unless the world will be able to strengthen significantly expanded global prevention efforts.
By the end of 2003, women accounted for nearly half of all people living with AIDS around the world, and constitute almost 60% of infections in sub-Saharan Africa. In addition, young women are several times more likely than young men to contract the disease through heterosexual contact. Worldwide, 62% of young people infected are girls, and that number soars to 75% in sub-Saharan Africa. A women's vulnerability to the virus due not only to biological differences, but also the deep-rooted social and economic inequalities, which further exacerbates their risk.
Sustiva cost
Because 70% of the world's poor are women, women have fewer economic opportunities. They are much more vulnerable to participate in sex transactions to pay for food, schooling and other basic necessities. They are also vulnerable to coercive or forced sex, and are often unable to negotiate condom use.
Many women, especially married women can not control the conditions under which sex occurs. Women especially not in a position to negotiate condom use or sex with my husband, who may have extramarital partners. Some studies have shown that married women are actually more at risk of HIV than unmarried women, because they are more likely to suffer relations in marriage.
HIV-positive women can transmit HIV to their children during pregnancy, during birth or through breastfeeding. Today, mother-to-child transmission (MTCT) of HIV is the primary means of acquiring HIV for more than 2 million children living with HIV. Although antiretroviral therapy significantly reduces the risk of HIV transmission from mother to child, only 1% of women in need now have access to this preventive therapy.
Sustiva cost
As AIDS ravages families and communities, the burden of caring for sick family members rests mainly women and girls - many of whom may be seriously ill themselves. A woman affected by HIV / AIDS is even plunged into poverty, losing the ability to provide for themselves and their children. Combined with the wide dissemination of the social stigma and the dissolution of the traditional family and support structures, HIV / AIDS is undermining the status of women in many countries.
Sustiva cost
HIV is not treated here becomes AIDS. AIDS is 100% fatal However, prolonging the life of anti-retroviral drugs began to transform HIV from a death sentence to the inevitable acceptable condition for those who, first of all, living in developed countries in a position to acquire them. We help people with HIV / AIDS at the "confidential" to get more affordable drugs from international sources tested drugs. Call now for more information (888) 380-6337.
HIV / AIDS medicine price list
Price Update (5/11/07)
HIV threat to the very fabric of human society as no disease in human history before. By 2010, an estimated mortality from pandemic opponent will be one of those with bubonic plague, which killed 93 million people. The numbers may be impressive, but we can not allow that they become numbing. Evidence of success in reducing the incidence of infections in countries such as Thailand and Uganda show that HIV / AIDS is not hopeless. A single and a global commitment to turning the tide on this disease is needed and the building. This would require efficient use of resources for research, prevention, care and treatment for those infected and affected by the disease.
By the end of 2003 there were 37.8 million people living with HIV / AIDS, including 17 million women and 2.1 million Children under the age of 15. 4.8 million people were newly infected with HIV in 2003, including 630000 children. In 2003 alone, a total of 2.9 million people who died of HIV / AIDS-related causes. UNAIDS predicts that an additional 45 million people will be infected with HIV in 126 low - and middle-income countries by 2010, unless the world will be able to strengthen significantly expanded global prevention efforts.
By the end of 2003, women accounted for nearly half of all people living with AIDS around the world, and constitute almost 60% of infections in sub-Saharan Africa. In addition, young women are several times more likely than young men to contract the disease through heterosexual contact. Worldwide, 62% of young people infected are girls, and that number soars to 75% in sub-Saharan Africa. A women's vulnerability to the virus due not only to biological differences, but also the deep-rooted social and economic inequalities, which further exacerbates their risk.
Sustiva cost
Because 70% of the world's poor are women, women have fewer economic opportunities. They are much more vulnerable to participate in sex transactions to pay for food, schooling and other basic necessities. They are also vulnerable to coercive or forced sex, and are often unable to negotiate condom use.
Many women, especially married women can not control the conditions under which sex occurs. Women especially not in a position to negotiate condom use or sex with my husband, who may have extramarital partners. Some studies have shown that married women are actually more at risk of HIV than unmarried women, because they are more likely to suffer relations in marriage.
HIV-positive women can transmit HIV to their children during pregnancy, during birth or through breastfeeding. Today, mother-to-child transmission (MTCT) of HIV is the primary means of acquiring HIV for more than 2 million children living with HIV. Although antiretroviral therapy significantly reduces the risk of HIV transmission from mother to child, only 1% of women in need now have access to this preventive therapy.
Sustiva cost
As AIDS ravages families and communities, the burden of caring for sick family members rests mainly women and girls - many of whom may be seriously ill themselves. A woman affected by HIV / AIDS is even plunged into poverty, losing the ability to provide for themselves and their children. Combined with the wide dissemination of the social stigma and the dissolution of the traditional family and support structures, HIV / AIDS is undermining the status of women in many countries.
Sustiva medication
Sustiva medication
Hi,
All drugs have side effects and toxicity. (Even the makers of Viagra warn that if you have an erection for Viagra, which lasts more than four hours, you should contact your doctor Yes, right.) Well, HIV drugs are no exception to the rule side-effects/toxicities. As with any medication, we have to weigh the potential benefits of taking the drug, the potential toxicity and long - and short-term side effects. Sustiva medication
In the Sustiva portion of your Atripla was associated with dyslipidemia, including elevated cholesterol (including an increase in LDL, the so-called "bad cholesterol"). This phenomenon is also seen protease inhibitors, often broader than with Sustiva, a non-nucleoside reverse transcriptase inhibitor. If you start cholesterol-lowering drugs? Not necessarily. Not everybody takes Sustiva or protease inhibitors had a significant increase in their cholesterol levels. So if your cholesterol levels are not raised, there would be no point in taking additional medication. And, as noted above, all medicines, including cholesterol-lowering drugs, have their own side-effect/toxicity profile. I would also like to point out that if your cholesterol is beginning to rise, will be the first intervention diet and exercise, and not additional medication.
Regarding your decision to start HIV medications "early" no one knows better the ideal time to start treatment. This is because anti-HIV drugs are relatively new, some very, very new, and therefore we do not know their full side-effect/toxicity profiles. This is especially true of long-term side effects / toxicity. For example, when Zerit (D4T) was introduced, we had no idea he would be associated with lipoatrophy down the road. The current trend in circulation worldwide guidelines is to begin treatment earlier. Most of the recommended guidelines crossed the starting point CD4 counts in the range of 200-250 for counting CD4 in the range of 350. This change in the guidelines was due to increasing HIV drugs (less toxic, more convenient dosing, fewer drug interactions, less likely to develop resistance, etc.). Eventually, if and when we are very reliable and effective anti-HIV drugs, treatment guidelines may also recommend starting treatment as soon as someone diagnosed as in the case with the majority of infections. For example, if you have a case of bacterial pneumonia or syphilis, you have to start treatment as soon as you receive your diagnosis. Eventually it will be this way with HIV and.
Sustiva medication
Finally, in comparison with HIV-AIDS puzzle. This term was invented by AIDS before we have identified the causative agent of HIV. AIDS is acquired immunodeficiency syndrome. A "syndrome" is, by definition, a set of symptoms. Because HIV infection comprises a wide range of diseases, including opportunistic infections and malignancies, it was difficult to quantify the early days of the epidemic cases. Consequently, the CDC and other agencies have developed AIDS case definition, collecting the most common symptoms of severe, and abnormal conditions laboratory tests . example, in the laboratory abnormality have absolute CD4 Cola-200 or less cut for diagnosis of AIDS. In retrospect, it is not realistic sense as someone is sick or is going to get. course, someone with a CD4 cell 205 can be much illness, than someone with a CD4 cell 198, even though the former are not diagnosed with AIDS according to the case definition. Had we learned the causative agent of AIDS is HIV virus since the beginning of the epidemic, we would never have created AIDS case definition based on symptoms and opportunistic infections. The better classification will be HIV-positive or HIV-negative. As with many other diseases, there are a number of severity of HIV from asymptomatic to symptomatic degree. Thus, I am not very hung on HIV and AIDS . "To my mind," AIDS is just one case definition and not associated with the dire predictions of morbidity and mortality. Keep in mind that a person is diagnosed with AIDS, even if his or her CD4 count dips below 200 only transiently, and then recovered sharply medical intervention. many people with this type of clinical course could be far healthier than someone who has never below 200 near CD4 cells, but also has a significant HIV-associated diseases along the way. Lastly, I mention of the terminology. term "complete AIDS" makes no sense, because AIDS is identified specific parameters, and hence, there is no such thing as "partially blown AIDS." Like HIV, AIDS, or you need it or not .
Hi,
All drugs have side effects and toxicity. (Even the makers of Viagra warn that if you have an erection for Viagra, which lasts more than four hours, you should contact your doctor Yes, right.) Well, HIV drugs are no exception to the rule side-effects/toxicities. As with any medication, we have to weigh the potential benefits of taking the drug, the potential toxicity and long - and short-term side effects. Sustiva medication
In the Sustiva portion of your Atripla was associated with dyslipidemia, including elevated cholesterol (including an increase in LDL, the so-called "bad cholesterol"). This phenomenon is also seen protease inhibitors, often broader than with Sustiva, a non-nucleoside reverse transcriptase inhibitor. If you start cholesterol-lowering drugs? Not necessarily. Not everybody takes Sustiva or protease inhibitors had a significant increase in their cholesterol levels. So if your cholesterol levels are not raised, there would be no point in taking additional medication. And, as noted above, all medicines, including cholesterol-lowering drugs, have their own side-effect/toxicity profile. I would also like to point out that if your cholesterol is beginning to rise, will be the first intervention diet and exercise, and not additional medication.
Regarding your decision to start HIV medications "early" no one knows better the ideal time to start treatment. This is because anti-HIV drugs are relatively new, some very, very new, and therefore we do not know their full side-effect/toxicity profiles. This is especially true of long-term side effects / toxicity. For example, when Zerit (D4T) was introduced, we had no idea he would be associated with lipoatrophy down the road. The current trend in circulation worldwide guidelines is to begin treatment earlier. Most of the recommended guidelines crossed the starting point CD4 counts in the range of 200-250 for counting CD4 in the range of 350. This change in the guidelines was due to increasing HIV drugs (less toxic, more convenient dosing, fewer drug interactions, less likely to develop resistance, etc.). Eventually, if and when we are very reliable and effective anti-HIV drugs, treatment guidelines may also recommend starting treatment as soon as someone diagnosed as in the case with the majority of infections. For example, if you have a case of bacterial pneumonia or syphilis, you have to start treatment as soon as you receive your diagnosis. Eventually it will be this way with HIV and.
Sustiva medication
Finally, in comparison with HIV-AIDS puzzle. This term was invented by AIDS before we have identified the causative agent of HIV. AIDS is acquired immunodeficiency syndrome. A "syndrome" is, by definition, a set of symptoms. Because HIV infection comprises a wide range of diseases, including opportunistic infections and malignancies, it was difficult to quantify the early days of the epidemic cases. Consequently, the CDC and other agencies have developed AIDS case definition, collecting the most common symptoms of severe, and abnormal conditions laboratory tests . example, in the laboratory abnormality have absolute CD4 Cola-200 or less cut for diagnosis of AIDS. In retrospect, it is not realistic sense as someone is sick or is going to get. course, someone with a CD4 cell 205 can be much illness, than someone with a CD4 cell 198, even though the former are not diagnosed with AIDS according to the case definition. Had we learned the causative agent of AIDS is HIV virus since the beginning of the epidemic, we would never have created AIDS case definition based on symptoms and opportunistic infections. The better classification will be HIV-positive or HIV-negative. As with many other diseases, there are a number of severity of HIV from asymptomatic to symptomatic degree. Thus, I am not very hung on HIV and AIDS . "To my mind," AIDS is just one case definition and not associated with the dire predictions of morbidity and mortality. Keep in mind that a person is diagnosed with AIDS, even if his or her CD4 count dips below 200 only transiently, and then recovered sharply medical intervention. many people with this type of clinical course could be far healthier than someone who has never below 200 near CD4 cells, but also has a significant HIV-associated diseases along the way. Lastly, I mention of the terminology. term "complete AIDS" makes no sense, because AIDS is identified specific parameters, and hence, there is no such thing as "partially blown AIDS." Like HIV, AIDS, or you need it or not .
HIV SUSTIVA
HIV SUSTIVA
Sustiva is anti-HIV therapy. It is in the category of HIV medicines, called non-nucleoside reverse transcriptase inhibitors (NNRTIs). Sustiva prevents HIV from entering healthy nucleus of T-cells. This prevents the cells from producing new virus, and reduces the virus in the body.
Sustiva was approved by the United States Food and medicines for the treatment of HIV in 1998. He was originally trained DuPont Pharmaceuticals, and is currently manufactured at Bristol-Myers Squibb for sale in the United States. In Europe and in many other parts of the world, Sustiva is a brand: Stocrin. Stocrin is manufactured by the company Merck Sharp and Dohme. Stocrin and Sustiva, the same drugs.
Sustiva should be used in combination with other drugs to treat HIV infection. This usually in combination with two nucleoside reverse transcriptase inhibitors (NRTIs).
Atripla, a combination pill containing Sustiva and NRTIs Viread (tenofovir), and Emtriva (emtricitabine), was approved for use in the United States in July 2006. Sustiva more can be purchased separately for use in combination with anti-HIV drugs, in addition to Viread, Emtriva, or Truvada (tenofovir and emtricitabine combined).
HIV SUSTIVA
What is known about Sustiva?
In Sustiva dose for adults is one 600mg tablet to take once a day.
Because Sustiva may cause sleepiness, dizziness, and the problem of concentration, it's probably better to take it at bedtime.
He recommended that Sustiva be taken on an empty stomach.
Children who are able to swallow the capsule can take Sustiva. Capsules containing smaller doses Sustiva there. Your child will determine the right dose of the doctor, depending on the child's age and body weight. To learn more about Sustiva dosage for children here. For children who can not swallow capsules, liquid formulation Sustiva is being developed by the manufacturer. Currently available through expanded access "program. If you care for a child requiring Sustiva, which could not swallow capsules, a health may enroll the child in an expanded access program by calling this number: (877) 372-7097.
For HIV-infected adults who start on HIV drug therapy for the first time, Sustiva is listed as "preferred" NNRTI option that the United States Department of Health and Human Services (DHHS), in its treatment guidelines. In NNRTI Viramune (nevirapine) is registered as an "alternative" version. To learn more about these recommendations and options, click here.
In DHHS recommends Sustiva will not be used during the first trimester (first three months) of pregnancy. HIV-positive women who are trying to get pregnant or not correctly and consistently using birth control during sex, should not use Sustiva.
If the viral load becomes detectable when taking the drug regime, which contains Sustiva, your doctor may order a drug-resistance test to see what your virus drugs become less sensitive j.
All evidence to date NNRTIs suffer from the cross-resistance. This means that if you have already tried, and is not a drug treatment in the past that contained either Viramune (nevirapine), or Rescriptor (delavirdine), a virus could be resistant to Sustiva. Similarly, if you are going to combat HIV drug treatment, which contains Sustiva and your virus becomes resistant to the drug, a virus is likely to be resistant to other NNRTIs. That is why it is very important that the use of drug resistance testing to determine which drugs your virus does not respond in the event that you experience in your rise in viral load when taking anti-HIV drug treatment. Fortunately, the new NNRTIs that are active against HIV strains resistant to current NNRTIs are currently being developed.
If you decide not to accept the drug regime, which contains Sustiva and not immediately switch to a different regime of drugs, careful planning is needed. It may take two to three weeks to Sustiva be completely eliminated from the body, while it only takes other anti-HIV drugs in a few days will be completely eliminated. If you stop taking the medication regime, which contains Sustiva, for instance, Sustiva and Combivir and not immediately switch to a different regime, it would be as Sustiva without taking any other medication, which can quickly lead to drug resistance. In turn, if you plan to stop drug treatment, which contains Sustiva, and they do not plan to immediately transition to the new regime, it is best to stop Sustiva first, a few days before to stop other anti-HIV drugs (for example, in the Combivir) . You have to plan it, to your health to stop your drug treatment.
Sustiva is anti-HIV therapy. It is in the category of HIV medicines, called non-nucleoside reverse transcriptase inhibitors (NNRTIs). Sustiva prevents HIV from entering healthy nucleus of T-cells. This prevents the cells from producing new virus, and reduces the virus in the body.
Sustiva was approved by the United States Food and medicines for the treatment of HIV in 1998. He was originally trained DuPont Pharmaceuticals, and is currently manufactured at Bristol-Myers Squibb for sale in the United States. In Europe and in many other parts of the world, Sustiva is a brand: Stocrin. Stocrin is manufactured by the company Merck Sharp and Dohme. Stocrin and Sustiva, the same drugs.
Sustiva should be used in combination with other drugs to treat HIV infection. This usually in combination with two nucleoside reverse transcriptase inhibitors (NRTIs).
Atripla, a combination pill containing Sustiva and NRTIs Viread (tenofovir), and Emtriva (emtricitabine), was approved for use in the United States in July 2006. Sustiva more can be purchased separately for use in combination with anti-HIV drugs, in addition to Viread, Emtriva, or Truvada (tenofovir and emtricitabine combined).
HIV SUSTIVA
What is known about Sustiva?
In Sustiva dose for adults is one 600mg tablet to take once a day.
Because Sustiva may cause sleepiness, dizziness, and the problem of concentration, it's probably better to take it at bedtime.
He recommended that Sustiva be taken on an empty stomach.
Children who are able to swallow the capsule can take Sustiva. Capsules containing smaller doses Sustiva there. Your child will determine the right dose of the doctor, depending on the child's age and body weight. To learn more about Sustiva dosage for children here. For children who can not swallow capsules, liquid formulation Sustiva is being developed by the manufacturer. Currently available through expanded access "program. If you care for a child requiring Sustiva, which could not swallow capsules, a health may enroll the child in an expanded access program by calling this number: (877) 372-7097.
For HIV-infected adults who start on HIV drug therapy for the first time, Sustiva is listed as "preferred" NNRTI option that the United States Department of Health and Human Services (DHHS), in its treatment guidelines. In NNRTI Viramune (nevirapine) is registered as an "alternative" version. To learn more about these recommendations and options, click here.
In DHHS recommends Sustiva will not be used during the first trimester (first three months) of pregnancy. HIV-positive women who are trying to get pregnant or not correctly and consistently using birth control during sex, should not use Sustiva.
If the viral load becomes detectable when taking the drug regime, which contains Sustiva, your doctor may order a drug-resistance test to see what your virus drugs become less sensitive j.
All evidence to date NNRTIs suffer from the cross-resistance. This means that if you have already tried, and is not a drug treatment in the past that contained either Viramune (nevirapine), or Rescriptor (delavirdine), a virus could be resistant to Sustiva. Similarly, if you are going to combat HIV drug treatment, which contains Sustiva and your virus becomes resistant to the drug, a virus is likely to be resistant to other NNRTIs. That is why it is very important that the use of drug resistance testing to determine which drugs your virus does not respond in the event that you experience in your rise in viral load when taking anti-HIV drug treatment. Fortunately, the new NNRTIs that are active against HIV strains resistant to current NNRTIs are currently being developed.
If you decide not to accept the drug regime, which contains Sustiva and not immediately switch to a different regime of drugs, careful planning is needed. It may take two to three weeks to Sustiva be completely eliminated from the body, while it only takes other anti-HIV drugs in a few days will be completely eliminated. If you stop taking the medication regime, which contains Sustiva, for instance, Sustiva and Combivir and not immediately switch to a different regime, it would be as Sustiva without taking any other medication, which can quickly lead to drug resistance. In turn, if you plan to stop drug treatment, which contains Sustiva, and they do not plan to immediately transition to the new regime, it is best to stop Sustiva first, a few days before to stop other anti-HIV drugs (for example, in the Combivir) . You have to plan it, to your health to stop your drug treatment.
Sustiva 600 mg
1. Name drug - SUSTIVA
SUSTIVA 600 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 600 mg of efavirenz.
Excipient: Every film-coated tablet contains 249.6 mg lactose monohydrate.
For a complete list of fillers, see section 6.1.
3. PHARMACEUTICALS FORM
The film-coated tablet
Dark yellow, capsule-shaped, printed with "SUSTIVA" on both sides.
4. CLINICAL PARTICULARS
SUSTIVA 600 mg
4.1 Therapeutic indications
SUSTIVA indicated in combination antiviral treatment for HIV-1-infected adults, adolescents and children 3 years and older.
SUSTIVA has not been adequately studied in patients with advanced HIV infection, namely in patients with CD4 counts <50 cells/mm3, and after the failure of protease inhibitor (PI) containing scheme. Although cross-resistance to efavirenz with PV was not documented, there are currently insufficient data on the effectiveness of the subsequent use of IP based combination therapy after failure of the scheme, containing SUSTIVA.
For more information about clinical and pharmacodynamic information, see section 5.1.
Posology 4.2 and the method of administration
Treatment should be initiated by a physician experienced in the management of HIV infection.
Along with antiretroviral therapy: SUSTIVA should be given in combination with other antiretroviral drugs (see section 4.5).
He recommended that SUSTIVA be taken on an empty stomach. Increasing concentrations of efavirenz observed after the introduction of SUSTIVA with food may lead to an increase in frequency of adverse events (see sections 4.4 and 5.2).
In order to increase the allowable nervous system undesirable consequences, bedtime dosing is recommended (see section 4.8).
Adults and adolescents over 40 kg: SUSTIVA recommended dose in combination with nucleoside analogue reverse transcriptase inhibitors (NRTIs), with or without PI (see section 4.5) is 600 mg orally once a day.
Efavirenz film-coated tablets are not suitable for children weighing less than 40 kg. Efavirenz hard capsules are available for these patients.
Dosage adjustment: if SUSTIVA was coadministered with voriconazole year voriconazole maintenance dose should be increased to 400 mg every 12 hours and SUSTIVA dose should be reduced by 50%, that is, to 300 mg once a day. When treatment with voriconazole stops, the initial dosage efavirenz should be restored (see section 4.5).
If SUSTIVA is coadministered with rifampicin, SUSTIVA dose should be increased to 800 mg / day (see section 4.5).
Renal failure: efavirenz pharmacokinetics have not been studied in patients with renal failure, but less than 1% of the efavirenz dose unchanged excretion in urine, so that the effects of deterioration of renal elimination of efavirenz should be kept to a minimum (see section 4,4).
Liver Disease: Patients with mild to moderate liver disease can be seen with their generally recommended dose of efavirenz. Patients should be carefully monitored for dose-related adverse events, particularly the nervous system, symptoms (see sections 4.3 and 4,4).
SUSTIVA 600 mg
4.3 Overdosage
Hypersensitivity to the active substance or to any of the excipients.
Efavirenz should not be used in patients with severe hepatic view (Child Pugh Class C) (see section 5.2).
Efavirenz should not be administered concurrently with terfenadine, astemizole, cisapride, midazolam, triazolam, pimozide, bepridil, or ergot alkaloids (such as ergotamine, dihydroergotamine, ergonovine and methylergonovine), as well as competition for CYP3A4 on efavirenz could result in inhibition of metabolism and create the potential for serious and / or life-threatening undesirable consequences [eg, cardiac arrhythmias, prolonged sedation or respiratory depression] (see section 4.5).
Herbal products containing St. John's wort (Hypericum perforatum), should not be used when taking efavirenz because of the risk of reducing the concentration of plasma and reducing clinical implications efavirenz (see section 4.5).
4.4 Special warnings and precautions for use
Efavirenz should not be used as a single agent for the treatment of HIV, or added as a single agent in the absence of treatment. As with all other non-nucleoside reverse transcriptase inhibitors (NNRTIs), resistant virus quickly arises when efavirenz is administered as monotherapy. Selection of new antiretroviral agent (s) to be used in combination with efavirenz should take into account the potential for viral cross-resistance (see section 5.1).
When prescription medications concurrently with SUSTIVA, physicians should refer to the appropriate Summary Characteristics products.
Patients should be informed that the current antiretroviral therapy, including efavirenz, has been proven to prevent the risk of HIV transmission through other sexual contact or blood contamination. Appropriate precautions should continue.
If any antiretroviral medicinal product in combination treatment interrupted because of the suspicion of intolerance, serious attention should be given to the simultaneous cessation of all anti-retroviral drugs. In antiretroviral drugs should be restarted at the same time to address intolerance symptoms. Intermittent monotherapy and the progressive restoration of antiretrovirals is not recommended because of the increasing capacity for the selection of resistant virus.
Rash: mild to moderate rash was reported in the clinical studies with efavirenz and normally permitted, in a continuous therapy. Relevant antihistamines, and / or corticosteroids may increase the allowable speed up the settlement and rash. Severe rash associated with blistering, moist desquamation or ulcers has been reported in fewer than 1% of patients with efavirenz. The incidence of erythema multiforme and Stevens-Johnson syndrome was about 0.1%. Efavirenz should be discontinued in patients developing severe rash associated with blistering, desquamation, mucosal involvement, or fever.
If therapy with efavirenz terminated, attention should be paid to interrupt therapy with other anti-retroviral drugs, to avoid the development of resistance to the effects of the virus (see section 4.8).
Rash was reported in 26 out of 57 children (46%) treated with efavirenz for 48 weeks and was severe in three patients. Prophylaxis with the antihistamines before the start of therapy with efavirenz in children can be considered.
Patients who discontinued treatment with the other NNRTIs because of the rash may be at a higher risk of rash in the treatment of efavirenz.
Psychiatric symptoms: psychiatric adverse experiences were reported in patients treated with efavirenz. Patients with a prior history of mental disorders, appear to be at greater risk of serious psychiatric adverse experiences. In particular, severe depression was greater in those with a history of depression. There were also post-marketing reports of severe depression, death from suicide, delusions and psychosis type of behaviour. Patients should be informed that if they are experiencing symptoms such as severe depression, psychosis or suicidal ideation, they should consult a doctor immediately assess the likelihood that symptoms may be associated with the use of efavirenz, and if so, to determine whether the risks outweigh the benefits of continuing therapy (see section 4.8).
Nervous system symptoms: Symptoms, including, but not limited to, dizziness, insomnia, drowsiness, and abnormal concentration violation dreaming frequently reported undesirable effects in patients receiving efavirenz 600 mg / day in the clinical studies (see section 4.8). Nervous system symptoms usually begin during the first one or two days of treatment, and generally resolve after the first 2 - 4 weeks. Patients should be informed that if they do occur, these common symptoms that can improve with continued therapy, and did not predict subsequent onset of any of the less frequent symptoms of mental disorders.
Confiscation: convulsions were rarely in patients receiving efavirenz, generally in the presence of known history of seizures. Patients who receive both anticonvulsant drugs primarily metabolized in the liver, such as phenytoin, carbamazepine and phenobarbital, may require periodic monitoring of plasma levels. In drug interaction studies, carbamazepine plasma concentrations decreased when carbamazepine was together with efavirenz (see section 4.5). Attention should be taken in any patient with a history of seizures.
Influence of food: the administration of SUSTIVA with food can increase the effects of efavirenz (see section 5.2), and may lead to an increase in the frequency of undesirable consequences. He recommended that SUSTIVA be taken on an empty stomach, preferably at bedtime.
Resumption of immune syndrome: in HIV-infected patients with severe immune deficiency at the time of the establishment of combination antiretroviral therapy (CART), an inflammatory reaction to the asymptomatic or residual opportunistic pathogens could arise and cause serious clinical conditions, or exacerbation of symptoms. Typically, these reactions have been observed in the first few weeks or months after the start of CART. Examples cytomegalovirus retinitis, generalized and / or focal mycobacterial infections, as well as Pneumocystis carinii pneumonia. Any inflammatory symptoms should be assessed and established treatment, if necessary.
SUSTIVA 600 mg
Lipodystrophy and metabolic abnormalities: combination antiretroviral therapy was associated with the redistribution of fat (lipodystrophy) in HIV patients. The long-term consequences of these events are currently unknown. Knowledge of the mechanism is incomplete. A connection between the visceral and lipomatosis PX and lipoatrophy and NRTIs was hypothesised. A higher risk was associated with lipodystrophy individual factors, such as old age, and drug-related factors such as longer duration of antiretroviral therapy and related metabolic disorders. Clinical analysis should include an assessment for physical signs of fat redistribution. Consideration should be given to the post of measuring serum lipids and glucose in the blood. Lipid disorders should be managed as clinically appropriate (see section 4.8).
Osteonecrosis: Though considered a multifactorial etiology (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis were reported particularly in patients with advanced HIV disease and / or long-term effect of combination antiretroviral therapy (CART ). Patients should be advised to seek medical advice if they are experiencing pain and joint pain, joint stiffness, or difficulty in movement.
Special population:
Liver disease: because of the extensive mediated by the cytochrome P450 metabolism of efavirenz and limited clinical experience in patients with chronic liver disease, caution must be exercised in administering efavirenz for patients with mild to moderate liver disease. Patients should be carefully monitored for dose-related adverse events, particularly the nervous system symptoms. Laboratory tests should be carried out to assess their liver disease on a periodic basis (see section 4.2).
Safety and efficacy has not been established efavirenz in patients with serious underlying liver disorders. Efavirenz is contraindicated in patients with severe hepatic of view (see section 4.3). In patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at increased risk of severe and potentially fatal liver adverse events. Patients with pre-existing liver dysfunction, including chronic active hepatitis are more frequent liver function abnormalities during combination antiretroviral therapy and should be monitored in accordance with normal practice. If there is evidence of worsening liver disease or persistent elevations of serum transaminases more than 5 times the upper limit of normal range, to continue therapy with efavirenz should be weighed against the potential risks of significant liver toxicity. In such patients, treatment interruption or termination should be considered (see section 4.8).
In patients with other medications associated with liver toxicity, monitoring of liver enzymes are also recommended. In the case of associated antiviral therapy against hepatitis B or C, please refer to the relevant information about the products of those drugs.
Renal failure: efavirenz pharmacokinetics have not been studied in patients with renal failure, but less than 1% of the efavirenz dose unchanged excretion in urine, so that the effects of deterioration of renal elimination of efavirenz should be kept to a minimum (see section 4,2). There is no experience in patients with severe renal failure and recommended close monitoring of security in this group.
Older people: the insufficient number of elderly patients who have been tested in clinical studies to determine whether they respond differently than younger patients.
Children: efavirenz have not been evaluated in children under 3 years old, or who weigh less than 13 kg. Therefore, efavirenz should not be given to children under 3 years old.
Lactose: This drug contains 250 mg lactose, in each-600 mg daily dose. This number is not likely to cause the symptoms of lactose intolerance.
Patients with rare hereditary problems galactose intolerance, Sami lactase deficiency or glucose-galactose malabsorption should not take this drug. Individuals with these conditions can take efavirenz oral solution, which is free of lactose.
4.5 Interactions with other drugs and other forms of interaction
Efavirenz is an inducer of CYP3A4 inhibitor and including some CYP isozymes CYP3A4 (see section 5.2). Other compounds, which are substrates of CYP3A4, possibly decreased plasma concentrations in joint jurisdiction with efavirenz. Efavirenz exposure can be changed when given the medicines and foods (for example, grapefruit juice), which affect CYP3A4 activity.
Efavirenz should not be administered concurrently with terfenadine, astemizole, cisapride, midazolam, triazolam, pimozide, bepridil, or ergot alkaloids (such as ergotamine, dihydroergotamine, ergonovine and methylergonovine), as the oppression of their metabolism may lead to a serious, life-threatening events (see . section 4.3).
Along antiretroviral drugs:
Protease inhibitors:
Amprenavir: while efavirenz was shown a reduction Cmax, AUC and Cmin in amprenavir about 40% in adults, when combined with ritonavir amprenavir, to offset the effect of efavirenz pharmacokinetics ritonavir booster effect. Therefore, if efavirenz is given in combination with amprenavir (600 mg twice daily) and ritonavir (100 or 200 mg twice daily), no dosage adjustment is necessary. For joint management efavirenz with low doses of ritonavir in combination with a protease inhibitor, see the section below on ritonavir.
SUSTIVA 600 mg
Moreover, if efavirenz is given in combination with amprenavir and nelfinavir, no dosage adjustment necessary for any of the drugs. Treatment with efavirenz in combination with saquinavir and amprenavir is not recommended because the impact of both PV is expected to be significantly reduced. No dosage recommendations can be made available for co-management with other IP amprenavir and efavirenz in children and patients with renal impairment. Such combinations should be avoided in patients with hepatic impairment.
SUSTIVA 600 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 600 mg of efavirenz.
Excipient: Every film-coated tablet contains 249.6 mg lactose monohydrate.
For a complete list of fillers, see section 6.1.
3. PHARMACEUTICALS FORM
The film-coated tablet
Dark yellow, capsule-shaped, printed with "SUSTIVA" on both sides.
4. CLINICAL PARTICULARS
SUSTIVA 600 mg
4.1 Therapeutic indications
SUSTIVA indicated in combination antiviral treatment for HIV-1-infected adults, adolescents and children 3 years and older.
SUSTIVA has not been adequately studied in patients with advanced HIV infection, namely in patients with CD4 counts <50 cells/mm3, and after the failure of protease inhibitor (PI) containing scheme. Although cross-resistance to efavirenz with PV was not documented, there are currently insufficient data on the effectiveness of the subsequent use of IP based combination therapy after failure of the scheme, containing SUSTIVA.
For more information about clinical and pharmacodynamic information, see section 5.1.
Posology 4.2 and the method of administration
Treatment should be initiated by a physician experienced in the management of HIV infection.
Along with antiretroviral therapy: SUSTIVA should be given in combination with other antiretroviral drugs (see section 4.5).
He recommended that SUSTIVA be taken on an empty stomach. Increasing concentrations of efavirenz observed after the introduction of SUSTIVA with food may lead to an increase in frequency of adverse events (see sections 4.4 and 5.2).
In order to increase the allowable nervous system undesirable consequences, bedtime dosing is recommended (see section 4.8).
Adults and adolescents over 40 kg: SUSTIVA recommended dose in combination with nucleoside analogue reverse transcriptase inhibitors (NRTIs), with or without PI (see section 4.5) is 600 mg orally once a day.
Efavirenz film-coated tablets are not suitable for children weighing less than 40 kg. Efavirenz hard capsules are available for these patients.
Dosage adjustment: if SUSTIVA was coadministered with voriconazole year voriconazole maintenance dose should be increased to 400 mg every 12 hours and SUSTIVA dose should be reduced by 50%, that is, to 300 mg once a day. When treatment with voriconazole stops, the initial dosage efavirenz should be restored (see section 4.5).
If SUSTIVA is coadministered with rifampicin, SUSTIVA dose should be increased to 800 mg / day (see section 4.5).
Renal failure: efavirenz pharmacokinetics have not been studied in patients with renal failure, but less than 1% of the efavirenz dose unchanged excretion in urine, so that the effects of deterioration of renal elimination of efavirenz should be kept to a minimum (see section 4,4).
Liver Disease: Patients with mild to moderate liver disease can be seen with their generally recommended dose of efavirenz. Patients should be carefully monitored for dose-related adverse events, particularly the nervous system, symptoms (see sections 4.3 and 4,4).
SUSTIVA 600 mg
4.3 Overdosage
Hypersensitivity to the active substance or to any of the excipients.
Efavirenz should not be used in patients with severe hepatic view (Child Pugh Class C) (see section 5.2).
Efavirenz should not be administered concurrently with terfenadine, astemizole, cisapride, midazolam, triazolam, pimozide, bepridil, or ergot alkaloids (such as ergotamine, dihydroergotamine, ergonovine and methylergonovine), as well as competition for CYP3A4 on efavirenz could result in inhibition of metabolism and create the potential for serious and / or life-threatening undesirable consequences [eg, cardiac arrhythmias, prolonged sedation or respiratory depression] (see section 4.5).
Herbal products containing St. John's wort (Hypericum perforatum), should not be used when taking efavirenz because of the risk of reducing the concentration of plasma and reducing clinical implications efavirenz (see section 4.5).
4.4 Special warnings and precautions for use
Efavirenz should not be used as a single agent for the treatment of HIV, or added as a single agent in the absence of treatment. As with all other non-nucleoside reverse transcriptase inhibitors (NNRTIs), resistant virus quickly arises when efavirenz is administered as monotherapy. Selection of new antiretroviral agent (s) to be used in combination with efavirenz should take into account the potential for viral cross-resistance (see section 5.1).
When prescription medications concurrently with SUSTIVA, physicians should refer to the appropriate Summary Characteristics products.
Patients should be informed that the current antiretroviral therapy, including efavirenz, has been proven to prevent the risk of HIV transmission through other sexual contact or blood contamination. Appropriate precautions should continue.
If any antiretroviral medicinal product in combination treatment interrupted because of the suspicion of intolerance, serious attention should be given to the simultaneous cessation of all anti-retroviral drugs. In antiretroviral drugs should be restarted at the same time to address intolerance symptoms. Intermittent monotherapy and the progressive restoration of antiretrovirals is not recommended because of the increasing capacity for the selection of resistant virus.
Rash: mild to moderate rash was reported in the clinical studies with efavirenz and normally permitted, in a continuous therapy. Relevant antihistamines, and / or corticosteroids may increase the allowable speed up the settlement and rash. Severe rash associated with blistering, moist desquamation or ulcers has been reported in fewer than 1% of patients with efavirenz. The incidence of erythema multiforme and Stevens-Johnson syndrome was about 0.1%. Efavirenz should be discontinued in patients developing severe rash associated with blistering, desquamation, mucosal involvement, or fever.
If therapy with efavirenz terminated, attention should be paid to interrupt therapy with other anti-retroviral drugs, to avoid the development of resistance to the effects of the virus (see section 4.8).
Rash was reported in 26 out of 57 children (46%) treated with efavirenz for 48 weeks and was severe in three patients. Prophylaxis with the antihistamines before the start of therapy with efavirenz in children can be considered.
Patients who discontinued treatment with the other NNRTIs because of the rash may be at a higher risk of rash in the treatment of efavirenz.
Psychiatric symptoms: psychiatric adverse experiences were reported in patients treated with efavirenz. Patients with a prior history of mental disorders, appear to be at greater risk of serious psychiatric adverse experiences. In particular, severe depression was greater in those with a history of depression. There were also post-marketing reports of severe depression, death from suicide, delusions and psychosis type of behaviour. Patients should be informed that if they are experiencing symptoms such as severe depression, psychosis or suicidal ideation, they should consult a doctor immediately assess the likelihood that symptoms may be associated with the use of efavirenz, and if so, to determine whether the risks outweigh the benefits of continuing therapy (see section 4.8).
Nervous system symptoms: Symptoms, including, but not limited to, dizziness, insomnia, drowsiness, and abnormal concentration violation dreaming frequently reported undesirable effects in patients receiving efavirenz 600 mg / day in the clinical studies (see section 4.8). Nervous system symptoms usually begin during the first one or two days of treatment, and generally resolve after the first 2 - 4 weeks. Patients should be informed that if they do occur, these common symptoms that can improve with continued therapy, and did not predict subsequent onset of any of the less frequent symptoms of mental disorders.
Confiscation: convulsions were rarely in patients receiving efavirenz, generally in the presence of known history of seizures. Patients who receive both anticonvulsant drugs primarily metabolized in the liver, such as phenytoin, carbamazepine and phenobarbital, may require periodic monitoring of plasma levels. In drug interaction studies, carbamazepine plasma concentrations decreased when carbamazepine was together with efavirenz (see section 4.5). Attention should be taken in any patient with a history of seizures.
Influence of food: the administration of SUSTIVA with food can increase the effects of efavirenz (see section 5.2), and may lead to an increase in the frequency of undesirable consequences. He recommended that SUSTIVA be taken on an empty stomach, preferably at bedtime.
Resumption of immune syndrome: in HIV-infected patients with severe immune deficiency at the time of the establishment of combination antiretroviral therapy (CART), an inflammatory reaction to the asymptomatic or residual opportunistic pathogens could arise and cause serious clinical conditions, or exacerbation of symptoms. Typically, these reactions have been observed in the first few weeks or months after the start of CART. Examples cytomegalovirus retinitis, generalized and / or focal mycobacterial infections, as well as Pneumocystis carinii pneumonia. Any inflammatory symptoms should be assessed and established treatment, if necessary.
SUSTIVA 600 mg
Lipodystrophy and metabolic abnormalities: combination antiretroviral therapy was associated with the redistribution of fat (lipodystrophy) in HIV patients. The long-term consequences of these events are currently unknown. Knowledge of the mechanism is incomplete. A connection between the visceral and lipomatosis PX and lipoatrophy and NRTIs was hypothesised. A higher risk was associated with lipodystrophy individual factors, such as old age, and drug-related factors such as longer duration of antiretroviral therapy and related metabolic disorders. Clinical analysis should include an assessment for physical signs of fat redistribution. Consideration should be given to the post of measuring serum lipids and glucose in the blood. Lipid disorders should be managed as clinically appropriate (see section 4.8).
Osteonecrosis: Though considered a multifactorial etiology (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis were reported particularly in patients with advanced HIV disease and / or long-term effect of combination antiretroviral therapy (CART ). Patients should be advised to seek medical advice if they are experiencing pain and joint pain, joint stiffness, or difficulty in movement.
Special population:
Liver disease: because of the extensive mediated by the cytochrome P450 metabolism of efavirenz and limited clinical experience in patients with chronic liver disease, caution must be exercised in administering efavirenz for patients with mild to moderate liver disease. Patients should be carefully monitored for dose-related adverse events, particularly the nervous system symptoms. Laboratory tests should be carried out to assess their liver disease on a periodic basis (see section 4.2).
Safety and efficacy has not been established efavirenz in patients with serious underlying liver disorders. Efavirenz is contraindicated in patients with severe hepatic of view (see section 4.3). In patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at increased risk of severe and potentially fatal liver adverse events. Patients with pre-existing liver dysfunction, including chronic active hepatitis are more frequent liver function abnormalities during combination antiretroviral therapy and should be monitored in accordance with normal practice. If there is evidence of worsening liver disease or persistent elevations of serum transaminases more than 5 times the upper limit of normal range, to continue therapy with efavirenz should be weighed against the potential risks of significant liver toxicity. In such patients, treatment interruption or termination should be considered (see section 4.8).
In patients with other medications associated with liver toxicity, monitoring of liver enzymes are also recommended. In the case of associated antiviral therapy against hepatitis B or C, please refer to the relevant information about the products of those drugs.
Renal failure: efavirenz pharmacokinetics have not been studied in patients with renal failure, but less than 1% of the efavirenz dose unchanged excretion in urine, so that the effects of deterioration of renal elimination of efavirenz should be kept to a minimum (see section 4,2). There is no experience in patients with severe renal failure and recommended close monitoring of security in this group.
Older people: the insufficient number of elderly patients who have been tested in clinical studies to determine whether they respond differently than younger patients.
Children: efavirenz have not been evaluated in children under 3 years old, or who weigh less than 13 kg. Therefore, efavirenz should not be given to children under 3 years old.
Lactose: This drug contains 250 mg lactose, in each-600 mg daily dose. This number is not likely to cause the symptoms of lactose intolerance.
Patients with rare hereditary problems galactose intolerance, Sami lactase deficiency or glucose-galactose malabsorption should not take this drug. Individuals with these conditions can take efavirenz oral solution, which is free of lactose.
4.5 Interactions with other drugs and other forms of interaction
Efavirenz is an inducer of CYP3A4 inhibitor and including some CYP isozymes CYP3A4 (see section 5.2). Other compounds, which are substrates of CYP3A4, possibly decreased plasma concentrations in joint jurisdiction with efavirenz. Efavirenz exposure can be changed when given the medicines and foods (for example, grapefruit juice), which affect CYP3A4 activity.
Efavirenz should not be administered concurrently with terfenadine, astemizole, cisapride, midazolam, triazolam, pimozide, bepridil, or ergot alkaloids (such as ergotamine, dihydroergotamine, ergonovine and methylergonovine), as the oppression of their metabolism may lead to a serious, life-threatening events (see . section 4.3).
Along antiretroviral drugs:
Protease inhibitors:
Amprenavir: while efavirenz was shown a reduction Cmax, AUC and Cmin in amprenavir about 40% in adults, when combined with ritonavir amprenavir, to offset the effect of efavirenz pharmacokinetics ritonavir booster effect. Therefore, if efavirenz is given in combination with amprenavir (600 mg twice daily) and ritonavir (100 or 200 mg twice daily), no dosage adjustment is necessary. For joint management efavirenz with low doses of ritonavir in combination with a protease inhibitor, see the section below on ritonavir.
SUSTIVA 600 mg
Moreover, if efavirenz is given in combination with amprenavir and nelfinavir, no dosage adjustment necessary for any of the drugs. Treatment with efavirenz in combination with saquinavir and amprenavir is not recommended because the impact of both PV is expected to be significantly reduced. No dosage recommendations can be made available for co-management with other IP amprenavir and efavirenz in children and patients with renal impairment. Such combinations should be avoided in patients with hepatic impairment.
Sustiva package insert
SUSTIVA ® Sustiva package insert
(efavirenz) capsules and tablets
Admission only
DESCRIPTION
SUSTIVA (efavirenz) is an HIV-1 specific non nucleoside, reverse transcriptase inhibitor (NNRTI).
Capsules: SUSTIVA in the form of capsules for oral administration containing either 50 mg, 100 mg, or
efavirenz 200 mg, and the following inactive ingredients: lactose monohydrate, magnesium stearate,
sodium lauryl sulfate and sodium starch glycolate. In capsule shell contains the following inactive
ingredients and dyes: gelatin, sodium lauryl sulfate, titanium dioxide and / or iron oxide yellow. V capsule
shells may also contains silicon dioxide. In capsules are printed with ink containing carmine 40 blue,
sustiva package insert
FD and C Blue № 2, and titanium dioxide.
Tablets: SUSTIVA is available as film-coated tablets for oral administration containing 600 mg
efavirenz, and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose
monohydrate, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. The film coatings
contains Opadry
®
Yellow and Opadry
®
Clear. In pill polished with carnauba wax, and printed
purple ink, Opacode
®
WB.
sustiva package insert
Important updates to the package Sustiva Insert
31 2007 year
In Sustiva (efavirenz) insert package has been updated to include drug-drug interaction information on the coadministration of efavirenz with rifampin, diltiazem, itraconazole, voriconazole, atorvastatin, pravastatin, simvastatin, pimozide and bepridil.
In clinical pharmacology section (Tables 1 and 2) have been revised to include the results of drug interaction studies with the drug diltiazem, itraconazole, voriconazole, atorvastatin, pravastatin, and simvastatin.
In CONTRAINIDCATION section has been reviewed in a position Sustiva should not be administered concurrently with bepridil, pimozide and standard doses of voriconazole.
In PRECAUTION: Drug Interaction section (Tablets 5 and 6) has been updated with information about the coadministration of efavirenz with rifampin, diltiazem (and other calcium channel blockers), itraconazole, ketoconazole, voriconazole, pimozide and bepridil.
sustiva package insert
In Dosing and Administration section is updated to include dosing information for the joint management and efavirenz voriconazole. In particular, if Sustiva was coadministered with voriconazole year voriconazole maintenance dose should be increased to 400 mg every 12 hours and SUSTIVA dose should be reduced to 300 mg once a day, using a capsule formulation (three 100 mg or 200 mg capsule and one 100 mg capsules). SUSTIVA tablets should not be disturbed.
Please refer to the attached pdf file for a detailed report on changes in the revised package insert.
sustiva package insert
(efavirenz) capsules and tablets
Admission only
DESCRIPTION
SUSTIVA (efavirenz) is an HIV-1 specific non nucleoside, reverse transcriptase inhibitor (NNRTI).
Capsules: SUSTIVA in the form of capsules for oral administration containing either 50 mg, 100 mg, or
efavirenz 200 mg, and the following inactive ingredients: lactose monohydrate, magnesium stearate,
sodium lauryl sulfate and sodium starch glycolate. In capsule shell contains the following inactive
ingredients and dyes: gelatin, sodium lauryl sulfate, titanium dioxide and / or iron oxide yellow. V capsule
shells may also contains silicon dioxide. In capsules are printed with ink containing carmine 40 blue,
sustiva package insert
FD and C Blue № 2, and titanium dioxide.
Tablets: SUSTIVA is available as film-coated tablets for oral administration containing 600 mg
efavirenz, and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose
monohydrate, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. The film coatings
contains Opadry
®
Yellow and Opadry
®
Clear. In pill polished with carnauba wax, and printed
purple ink, Opacode
®
WB.
sustiva package insert
Important updates to the package Sustiva Insert
31 2007 year
In Sustiva (efavirenz) insert package has been updated to include drug-drug interaction information on the coadministration of efavirenz with rifampin, diltiazem, itraconazole, voriconazole, atorvastatin, pravastatin, simvastatin, pimozide and bepridil.
In clinical pharmacology section (Tables 1 and 2) have been revised to include the results of drug interaction studies with the drug diltiazem, itraconazole, voriconazole, atorvastatin, pravastatin, and simvastatin.
In CONTRAINIDCATION section has been reviewed in a position Sustiva should not be administered concurrently with bepridil, pimozide and standard doses of voriconazole.
In PRECAUTION: Drug Interaction section (Tablets 5 and 6) has been updated with information about the coadministration of efavirenz with rifampin, diltiazem (and other calcium channel blockers), itraconazole, ketoconazole, voriconazole, pimozide and bepridil.
sustiva package insert
In Dosing and Administration section is updated to include dosing information for the joint management and efavirenz voriconazole. In particular, if Sustiva was coadministered with voriconazole year voriconazole maintenance dose should be increased to 400 mg every 12 hours and SUSTIVA dose should be reduced to 300 mg once a day, using a capsule formulation (three 100 mg or 200 mg capsule and one 100 mg capsules). SUSTIVA tablets should not be disturbed.
Please refer to the attached pdf file for a detailed report on changes in the revised package insert.
sustiva package insert
Sustiva drug
Drugs for you: Sustiva
Sustiva drug
Liz Highleyman
January 2004 (2005)
What are the different names for this drug?
Sustiva, Stocrin (outside the United States) - brands
efavirenz - the generic name
What kind of drug Sustiva?
Sustiva belongs to a class of HIV drugs called non-nucleoside reverse transcriptase inhibitors (NNRTIs), also known as non-nucleoside analogues, or "no-nukes".
As Sustiva work?
In NNRTIs block reverse transcriptase, the HIV protein that it is necessary to make more copies. This may slow down HIV infection.
Who Sustiva approved for?
In Food and Drug (FDA) has approved Sustiva for use in combination with other HIV drugs for the treatment of HIV infection in adults and children over three years.
Sustiva drug
In FDA also granted preliminary approval of the overall formulation of Sustiva, although this version is not yet available in the United States
How to take Sustiva?
Sustiva comes in:
50 milligram (mg), 100 mg, 200 mg capsules
600 mg Tablets
The liquid formulation is currently being studied in children under three years of age, and through increased access to the program from the manufacturer
The normal dose for adults is one 600 mg tablet once a day.
Check with the child doctor dosage for children.
Sustiva is to be used with other drugs to treat HIV infection.
You can take Sustiva with food or on an empty stomach, but to take it on an empty stomach at bedtime reduces side effects. Sustiva should not be taken with a big fat meal because it increases the likelihood of side effects.
Talk with your doctor if you have liver problems or mental health issues (such as depression), or using street drugs or alcohol.
It may take two to three weeks to Sustiva be excluded from your body after you stop taking it. Careful planning must be a doctor if you stop taking the medication regime, which contains Sustiva, especially if you do not immediately switch to another drug treatment.
Why is it so important to take Sustiva exactly as prescribed?
Sustiva is one of the easiest drugs for HIV to take you to take one pill once a day. Once-daily medications handy, but more demanding because good adherence is crucial. The lack of a pass or doses can cause your blood drug levels fall too low, and resistance can develop. When a virus becomes resistant to HIV drugs, drugs that may stop working.
As Sustiva used?
Sustiva can be used if you are just starting treatment of HIV infection.
Studies have shown that Sustiva can be as effective or more effective than a protease inhibitor (PI) regimes in people treated for the first time (including those with high viral load).
Sustiva is an option to consider if you want "protease-sparing" drug regime (a regime that does not include PI).
Sustiva can be used if you were treated before, but it does not work well for people whose virus is already resistant to other NNRTIs: Rescriptor (delavirdine) and Viramune (nevirapine).
Your doctor may run resistance tests to help determine whether Sustiva is likely to work for you.
Sustiva seems to overcome the blood-brain barrier (which protects the brain and spinal cord), so that he may be able to fight HIV in the brain.
What happens if my virus develops resistance to Sustiva?
If the virus develops resistance to Sustiva he may stop working or not working, but for you. You can also benefit from other NNRTIs.
Sustiva whether interact with other drugs?
Sometimes taking more than one medication may cause drug interactions. Taking certain drugs (such as cholesterol-lowering drugs), with Sustiva may change the amount of one or both drugs in the blood. Your doctor may need to adjust the dose of your medicine, to avoid under-or overdosing.
Sustiva blood lowers the level of most PV. Your doctor will be necessary to increase the dosage of Crixivan (indinavir), Agenerase (amprenavir), Reyataz (atazanavir), Kaletra (lopinavir / ritonavir) and Lexiva (fosamprenavir)
Sustiva and Fortovase (saquinavir), or Invirase (saquinavir), should not be used together
Methadone doses may need to be increased if you are taking Sustiva
Sustiva drug
Sustiva reduces the effectiveness of birth control pills, so that alternative methods of birth control should be used.
Some medicines, including some sedatives, antihistamines, antibiotics, antifungals, migraine headache pain, acid reflux, and TB drugs should not be taken with Sustiva. In addition, you should not take St. John's wort, an herbal information on the supplement.
Sustiva plus EU Videx (didanosine or ddI), as well as Viread (tenofovir), should not be used in new patients with HIV therapy.
Be sure your doctor knows about all the medications you are taking (including information, prescription, street drugs and herbs), even if you only use them from time to time.
For more information and additional resources to check the interaction between specific drugs you are taking, see our information sheet on drug interactions.
Sustiva told the FDA label change
In Sustiva (efavirenz) insert package has been recently updated the Federal Drug (FDA), drug-drug interactions include information declare Sustiva should not be administered concurrently with bepridil (which is a calcium channel blocker), pimozide (which for some exemptions, and mood disorders) and standard doses of voriconazole (which is a very popular anti-fungal treatment). In FDA stresses that SUSTIVA tablets should not be disturbed.
What are the side effects?
Sustiva side effects tend to occur during the first two to four weeks of treatment, and generally improve as your body adjusts to the medication. In some cases, side effects can last longer than the first month.
Sustiva drug
Many of the side effects associated with Sustiva affects the central nervous system (CNS):
Dizziness
Insomnia (sleep problems)
Drowsiness
The problem of concentration
Vivid dreams
Changes in mood
Depression
Other side effects include:
Skin rash (rash may be a serious problem in some children)
Headaches
Nausea
Diarrhea
Fatigue (unusual fatigue)
Many people believe that they can cope with the side effects better if they are taking Sustiva at bedtime. Your doctor can help you manage the side effects of Sustiva by prescription drugs for the treatment of insomnia and anxiety. If the side effects will not disappear or become unbearable, call your doctor for advice. Do not simply stop taking the medicine.
More serious side effects:
Although rare, some people have clinical depression, paranoia and suicidal thoughts
Sustiva may cause less rash NNRTI than other drugs, but in rare cases, this has led to a life-threatening hypersensitivity reaction (Stevens-Johnson syndrome). Symptoms may include severe rashes, blisters, mouth ulcers, tumors, high fever and weakness
Liver toxicity: this may be indicated by elevated liver enzymes, or yellowing of the skin and eyes (jaundice)
Call your doctor immediately if you experience any of the more serious side effects.
What specific research has been done on women and Sustiva?
Sustiva has been examined in many women. Study pharmacokinetics Sustiva (as a drug-processing body), showed that the drug behaves in the same way women and men, but some studies show that Sustiva can reach higher levels in women. The drug manufacturer does not recommend any adjustments based on the doses of sex and weight.
Study DMP266-006 compared Retrovir (zidovudine, or AZT), and Epivir (lamivudine or 3TC), and Sustiva for Retrovir plus Epivir Crixivan plus Sustiva plus Crixivan to people who have not taken protease inhibitors, or NNRTIs before. The study included 17 per cent women, or about 215 women from the 1266 total participants.
After 48 weeks, more people taking Retrovir plus Epivir plus Sustiva was undetectable viral load than those who either Retrovir Epivir plus plus plus Sustiva Crixivan or Crixivan. More people in treatment Crixivan groups stopped because of side effects (although more people in the Sustiva group developed rashes or nervous system side effects). At 72 weeks, plus Retrovir Epivir plus Sustiva have worked better, but for three years, the rate of treatment failure in the Sustiva and Crixivan groups were similar.
The study ACTG 364, compared with Sustiva Viracept (nelfinavir) for Sustiva Viracept, as well as treatment and experienced people who are also nucleoside reverse transcriptase inhibitors (NRTIs). This trial included 12 per cent women, or about 23 women from a total of 196 participants. In this study, people taking Viracept plus Sustiva plus NRTIs or Sustiva plus NRTIs are more likely to achieve undetectable viral load than those taking Viracept plus NRTIs.
DMP-020 Study found that Sustiva plus Crixivan plus NRTIs worked better than Crixivan plus NRTIs without Sustiva. This process included about 17 per cent women, or 55 women from a total of 327 participants.
Study AI424-034 compared Retrovir plus Epivir plus Sustiva to Retrovir plus Epivir plus Reyataz in people who do not use HIV medicines before. The study included 35 per cent of women, or about 280 women from a total of 805 participants. The study Sustiva and Reyataz works equally well for HIV, but not Reyataz increased blood fat levels possible Sustiva.
ACTG 384, a large study comparing six different combinations of drugs, it was found that Retrovir plus Epivir plus Sustiva was the first one of the best schemes in terms of effectiveness and side effects.
In the 2NN study compared Zerit (stavudine, or d4T), as well as Epivir plus Sustiva compared Zerit plus Epivir plus Viramune to Zerit Epivir plus plus plus Sustiva Viramune people who had not taken HIV drugs before. This trial included 37 per cent of women, or about 449 women from the 1216 total participants.
The study, Sustiva and Viramune worked about equally well in general but Sustiva how to work better in people with high viral loads. People who occupy and Sustiva Viramune did worse than those who had only one NNRTI, as a treatment stopped because of side effects.
The study ACTG 5095 found that the drug circuits containing Sustiva worked better than all-NRTI plus Retrovir combination of Epivir plus Ziagen (abacavir), the three drugs in combination pill Trizivir. The study included 19 per cent, or about 218 women from the 1147 total participants.
A number of studies looked at people who move from PV to NNRTIs (for example, a study DMP266-049, including 10 per cent women, or about 22 women from a total of 226 participants). In general, these studies have shown that people who move from PI to Sustiva have similar or better response to treatment, as well as raising HDL ( "good") cholesterol, lower levels of LDL ( "bad") cholesterol and lower levels of triglycerides, that can protect against heart disease.
In terms of side effects, studies show that Sustiva can cause a skin rash or nervous system side effects. The study DMP266-006 (described above), 34 percent of participants taking Sustiva developed a rash, and 58 percent developed nervous system side effects. These side effects were most likely during the first month of treatment. Research does not seem to indicate that women taking Sustiva experience any more side effects than men. But we know that in general mood, depression and disorders more often in women and require further research on the nervous system side effects in women with this therapy.
What about pregnancy?
Studies have shown that pregnant women who use HIV drugs can significantly reduce the risk of transmission of HIV to their babies. There was no formal studies on the use of Sustiva during pregnancy. However, Sustiva has recently been linked to birth defects in humans resulting in FDA recommend Sustiva not be used during pregnancy. Because of this, pregnant women should not use Sustiva, and women who take the drug should use effective birth control. (Sustiva reduces the effectiveness of birth control pills, so that alternative methods of birth control should be used.)
Check with a doctor about the best treatment options for you and your child, if you are thinking to get pregnant.
Click here to learn more about pregnancy.
Are there any special considerations?
Testing for drugs
Sustiva could lead to a false positive result, if you get a drug test for marijuana.
Immune conversion syndrome
People who are beginning to treat HIV infection for the first time might be immunodeficiency syndrome or Restore IRS (also called Immune Restoration Inflammatory Syndrome, or IRIS). IRS may occur as a result of obtaining the immune system stronger, and in response to the HIV-related such as Mycobacterium avium infection (MAC), cytomegalovirus (CMV), Pneumocystis jirovecii pneumonia (PCP), and tuberculosis (TB). People may treat these infections in the past or do not even know they have them. If you notice any unusual symptoms shortly after the start of HIV drugs for the first time, let your doctor know immediately, so you can be evaluated and, if necessary, treatment.
Sustiva drug
Liz Highleyman
January 2004 (2005)
What are the different names for this drug?
Sustiva, Stocrin (outside the United States) - brands
efavirenz - the generic name
What kind of drug Sustiva?
Sustiva belongs to a class of HIV drugs called non-nucleoside reverse transcriptase inhibitors (NNRTIs), also known as non-nucleoside analogues, or "no-nukes".
As Sustiva work?
In NNRTIs block reverse transcriptase, the HIV protein that it is necessary to make more copies. This may slow down HIV infection.
Who Sustiva approved for?
In Food and Drug (FDA) has approved Sustiva for use in combination with other HIV drugs for the treatment of HIV infection in adults and children over three years.
Sustiva drug
In FDA also granted preliminary approval of the overall formulation of Sustiva, although this version is not yet available in the United States
How to take Sustiva?
Sustiva comes in:
50 milligram (mg), 100 mg, 200 mg capsules
600 mg Tablets
The liquid formulation is currently being studied in children under three years of age, and through increased access to the program from the manufacturer
The normal dose for adults is one 600 mg tablet once a day.
Check with the child doctor dosage for children.
Sustiva is to be used with other drugs to treat HIV infection.
You can take Sustiva with food or on an empty stomach, but to take it on an empty stomach at bedtime reduces side effects. Sustiva should not be taken with a big fat meal because it increases the likelihood of side effects.
Talk with your doctor if you have liver problems or mental health issues (such as depression), or using street drugs or alcohol.
It may take two to three weeks to Sustiva be excluded from your body after you stop taking it. Careful planning must be a doctor if you stop taking the medication regime, which contains Sustiva, especially if you do not immediately switch to another drug treatment.
Why is it so important to take Sustiva exactly as prescribed?
Sustiva is one of the easiest drugs for HIV to take you to take one pill once a day. Once-daily medications handy, but more demanding because good adherence is crucial. The lack of a pass or doses can cause your blood drug levels fall too low, and resistance can develop. When a virus becomes resistant to HIV drugs, drugs that may stop working.
As Sustiva used?
Sustiva can be used if you are just starting treatment of HIV infection.
Studies have shown that Sustiva can be as effective or more effective than a protease inhibitor (PI) regimes in people treated for the first time (including those with high viral load).
Sustiva is an option to consider if you want "protease-sparing" drug regime (a regime that does not include PI).
Sustiva can be used if you were treated before, but it does not work well for people whose virus is already resistant to other NNRTIs: Rescriptor (delavirdine) and Viramune (nevirapine).
Your doctor may run resistance tests to help determine whether Sustiva is likely to work for you.
Sustiva seems to overcome the blood-brain barrier (which protects the brain and spinal cord), so that he may be able to fight HIV in the brain.
What happens if my virus develops resistance to Sustiva?
If the virus develops resistance to Sustiva he may stop working or not working, but for you. You can also benefit from other NNRTIs.
Sustiva whether interact with other drugs?
Sometimes taking more than one medication may cause drug interactions. Taking certain drugs (such as cholesterol-lowering drugs), with Sustiva may change the amount of one or both drugs in the blood. Your doctor may need to adjust the dose of your medicine, to avoid under-or overdosing.
Sustiva blood lowers the level of most PV. Your doctor will be necessary to increase the dosage of Crixivan (indinavir), Agenerase (amprenavir), Reyataz (atazanavir), Kaletra (lopinavir / ritonavir) and Lexiva (fosamprenavir)
Sustiva and Fortovase (saquinavir), or Invirase (saquinavir), should not be used together
Methadone doses may need to be increased if you are taking Sustiva
Sustiva drug
Sustiva reduces the effectiveness of birth control pills, so that alternative methods of birth control should be used.
Some medicines, including some sedatives, antihistamines, antibiotics, antifungals, migraine headache pain, acid reflux, and TB drugs should not be taken with Sustiva. In addition, you should not take St. John's wort, an herbal information on the supplement.
Sustiva plus EU Videx (didanosine or ddI), as well as Viread (tenofovir), should not be used in new patients with HIV therapy.
Be sure your doctor knows about all the medications you are taking (including information, prescription, street drugs and herbs), even if you only use them from time to time.
For more information and additional resources to check the interaction between specific drugs you are taking, see our information sheet on drug interactions.
Sustiva told the FDA label change
In Sustiva (efavirenz) insert package has been recently updated the Federal Drug (FDA), drug-drug interactions include information declare Sustiva should not be administered concurrently with bepridil (which is a calcium channel blocker), pimozide (which for some exemptions, and mood disorders) and standard doses of voriconazole (which is a very popular anti-fungal treatment). In FDA stresses that SUSTIVA tablets should not be disturbed.
What are the side effects?
Sustiva side effects tend to occur during the first two to four weeks of treatment, and generally improve as your body adjusts to the medication. In some cases, side effects can last longer than the first month.
Sustiva drug
Many of the side effects associated with Sustiva affects the central nervous system (CNS):
Dizziness
Insomnia (sleep problems)
Drowsiness
The problem of concentration
Vivid dreams
Changes in mood
Depression
Other side effects include:
Skin rash (rash may be a serious problem in some children)
Headaches
Nausea
Diarrhea
Fatigue (unusual fatigue)
Many people believe that they can cope with the side effects better if they are taking Sustiva at bedtime. Your doctor can help you manage the side effects of Sustiva by prescription drugs for the treatment of insomnia and anxiety. If the side effects will not disappear or become unbearable, call your doctor for advice. Do not simply stop taking the medicine.
More serious side effects:
Although rare, some people have clinical depression, paranoia and suicidal thoughts
Sustiva may cause less rash NNRTI than other drugs, but in rare cases, this has led to a life-threatening hypersensitivity reaction (Stevens-Johnson syndrome). Symptoms may include severe rashes, blisters, mouth ulcers, tumors, high fever and weakness
Liver toxicity: this may be indicated by elevated liver enzymes, or yellowing of the skin and eyes (jaundice)
Call your doctor immediately if you experience any of the more serious side effects.
What specific research has been done on women and Sustiva?
Sustiva has been examined in many women. Study pharmacokinetics Sustiva (as a drug-processing body), showed that the drug behaves in the same way women and men, but some studies show that Sustiva can reach higher levels in women. The drug manufacturer does not recommend any adjustments based on the doses of sex and weight.
Study DMP266-006 compared Retrovir (zidovudine, or AZT), and Epivir (lamivudine or 3TC), and Sustiva for Retrovir plus Epivir Crixivan plus Sustiva plus Crixivan to people who have not taken protease inhibitors, or NNRTIs before. The study included 17 per cent women, or about 215 women from the 1266 total participants.
After 48 weeks, more people taking Retrovir plus Epivir plus Sustiva was undetectable viral load than those who either Retrovir Epivir plus plus plus Sustiva Crixivan or Crixivan. More people in treatment Crixivan groups stopped because of side effects (although more people in the Sustiva group developed rashes or nervous system side effects). At 72 weeks, plus Retrovir Epivir plus Sustiva have worked better, but for three years, the rate of treatment failure in the Sustiva and Crixivan groups were similar.
The study ACTG 364, compared with Sustiva Viracept (nelfinavir) for Sustiva Viracept, as well as treatment and experienced people who are also nucleoside reverse transcriptase inhibitors (NRTIs). This trial included 12 per cent women, or about 23 women from a total of 196 participants. In this study, people taking Viracept plus Sustiva plus NRTIs or Sustiva plus NRTIs are more likely to achieve undetectable viral load than those taking Viracept plus NRTIs.
DMP-020 Study found that Sustiva plus Crixivan plus NRTIs worked better than Crixivan plus NRTIs without Sustiva. This process included about 17 per cent women, or 55 women from a total of 327 participants.
Study AI424-034 compared Retrovir plus Epivir plus Sustiva to Retrovir plus Epivir plus Reyataz in people who do not use HIV medicines before. The study included 35 per cent of women, or about 280 women from a total of 805 participants. The study Sustiva and Reyataz works equally well for HIV, but not Reyataz increased blood fat levels possible Sustiva.
ACTG 384, a large study comparing six different combinations of drugs, it was found that Retrovir plus Epivir plus Sustiva was the first one of the best schemes in terms of effectiveness and side effects.
In the 2NN study compared Zerit (stavudine, or d4T), as well as Epivir plus Sustiva compared Zerit plus Epivir plus Viramune to Zerit Epivir plus plus plus Sustiva Viramune people who had not taken HIV drugs before. This trial included 37 per cent of women, or about 449 women from the 1216 total participants.
The study, Sustiva and Viramune worked about equally well in general but Sustiva how to work better in people with high viral loads. People who occupy and Sustiva Viramune did worse than those who had only one NNRTI, as a treatment stopped because of side effects.
The study ACTG 5095 found that the drug circuits containing Sustiva worked better than all-NRTI plus Retrovir combination of Epivir plus Ziagen (abacavir), the three drugs in combination pill Trizivir. The study included 19 per cent, or about 218 women from the 1147 total participants.
A number of studies looked at people who move from PV to NNRTIs (for example, a study DMP266-049, including 10 per cent women, or about 22 women from a total of 226 participants). In general, these studies have shown that people who move from PI to Sustiva have similar or better response to treatment, as well as raising HDL ( "good") cholesterol, lower levels of LDL ( "bad") cholesterol and lower levels of triglycerides, that can protect against heart disease.
In terms of side effects, studies show that Sustiva can cause a skin rash or nervous system side effects. The study DMP266-006 (described above), 34 percent of participants taking Sustiva developed a rash, and 58 percent developed nervous system side effects. These side effects were most likely during the first month of treatment. Research does not seem to indicate that women taking Sustiva experience any more side effects than men. But we know that in general mood, depression and disorders more often in women and require further research on the nervous system side effects in women with this therapy.
What about pregnancy?
Studies have shown that pregnant women who use HIV drugs can significantly reduce the risk of transmission of HIV to their babies. There was no formal studies on the use of Sustiva during pregnancy. However, Sustiva has recently been linked to birth defects in humans resulting in FDA recommend Sustiva not be used during pregnancy. Because of this, pregnant women should not use Sustiva, and women who take the drug should use effective birth control. (Sustiva reduces the effectiveness of birth control pills, so that alternative methods of birth control should be used.)
Check with a doctor about the best treatment options for you and your child, if you are thinking to get pregnant.
Click here to learn more about pregnancy.
Are there any special considerations?
Testing for drugs
Sustiva could lead to a false positive result, if you get a drug test for marijuana.
Immune conversion syndrome
People who are beginning to treat HIV infection for the first time might be immunodeficiency syndrome or Restore IRS (also called Immune Restoration Inflammatory Syndrome, or IRIS). IRS may occur as a result of obtaining the immune system stronger, and in response to the HIV-related such as Mycobacterium avium infection (MAC), cytomegalovirus (CMV), Pneumocystis jirovecii pneumonia (PCP), and tuberculosis (TB). People may treat these infections in the past or do not even know they have them. If you notice any unusual symptoms shortly after the start of HIV drugs for the first time, let your doctor know immediately, so you can be evaluated and, if necessary, treatment.
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