United States - English - NLM (National Library of Medicine)

micro labs limited - nevirapine (unii: 99dk7fvk1h) (nevirapine - unii:99dk7fvk1h) - nevirapine 200 mg - nevirapine tablet is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (hiv-1) infection in adults and pediatric patients 15 days and older [see clinical studies (14.1, 14.2)] . limitations of use: based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, nevirapine tablet is not recommended to be initiated, unless the benefit outweighs the risk, in: - adult females with cd4 + cell counts greater than 250 cells/mm 3 or - adult males with cd4 + cell counts greater than 400 cells/mm 3 [see warnings and precautions (5.1)] . nevirapine is contraindicated: - in patients with moderate or severe (child-pugh class b or c, respectively) hepatic impairment [see  warnings and precautions (5.1) and use in specific po

United States - English - NLM (National Library of Medicine)

alvogen inc. - nevirapine (unii: 99dk7fvk1h) (nevirapine - unii:99dk7fvk1h) - nevirapine 100 mg - nevirapine extended-release tablets are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (hiv-1) infection in adults and pediatric patients 6 years of age or older with a body surface area (bsa) of 1.17 m2 or greater [see clinical studies (14.1, 14.2)] . limitations of use: based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, nevirapine extended-release tablets are not recommended to be initiated, unless the benefit outweighs the risk, in: - adult females with cd4+ cell counts greater than 250 cells/mm3 or - adult males with cd4+ cell counts greater than 400 cells/mm3 [ see warnings and precautions (5.1)]. nevirapine extended-release tablets are contraindicated: - in patients with moderate or severe (child-pugh class b or c, respectively) hepatic impairment [see warnings and precautions (5.1) and use in specific populations (8.7)]. - for use as part of occupational and non-occupational post-ex

United States - English - NLM (National Library of Medicine)

camber pharmaceuticals, inc. - nevirapine (unii: 99dk7fvk1h) (nevirapine - unii:99dk7fvk1h) - nevirapine 200 mg - nevirapine tablets are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (hiv-1) infection in adults and pediatric patients 15 days and older [see clinical studies (14.1, 14.2)] . limitations of use:  based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, nevirapine tablets are not recommended to be initiated, unless the benefit outweighs the risk, in:  - adult females with cd4 + cell counts greater than 250 cells/mm 3 or  - adult males with cd4 + cell counts greater than 400 cells/mm3 [see warnings and precautions (5.1)] .  nevirapine tablets are contraindicated:  - in patients with moderate or severe (child-pugh class b or c, respectively) hepatic impairment [see warnings and precautions

United States - English - NLM (National Library of Medicine)

amneal pharmaceuticals llc - nevirapine (unii: 99dk7fvk1h) (nevirapine - unii:99dk7fvk1h) - nevirapine 200 mg - nevirapine tablets, usp are indicated for use in combination with other antiretroviral agents for the treatment of hiv-1 infection. this indication is based on one principal clinical trial (bi 1090) that demonstrated prolonged suppression of hiv-1 rna and two smaller supportive trials, one of which (bi 1046) is described below. additional important information regarding the use of nevirapine tablets, usp for the treatment of hiv-1 infection: - based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, nevirapine tablets, usp should not be initiated in adult females with cd4+ cell counts greater than 250 cells/mm3 or in adult males with cd4+ cell counts greater than 400 cells/mm3 unless the benefit outweighs the risk [see boxed warning and warnings and precautions (5.1) ]. - the 14-day lead-in period with nevirapine tablets, usp 200 mg daily dosing must be strictly followed; it has been demonstrated to reduce the frequency of rash [see dosage and administration (2.4) and warnings and precautions (5.2) ]. - if rash persists beyond the 14-day lead-in period, do not dose escalate to 200 mg twice daily. the 200 mg once-daily dosing regimen should not be continued beyond 28 days, at which point an alternative regimen should be sought. nevirapine, usp is contraindicated in patients with moderate or severe (child-pugh class b or c, respectively) hepatic impairment [see warnings and precautions (5.1) and use in specific populations (8.7) ]. nevirapine, usp is contraindicated for use as part of occupational and non-occupational post-exposure prophylaxis (pep) regimens [see warnings and precautions (5.1) ]. teratogenic effects, pregnancy category b. no observable teratogenicity was detected in reproductive studies performed in pregnant rats and rabbits. the maternal and developmental no-observable-effect level dosages produced systemic exposures approximately equivalent to or approximately 50% higher in rats and rabbits, respectively, than those seen at the recommended daily human dose (based on auc). in rats, decreased fetal body weights were observed due to administration of a maternally toxic dose (exposures approximately 50% higher than that seen at the recommended human clinical dose). there are no adequate and well-controlled trials of nevirapine in pregnant women. the antiretroviral pregnancy registry, which has been surveying pregnancy outcomes since january 1989, has not found an increased risk of birth defects following first trimester exposures to nevirapine. the prevalence of birth defects after any trimester exposure to nevirapine is comparable to the prevalence observed in the general population. severe hepatic events, including fatalities, have been reported in pregnant women receiving chronic nevirapine therapy as part of combination treatment of hiv-1 infection. regardless of pregnancy status, women with cd4+ cell counts greater than 250 cells/mm3 should not initiate nevirapine unless the benefit outweighs the risk. it is unclear if pregnancy augments the risk observed in non-pregnant women [see boxed warning ]. nevirapine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. antiretroviral pregnancy registry to monitor maternal-fetal outcomes of pregnant women exposed to nevirapine, an antiretroviral pregnancy registry has been established. physicians are encouraged to register patients by calling 1-800-258-4263. the centers for disease control and prevention recommend that hiv-1 infected mothers not breastfeed their infants to avoid risking postnatal transmission of hiv-1. nevirapine is excreted in breast milk. because of both the potential for hiv-1 transmission and the potential for serious adverse reactions in nursing infants, mothers should be instructed not to breastfeed if they are receiving nevirapine. the safety, pharmacokinetic profile, and virologic and immunologic responses of nevirapine have been evaluated in hiv-1 infected pediatric subjects age 3 months to 18 years [see adverse reactions (6.2) and clinical studies (14.2) ]. the safety and pharmacokinetic profile of nevirapine has been evaluated in hiv-1 infected pediatric subjects age 15 days to less than 3 months [see adverse reactions (6.2) and clinical studies (14.2) ]. the most frequently reported adverse events related to nevirapine in pediatric subjects were similar to those observed in adults, with the exception of granulocytopenia, which was more commonly observed in children receiving both zidovudine and nevirapine [see adverse reactions (6.2) and clinical studies (14.2) ]. clinical trials of nevirapine did not include sufficient numbers of subjects aged 65 and older to determine whether elderly subjects respond differently from younger subjects. in general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. in subjects with renal impairment (mild, moderate or severe), there were no significant changes in the pharmacokinetics of nevirapine. nevirapine is extensively metabolized by the liver and nevirapine metabolites are extensively eliminated by the kidney. nevirapine metabolites may accumulate in patients receiving dialysis; however, the clinical significance of this accumulation is not known. no adjustment in nevirapine dosing is required in patients with crcl greater than or equal to 20 ml/min. in patients undergoing chronic hemodialysis, an additional 200 mg dose following each dialysis treatment is indicated [see dosage and administration (2.4) and clinical pharmacology (12.3) ]. because increased nevirapine levels and nevirapine accumulation may be observed in patients with serious liver disease, do not administer nevirapine to patients with moderate or severe (child-pugh class b or c, respectively) hepatic impairment [see contraindications (4.1), warnings and precautions (5.1), and clinical pharmacology (12.3) ].

United States - English - NLM (National Library of Medicine)

aurobindo pharma limited - nevirapine hemihydrate (unii: b7xf2td73c) (nevirapine - unii:99dk7fvk1h) - nevirapine 50 mg in 5 ml - nevirapine oral suspension is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (hiv-1) infection in adults and pediatric patients 15 days and older [see clinical studies (14.1, 14.2)] . limitations of use: based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, nevirapine oral suspension is not recommended to be initiated, unless the benefit outweighs the risk, in: - adult females with cd4+ cell counts greater than 250 cells/mm3 or - adult males with cd4+ cell counts greater than 400 cells/mm3 [see warnings and precautions (5.1)]. nevirapine oral suspension is contraindicated: - in patients with moderate or severe (child-pugh class b or c, respectively) hepatic impairment [see warnings and precautions (5.1)  and use in specific populations (8.7) ]. - for use as part of occupational and non-occupational post-exposure prophylaxis (pep) regimens [see warnings and precautions (5.1)]. pregnancy exp

United States - English - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - nevirapine (unii: 99dk7fvk1h) (nevirapine - unii:99dk7fvk1h) - nevirapine 200 mg - nevirapine is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (hiv-1) infection in adults and pediatric patients 15 days and older [see clinical studies (14.1, 14.2)]. limitations of use: based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, nevirapine is not recommended to be initiated, unless the benefit outweighs the risk, in: nevirapine is contraindicated: there is a pregnancy registry that monitors pregnancy outcomes in women exposed to nevirapine during pregnancy. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. available data from the apr show no difference in the risk of overall major birth defects for nevirapine compared with the background rate for major birth defects of 2.7% in the u.s. reference population of the metropolitan atlanta congenital defects program (macdp) [see data] . the rate of miscarriage is not reported in the apr. the estimated background rate of miscarriage in clinically recognized pregnancies in the u.s. general population is 15-20%. the background risk of birth defects and miscarriage for the indicated population is unknown. methodological limitations of the apr include the use of macdp as the external comparator group. the macdp population is not disease-specific, evaluates women and infants from a limited geographic area, and does not include outcomes for births that occurred at < 20 weeks gestation. in literature reports, immediate-release nevirapine exposure (cmin ) can be up to 29% lower during pregnancy. however, as this reduction was not found to be clinically meaningful, dose adjustment is not necessary [see data] . there is a risk for severe hepatic events in pregnant women exposed to nevirapine [see clinical considerations]. in animal reproduction studies, no evidence of adverse developmental outcomes was observed following oral administration of nevirapine during organogenesis in the rat and rabbit, at systemic exposures (auc) to nevirapine approximately equal (rats) and 50% higher (rabbits) than the exposure in humans at the recommended 400 mg daily dose [see data]. severe hepatic events, including fatalities, have been reported in pregnant women receiving chronic nevirapine therapy as part of combination treatment of hiv-1 infection. regardless of pregnancy status, women with cd4+ cell counts greater than 250 cells/mm3 should not initiate nevirapine unless the benefit outweighs the risk. it is unclear if pregnancy augments the risk observed in non-pregnant women [see warnings and precautions (5.1)] . based on prospective reports to the apr of exposures to nevirapine during pregnancy resulting in live births (including over 1100 exposed in the first trimester and over 1500 exposed in the second/third trimester), the prevalence of birth defects in live births was 3.0% (95% ci: 2.1%, 4.1%) and 3.3% (95% ci: 2.4%, 4.3%) following first and second/third trimester exposure, respectively, to nevirapine-containing regimens, compared with the background birth defect rate of 2.7% in a u.s. reference population of the macdp. there are several literature reports of chronic administration of immediate-release nevirapine during pregnancy, in which nevirapine pharmacokinetics were compared between pregnancy and postpartum. in these studies, the mean difference in nevirapine cmin during pregnancy as compared to postpartum ranged from no difference to approximately 29% lower. nevirapine was administered orally to pregnant rats (at 0, 12.5, 25, and 50 mg per kg per day) and rabbits (at 0, 30, 100, and 300 mg per kg per day) through organogenesis (on gestation days 7 through 16, and 6 through 18, respectively). no adverse developmental effects were observed at doses producing systemic exposures (auc) approximately equivalent to (rats) or approximately 50% higher (rabbits) than human exposure at the recommended daily dose. in rats, decreased fetal body weights were observed at a maternally toxic dose at an exposure approximately 50% higher than the recommended daily dose. the centers for disease control and prevention recommend that hiv-1 infected mothers in the united states not breastfeed their infants to avoid risking postnatal transmission of hiv-1 infection. published data report that nevirapine is present in human milk [see data] . there are limited data on the effects of nevirapine on the breastfed infant. there is no information on the effects of nevirapine on milk production. because of the potential for (1) hiv-1 transmission (in hiv-negative infants), (2) developing viral resistance (in hiv-positive infants), and (3) serious adverse reactions in nursing infants, mothers should not breastfeed if they are receiving nevirapine. based on five publications, immediate-release nevirapine was excreted in breast milk at median concentrations ranging from 4080 to 6795 ng/ml, and the median maternal breast milk to maternal plasma concentration ratio range was 59 to 88%. reported infant nevirapine median plasma concentrations were low, ranging from 734 to 1140 ng/ml. the estimated nevirapine dose of 704 to 682 mcg/kg/day for infants fed exclusively with breast milk was lower than the daily recommended nevirapine dose for infants. published literature indicates that rash and hyperbilirubinemia have been seen in infants exposed to nevirapine through breastmilk. limited human data are insufficient to determine the risk of infertility in humans. based on results from animal fertility studies conducted in rats, nevirapine may reduce fertility in females of reproductive potential. it is not known if these effects on fertility are reversible [see nonclinical toxicology (13.1)]. the safety, pharmacokinetic profile, and virologic and immunologic responses of nevirapine have been evaluated in hiv-1 infected pediatric subjects aged 3 months to 18 years [see adverse reactions (6.1) and clinical studies (14.2)] . the safety and pharmacokinetic profile of nevirapine has been evaluated in hiv-1 infected pediatric subjects aged 15 days to less than 3 months [see adverse reactions (6.1) and clinical studies (14.2)] . the most frequently reported adverse events related to nevirapine in pediatric subjects were similar to those observed in adults, with the exception of granulocytopenia, which was more commonly observed in children receiving both zidovudine and nevirapine [see adverse reactions (6.1) and clinical studies (14.2)] . clinical trials of nevirapine did not include sufficient numbers of subjects aged 65 and older to determine whether elderly subjects respond differently from younger subjects. in general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. in subjects with renal impairment (mild, moderate or severe), there were no significant changes in the pharmacokinetics of nevirapine. nevirapine is extensively metabolized by the liver and nevirapine metabolites are extensively eliminated by the kidney. nevirapine metabolites may accumulate in patients receiving dialysis; however, the clinical significance of this accumulation is not known. no adjustment in nevirapine dosing is required in patients with crcl greater than or equal to 20 ml per min. the pharmacokinetics of nevirapine have not been evaluated in patients with crcl less than 20 ml per min. in patients undergoing chronic hemodialysis, an additional 200 mg dose following each dialysis treatment is indicated [see dosage and administration (2.4) and clinical pharmacology (12.3)] . because increased nevirapine levels and nevirapine accumulation may be observed in patients with serious liver disease, do not administer nevirapine to patients with moderate or severe (child-pugh class b or c, respectively) hepatic impairment [see contraindications (4), warnings and precautions (5.1), and clinical pharmacology (12.3)] .

United States - English - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - nevirapine (unii: 99dk7fvk1h) (nevirapine - unii:99dk7fvk1h) - nevirapine 100 mg - nevirapine extended-release tablets are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (hiv-1) infection in adults and pediatric patients 6 years of age or older with a body surface area (bsa) of 1.17 m2 or greater [see clinical studies (14.1, 14.2)] . limitations of use: based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, nevirapine extended-release tablets are not recommended to be initiated, unless the benefit outweighs the risk, in: nevirapine extended-release tablets are contraindicated: there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to nevirapine during pregnancy. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. available data from the apr show no difference in the risk of overall major birth defects for nevirapine compared with the background rate for major birth defects of 2.7% in a u.s. reference population of the metropolitan atlanta congenital defects program (macdp) [see data] . the rate of miscarriage is not reported in the apr. the estimated background rate of miscarriage in clinically recognized pregnancies in the u.s. general population is 15-20%. the background risk of birth defects and miscarriage for the indicated population is unknown. methodological limitations of the apr include the use of macdp as the external comparator group. the macdp population is not disease-specific, evaluates women and infants from a limited geographic area, and does not include outcomes for births that occurred at < 20 weeks gestation. there is a risk for severe hepatic events in pregnant women exposed to nevirapine extended-release tablets [see clinical considerations] . in animal reproduction studies, no evidence of adverse developmental outcomes was observed following oral administration of nevirapine during organogenesis in the rat and rabbit, at systemic exposures (auc) to nevirapine approximately equal (rats) and 50% higher (rabbits) than the exposure in humans at the recommended 400 mg daily dose [see data] . severe hepatic events, including fatalities, have been reported in pregnant women receiving chronic nevirapine therapy as part of combination treatment of hiv-1 infection. regardless of pregnancy status, women with cd4+ cell counts greater than 250 cells/mm3 should not initiate nevirapine unless the benefit outweighs the risk. it is unclear if pregnancy augments the risk observed in non-pregnant women [see warnings and precautions (5.1)] . based on prospective reports to the apr of exposures to nevirapine during pregnancy resulting in live births (including over 1100 exposed in the first trimester and over 1500 exposed in the second/third trimester), the prevalence of birth defects in live births was 3.0% (95% ci: 2.1%, 4.1%) and 3.3% (95% ci: 2.4%, 4.3%) following first and second/third-trimester exposure, respectively, to nevirapine-containing regimens, compared with the background birth defect rate of 2.7% in a u.s. reference population of the macdp. nevirapine was administered orally to pregnant rats (at 0, 12.5, 25, and 50 mg/kg/day), and rabbits (at 0, 30, 100, and 300 mg/kg/day) through organogenesis (on gestation days 7 through 16 and 6 through 18, respectively). no adverse developmental effects were observed at doses producing systemic exposures (auc) approximately equivalent to (rats) or approximately 50% higher (rabbits) than human exposure at the recommended daily dose. in rats, decreased fetal body weights were observed at a maternally toxic dose at an exposure approximately 50% higher than the recommended daily dose. the centers for disease control and prevention recommend that hiv-1 infected mothers in the united states not breastfeed their infants to avoid risking postnatal transmission of hiv-1 infection. published data report that immediate-release nevirapine is present in human milk. there are limited data on the effects of nevirapine on the breastfed infant. there is no information on the effects of nevirapine on milk production. because of the potential for (1) hiv-1 transmission (in hiv-negative infants), (2) developing viral resistance (in hiv-positive infants), and (3) serious adverse reactions in nursing infants, mothers should not breastfeed if they are receiving nevirapine extended-release tablets. limited human data are insufficient to determine the risk of infertility in humans. based on results from animal fertility studies conducted in rats, nevirapine extended-release tablets may reduce fertility in females of reproductive potential. it is not known if these effects on fertility are reversible [see nonclinical toxicology (13.1)] . nevirapine extended-release tablets are indicated for use in combination with other antiretroviral agents for the treatment of hiv-1 infection in children 6 years of age or older with a bsa of 1.17 m2 or greater [see indications and usage (1) and dosage and administration (2.3)]. the use of nevirapine extended-release tablets for the treatment of hiv-1 infection in pediatric patients 6 to less than 18 years of age is based on pharmacokinetic, safety, and antiviral activity data from an open-label trial with nevirapine extended-release tablets. the results of this trial were supported by previous demonstration of efficacy in adult patients [see adverse reactions (6.1) , clinical pharmacology (12.3), and clinical studies (14.2)]. nevirapine extended-release tablets are not recommended for children less than 6 years of age. trial 1100.1518 did not provide sufficient pharmacokinetic data for children 3 to less than 6 years of age to support the use of nevirapine extended-release tablets in this age group. furthermore, nevirapine extended-release tablets are not recommended for children less than 3 years of age because they are not able to swallow tablets. clinical studies of nevirapine extended-release tablets did not include sufficient numbers of subjects aged 65 and older to determine whether elderly subjects respond differently from younger subjects. in general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. in subjects with renal impairment (mild, moderate or severe), there were no significant changes in the pharmacokinetics of nevirapine. nevirapine is extensively metabolized by the liver and nevirapine metabolites are extensively eliminated by the kidney. nevirapine metabolites may accumulate in patients receiving dialysis; however, the clinical significance of this accumulation is not known. no adjustment in nevirapine dosing is required in patients with crcl greater than or equal to 20 ml per min. the pharmacokinetics of nevirapine have not been evaluated in patients with crcl less than 20 ml per min. in patients undergoing chronic hemodialysis, an additional dose of immediate-release nevirapine (200 mg) following each dialysis treatment is indicated [see dosage and administration (2.5) and clinical pharmacology (12.3)]. nevirapine extended-release tablets have not been studied in patients with renal dysfunction. because increased nevirapine levels and nevirapine accumulation may be observed in patients with serious liver disease, do not administer nevirapine to patients with moderate or severe (child-pugh class b or c, respectively) hepatic impairment [see contraindications (4), warnings and precautions (5.1), and clinical pharmacology (12.3)]. nevirapine extended-release tablets have not been evaluated in subjects with hepatic impairment.

United States - English - NLM (National Library of Medicine)

state of florida doh central pharmacy - nevirapine (unii: 99dk7fvk1h) (nevirapine - unii:99dk7fvk1h) - nevirapine 200 mg - nevirapine tablets are indicated for use in combination with other antiretroviral agents for the treatment of hiv-1 infection. this indication is based on one principal clinical trial (bi 1090) that demonstrated prolonged suppression of hiv-1 rna and two smaller supportive trials, one of which (bi 1046) is described below. additional important information regarding the use of nevirapine tablets for the treatment of hiv-1 infection: - based on serious and life threatening hepatotoxicity observed in controlled and uncontrolled trials, nevirapine tablets should not be initiated in adult females with cd4+ cell counts greater than 250 cells/mm3 or in adult males with cd4+ cell counts greater than 400 cells/mm3 unless the benefit outweighs the risk [see boxed warning and warnings and precautions (5.1) ]. - the 14-day lead-in period with nevirapine tablets 200 mg daily dosing must be strictly followed; it has been demonstrated to reduce the frequency of rash [see dosage and administration (2.4) and warnings and

United States - English - NLM (National Library of Medicine)

aurobindo pharma limited - nevirapine (unii: 99dk7fvk1h) (nevirapine - unii:99dk7fvk1h) - nevirapine 200 mg - nevirapine tablets are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (hiv-1) infection in adults and pediatric patients 15 days and older [see clinical studies (14.1, 14.2)] . limitations of use: based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, nevirapine tablets is not recommended to be initiated, unless the benefit outweighs the risk, in:  - adult females with cd4+ cell counts greater than 250 cells/mm3 or  - adult males with cd4+ cell counts greater than 400 cells/mm3 [see warnings and precautions (5.1)]. nevirapine tablets are contraindicated: - in patients with moderate or severe (child-pugh class b or c, respectively) hepatic impairment [see warnings and precautions (5.1)  and use in specific populations (8.7) ] . - for use as part of occupational and non-occupational post-exposure prophylaxis (pep) regimens [see warnings and precautions (5.1)]. pregnancy exposure registry there is a p

United States - English - NLM (National Library of Medicine)

breckenridge pharmaceutical, inc. - nevirapine (unii: 99dk7fvk1h) (nevirapine - unii:99dk7fvk1h) - nevirapine 200 mg - nevirapine is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (hiv-1) infection in adults and pediatric patients 15 days and older. [see clinical studies (14.1, 14.2)] limitations of use: based on serious and life-threatening hepatotoxicity observed in controlled and uncontrolled trials, nevirapine is not recommended to be initiated, unless the benefit outweighs the risk, in: nevirapine is contraindicated: pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to nevirapine during pregnancy. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. risk summary available data from the apr show no difference in the risk of overall major birth defects for nevirapine compared with the background rate for major birth defects of 2.7% in the u.s. reference population of the metropolitan atlanta congenital defects program (m