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

remedyrepack inc. - atazanavir sulfate (unii: 4mt4vie29p) (atazanavir - unii:qzu4h47a3s) - atazanavir 300 mg - atazanavir sulfate capsules are indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection for patients 6 years and older weighing at least 15 kg. limitations of use: - atazanavir is not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus. - use of atazanavir/ritonavir in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions [see microbiology ( 12.4)] . atazanavir sulfate capsules are contraindicated: - in patients with previously demonstrated clinically significant hypersensitivity (e.g., stevens-johnson syndrome, erythema multiforme, or toxic skin eruptions) to any of the components of atazanavir sulfate capsules [see warnings and precautions ( 5.2)] . - when coadministered with drugs that are highly dependent on cyp3a or ugt1a1 for clearance, and for which

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

teva pharmaceuticals usa, inc. - atazanavir sulfate (unii: 4mt4vie29p) (atazanavir - unii:qzu4h47a3s) - atazanavir 150 mg - atazanavir capsules are indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection in adults and in pediatric patients 6 years and older weighing at least 15 kg. limitations of use: - atazanavir capsules are not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus [see use in specific populations (8.4)] . - use of atazanavir capsules with ritonavir in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions [see microbiology (12.4)] . atazanavir is contraindicated: - in patients with previously demonstrated clinically significant hypersensitivity (eg, stevens-johnson syndrome, erythema multiforme, or toxic skin eruptions) to any of the components of atazanavir capsules [see warnings and precautions (5.2)] . - when coadministered with drugs that are highly dependent on cyp3a or ugt1a1 for clearance, and for which elevated plasma concentrations of the interacting drugs are associated with serious and/or life-threatening events (see table 6). - when coadministered with drugs that strongly induce cyp3a and may lead to lower exposure and loss of efficacy of atazanavir (see table 6). table 6 displays drugs that are contraindicated with atazanavir. drug class drugs within class that are contraindicated with atazanavir alpha 1-adrenoreceptor antagonist alfuzosin antiarrhythmics amiodarone (with ritonavir), quinidine (with ritonavir) antimycobacterials rifampin antineoplastics apalutamide, encorafenib, irinotecan, ivosidenib antipsychotics lurasidone (with ritonavir), pimozide benzodiazepines orally administered midazolama , triazolam ergot derivatives dihydroergotamine, ergonovine, ergotamine, methylergonovine gi motility agent cisapride hepatitis c direct-acting antivirals elbasvir/grazoprevir; glecaprevir/pibrentasvir herbal products st. john’s wort (hypericum perforatum ) lipid-modifying agents: lomitapide, lovastatin, simvastatin phosphodiesterase-5 (pde-5) inhibitor sildenafilb when dosed as revatio® for the treatment of pulmonary arterial hypertension protease inhibitors indinavir non-nucleoside reverse transcriptase inhibitors nevirapine pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in patients exposed to atazanavir during pregnancy. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. risk summary atazanavir has been evaluated in a limited number of women during pregnancy. available human and animal data suggest that atazanavir does not increase the risk of major birth defects overall compared to the background rate [see data] . in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. no treatment-related malformations were observed in rats and rabbits, for which the atazanavir exposures were 0.7 to 1.2 times of those at the human clinical dose (300 mg/day atazanavir boosted with 100 mg/day ritonavir). when atazanavir was administered to rats during pregnancy and throughout lactation, reversible neonatal growth retardation was observed [see data] . clinical considerations dose adjustments during pregnancy and the postpartum period - atazanavir must be administered with ritonavir in pregnant patients. - for pregnant patients, no dosage adjustment is required for atazanavir with the following exceptions: - for treatment-experienced pregnant women during the second or third trimester, when atazanavir is coadministered with either an h2 -receptor antagonist or tenofovir df, atazanavir 400 mg with ritonavir 100 mg once daily is recommended. there are insufficient data to recommend an atazanavir dose for use with both an h2 -receptor antagonist and tenofovir df in treatment-experienced pregnant patients. - no dosage adjustment is required for postpartum patients. however, patients should be closely monitored for adverse events because atazanavir exposures could be higher during the first 2 months after delivery [see dosage and administration (2.6) and clinical pharmacology (12.3)] . maternal adverse reactions cases of lactic acidosis syndrome, sometimes fatal, and symptomatic hyperlactatemia have occurred in pregnant women using atazanavir in combination with nucleoside analogues, which are associated with an increased risk of lactic acidosis syndrome. hyperbilirubinemia occurs frequently in patients who take atazanavir [see warnings and precautions (5.8)] , including those who are pregnant [see data] . advise pregnant women of the potential risks of lactic acidosis syndrome and hyperbilirubinemia. fetal/neonatal adverse reactions all infants, including neonates exposed to atazanavir in utero , should be monitored for the development of severe hyperbilirubinemia during the first few days of life [see data] . data human data in study ai424-182, atazanavir with ritonavir (300/100 mg or 400/100 mg) coadministered with lamivudine/zidovudine (150 mg/ 300 mg, as fixed-dose product) was administered to 41 pregnant women with hiv-1 infection, during the second or third trimester. among the 39 women who completed the study, 38 women achieved an hiv-1 rna less than 50 copies/ml at time of delivery. six of 20 (30%) women on atazanavir with ritonavir 300/100 mg and 13 of 21 (62%) women on atazanavir with ritonavir 400/100 mg experienced hyperbilirubinemia (total bilirubin greater than or equal to 2.6 times uln). there were no cases of lactic acidosis observed in clinical trial ai424-182. atazanavir drug concentrations in fetal umbilical cord blood were approximately 12% to 19% of maternal concentrations. among the 40 infants born to 40 pregnant women with hiv-1 infection, all had test results that were negative for hiv-1 dna at the time of delivery and/or during the first 6 months postpartum. all 40 infants received antiretroviral prophylactic treatment containing zidovudine. no evidence of severe hyperbilirubinemia (total bilirubin levels greater than 20 mg/dl) or acute or chronic bilirubin encephalopathy was observed among neonates in this study. however, 10/36 (28%) infants (6 greater than or equal to 38 weeks gestation and 4 less than 38 weeks gestation) had bilirubin levels of 4 mg/dl or greater within the first day of life. lack of ethnic diversity was a study limitation. in the study population, 33/40 (83%) infants were black/african american, who have a lower incidence of neonatal hyperbilirubinemia than caucasians and asians. in addition, women with rh incompatibility were excluded, as well as women who had a previous infant who developed hemolytic disease and/or had neonatal pathologic jaundice (requiring phototherapy). additionally, of the 38 infants who had glucose samples collected in the first day of life, 3 had adequately collected serum glucose samples with values of less than 40 mg/dl that could not be attributed to maternal glucose intolerance, difficult delivery, or sepsis. based on prospective reports from the apr of approximately 1600 live births following exposure to atazanavir-containing regimens (including 1037 live births in infants exposed in the first trimester and 569 exposed in second/third trimesters), there was no difference between atazanavir, and overall birth defects compared with the background birth defect rate. in the u.s. general population, the estimated background risk of major birth defects in clinically recognized pregnancies is 2 to 4%. animal data in animal reproduction studies, there was no evidence of mortality or teratogenicity in offspring born to animals at systemic drug exposure levels (auc) 0.7 (in rabbits) to 1.2 (in rats) times those observed at the human clinical dose (300 mg/day atazanavir boosted with 100 mg/day ritonavir). in pre- and postnatal development studies in the rat, atazanavir caused neonatal growth retardation during lactation that reversed after weaning. maternal drug exposure at this dose was 1.3 times the human exposure at the recommended clinical exposure. minimal maternal toxicity occurred at this exposure level. risk summary the centers for disease control and prevention recommend that patients with hiv-1 infection, not breastfeed their infants to avoid risking postnatal transmission of hiv-1. atazanavir has been detected in human milk. no data are available regarding atazanavir effects on milk production. atazanavir was present in the milk of lactating rats and was associated with neonatal growth retardation that reversed after weaning. because of both the potential for hiv-1 transmission and the potential for serious adverse reactions in breastfed infants, advise women not to breastfeed. atazanavir capsules are indicated in combination with other antiretroviral agents for the treatment of pediatric patients with hiv-1 infection, 6 years of age and older weighing at least 15 kg. atazanavir is not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus [see indications and usage (1)] . all atazanavir contraindications, warnings, and precautions apply to pediatric patients [see contraindications (4) and warnings and precautions (5)] . the safety, pharmacokinetic profile, and virologic response of atazanavir in pediatric patients at least 6 years of age and older weighing at least 15 kg were established in an open-label, multicenter clinical trial: pactg 1020a [see clinical pharmacology (12.3) and clinical studies (14.3)] . the safety profile in pediatric patients was generally similar to that observed in adults [see adverse reactions (6.1)] . see dosage and administration (2.4) for dosing recommendations for the use of atazanavir capsules. clinical studies of atazanavir did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. based on a comparison of mean single-dose pharmacokinetic values for cmax and auc, a dose adjustment based upon age is not recommended. in general, appropriate caution should be exercised in the administration and monitoring of atazanavir in elderly patients reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. a study of the pharmacokinetics of atazanavir was performed in young (n=29; 18 to 40 years) and elderly (n=30; ≥65 years) healthy subjects. there were no clinically significant pharmacokinetic differences observed due to age or gender. atazanavir is not recommended for use in treatment-experienced patients with hiv-1 infection, who have end-stage renal disease managed with hemodialysis [see dosage and administration (2.7) and clinical pharmacology (12.3)]. atazanavir is not recommended for use in patients with severe hepatic impairment. atazanavir with ritonavir is not recommended in patients with any degree of hepatic impairment [see dosage and administration (2.8) and clinical pharmacology (12.3)].

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

golden state medical supply inc. - atazanavir sulfate (unii: 4mt4vie29p) (atazanavir - unii:qzu4h47a3s) - atazanavir sulfate capsules are indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection for patients 6 years and older weighing at least 15 kg. limitations of use: - atazanavir is not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus. - use of atazanavir/ritonavir in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions [see microbiology ( 12.4)] . atazanavir sulfate capsules are contraindicated: - in patients with previously demonstrated clinically significant hypersensitivity (e.g., stevens-johnson syndrome, erythema multiforme, or toxic skin eruptions) to any of the components of atazanavir sulfate capsules [see warnings and precautions ( 5.2)] . - wh

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

american health packaging - atazanavir sulfate (unii: 4mt4vie29p) (atazanavir - unii:qzu4h47a3s) - atazanavir capsule is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection for patients 6 years and older weighing at least 15 kg. limitations of use: - atazanavir capsules are not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus. - use of atazanavir capsules/ritonavir in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions [see microbiology (12.4)] . atazanavir capsules are contraindicated: - in patients with previously demonstrated clinically significant hypersensitivity (e.g., stevens-johnson syndrome, erythema multiforme, or toxic skin eruptions) to any of the components of atazanavir capsules [see warnings and precautions (5.2)]. - when coadministered with drugs that are highly dependent on cyp3a or ugt1a1 for clearance, and for which elevated plasma concentrations of the interacting drugs are associated with serious and/or life-threatening

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

major pharmaceuticals - atazanavir sulfate (unii: 4mt4vie29p) (atazanavir - unii:qzu4h47a3s) - atazanavir capsule  is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection for patients 6 years and older weighing at least 15 kg. limitations of use: atazanavir capsules are contraindicated: table 6 displays drugs that are contraindicated with atazanavir capsules.   drug class drugs within class that are contraindicated with atazanavir capsules clinical comment alpha 1-‑adrenoreceptor antagonist alfuzosin potential for increased alfuzosin concentrations, which can result in hypotension. antimycobacterials rifampin rifampin substantially decreases plasma concentrations of atazanavir, which may result in loss of therapeutic effect and development of resistance. antineoplastics irinotecan atazanavir inhibits ugt1a1 and may interfere with the metabolism of irinotecan, resulting in increased irinotecan toxicities. antipsychotics lurasidone potential for serious and/or life-threatening reactions if atazanavir capsules are coadministered with ritonavir.   pimozide potenti

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

remedyrepack inc. - atazanavir sulfate (unii: 4mt4vie29p) (atazanavir - unii:qzu4h47a3s) - atazanavir capsule  is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection in adults and in pediatric patients 6 years and older weighing at least 15 kg. limitations of use: - atazanavir capsules are not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus [see use in specific populations (8.4)].   - use of atazanavir capsules with ritonavir in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions [see microbiology (12.4)] . atazanavir capsules are contraindicated: - in patients with previously demonstrated clinically significant hypersensitivity (e.g., stevens-johnson syndrome, erythema multiforme, or toxic skin eruptions) to any of the components of atazanavir capsules [see warnings and precautions (5.2)]

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

aurobindo pharma limited - atazanavir sulfate (unii: 4mt4vie29p) (atazanavir - unii:qzu4h47a3s) - atazanavir capsule  is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection in adults and in pediatric patients 6 years and older weighing at least 15 kg. limitations of use: - atazanavir capsules are not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus [see use in specific populations (8.4)].   - use of atazanavir capsules with ritonavir in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions [see microbiology (12.4)] . atazanavir capsules are contraindicated: - in patients with previously demonstrated clinically significant hypersensitivity (e.g., stevens-johnson syndrome, erythema multiforme, or toxic skin eruptions) to any of the components of atazanavir capsules [see warnings and precautions (5.2)]. - when coadministered with drugs that are highly dependent on cyp3a or ugt1a1 for clearance, and for which elevated plasma concentrations of the interacting drugs are associated with serious and/or life-threatening events (see table 6). - when coadministered with drugs that strongly induce cyp3a and may lead to lower exposure and loss of efficacy of atazanavir capsules (see table 6). table 6 displays drugs that are contraindicated with atazanavir capsules. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in patients exposed to atazanavir during pregnancy. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. risk summary atazanavir has been evaluated in a limited number of women during pregnancy. available human and animal data suggest that atazanavir does not increase the risk of major birth defects overall compared to the background rate [see data]. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. no treatment-related malformations were observed in rats and rabbits, for which the atazanavir exposures were 0.7 to 1.2 times of those at the human clinical dose (300 mg/day atazanavir boosted with 100 mg/day ritonavir). when atazanavir was administered to rats during pregnancy and throughout lactation, reversible neonatal growth retardation was observed [see data] . clinical considerations dose adjustments during pregnancy and the postpartum period - atazanavir must be administered with ritonavir in pregnant patients. - for pregnant patients, no dosage adjustment is required for atazanavir with the following exceptions: for treatment-experienced pregnant women during the second or third trimester, when atazanavir is coadministered with either an h2 -receptor antagonist or tenofovir df, atazanavir 400 mg with ritonavir 100 mg once daily is recommended. there are insufficient data to recommend a atazanavir dose for use with both an h2 -receptor antagonist and tenofovir df in treatment-experienced pregnant patients. - for treatment-experienced pregnant women during the second or third trimester, when atazanavir is coadministered with either an h2 -receptor antagonist or tenofovir df, atazanavir 400 mg with ritonavir 100 mg once daily is recommended. there are insufficient data to recommend a atazanavir dose for use with both an h2 -receptor antagonist and tenofovir df in treatment-experienced pregnant patients. - no dosage adjustment is required for postpartum patients. however, patients should be closely monitored for adverse events because atazanavir exposures could be higher during the first 2 months after delivery [see dosage and administration (2.6) and clinical pharmacology (12.3)]. maternal adverse reactions cases of lactic acidosis syndrome, sometimes fatal, and symptomatic hyperlactatemia have occurred in pregnant women using atazanavir in combination with nucleoside analogues, which are associated with an increased risk of lactic acidosis syndrome. hyperbilirubinemia occurs frequently in patients who take atazanavir [see warnings and precautions (5.8)] , including those who are pregnant [see data] . advise pregnant women of the potential risks of lactic acidosis syndrome and hyperbilirubinemia. fetal/neonatal adverse reactions all infants, including neonates exposed to atazanavir in utero , should be monitored for the development of severe hyperbilirubinemia during the first few days of life [see data]. data human data in study ai424-182, atazanavir with ritonavir (300/100 mg or 400/100 mg) coadministered with lamivudine/zidovudine (150 mg/ 300 mg, as fixed-dose product) was administered to 41 pregnant women with hiv-1 infection, during the second or third trimester. among the 39 women who completed the study, 38 women achieved an hiv-1 rna less than 50 copies/ml at time of delivery. six of 20 (30%) women on atazanavir with ritonavir 300/100 mg and 13 of 21 (62%) women on atazanavir with ritonavir 400/100 mg experienced hyperbilirubinemia (total bilirubin greater than or equal to 2.6 times uln). there were no cases of lactic acidosis observed in clinical trial ai424-182. atazanavir drug concentrations in fetal umbilical cord blood were approximately 12% to 19% of maternal concentrations. among the 40 infants born to 40 pregnant women with hiv-1 infection, all had test results that were negative for hiv-1 dna at the time of delivery and/or during the first 6 months postpartum. all 40 infants received antiretroviral prophylactic treatment containing zidovudine. no evidence of severe hyperbilirubinemia (total bilirubin levels greater than 20 mg/dl) or acute or chronic bilirubin encephalopathy was observed among neonates in this study. however, 10/36 (28%) infants (6 greater than or equal to 38 weeks gestation and 4 less than 38 weeks gestation) had bilirubin levels of 4 mg/dl or greater within the first day of life. lack of ethnic diversity was a study limitation. in the study population, 33/40 (83%) infants were black/african american, who have a lower incidence of neonatal hyperbilirubinemia than caucasians and asians. in addition, women with rh incompatibility were excluded, as well as women who had a previous infant who developed hemolytic disease and/or had neonatal pathologic jaundice (requiring phototherapy). additionally, of the 38 infants who had glucose samples collected in the first day of life, 3 had adequately collected serum glucose samples with values of less than 40 mg/dl that could not be attributed to maternal glucose intolerance, difficult delivery, or sepsis. based on prospective reports from the apr of approximately 1600 live births following exposure to atazanavir-containing regimens (including 1037 live births in infants exposed in the first trimester and 569 exposed in second/third trimesters), there was no difference between atazanavir, and overall birth defects compared with the background birth defect rate. in the u.s. general population, the estimated background risk of major birth defects in clinically recognized pregnancies is 2 to 4%. animal data in animal reproduction studies, there was no evidence of mortality or teratogenicity in offspring born to animals at systemic drug exposure levels (auc) 0.7 (in rabbits) to 1.2 (in rats) times those observed at the human clinical dose (300 mg/day atazanavir boosted with 100 mg/day ritonavir). in pre- and postnatal development studies in the rat, atazanavir caused neonatal growth retardation during lactation that reversed after weaning. maternal drug exposure at this dose was 1.3 times the human exposure at the recommended clinical exposure. minimal maternal toxicity occurred at this exposure level. risk summary the   centers for   disease   control and prevention recommend that patients with hiv-1 infection, not breastfeed their   infants   to avoid risking postnatal transmission of   hiv-1. atazanavir has been detected in human milk. no data are available regarding atazanavir effects on milk production. atazanavir was present in the milk of lactating rats and was associated with neonatal growth retardation that reversed after weaning. because of both the potential for hiv-1 transmission and the potential for serious adverse reactions in breastfed infants, advise women not to breastfeed. atazanavir capsule is indicated in combination with other antiretroviral agents for the treatment of pediatric patients with hiv-1 infection, 6 years of age and older weighing at least 15 kg. atazanavir is not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus [see indications and usage (1)] . all atazanavir contraindications, warnings, and precautions apply to pediatric patients [see contraindications (4) and warnings and precautions (5)] . the safety, pharmacokinetic profile, and virologic response of atazanavir in pediatric patients at least 6 years of age and older weighing at least 15 kg were established in an open-label, multicenter clinical trial: pactg 1020a [see clinical pharmacology (12.3) and clinical studies (14.3)] . the safety profile in pediatric patients was generally similar to that observed in adults [see adverse reactions (6.1)] . see dosage and administration (2.4) for dosing recommendations for the use of atazanavir capsules. clinical studies of atazanavir did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. based on a comparison of mean single-dose pharmacokinetic values for cmax and auc, a dose adjustment based upon age is not recommended. in general, appropriate caution should be exercised in the administration and monitoring of atazanavir in elderly patients reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. a study of the pharmacokinetics of atazanavir was performed in young (n=29; 18 to 40 years) and elderly (n=30; ≥65 years) healthy subjects. there were no clinically significant pharmacokinetic differences observed due to age or gender. atazanavir is not recommended for use in treatment-experienced patients with hiv-1 infection, who have end-stage renal disease managed with hemodialysis [see  dosage and administration (2.7) and clinical pharmacology (12.3)] . atazanavir is not recommended for use in patients with severe hepatic impairment. atazanavir with ritonavir is not recommended in patients with any degree of hepatic impairment [see dosage and administration (2.8) and clinical pharmacology (12.3)].

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

northstar rx llc - atazanavir sulfate (unii: 4mt4vie29p) (atazanavir - unii:qzu4h47a3s) - atazanavir capsule is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection in adults and in pediatric patients 6 years and older weighing at least 15 kg. limitations of use: - atazanavir capsules are not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus [see use in specific populations (8.4)].   - use of atazanavir capsules with ritonavir in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions [see microbiology (12.4)] . atazanavir capsules are contraindicated: - in patients with previously demonstrated clinically significant hypersensitivity (e.g., stevens-johnson syndrome, erythema multiforme, or toxic skin eruptions) to any of the components of atazanavir capsules [see warnings and precautions (5.2)]. - when coadministered with drugs that are highly dependent on cyp3a or ugt1a1 for clearance, and for which elevated plasma concentrations of the interacting drugs are associated with serious and/or life-threatening events (see table 6). - when coadministered with drugs that strongly induce cyp3a and may lead to lower exposure and loss of efficacy of atazanavir capsules (see table 6). table 6 displays drugs that are contraindicated with atazanavir capsules. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in patients exposed to atazanavir during pregnancy. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. risk summary atazanavir has been evaluated in a limited number of women during pregnancy. available human and animal data suggest that atazanavir does not increase the risk of major birth defects overall compared to the background rate [see data]. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. no treatment-related malformations were observed in rats and rabbits, for which the atazanavir exposures were 0.7 to 1.2 times of those at the human clinical dose (300 mg/day atazanavir boosted with 100 mg/day ritonavir). when atazanavir was administered to rats during pregnancy and throughout lactation, reversible neonatal growth retardation was observed [see data] . clinical considerations dose adjustments during pregnancy and the postpartum period - atazanavir must be administered with ritonavir in pregnant patients. - for pregnant patients, no dosage adjustment is required for atazanavir with the following exceptions: for treatment-experienced pregnant women during the second or third trimester, when atazanavir is coadministered with either an h2 -receptor antagonist or tenofovir df, atazanavir 400 mg with ritonavir 100 mg once daily is recommended. there are insufficient data to recommend a atazanavir dose for use with both an h2 -receptor antagonist and tenofovir df in treatment-experienced pregnant patients. - for treatment-experienced pregnant women during the second or third trimester, when atazanavir is coadministered with either an h2 -receptor antagonist or tenofovir df, atazanavir 400 mg with ritonavir 100 mg once daily is recommended. there are insufficient data to recommend a atazanavir dose for use with both an h2 -receptor antagonist and tenofovir df in treatment-experienced pregnant patients. - no dosage adjustment is required for postpartum patients. however, patients should be closely monitored for adverse events because atazanavir exposures could be higher during the first 2 months after delivery [see dosage and administration (2.6) and clinical pharmacology (12.3)]. maternal adverse reactions cases of lactic acidosis syndrome, sometimes fatal, and symptomatic hyperlactatemia have occurred in pregnant women using atazanavir in combination with nucleoside analogues, which are associated with an increased risk of lactic acidosis syndrome. hyperbilirubinemia occurs frequently in patients who take atazanavir [see warnings and precautions (5.8)] , including those who are pregnant [see data] . advise pregnant women of the potential risks of lactic acidosis syndrome and hyperbilirubinemia. fetal/neonatal adverse reactions all infants, including neonates exposed to atazanavir in utero , should be monitored for the development of severe hyperbilirubinemia during the first few days of life [see data]. data human data in study ai424-182, atazanavir with ritonavir (300/100 mg or 400/100 mg) coadministered with lamivudine/zidovudine (150 mg/ 300 mg, as fixed-dose product) was administered to 41 pregnant women with hiv-1 infection, during the second or third trimester. among the 39 women who completed the study, 38 women achieved an hiv-1 rna less than 50 copies/ml at time of delivery. six of 20 (30%) women on atazanavir with ritonavir 300/100 mg and 13 of 21 (62%) women on atazanavir with ritonavir 400/100 mg experienced hyperbilirubinemia (total bilirubin greater than or equal to 2.6 times uln). there were no cases of lactic acidosis observed in clinical trial ai424-182. atazanavir drug concentrations in fetal umbilical cord blood were approximately 12% to 19% of maternal concentrations. among the 40 infants born to 40 pregnant women with hiv-1 infection, all had test results that were negative for hiv-1 dna at the time of delivery and/or during the first 6 months postpartum. all 40 infants received antiretroviral prophylactic treatment containing zidovudine. no evidence of severe hyperbilirubinemia (total bilirubin levels greater than 20 mg/dl) or acute or chronic bilirubin encephalopathy was observed among neonates in this study. however, 10/36 (28%) infants (6 greater than or equal to 38 weeks gestation and 4 less than 38 weeks gestation) had bilirubin levels of 4 mg/dl or greater within the first day of life. lack of ethnic diversity was a study limitation. in the study population, 33/40 (83%) infants were black/african american, who have a lower incidence of neonatal hyperbilirubinemia than caucasians and asians. in addition, women with rh incompatibility were excluded, as well as women who had a previous infant who developed hemolytic disease and/or had neonatal pathologic jaundice (requiring phototherapy). additionally, of the 38 infants who had glucose samples collected in the first day of life, 3 had adequately collected serum glucose samples with values of less than 40 mg/dl that could not be attributed to maternal glucose intolerance, difficult delivery, or sepsis. based on prospective reports from the apr of approximately 1600 live births following exposure to atazanavir-containing regimens (including 1037 live births in infants exposed in the first trimester and 569 exposed in second/third trimesters), there was no difference between atazanavir, and overall birth defects compared with the background birth defect rate. in the u.s. general population, the estimated background risk of major birth defects in clinically recognized pregnancies is 2 to 4%. animal data in animal reproduction studies, there was no evidence of mortality or teratogenicity in offspring born to animals at systemic drug exposure levels (auc) 0.7 (in rabbits) to 1.2 (in rats) times those observed at the human clinical dose (300 mg/day atazanavir boosted with 100 mg/day ritonavir). in pre- and postnatal development studies in the rat, atazanavir caused neonatal growth retardation during lactation that reversed after weaning. maternal drug exposure at this dose was 1.3 times the human exposure at the recommended clinical exposure. minimal maternal toxicity occurred at this exposure level. risk summary the centers for disease control and prevention recommend that patients with hiv-1 infection, not breastfeed their infants to avoid risking postnatal transmission of hiv-1. atazanavir has been detected in human milk. no data are available regarding atazanavir effects on milk production. atazanavir was present in the milk of lactating rats and was associated with neonatal growth retardation that reversed after weaning. because of both the potential for hiv-1 transmission and the potential for serious adverse reactions in breastfed infants, advise women not to breastfeed. atazanavir capsule is indicated in combination with other antiretroviral agents for the treatment of pediatric patients with hiv-1 infection, 6 years of age and older weighing at least 15 kg. atazanavir is not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus [see indications and usage (1)] . all atazanavir contraindications, warnings, and precautions apply to pediatric patients [see contraindications (4) and warnings and precautions (5)] . the safety, pharmacokinetic profile, and virologic response of atazanavir in pediatric patients at least 6 years of age and older weighing at least 15 kg were established in an open-label, multicenter clinical trial: pactg 1020a [see clinical pharmacology (12.3) and clinical studies (14.3)] . the safety profile in pediatric patients was generally similar to that observed in adults [see adverse reactions (6.1)] . see dosage and administration (2.4) for dosing recommendations for the use of atazanavir capsules. clinical studies of atazanavir did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. based on a comparison of mean single-dose pharmacokinetic values for cmax and auc, a dose adjustment based upon age is not recommended. in general, appropriate caution should be exercised in the administration and monitoring of atazanavir in elderly patients reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. a study of the pharmacokinetics of atazanavir was performed in young (n=29; 18 to 40 years) and elderly (n=30; ≥65 years) healthy subjects. there were no clinically significant pharmacokinetic differences observed due to age or gender. atazanavir is not recommended for use in treatment-experienced patients with hiv-1 infection, who have end-stage renal disease managed with hemodialysis [see  dosage and administration (2.7) and clinical pharmacology (12.3)] . atazanavir is not recommended for use in patients with severe hepatic impairment. atazanavir with ritonavir is not recommended in patients with any degree of hepatic impairment [see dosage and administration (2.8) and clinical pharmacology (12.3)].

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

greenstone llc - atazanavir sulfate (unii: 4mt4vie29p) (atazanavir - unii:qzu4h47a3s) - atazanavir 150 mg - atazanavir is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection for patients 3 months and older weighing at least 5 kg. limitations of use: atazanavir is contraindicated: table 6 displays drugs that are contraindicated with atazanavir. drug class drugs within class that are contraindicated with atazanavir clinical comment alpha 1-adrenoreceptor antagonist alfuzosin potential for increased alfuzosin concentrations, which can result in hypotension. antimycobacterials rifampin rifampin substantially decreases plasma concentrations of atazanavir, which may result in loss of therapeutic effect and development of resistance. antineoplastics irinotecan atazanavir inhibits ugt1a1 and may interfere with the metabolism of irinotecan, resulting in increased irinotecan toxicities. antipsychotics lurasidone potential for serious and/or life-threatening reactions if atazanavir is coadministered with ritonavir. pimozide potential for serious and/or life-threatening reactions such

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

physicians total care, inc. - atazanavir sulfate (unii: 4mt4vie29p) (atazanavir - unii:qzu4h47a3s) - atazanavir 150 mg - reyataz® (atazanavir sulfate) is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection. this indication is based on analyses of plasma hiv-1 rna levels and cd4+ cell counts from controlled studies of 96 weeks duration in antiretroviral-naive and 48 weeks duration in antiretroviral-treatment-experienced adult and pediatric patients at least 6 years of age. the following points should be considered when initiating therapy with reyataz: - in study ai424-045, reyataz/ritonavir and lopinavir/ritonavir were similar for the primary efficacy outcome measure of time-averaged difference in change from baseline in hiv rna level. this study was not large enough to reach a definitive conclusion that reyataz/ritonavir and lopinavir/ritonavir are equivalent on the secondary efficacy outcome measure of proportions below the hiv rna lower limit of detection [see clinical studies (14.2) ]. - the number of baseline primary protease inhibitor mutations affects the virologic response to