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

lannett company, inc. - lopinavir (unii: 2494g1jf75) (lopinavir - unii:2494g1jf75), ritonavir (unii: o3j8g9o825) (ritonavir - unii:o3j8g9o825) - lopinavir 80 mg in 1 ml - lopinavir and ritonavir is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection in adults and pediatric patients 14 days and older. limitations of use: - genotypic or phenotypic testing and/or treatment history should guide the use of lopinavir and ritonavir. the number of baseline lopinavir resistance-associated substitutions affects the virologic response to lopinavir and ritonavir [see microbiology ( 12.4 )] . genotypic or phenotypic testing and/or treatment history should guide the use of lopinavir and ritonavir. the number of baseline lopinavir resistance-associated substitutions affects the virologic response to lopinavir and ritonavir [see microbiology ( 12.4 )] . - lopinavir and ritonavir is contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g., toxic epidermal necrolysis, stevens-johnson syndrome, erythema multiforme, urticaria, angioedema) to any of its ingredients, including ritonavir. lopinavir and riton

Israel - English - Ministry of Health

teva israel ltd - atazanavir as sulfate - capsules - atazanavir as sulfate 200 mg - atazanavir - atazanavir teva ® is indicated in combination with other antiretroviral agents for for the treatment of hiv-1 infection.

Israel - English - Ministry of Health

teva israel ltd - atazanavir as sulfate - capsules - atazanavir as sulfate 300 mg - atazanavir - atazanavir teva ® is indicated in combination with other antiretroviral agents for for the treatment of hiv-1 infection.

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)

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)

mylan pharmaceuticals inc. - fosamprenavir calcium (unii: id1gu2627n) (amprenavir - unii:5s0w860xnr) - fosamprenavir 700 mg - fosamprenavir calcium tablets are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (hiv-1) infection. the following points should be considered when initiating therapy with fosamprenavir plus ritonavir in protease inhibitor-experienced patients: there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to fosamprenavir during pregnancy. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. limited data are available for use of fosamprenavir in pregnancy. fosamprenavir 700 mg twice daily taken with ritonavir 100 mg twice daily should only be considered in pregnant patients who are already on a stable twice-daily regimen of fosamprenavir/ritonavir 700 mg/100 mg prior to pregnancy, and who are virologically suppressed (hiv-1 rna less than 50 copies per ml) (see clinical considerations and data). there are insufficient human data on the use of fosam

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

west-ward pharmaceuticals corp. - ritonavir (unii: o3j8g9o825) (ritonavir - unii:o3j8g9o825) - ritonavir 100 mg - ritonavir tablets are indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection. when co-administering ritonavir with other protease inhibitors, see the full prescribing information for the co-administered protease inhibitor including important information for use in special populations. pregnancy exposure registry: there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ritonavir during pregnancy. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1–800–258–4263. risk summary: prospective pregnancy data from the antiretroviral pregnancy registry (apr) are not sufficient to adequately assess the risk of birth defects or miscarriage. available data from the apr show no difference in the rate of overall birth defects for ritonavir compared to 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] . in animal reproduction studies, no evidence of adverse developmental outcomes was observed with oral administration of ritonavir to pregnant rats and rabbits. during organogenesis in the rat and rabbit, systemic exposure (auc) was approximately 1/3 lower than human exposure at the recommended daily dose. in the rat pre- and post-natal developmental study, maternal systemic exposure to ritonavir was approximately 1/2 of the exposure in humans at the recommended daily dose, based on a body surface area conversion factor [see data] . ritonavir oral solution is not recommended during pregnancy because there is no known safe level of ethanol exposure during pregnancy [see clinical considerations, dosage and administration (2.3) and warnings and precautions (5.2)] . the background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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. clinical considerations: dose adjustments during pregnancy and the postpartum period: ritonavir oral solution contains approx. 43% ethanol (v/v) and approx. 27% (w/v) propylene glycol and is not recommended during pregnancy because there is no known safe level of ethanol exposure during pregnancy [see dosage and administration (2.3) and warnings and precautions (5.2)] . data: human data: based on prospective reports to the apr of approximately 6,100 live births following exposure to ritonavir-containing regimens (including over 2,800 live births exposed in the first trimester and over 3,200 live births exposed in the second and third trimesters), there was no difference in the rate of overall birth defects for ritonavir compared with the background birth defect rate of 2.7% in the u.s. reference population of the macdp. the prevalence of birth defects in live births was 2.3% (95% ci: 1.7% to 2.9%) following first-trimester exposure to ritonavir-containing regimens and 2.9% (95% ci: 2.3% to 3.5%) following second and third trimester exposure to ritonavir-containing regimens. while placental transfer of ritonavir and fetal ritonavir concentrations are generally low, detectable levels have been observed in cord blood samples and neonate hair. animal data: ritonavir was administered orally to pregnant rats (at 0, 15, 35, and 75 mg/kg/day) and rabbits (at 0, 25, 50, and 110 mg/kg/day) during organogenesis (on gestation days 6 through 17 and 6 through 19, respectively). no evidence of teratogenicity due to ritonavir was observed in rats and rabbits at doses producing systemic exposures (auc) equivalent to approximately 1/3 lower than human exposure at the recommended daily dose. developmental toxicity observed in rats (early resorptions, decreased fetal body weight and ossification delays and developmental variations) occurred at a maternally toxic dose, at an exposure equivalent to approximately 1/3 lower than human exposure at the recommended daily dose. a slight increase in the incidence of cryptorchidism was also noted in rats (at a maternally toxic dose) at an exposure approximately 1/5 lower than human exposure at the recommended daily dose. developmental toxicity was observed in rabbits (resorptions, decreased litter size and decreased fetal weights) at maternally toxic doses approximately 1.8 times higher than the recommended daily dose, based on a body surface area conversion factor. in pre-and postnatal development study in rats, ritonavir was administered at doses of 0, 15, 35, and 60 mg/kg/day from gestation day 6 through postnatal day 20. at doses of 60 mg/kg/day, no developmental toxicity was noted with ritonavir dosage equivalent to 1/2 of the recommended daily dose, based on a body surface area conversion factor. risk summary: the centers for disease control and prevention recommend that hiv-infected mothers not breastfeed their infants to avoid risking postnatal transmission of hiv. limited published data reports that ritonavir is present in human milk. there is no information on the effects of ritonavir on the breastfed infant or the effects of the drug on milk production. because of the potential for (1) hiv transmission (in hiv-negative infants), (2) developing viral resistance (in hiv-positive infants) and (3) serious adverse reactions in a breastfed infant, instruct mothers not to breastfeed if they are receiving ritonavir. contraception: use of ritonavir may reduce the efficacy of combined hormonal contraceptives. advise patients using combined hormonal contraceptives to use an effective alternative contraceptive method or an additional barrier method of contraception [see drug interactions (7.2)] . in hiv-infected patients age greater than 1 month to 21 years, the antiviral activity and adverse event profile seen during clinical trials and through postmarketing experience were similar to that for adult patients. clinical studies of ritonavir did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. no dose adjustment of ritonavir is necessary for patients with either mild (child-pugh class a) or moderate (child-pugh class b) hepatic impairment. no pharmacokinetic or safety data are available regarding the use of ritonavir in subjects with severe hepatic impairment (child-pugh class c), therefore, ritonavir is not recommended for use in patients with severe hepatic impairment [see warnings and precautions (5.3), clinical pharmacology (12.3)].

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

remedyrepack inc. - ritonavir (unii: o3j8g9o825) (ritonavir - unii:o3j8g9o825) - ritonavir 100 mg - ritonavir tablets are indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection. - when co-administering ritonavir with other protease inhibitors, see the full prescribing information for that protease inhibitor including contraindication information. - ritonavir is contraindicated in patients with known hypersensitivity (e.g., toxic epidermal necrolysis (ten) or stevens-johnson syndrome) to ritonavir or any of its ingredients. - ritonavir is contraindicated with drugs that are highly dependent on cyp3a for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening reactions. - ritonavir is contraindicated with drugs that are potent cyp3a inducers where significantly reduced lopinavir plasma concentrations may be associated with the potential for loss of virologic response and possible resistance and cross-resistance. drug class drugs within class that are contraindicated with ritonavir 2 clinical comments alpha 1 -adreno

Israel - English - Ministry of Health

teva pharmaceutical industries ltd, israel - darunavir - film coated tablets - darunavir 800 mg - darunavir - darunavir teva co-administered with 100 mg ritonavir and with other antiretroviral agents,is indicated for the treatment of human immunodeficiency virus (hiv-1) infection for patients over 18 years of age.