pirfenidone - search results

European Union - English - EMA (European Medicines Agency)

pirfenidone axunio (previously pirfenidone aet)

axunio pharma gmbh - pirfenidone - idiopathic pulmonary fibrosis - immunosuppressants - pirfenidone aet is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (ipf).

Australia - English - Department of Health (Therapeutic Goods Administration)

pirfenidone sandoz pirfenidone 801 mg film-coated tablet bottle

sandoz pty ltd - pirfenidone, quantity: 801 mg - tablet - excipient ingredients: pregelatinised starch; croscarmellose sodium; hyprolose; magnesium stearate; silicon dioxide; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black - pirfenidone sandoz is indicated for the treatment of idiopathic pulmonary fibrosis (ipf).

Australia - English - Department of Health (Therapeutic Goods Administration)

pirfenidone sandoz pirfenidone 267 mg film-coated tablet bottle

sandoz pty ltd - pirfenidone, quantity: 267 mg - tablet - excipient ingredients: hyprolose; silicon dioxide; croscarmellose sodium; magnesium stearate; pregelatinised starch; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350 - pirfenidone sandoz is indicated for the treatment of idiopathic pulmonary fibrosis (ipf)

European Union - English - EMA (European Medicines Agency)

pirfenidone viatris

viatris limited - pirfenidone - idiopathic pulmonary fibrosis; lung diseases; respiratory tract diseases - immunosuppressants - pirfenidone viatris is indicated in adults for the treatment of mild to moderate idiopathic pulmonary fibrosis (ipf).

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

pirfenidone capsule pirfenidone tablet, film coated

laurus labs limited - pirfenidone (unii: d7nld2jx7u) (pirfenidone - unii:d7nld2jx7u) - pirfenidone is indicated for the treatment of idiopathic pulmonary fibrosis (ipf). none. risk summary the data with pirfenidone use in pregnant women are insufficient to inform on drug associated risks for major birth defects and miscarriage. in animal reproduction studies, pirfenidone was not teratogenic in rats and rabbits at oral doses up to 3 and 2 times, respectively, the maximum recommended daily dose (mrdd) in adults [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. data animal data animal reproductive studies were conducted in rats and rabbits. in a combined fertility and embryofetal development study, female rats received pirfenidone at oral doses of 0, 50, 150, 450, and 1,000 mg/kg/day from 2 weeks prior to mating, during the mating phase, and throughout the periods of early embryonic development from gestation days (gd) 0 to 5 and organogenesis from gd 6 to 17. in an embryofetal development study, pregnant rabbits received pirfenidone at oral doses of 0, 30, 100, and 300 mg/kg/day throughout the period of organogenesis from gd 6 to 18. in these studies, pirfenidone at doses up to 3 and 2 times, respectively, the maximum recommended daily dose (mrdd) in adults (on mg/m2 basis at maternal oral doses up to 1,000 mg/kg/day in rats and 300 mg/kg/day in rabbits, respectively) revealed no evidence of impaired fertility or harm to the fetus due to pirfenidone. in the presence of maternal toxicity, acyclic/irregular cycles (e.g., prolonged estrous cycle) were seen in rats at doses approximately equal to and higher than the mrdd in adults (on a mg/m2 basis at maternal doses of 450 mg/kg/day and higher). in a pre- and post-natal development study, female rats received pirfenidone at oral doses of 0, 100, 300, and 1,000 mg/kg/day from gd 7 to lactation day 20. prolongation of the gestation period, decreased numbers of live newborn, and reduced pup viability and body weights were seen in rats at an oral dosage approximately 3 times the mrdd in adults (on a mg/m2 basis at a maternal oral dose of 1,000 mg/kg/day). risk summary no information is available on the presence of pirfenidone in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. the lack of clinical data during lactation precludes clear determination of the risk of pirfenidone to an infant during lactation; therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for pirfenidone and the potential adverse effects on the breastfed child from pirfenidone or from the underlying maternal condition. data animal data: a study with radio-labeled pirfenidone in rats has shown that pirfenidone or its metabolites are excreted in milk. there are no data on the presence of pirfenidone or its metabolites in human milk, the effects of pirfenidone on the breastfed child, or its effects on milk production. safety and effectiveness of pirfenidone in pediatric patients have not been established. of the total number of subjects in the clinical studies receiving pirfenidone, 714 (67%) were 65 years old and over, while 231 (22%) were 75 years old and over. no overall differences in safety or effectiveness were observed between older and younger patients. no dosage adjustment is required based upon age. pirfenidone should be used with caution in patients with mild (child pugh class a) to moderate (child pugh class b) hepatic impairment. monitor for adverse reactions and consider dosage modification or discontinuation of pirfenidone as needed [ see dosage and administration (2.3)] . the safety, efficacy, and pharmacokinetics of pirfenidone have not been studied in patients with severe hepatic impairment. pirfenidone is not recommended for use in patients with severe (child pugh class c) hepatic impairment [see clinical pharmacology (12.3)] . pirfenidone should be used with caution in patients with mild (clcr 50 to 80 ml/min), moderate (clcr 30 to 50 ml/min), or severe (clcr less than 30 ml/min) renal impairment [see clinical pharmacology (12.3)]. monitor for adverse reactions and consider dosage modification or discontinuation of pirfenidone as needed [ see dosage and administration (2.3) ] . the safety, efficacy, and pharmacokinetics of pirfenidone have not been studied in patients with end-stage renal disease requiring dialysis. use of pirfenidone in patients with end-stage renal diseases requiring dialysis is not recommended. smoking causes decreased exposure to pirfenidone [see clinical pharmacology (12.3)], which may alter the efficacy profile of pirfenidone. instruct patients to stop smoking prior to treatment with pirfenidone and to avoid smoking when using pirfenidone.