avacopan - search results

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

tavneos- avacopan capsule

chemocentryx, inc. - avacopan (unii: o880nm097t) (avacopan - unii:o880nm097t) - tavneos is indicated as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (anca)-associated vasculitis (granulomatosis with polyangiitis [gpa] and microscopic polyangiitis [mpa]) in combination with standard therapy including glucocorticoids. tavneos does not eliminate glucocorticoid use. tavneos is contraindicated in patients with serious hypersensitivity reaction to avacopan or to any of the excipients [see warnings and precautions (5.2)]. risk summary there are no adequate and well-controlled studies with tavneos in pregnant women to inform a drug-associated risk. in animal reproduction studies, oral administration of avacopan to pregnant hamsters and rabbits during the period of organogenesis produced no evidence of fetal harm with exposures up to approximately 5 and 0.6 times, respectively, the exposure at the maximum recommended human dose (mrhd) of 30 mg twice daily (on an area under the curve [auc] basis). avacopan caused an increase in the number of abortions in rabbits at an exposure 0.6 times the mrhd (see animal data) . the background risk of major birth defects and miscarriage for the indicated population are unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. data animal data in an embryo-fetal development study with pregnant hamsters dosed by the oral route during the period of organogenesis from gestation days 6 to 12, avacopan produced an increase in the incidence of a skeletal variation, described as supernumerary ribs, at an exposure that was 5 times the mrhd (on an auc basis with a maternal oral dose of 1000 mg/kg/day). no structural abnormalities were noted with exposures up to 5 times the mrhd (on an auc basis with maternal oral doses up to 1000 mg/kg/day). in an embryo-fetal development study with pregnant rabbits dosed by the oral route during the period of organogenesis from gestation days 6 to 18, avacopan caused an increase in the number of abortions at an exposure 0.6 times the mrhd (on an auc basis with a maternal oral dose of 200 mg/kg/day), however, no evidence of fetal harm was observed with such exposures. maternal toxicity, as evidenced by decreased body weight gains, was observed at exposures 0.6 times and higher than the mrhd (on an auc basis with maternal oral doses of 30 mg/kg/day and higher). in a prenatal and postnatal development study with pregnant hamsters dosed by the oral route during the periods of gestation and lactation from gestation day 6 to lactation day 20, avacopan had no effects on the growth and development of offspring with exposures up to approximately 5 times the mrhd (on an auc basis with maternal oral doses up to 1000 mg/kg/day). risk summary there are no available data on the effects of avacopan on the breastfed child or on milk production. it is unknown whether avacopan is secreted in human milk. avacopan was detected in the plasma of undosed hamster pups nursing from drug-treated dams (see animal data) . the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for tavneos and any potential adverse effects on the breast-fed infant from tavneos or from the underlying maternal condition. animal data avacopan has not been measured in the milk of lactating animals; however, it was detected in the plasma of nursing offspring in a pre- and post-natal development study with hamsters at a pup to maternal plasma ratio of 0.37. this finding suggests that avacopan is secreted into the milk of lactating hamsters. [see nonclinical toxicology (13.1)]. the safety and effectiveness of tavneos in pediatric patients have not been established. of the 86 geriatric patients who received tavneos in the phase 3 randomized clinical trial for anca-associated vasculitis [see clinical studies (14)] , 62 patients were between 65-74 years and 24 were 75 years or older. no overall differences in safety or effectiveness were observed between geriatric patients and younger patients. no dose adjustment is required for patients with mild, moderate, or severe renal impairment [see clinical pharmacology (12.3)] . tavneos has not been studied in patients with anca-associated vasculitis who are on dialysis. no dosage adjustment is recommended for patients with mild or moderate (as indicated by the child-pugh method) hepatic impairment [clinical pharmacology (12.3)] . tavneos has not been studied in patients with severe hepatic impairment (child-pugh class c).

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

tavneos avacopan 10 mg hard capsule bottle

seqirus pty ltd - avacopan, quantity: 10 mg - capsule, hard - excipient ingredients: shellac; iron oxide yellow; titanium dioxide; iron oxide red; gelatin; potassium hydroxide; iron oxide black; peg-40 hydrogenated castor oil; macrogol 4000; polysorbate 80 - tavneos, in combination with a rituximab or cyclophosphamide based regimen, is indicated for the treatment of adults with anti-neutrophil cytoplasmic autoantibody (anca)-associated vasculitis (granulomatosis with polyangiitis [gpa] and microscopic polyangiitis [mpa]).

Israel - English - Ministry of Health

tavneos

cts ltd - avacopan - hard capsule - avacopan 10 mg - avacopan - tavneos, in combination with a rituximab or cyclophosphamide regimen, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (gpa) or microscopic polyangiitis (mpa).

European Union - English - EMA (European Medicines Agency)

tavneos

vifor fresenius medical care renal pharma france - avacopan - microscopic polyangiitis; wegener granulomatosis - immunosuppressants - tavneos, in combination with a rituximab or cyclophosphamide regimen, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (gpa) or microscopic polyangiitis (mpa).