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

seqirus pty ltd - difelikefalin acetate, quantity: 55 microgram (equivalent: difelikefalin, qty 50 microgram) - injection, solution - excipient ingredients: sodium chloride; sodium acetate trihydrate; acetic acid; water for injections - korsuva is indicated for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adult patients on haemodialysis.

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

vifor (international) inc. - difelikefalin acetate (unii: 0p70ar5byb) (difelikefalin - unii:na1u919mro) - korsuva is indicated for the treatment of moderate-to-severe pruritus associated with chronic kidney disease (ckd-ap) in adults undergoing hemodialysis (hd). limitations of use korsuva has not been studied in patients on peritoneal dialysis and is not recommended for use in this population. none risk summary the limited human data on use of korsuva in pregnant women are not sufficient to evaluate a drug-associated risk for major birth defects or miscarriage. in animal reproduction studies, intravenous injection of difelikefalin to pregnant rats and rabbits during the period of organogenesis at doses 711 and 10 times the maximum recommended human dose (mrhd), respectively, resulted in no adverse effects in either rats or rabbits (see data) . the estimated background risk of major birth defects and miscarriage for the indicated population is 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 embryofetal development study, difelikefalin was administered by intravenous injection to pregnant rats at doses of 0.25, 2.5, and 25 mg/kg/day during the period of organogenesis. difelikefalin was not associated with embryofetal lethality or fetal malformations. difelikefalin increased the incidences of skeletal variations (wavy ribs and incompletely ossified ribs) at the dose of 25 mg/kg/day (711 times the mrhd based on auc comparison). in an embryofetal development study, difelikefalin was administered by intravenous injection to pregnant rabbits at doses of 0.025, 0.05, and 0.1 mg/kg/day during the period of organogenesis. maternal toxicity evidenced by decreased maternal body weight gain was noted in all dose groups. difelikefalin was not associated with embryofetal lethality or fetal malformations at doses up to 0.1 mg/kg/day (10 times the mrhd based on auc comparison). in a prenatal and postnatal development study, difelikefalin was administered by intravenous injection to pregnant rats at doses of 0.6, 2.5, and 10 mg/kg/day beginning on gestation day 7 and continuing through lactation day 20. persisting effects on decreased maternal body weight and/or maternal body weight gain as well as food consumption were noted at doses greater than or equal to 2.5 mg/kg/day (68 times the mrhd based on auc comparison). no maternal effects were observed at 0.6 mg/kg/day (14 times the mrhd based on auc comparison). no difelikefalin-related effects on postnatal developmental, neurobehavioral, or reproductive performance of offspring were noted at doses up to 10 mg/kg/day (282 times the mrhd based on auc comparison). risk summary there are no data regarding the presence of korsuva in human milk or effects on the breastfed infant or on milk production. studies in rats showed difelikefalin was transferred into the milk in lactating rats. when a drug is present in animal milk, it is likely that the drug will be present in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for korsuva and any potential adverse effects on the breastfed child from korsuva or from the underlying maternal condition. data animal data difelikefalin was administered to lactating rats by intravenous injection at doses of 0.6, 2.5, or 10 mg/kg/day from gestation day 7 through lactation day 14. difelikefalin was detected in the milk of the lactating rats with the concentration ratio for milk:plasma of 0.04 to 0.05 across the doses. there was no measurable difelikefalin in the plasma of nursing pups. the safety and effectiveness of korsuva in pediatric patients have not been established. of the 848 subjects in the placebo-controlled studies who received korsuva, 278 subjects (32.8%) were 65 years of age and older and 98 subjects (11.6%) were 75 years of age and older. no overall differences in safety or effectiveness of korsuva have been observed between patients 65 years of age and older and younger adult subjects, with the exception of the incidence of somnolence which was higher in korsuva-treated subjects 65 years of age and older (7.0%) than in korsuva-treated subjects less than 65 years of age (2.8%), and was comparable in both placebo age groups (3.0% and 2.1%, respectively). no differences in plasma concentrations of korsuva were observed between subjects 65 years of age and older and younger adult subjects [see clinical pharmacology ( 12.3)] . the influence of mild-to-moderate hepatic impairment on the pharmacokinetics of korsuva was evaluated in a population pharmacokinetic analysis which concluded that no korsuva dosage adjustments are needed in these populations [see clinical pharmacology ( 12.3)] . the influence of severe hepatic impairment on the pharmacokinetics of korsuva in subjects undergoing hd has not been evaluated; therefore, use of korsuva in this population is not recommended.

Israel - English - Ministry of Health

cts ltd - difelikefalin as acetate - solution for injection - difelikefalin as acetate 50 mcg / 1 ml - difelikefalin - korsuva is indicated for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adult patients on haemodialysis

European Union - English - EMA (European Medicines Agency)

vifor fresenius medical care renal pharma france - difelikefalin - pruritus - all other therapeutic products - kapruvia is indicated for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adult patients on haemodialysis (see section 5.1).

Canada - English - Health Canada

kefa hightech corporation - didecyl dimethyl ammonium chloride - liquid - 7.5% - didecyl dimethyl ammonium chloride 7.5% - disinfectants (for agents used on object)

Canada - English - Health Canada

vifor fresenius medical care renal pharma ltd - difelikefalin (difelikefalin acetate) - solution - 50mcg - difelikefalin (difelikefalin acetate) 50mcg

Ireland - English - HPRA (Health Products Regulatory Authority)

bimeda animal health limited - cefalexin; dihydrostreptomycin sulfate - intramammary suspension - 500/500 mg/syringe - cefalexin, combinations with other antibacterials

Israel - English - Ministry of Health

vitamed ltd,binyamina - cefazolin sodium 1000 mg/vial - powder for solution for injection - cefazolin - kefazin is indicated for the treatment of infections due to susceptible organisms.

Singapore - English - HSA (Health Sciences Authority)

vifor pharma asia pacific pte. ltd. - difelikefalin acetate eqv difelikefalin - injection, solution - difelikefalin acetate eqv difelikefalin 0.05mg/ ml