KORSUVA (difelikefalin acetate)

The pharmacokinetics of difelikefalin is dose proportional over a single dosage range from 1 to 3 mcg/kg (2 to 6 times the recommended dosage) and multiple intravenous dosage range from 0.5 to 2.5 mcg/kg (1 to 5 times the recommended dosage) in chronic kidney disease patients undergoing HD. Steady-state was reached after the second administered dosage and the mean accumulation ratio was up to 1.6.

DistributionThe mean volume of distribution of difelikefalin is approximately 238 mL/kg. Difelikef...

The efficacy of KORSUVA was evaluated in two randomized, multicenter, double-blind, placebo-controlled trials (Trial 1 [NCT03422653] and Trial 2 [NCT03636269]) that enrolled a total of 851 subjects 18 years of age and older undergoing HD who had moderate-to-severe pruritus. In both trials, subjects received intravenous bolus injections of KORSUVA 0.5 mcg per kilogram of dry body weight into the venous line of the hemodialysis circuit at the end of each hemodialysis session or placebo three times per week for 12 weeks. In both trials, a 7-day run-in period prior to randomization was used to con...

The following clinically significant adverse reactions are described elsewhere in the labeling: Dizziness, Somnolence, Mental Status Changes, and Gait Disturbances [see Warnings and Precautions (5.1) ] The most common adverse reactions (incidence ≥2% and ≥1% higher than placebo) were diarrhea, dizziness, nausea, gait disturbances, including falls, hyperkalemia, headache, somnolence, and mental status change. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Vifor (International) Inc. at 1-844...

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Dizziness, Somnolence, Mental Status Changes, and Gait Disturbances: Dizziness, somnolence, mental status changes, and gait disturbances, including falls, have occurred. Centrally-acting depressant medications, sedating antihistamines, and opioid analgesics should be used with caution during treatment with KORSUVA. ( 5.1 ) Risk of Driving and Operating Machinery: May impair mental or physical abilities. Advise patients not to drive or operate dangerous machinery until the effect of KORSUVA on a ...