korsuva

Recommended dosage is 0.5 mcg/kg. ( 2.1 ) Administer by intravenous bolus injection into the venous line of the dialysis circuit at the end of each HD treatment. ( 2.1 ) Do not mix or dilute KORSUVA prior to administration. ( 2.2 ) Administer within 4 hours of syringe preparation. ( 2.3 ) See full prescribing information for additional recommendations on preparation and administration of KORSUVA. ( 2.2 , 2.3 ) 2.1 Dosage The recommended dosage of KORSUVA is 0.5 mcg/kg administered by intravenous bolus injection into the venous line of the dialysis circuit at the end of each HD treatment [see Dosage and Administration (2.3) ] . If a regularly scheduled HD treatment is missed, resume KORSUVA at the end of the next HD treatment. 2.2 Preparation Instructions Do not mix or dilute KORSUVA prior to administration. Inspect KORSUVA for particulate matter and discoloration prior to administration. The solution should be clear and colorless. Do not use KORSUVA vials if particulate matter or discoloration is observed. KORSUVA is supplied in a single-dose vial. Discard any unused product. Injection volume to be administered is determined by patient's target dry body weight in kilograms (one patient may use less than the full contents of the vial or use more than one vial). See Table 1 . Table 1. KORSUVA Injection Volumes Based on Target Dry Body Weight Target Dry Body Weight Range (kg)…

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 1-844-835-8277 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. A total of 1306 subjects undergoing HD who had moderate-to-severe pruritus were treated with KORSUVA in placebo-controlled and uncontrolled Phase 3 clinical trials. Of these, 711 were treated for at least 6 months and 400 were treated for at least one year. Two placebo-controlled Phase 3 trials (Trial 1 and Trial 2), in subjects undergoing HD who had moderate-to-severe pruritus were pooled to evaluate the safety of KORSUVA in comparison to placebo up to 12 weeks. In total, 848 subjects were evaluated (424 in KORSUVA group and 424 in…

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Single doses of KORSUVA up to 12 times and multiple doses of KORSUVA up to 5 times the recommended dosage of 0.5 mcg/kg were administered in clinical studies in subjects undergoing HD. A dose-dependent increase in adverse reactions, including dizziness, somnolence, mental status changes, paresthesia, fatigue, hypertension, and vomiting, were observed. In the event of overdosage, provide the appropriate medical attention based on patient's clinical status. Difelikefalin is primarily eliminated by the kidneys with a low plasma protein binding of approximately 23% to 28% in dialysis patients. Hemodialysis for 4 hours using a high-flux dialyzer effectively cleared approximately 70% to 80% of difelikefalin from plasma, and difelikefalin was not detectable in plasma at the end of the second of two dialysis cycles. [see Clinical Pharmacology (12.3) ].

U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.