Korsuva

5 mcg/kg. 1 ) Administer by intravenous bolus injection into the venous line of the dialysis circuit at the end of each HD treatment. 1 ) Do not mix or dilute KORSUVA prior to administration. 2 ) Administer within 4 hours of syringe preparation.

3 ) See full prescribing information for additional recommendations on preparation and administration of KORSUVA. 3) ] . If a regularly scheduled HD treatment is missed, resume KORSUVA at the end of the next HD treatment. 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.

1 mL). For patient target dry body weight outside of the ranges in Table 1, use this formula. 3 Administration Instructions KORSUVA is removed by the dialyzer membrane and must be administered after blood is no longer circulating through the dialyzer.

Administer KORSUVA by intravenous bolus injection into the venous line of the dialysis circuit at the end of each HD session. The dose may be given either during or after rinse back of the dialysis circuit. If the dose is given after rinse back, administer KORSUVA into the venous line followed by at least 10 mL of normal saline flush.

If the dose is given during rinse back, no additional normal saline is needed to flush the line. The dose must be administered within 4 hours of the syringe preparation. Discard any unused product.

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.

gov/medwatch . 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 placebo group).

The mean age of the subjects was 59 years (range 22 to 88 years), and 59% of the subjects were male. Of the total subjects, 61% were White, 29% were Black or African American, and 5% were Asian. Table 2 summarizes the adverse reactions that occurred at a rate of ≥2% in the KORSUVA group and ≥1% higher than that of the placebo group during the 12-week placebo-controlled period of Trials 1 and 2.

7% for subjects taking placebo. 5% and 0%, respectively). 8% in the placebo group. 2) Mental Status Change Mental Status Change includes: preferred terms of confusional state and mental status change. 4% of subjects who received placebo.

Falls were reported as serious adverse reactions in < 1% of subjects receiving KORSUVA and placebo, with one subject discontinuing KORSUVA due to gait disturbance. 8% of subjects who received placebo. Dizziness occurred within the first 3 weeks of treatment and was generally transient.

5 WARNINGS AND PRECAUTIONS 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.

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 patient's ability to drive or operate machinery is known.

1) ] . 0% of patients who received placebo. 8%). Concomitant use of centrally-acting depressant medications, sedating antihistamines and opioid analgesics may increase the likelihood of these adverse reactions and should be used with caution during treatment with KORSUVA.

2 Risk of Driving and Operating Machinery Dizziness, somnolence, and mental status changes have occurred in patients taking KORSUVA. KORSUVA may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car and operating machinery.

Advise patients not to drive or operate dangerous machinery until the effect of KORSUVA on a patient's ability to drive or operate machinery is known .

4 CONTRAINDICATIONS None None