WARNINGS AND PRECAUTIONS
Dizziness, Somnolence, Mental Status Changes, and Gait Disturbances: These adverse reactions, including falls, have occurred in patients taking KORSUVA and may subside with continued treatment. 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.
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 their ability to do so is known.
The most common adverse reactions (incidence ≥2% and ≥1% higher than placebo) were diarrhea (9.0%), dizziness (6.8%), nausea (6.6%), gait disturbances, including falls (6.6%), hyperkalemia (4.7%), headache (4.5%), somnolence (4.2%), and mental status changes (3.3%).
USE IN SPECIFIC POPULATIONS
Severe Hepatic Impairment: The influence of severe hepatic impairment on the pharmacokinetics of KORSUVA in subjects undergoing hemodialysis (HD) has not been evaluated; therefore, use of KORSUVA in this population is not recommended.
Geriatric Use: The incidence of somnolence was higher in KORSUVA-treated subjects aged 65 years and older (7.0%) than in KORSUVA-treated subjects less than 65 years of age (2.8%). The incidence was comparable in both placebo age groups (3.0% and 2.1%, respectively).
KORSUVA is indicated for the treatment of moderate to severe pruritus associated with chronic kidney disease (CKD-aP) in adults undergoing hemodialysis (HD).
Limitation of Use: KORSUVA has not been studied in patients on peritoneal dialysis and is not recommended for use in this population.
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CKD=chronic kidney disease; CKD-aP=chronic kidney disease–associated pruritus; HD=hemodialysis.
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