IN ADULT HEMODIALYSIS PATIENTS WITH MODERATE-TO-SEVERE CKD-ASSOCIATED PRURITUS (CKD-aP),

KORSUVA provides significant
CKD-itch relief

KORSUVA DEMONSTRATED PROVEN EFFICACY

KORSUVA DEMONSTRATED PROVEN EFFICACY

KORSUVA DEMONSTRATED PROVEN EFFICACY

KORSUVA produced clinically meaningful reductions in CKD-itch:

  • The efficacy of KORSUVA was evaluated in two randomized, multicenter, double-blind, placebo-controlled trials (KALM-1 and KALM-2) that enrolled a total of 851 subjects 18
    years of age and older undergoing HD who had moderate-to-severe pruritus
  • In each trial, efficacy was assessed based on the proportion of subjects achieving a
    4-point or greater improvement (reduction) from baseline in the weekly mean of the daily 24-hour WI-NRS score at week 12
  • Mean baseline WI-NRS scores were 7.1 and 7.2 in KALM-1 and KALM-2, respectively

KORSUVA PROVIDED RAPID AND SUSTAINED RELIEF

Itch reduction was seen by week 4 and sustained through week 12

KORSUVA PROVIDED RAPID AND SUSTAINED RELIEF

KORSUVA PROVIDED RAPID AND SUSTAINED RELIEF

  • Test for statistical significance was not prespecified at weeks 4 and 8 in KALM-1

KORSUVA PROVIDED RAPID AND SUSTAINED RELIEF

KORSUVA PROVIDED RAPID AND SUSTAINED RELIEF

  • Significantly more KORSUVA patients achieved a ≥4-point improvement in itch intensity at
    12 weeks than placebo patients

Video: Korsuva Safety and Efficacy

KORSUVA safety and efficacy video

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WORST ITCHING INTENSITY NUMERICAL RATING SCALE (WI-NRS)

WI-NRS: Worst itching intensity over the past 24 hours on a scale of 1 to 10

WI-NRS: Worst itching intensity over the past 24 hours on a scale of 1 to 10

  • WI-NRS is a validated scale that measures patient-reported itch intensity over a 24-hour period1,2
  • It is a numerical rating ranging from 0 (“no itch”) to 10 (“worst itch imaginable”)

References: 1. Data on file as of August 2020. Cara Therapeutics. 2. Vernon M, Ständer S, Munera C, et al. Clinically meaningful change in itch intensity scores: An evaluation in patients with chronic kidney disease–associated pruritus. J Am Acad Dermatol. 2021;84(4):1132–1134. doi:10.1016/j.jaad.2020.06.991

Safety
INDICATION

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.

IMPORTANT SAFETY INFORMATION

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.

ADVERSE REACTIONS

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) (see Warnings and Precautions).

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INDICATION

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.

IMPORTANT SAFETY INFORMATION

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. The incidence of somnolence 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%). 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.

ADVERSE REACTIONS

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) (see Warnings and Precautions).