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CKD-aP is prevalent

MANY HEMODIALYSIS (HD) PATIENTS REPORTED SUFFERING FROM CKD-AP1

In the Dialysis Outcomes and Practice Patterns Study (DOPPS)*:

ckd

of HD patients in
the U.S. reported that
they suffered from CKD-aP

ckd2

of HD patients in
the U.S. were moderately
to extremely bothered by itch

PATIENTS MAY NOT ALWAYS REPORT THEIR ITCHING2

In DOPPS:

ckd3

of medical directors
underestimated the prevalence of
CKD-aP in their dialysis facilities

ckd2

of U.S. HD patients who were nearly
always or always bothered by itching did
not report it to any healthcare provider

*Phases 4–6 of DOPPS (a prospective cohort study) included 34,694 HD patients in 21 countries from 2009–2018; 23,264 patients were eligible for analysis of the primary outcome. The primary clinical outcome was time to all-cause mortality; dialysis-related outcomes included withdrawal from dialysis and missed HD sessions; patient-reported outcomes included measures of health-related quality of life, depression, and sleep quality.

Figure calculated based on total patients reporting being somewhat to extremely bothered by itching.

Phases 1–5 of DOPPS (a prospective cohort study) included 51,062 HD patients in 21 countries
from 1996–2015; 35,452 patients answered the question regarding how bothered they were by
itchy skin in a questionnaire and were included in this analysis.

References: 1. Sukul N, Karaboyas A, Csomor PA, et al. Self-reported pruritus and clinical,
dialysis-related, and patient-reported outcomes in hemodialysis patients. Kidney Med.
2020;3(1):42–53. doi:10.1016/j.xkme.2020.08.011  2. Rayner HC, Larkina M, Wang M, et al.
International comparisons of prevalence, awareness, and treatment of pruritus in people on
hemodialysis. Clin J Am Soc Nephrol. 2017;12(12):2000–2007. doi:10.2215/CJN.03280317

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).