The safety of KORSUVA was studied in over 1300 people undergoing dialysis with moderate-to-severe chronic kidney disease–associated pruritus (CKD-aP).
711 people with moderate-to-severe pruritus undergoing dialysis received KORSUVA for at least 6 months in clinical trials, and 400 people received KORSUVA for at least one year.
In 2 trials studying 851 patients:
- 2.6% of people receiving KORSUVA stopped treatment due to a side effect (0.7% of people stopped placebo due to a side effect).
- Serious side effects occurred in 4.5% of people who received KORSUVA and 2.8% of people who received placebo.
Side effects in clinical studies
These side effects can occur during treatment with KORSUVA:
|Most frequent side effects*||KORSUVA||Placebo|
|Trouble walking (including falls)||6.6%||5.4%|
|Mental status changes (e.g., confusion)||3.3%||1.4%|
*Side effects in ≥2% of KORSUVA-treated subjects and ≥1% higher than placebo. 848 subjects were evaluated (424 in KORSUVA group and 424 in placebo group).
When starting any new treatment, it’s important to understand the potential side effects. KORSUVA was generally well tolerated in clinical trials with over 1300 patients.
Contact your healthcare team right away if you experience any of the symptoms listed above. These are not all of the possible side effects of KORSUVA. Talk to your healthcare team about the possible side effects of KORSUVA and ask if it may be right for you.
Sleepiness is more likely to happen in patients who are 65 years or older.
Taking certain medications for depression, anxiety, epilepsy, insomnia, allergies, or pain may increase the likelihood of these side effects, and these medications should be used with caution during treatment with KORSUVA.
KORSUVA may impair your ability to perform potentially hazardous activities such as driving a car or operating heavy machinery. You should not drive a car or operate dangerous machinery until you know how KORSUVA affects your ability to perform these activities.