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 |
|---|---|---|
| Diarrhea | 9.0% | 5.7% |
| Dizziness | 6.8% | 3.8% |
| Nausea | 6.6% | 4.5% |
| Trouble walking (including falls) | 6.6% | 5.4% |
| High potassium | 4.7% | 3.5% |
| Headache | 4.5% | 2.6% |
| Sleepiness | 4.2% | 2.4% |
| 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.
WHAT IS KORSUVA?
KORSUVA is a prescription medicine used to treat moderate-to-severe pruritus (itching) associated with chronic kidney disease (CKD-aP) in adults undergoing hemodialysis (HD).
KORSUVA is not recommended in patients undergoing peritoneal dialysis (fluid taken from abdomen).
IMPORTANT SAFETY INFORMATION
What are the possible side effects of KORSUVA?
KORSUVA may cause serious side effects, including:
- Dizziness, sleepiness, mental status changes (e.g., confusion), and trouble walking (which may lead to falls). Sleepiness is more likely to occur in patients who are 65 years or older. Taking KORSUVA with centrally acting depressant medications (including anti-depressants and medicines used for anxiety, epilepsy, insomnia), sedating antihistamines (allergy medicines that can cause drowsiness), and opioid analgesics (certain pain medications) may increase the likelihood of these side effects.
- Impairment of mental or physical abilities. You should not drive or operate dangerous machinery until the effect of KORSUVA on your ability to drive or operate machinery is known. The most common side effects of KORSUVA include: diarrhea, dizziness, nausea, trouble walking (including falls), high potassium, headache, sleepiness, and mental status changes (e.g., confusion).
What should I tell my doctor before taking KORSUVA?
Before you take KORSUVA, tell your doctor if you:
- are currently taking centrally acting depressant medications (including anti-depressants and medicines used for anxiety, epilepsy, insomnia), sedating antihistamines (allergy medicines that can cause drowsiness) or opioid analgesics (certain pain medications)
- regularly drive or operate dangerous machinery
Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Tell your doctor if you are pregnant or breastfeeding or plan to become pregnant or breastfeed. In pre-clinical studies, KORSUVA was shown to be transferable into breastmilk.
Tell your doctor if you have any side effect that bothers you or does not go away. These are not all of the possible side effects of KORSUVA. You may report side effects to Vifor (International) Inc. at
1-844-835-8277 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
The risk information provided here is not comprehensive and does not take the place of talking with your doctor about your medical condition or treatment. To learn more about KORSUVA, talk with your healthcare provider or pharmacist.
WHAT IS KORSUVA?
KORSUVA is a prescription medicine used to treat moderate-to-severe pruritus (itching) associated with chronic kidney disease (CKD-aP) in adults undergoing hemodialysis (HD).
KORSUVA is not recommended in patients undergoing peritoneal dialysis (fluid taken from abdomen).
IMPORTANT SAFETY INFORMATION
What are the possible side effects of KORSUVA?
KORSUVA may cause serious side effects, including:
- Dizziness, sleepiness, mental status changes (e.g., confusion), and trouble walking (which may lead to falls). Sleepiness is more likely to occur in patients who are 65 years or older. Taking KORSUVA with centrally acting depressant medications (including anti-depressants and medicines used for anxiety, epilepsy, insomnia), sedating antihistamines (allergy medicines that can cause drowsiness), and opioid analgesics (certain pain medications) may increase the likelihood of these side effects.
- Impairment of mental or physical abilities. You should not drive or operate dangerous machinery until the effect of KORSUVA on your ability to drive or operate machinery is known. The most common side effects of KORSUVA include: diarrhea, dizziness, nausea, trouble walking (including falls), high potassium, headache, sleepiness, and mental status changes (e.g., confusion).
What should I tell my doctor before taking KORSUVA?
Before you take KORSUVA, tell your doctor if you:
- are currently taking centrally acting depressant medications (including anti-depressants and medicines used for anxiety, epilepsy, insomnia), sedating antihistamines (allergy medicines that can cause drowsiness) or opioid analgesics (certain pain medications)
- regularly drive or operate dangerous machinery
Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Tell your doctor if you are pregnant or breastfeeding or plan to become pregnant or breastfeed. In pre-clinical studies, KORSUVA was shown to be transferable into breastmilk.
Tell your doctor if you have any side effect that bothers you or does not go away. These are not all of the possible side effects of KORSUVA. You may report side effects to Vifor (International) Inc. at 1-844-835-8277 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
The risk information provided here is not comprehensive and does not take the place of talking with your doctor about your medical condition or treatment. To learn more about KORSUVA, talk with your healthcare provider or pharmacist.