Korsuva is a synthetic peptide and opioid agonist that is injected to treat pruritus or itchy skin in adults with chronic kidney disease (CKD) who are undergoing hemodialysis.

Korsuva was the first therapy to be approved by the US Food and Drug Administration (FDA) for this condition when it was approved in August 2021.

Korsuva works by targeting and activating the kappa opioid receptors in your peripheral nervous system. It's not known exactly how this helps to treat pruritus, but it's thought an imbalance in mu- and kappa-opioid receptor system activity plays a role in the development of pruritus.

What is Korsuva used for?

Korsuva is a prescription medicine used to treat moderate-to-severe pruritus associated with CKD in adults undergoing hemodialysis.

Korsuva is not recommended in patients undergoing peritoneal dialysis (fluid taken from abdomen).

Korsuva may cause serious side effects, including:

• Dizziness
• Sleepiness. Sleepiness is more likely to occur in patients who are 65 years or older.
• Mental status changes, such as confusing
• Trouble walking (which may lead to falls).

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.

Who should not receive Korsuva?

Do not take Korsuva is your are allergic to difelikefalin or any of the other ingredients in Korsuva. See below for a complete list of ingredients.

• Korsuva is administered by a healthcare professional at the end of each hemodialysis treatment.
• Korsuva is given by intravenous (IV) bolus injection through the venous line on your dialysis circuit.

The recommended dose of Korsuva is 0.5 mcg/kg given by intravenous bolus injection into the venous line of the dialysis circuit at the end of each hemodialysis treatment.

See the full prescribing information for further information about Korsuva dosing.

Do not take Korsuva is your are allergic to difelikefalin or any of the other ingredients in Korsuva. See below for a complete list of ingredients.

What should I tell my doctor before receiving Korsuva?

Before receiving Korsuva tell you doctor about all of your medical conditions including if you:

• have depression, anxiety, epilepsy or insomnia and take a centrally acting depressant medication
• have allergies and take a sedating antihistamine
• have a condition that causes pain that you treat with an opioid analgesic

If you miss a hemodialysis session and your dose of Korsuva, resume treatment with Korsuva again at your next hemodialysis treatment.

Korsuva may impair your 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
• mental status changes, such as confusion

These are not all of the possible side effects of Korsuva. Tell your doctor if you have any side effect that bothers you or does not go away.

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.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.