General MedicinePrescription OnlyPregnancy Cat. Not classifiedFDA Yes

Korsuva

DIFELIKEFALIN

1 INDICATIONS AND USAGE KORSUVA is indicated for the treatment of moderate-to-severe pruritus associated with chronic kidney disease (CKD-aP) in adults undergoing hemodialysis (HD). KORSUVA is a kappa opioid receptor agonist indicated for the treatment of moderate-to-severe pruritus associated with chronic kidney disease (CKD-aP) in adults undergoing hemodialysis (HD). ( 1 ) Limitation of Use Korsuva has not been studied in patients on peritoneal dialysis and is not recommended for use in this p...

Medically reviewed by MedCentralHub Medical Review Board, Licensed Pharmacists & Physicians · May 2026

Brand names:Korsuva

Rx Only

KorsuvaMedication

Quick Reference

Medicine ClassGeneral Medicine

FDA ApprovedYes

PregnancyCategory Not classified

Check Interactions Dosage Details

Quick Facts

Active ingredient: DIFELIKEFALIN
Medicine class: General Medicine
Brand names: Korsuva
Availability: Prescription only (Rx)
Pregnancy category: Not classified
Half-life: half-life of difelikefalin in HD subjects prior to dialysis ranged between 23 and 31 hours
FDA approved: Yes

Korsuva (DIFELIKEFALIN) medication overview

What Is Korsuva?

Korsuva (DIFELIKEFALIN) belongs to the General Medicine class of medications. It was first approved by the FDA in Yes. This medication requires a prescription from a licensed healthcare provider.

Key Safety Information

•Always follow the dose recommended by your healthcare professional. Taking more than prescribed increases the risk of side effects including serious complications.
•Seek emergency care if you experience signs of an allergic reaction — hives, swelling, difficulty breathing, or rash. Stop the medication and call your doctor immediately.
•Some medications can increase the risk of cardiovascular events. Tell your doctor if you have high blood pressure, a history of heart attack or stroke, or any pre-existing health condition.
•Avoid or limit alcohol while taking Korsuva. Do not drink alcohol without first discussing it with your healthcare provider as it may increase adverse effects.
•Take Korsuva with food or a full glass of water if stomach upset occurs. Stop use and talk to your doctor if you experience persistent stomach pain or GI symptoms.
•Tell your doctor about all medications, supplements, and vitamins you take. Some combinations significantly increase the risk of harm.

This is a summary only. Always read the full prescribing information and consult your healthcare provider for personalized medical advice.

Uses & Indications

Korsuva is prescribed for the following conditions. Some uses are FDA-approved indications; others may be evidence-based off-label uses. Consult your healthcare provider for personalized guidance.

1 INDICATIONS AND USAGE KORSUVA is indicated for the treatment of moderate-to-severe pruritus associated with chronic kidney disease (CKD-aP) in adults undergoing hemodialysis (HD).

KORSUVA is a kappa opioid receptor agonist indicated for the treatment of moderate-to-severe pruritus associated with chronic kidney disease (CKD-aP) in adults undergoing hemodialysis (HD).

( 1 ) Limitation of Use Korsuva has not been studied in patients on peritoneal dialysis and is not recommended for use in this population.

( 1 ) Limitations of Use KORSUVA has not been studied in patients on peritoneal dialysis and is not recommended for use in this population.

Dosage Guide

The following are general dosing guidelines only. Your actual dose should be determined by your healthcare provider based on your condition, renal/hepatic function, and other medications.

Adult Dosage

2 DOSAGE AND ADMINISTRATION Recommended dosage is 0.5 mcg/kg. ( 2.1 ) Administer by intravenous bolus injection into the venous line of the dialysis circuit at the end of each HD treatment. ( 2.1 ) Do not mix or dilute KORSUVA prior to administration. ( 2.2 ) Administer within 4 hours of syringe preparation. ( 2.3 ) See full prescribing information for additional recommendations on preparation and administration of KORSUVA. ( 2.2 , 2.3 ) 2.1 Dosage The recommended dosage of KORSUVA is 0.5 mcg/kg administered by intravenous bolus injection into the venous line of the dialysis circuit at the end of each HD treatment [see Dosage and Administration (2.3) ] . If a regularly scheduled HD treatment is missed, resume KORSUVA at the end of the next HD treatment. 2.2 Preparation Instructions Do not mix or dilute KORSUVA prior to administration. Inspect KORSUVA for particulate matter and discoloration prior to administration. The solution should be clear and colorless. Do not use KORSUVA vials if

Available Forms

Available Strengths

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Side Effects

Common

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Dizziness, Somnolence, Mental Status Changes, and Gait Disturbances [see Warnings and Precautions (5.1) ] The most common adverse reactions (incidence ≥2% and ≥1% higher than placebo) were diarrhea, dizziness, nausea, gait disturbances, including falls, hyperkalemia, headache, somnolence, and mental status change.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Vifor (International) Inc.
at 1-844-835-8277 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
A total of 1306 subjects undergoing HD who had moderate-to-severe pruritus were treated with KORSUVA in placebo-controlled and uncontrolled Phase 3 clinical trials.
Of these, 711 were treated for at least 6 months and 400 were treated for at least one year.
Two placebo-controlled Phase 3 trials (Trial 1 and Trial 2), in subjects undergoing HD who had moderate-to-severe pruritus were pooled to evaluate the safety of KORSUVA in comparison to placebo up to 12 weeks.

Serious

5 WARNINGS AND PRECAUTIONS Dizziness, Somnolence, Mental Status Changes, and Gait Disturbances: Dizziness, somnolence, mental status changes, and gait disturbances, including falls, have occurred.
Centrally-acting depressant medications, sedating antihistamines, and opioid analgesics should be used with caution during treatment with KORSUVA.
( 5.1 ) Risk of Driving and Operating Machinery: May impair mental or physical abilities.
Advise patients not to drive or operate dangerous machinery until the effect of KORSUVA on a patient's ability to drive or operate machinery is known.
( 5.2 ) 5.1 Dizziness, Somnolence, Mental Status Changes, and Gait Disturbances Dizziness, somnolence, mental status changes, and gait disturbances, including falls, have occurred in patients taking KORSUVA and may subside over time with continued treatment [see Adverse Reactions (6.1) ] .

Rare

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Medicine Interactions

Always inform your healthcare provider and pharmacist about ALL medications you take, including prescriptions, OTC medicines, vitamins, and supplements.

MajorModerateMinor

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Warnings & Contraindications

5 WARNINGS AND PRECAUTIONS Dizziness, Somnolence, Mental Status Changes, and Gait Disturbances: Dizziness, somnolence, mental status changes, and gait disturbances, including falls, have occurred. Centrally-acting depressant medications, sedating antihistamines, and opioid analgesics should be used with caution during treatment with KORSUVA. ( 5.1 ) Risk of Driving and Operating Machinery: May imp

How Korsuva Works

12.1 Mechanism of Action KORSUVA is a kappa opioid receptor (KOR) agonist. The relevance of KOR activation to therapeutic effectiveness is not known.

Pharmacokinetics

Half-Life

half-life of difelikefalin in HD subjects prior to dialysis ranged between 23 and 31 hours

Metabolism

Metabolism Difelikefalin is not metabolized by cytochrome P450 (CYP) enzymes CYP1A2, CYP2C19, CYP2C8, CYP2C9, CYP2D6 or CYP3A observed in human hepatic microsomes or hepatocytes, in vitro

Excretion

Excretion Following administration of difelikefalin to HD patients, 11% of the dosage was excreted in urine, 59% in feces, and 20% in dialysate fluid

Pregnancy & Breastfeeding Safety

Not classified

FDA Pregnancy Category Not classified

Consult your healthcare provider.

Full Pregnancy Information

Breastfeeding

Many medications pass into breast milk in varying amounts. Before using Korsuvawhile breastfeeding, discuss the benefits and risks with your healthcare provider or pharmacist — they can weigh your dose, your infant's age, and available lactation safety data to find the safest option for you and your baby.

Storage & Handling

Storage and Handling Store vials at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Do not freeze. KORSUVA injection must be administered within 4 hours of syringe preparation; prepared syringes can be stored at ambient temperat

Frequently Asked Questions

Sources & References

• FDA Prescribing Information — Official labeling and package insert for Korsuva
• U.S. National Library of Medicine — MedlinePlus drug information
• American Hospital Formulary Service (AHFS) — Clinical pharmacology monograph
• PubMed / MEDLINE — View clinical studies

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Medical Disclaimer

The information on this page is for educational purposes only and is not intended as medical advice, diagnosis, or treatment. Always consult your doctor, pharmacist, or qualified healthcare provider before starting, stopping, or changing any medication.