Difelikefalin

Difelikefalin is a prescription medication used for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis (HD).

• Difelikefalin is available under the following different brand names: Korsuva.

Common side effects of Difelikefalin include:

• diarrhea
• dizziness
• nausea
• gait disturbances, including falls
• high blood potassium (hyperkalemia)
• headache
• drowsiness
• change in mental status

Serious side effects of Difelikefalin include:

• signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat
• signs of high potassium levels like a heartbeat that does not feel normal; feeling confusion; feeling weak, lightheaded, or dizzy; feeling like passing out; numbness or tingling; or shortness of breath
• trouble walking
• falls
• feeling confused

Rare side effects of Difelikefalin include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Injectable solution

• 65 mcg/1.3 mL

Pruritus

Adult dosage

• 0.5 mcg/kg IV push into the venous line of the dialysis circuit at the end of each HD treatment

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Difelikefalin has severe interactions with no other drugs
• Difelikefalin has serious interactions with the following drugs:
  • olopatadine intranasal
  • ropeginterferon alfa 2b
• Difelikefalin has moderate interactions with at least 219 other drugs
• Difelikefalin has minor interactions with no other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Difelikefalin?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Difelikefalin?”

Cautions

• Dizziness, somnolence, mental status changes, and gait disturbances (eg, falls) have occurred; may subside over time with continued treatment
• May impair mental or physical abilities; advise patients not to drive or operate dangerous machinery until the effect on a patient’s ability to drive or operate machinery is known
• Drug interaction overview
  • Centrally acting depressant medications, sedating antihistamines, and opioid analgesics may increase the adverse reactions of difelikefalin; use with caution

Pregnancy and Lactation

• Limited human data are insufficient on use in pregnant women to evaluate drug-associated risks for major birth defects or miscarriage
• Lactation
  • There are no data regarding the drug’s presence in human milk, its effects on breastfed infants, or milk production
  • Studies showed difelikefalin was transferred into milk in lactating rats
  • When a drug is present in animal milk, it is likely that the drug will be present in human milk