Difelikefalin

What is Difelikefalin?

• Difelikefalin (Korsuva) is a kappa opioid receptor agonist used to treat moderate-to-severe pruritus associated with chronic kidney disease in certain populations.

Difelikefalin

Difelikefalin (2)

What are the uses of this medicine?

• Difelikefalin (Korsuva) is used for the treatment of moderate-to-severe pruritus associated with chronic kidney disease (CKD-aP) in adults undergoing hemodialysis (HD).

Limitations of Use:

• Korsuva has not been studied in patients on peritoneal dialysis and is not recommended for use in this population.

How does this medicine work?

• Korsuva is a kappa opioid receptor (KOR) agonist.
• It acts as a peripherally specific, highly selective agonist of the κ-opioid receptor (KOR).
• Difelikefalin acts as an analgesic by activating KORs on peripheral nerve terminals and KORs expressed by certain immune system cells.
• Activation of KORs on peripheral nerve terminals results in the inhibition of ion channels responsible for afferent nerve activity, causing reduced transmission of pain signals, while activation of KORs expressed by immune system cells results in reduced release of proinflammatory, nerve-sensitizing mediators (e.g., prostaglandins).
• The relevance of KOR activation to therapeutic effectiveness is not known.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• No formal drug interaction studies have been conducted with Korsuva.

Is this medicine FDA approved?

• Difelikefalin was approved for medical use in the United States in August 2021.

How should this medicine be used?

Recommended dosage:

• The recommended dosage ofKorsuva 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.
• If a regularly scheduled HD treatment is missed, resumeKorsuva at the end of the next HD treatment.

Administration:

• Administer by intravenous bolus injection into the venous line of the dialysis circuit at the end of each HD treatment.
• Do not mix or diluteKorsuva prior to administration.
• Administer within 60 minutes of syringe preparation.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 65 mcg /1.3 mL (50 mcg/mL) of difelikefalin

This medicine is available in fallowing brand namesː

• Korsuva

What side effects can this medication cause?

The most common side effects of this medicine include:

• diarrhea
• dizziness
• nausea
• gait disturbances, including falls
• hyperkalemia
• headache
• somnolence
• mental status change

What special precautions should I follow?

• Dizziness, somnolence, mental status changes, and gait disturbances, including falls, have occurred in patients takingKorsuva and may subside over time with continued treatment. Centrally-acting depressant medications, sedating antihistamines, and opioid analgesics should be used with caution during treatment withKorsuva.
• Dizziness, somnolence, and mental status changes have occurred in patients takingKorsuva. Korsuva may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car and operating machinery. Advise patients not to drive or operate dangerous machinery until the effect ofKorsuva on a patient’s ability to drive or operate machinery is known.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• dizziness
• somnolence
• mental status changes
• paresthesia
• fatigue
• hypertension
• vomiting

Management of overdosage:

• In the event of overdosage, provide the appropriate medical attention based on patient’s clinical status. Difelikefalin is primarily eliminated by the kidneys with a low plasma protein binding.
• Hemodialysis for 4 hours using a high-flux dialyzer effectively cleared approximately 70% to 80% of difelikefalin from plasma, and difelikefalin was not detectable in plasma at the end of the second of two dialysis cycles.

Can this medicine be used in pregnancy?

• The limited human data on use ofKorsuva in pregnant women are not sufficient to evaluate a drug-associated risk for major birth defects or miscarriage.

Can this medicine be used in children?

• The safety and effectiveness ofKorsuva in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• difelikefalin acetate

Inactive ingredients:

• sodium chloride
• acetic acid
• sodium acetate
• water

Who manufactures and distributes this medicine?

Manufactured for:

• Cara Therapeutics, Inc.
• Stamford, CT

Marketed by:

• Vifor (International) Inc.,
• Rechenstrasse , Gallen, Switzerland

• Korsuva is a trademark of Cara Therapeutics, Inc.

What should I know about storage and disposal of this medication?

• 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).
• Do not freeze.
• Korsuva injection must be administered within 60 minutes of syringe preparation; prepared syringes can be stored at ambient temperature 20°C to 25°C (68°F to 77°F) until dosing.
• Korsuva injection is supplied in a single-dose vial.
• Any unused drug remaining after injection must be discarded.

• Dailymed label info on Difelikefalin
• FDA Difelikefalin

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