Generic
Difelikefalin Acetate
1 brands available in the market
At a glance
Difelikefalin Acetate is a kappa opioid receptor agonist used for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis.
Description
Difelikefalin Acetate is a kappa opioid receptor agonist used in the treatment of pruritus associated with chronic kidney disease in patients undergoing hemodialysis. It activates kappa opioid receptors to help relieve itching.
Indications
- Moderate-to-severe pruritus associated with chronic kidney disease (CKD-aP) in adults undergoing hemodialysis
Therapeutic class
Other Anti-protozoals
Pharmacological class
Kappa Opioid Receptor Agonist
Pharmacology
Difelikefalin Acetate is a kappa opioid receptor agonist used in the treatment of pruritus associated with chronic kidney disease in patients undergoing hemodialysis.
Mechanism of action
Difelikefalin Acetate activates kappa opioid receptors to help relieve itching.
Dosage
Adult: 0.5 mcg/kg administered by intravenous bolus injection into the venous line of the dialysis circuit at the end of each hemodialysis treatment.
Administration
Administer as an intravenous bolus injection into the venous line of the dialysis circuit. Do not mix or dilute prior to administration. Administer within 60 minutes of syringe preparation.
Missed dose
If a regularly scheduled hemodialysis treatment is missed, resume at the end of the next hemodialysis treatment.
Side effects
Common: Diarrhea, dizziness, nausea, gait disturbances (including falls), hyperkalemia, headache, somnolence, mental status changes.
Precautions & warnings
Dizziness, somnolence, mental status changes, and gait disturbances may occur; caution with centrally-acting depressants, sedating antihistamines, and opioid analgesics. Avoid driving or operating dangerous machinery.
Contraindications
Hypersensitivity.
Drug interactions
No clinical studies evaluating drug interaction potential were conducted.
Food interactions
Can be used with or without food.
Use in pregnancy
Limited human data on use in pregnant women are not sufficient.
Pregnancy Category: N/A — always consult a doctor before taking during pregnancy.
Use in lactation
No data regarding the presence of Difelikefalin Acetate in human milk.
Pediatric use
Safety and effectiveness in pediatric patients have not been established.
Geriatric use
No overall differences in safety or effectiveness have been observed between patients 65 years and older and young adult subjects.
Renal / hepatic impairment
No dose adjustment needed in renal impairment (drug is eliminated through dialysis).
Overdose effects
Overdose may cause dizziness, somnolence, mental status changes, paresthesia, fatigue, hypertension, and vomiting; provide appropriate medical attention based on clinical status.
Storage conditions
Do not store above 25°C. Keep away from light and moisture. Keep out of reach of children.
Chemical structure
Difelikefalin Acetate