Nurses Compass
Drug Guide
Difelikefalin acetate
Classification
Therapeutic: Analgesic, Neurokinin-1 receptor agonist for pruritus
Pharmacological: Kappa-opioid receptor agonist
FDA Approved Indications
- Treatment of moderate-to-severe pruritus in adult patients with chronic kidney disease on dialysis
Mechanism of Action
Difelikefalin binds selectively to kappa-opioid receptors on peripheral sensory nerves and immune cells, reducing pruritus signals and inflammatory responses associated with chronic kidney disease-related pruritus.
Dosage and Administration
Adult: Start with 0.5 mcg/kg administered intravenously three times per week after dialysis; doses may be adjusted based on response and tolerability.
Pediatric: Not approved for pediatric use.
Geriatric: No specific dosage adjustments; monitor for increased sensitivity.
Renal Impairment: Use as per dialysis schedule; no dosage adjustment needed for dialysis patients.
Hepatic Impairment: No specific data; caution advised.
Pharmacokinetics
Absorption: Administered intravenously, so absorption is complete.
Distribution: Limited data available; likely distributes to peripheral tissues.
Metabolism: Not extensively metabolized; primarily cleared renally.
Excretion: Excreted unchanged in urine; clearance related to renal function.
Half Life: Approximately 7 hours.
Contraindications
- Hypersensitivity to difelikefalin or components of the formulation.
Precautions
- Use cautiously in patients with known sensitivities.
- Limited data in hepatic impairment; use cautiously.
Adverse Reactions - Common
- Increased salivation (Unknown)
- Somnolence (Unknown)
- Dizziness (Unknown)
Adverse Reactions - Serious
- Hypersensitivity reactions, including anaphylaxis (Rare)
- Postural dizziness leading to falls (Uncommon)
Drug-Drug Interactions
- Limited interaction data available; caution with other CNS depressants.
Drug-Food Interactions
N/ADrug-Herb Interactions
N/ANursing Implications
Assessment: Monitor for signs of hypersensitivity and adverse reactions.
Diagnoses:
- Risk for falls due to dizziness or hypotension.
Implementation: Administer as per prescribed schedule, monitor patient's response, and watch for side effects.
Evaluation: Assess pruritus severity and monitor for adverse effects.
Patient/Family Teaching
- Report any allergic reactions immediately.
- Do not stop therapy without consulting healthcare provider.
- Be cautious when performing activities that require alertness until response to medication is known.
Special Considerations
Black Box Warnings:
- None at this time.
Genetic Factors: No special genetic considerations known.
Lab Test Interference: No known interference.
Overdose Management
Signs/Symptoms: Potential for exaggerated adverse reactions, sedation, hypotension.
Treatment: Supportive care, monitor vital signs, no specific antidote.
Storage and Handling
Storage: Store at room temperature, 20°C to 25°C (68°F to 77°F).
Stability: Stable for the duration of the labeled shelf life when stored properly.