Note: Dose should be determined using the patient’s target dry body weight. Total injection volume (mL) = patient target dry body weight (kg) × 0.01, rounded to the nearest tenth (0.1 mL).
Chronic kidney disease associated pruritus, moderate to severe: IV: 0.5 mcg/kg administered into the venous line of the dialysis circuit at the end of each hemodialysis session.
Hemodialysis, intermittent (thrice weekly): Dialyzable (70% to 80%): No dosage adjustment necessary. Administer after each dialysis session.
Mild to moderate impairment: No dosage adjustment necessary.
Severe impairment: Use not recommended (has not been studied).
Refer to adult dosing.
Korsuva: FDA approved August 2021; availability anticipated in Q1 of 2022.
IV: Administer via IV bolus into the venous line of the hemodialysis circuit at the end of hemodialysis (blood should no longer be circulating through the dialyzer). Administer during or after the rinse back of the dialysis circuit; if administered after the rinse back, flush with ≥10 mL of NS.
Chronic kidney disease associated pruritus, moderate to severe: Treatment of moderate to severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis.
Limitations of use: Has not been studied in patients on peritoneal dialysis.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
1% to 10%:
Endocrine & metabolic: Hyperkalemia (5%)
Gastrointestinal: Diarrhea (9%), nausea (7%)
Nervous system: Abnormal gait (7%; including falling), altered mental status (3%; including confusion), dizziness (7%), drowsiness (4%), headache (5%)
There are no contraindications listed in the manufacturer's labeling.
Concerns related to adverse effects:
• CNS effects: Dizziness, somnolence, mental status changes, and gait disturbances, including falls, have been reported. Some effects (eg, dizziness, somnolence) are more likely to occur during the first few weeks of therapy and may subside with continued dosing. Patients must be cautioned about performing tasks that require mental alertness (eg, operating machinery, driving). Risk may be increased with concomitant use of other CNS depressants (eg, sedating antihistamines, opioid analgesics).
Disease-related concerns:
• Hepatic impairment: Avoid use in severe impairment (has not been studied).
Special populations:
• Elderly: Incidence of somnolence is increased in patients ≥65 years of age.
None known.
CNS Depressants: Difelikefalin may enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy
Adverse events were not observed in animal reproduction studies.
It is not known if difelikefalin is present in breast milk.
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
Relief of itching; mental status.
Difelikefalin is a kappa opioid receptor agonist. The mechanism for improvement of pruritus has not been established.
Distribution: Vd: ~238 mL/kg.
Protein binding: 23% to 28%.
Metabolism: Not metabolized by CYP enzymes.
Half-life elimination: 23 to 31 hours.
Excretion: Urine (11%); feces (59%); dialysate fluid (20%).
