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Difelikefalin Dosage

Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Pruritus

0.5 mcg/kg IV at the end of each hemodialysis (HD) treatment

Comments:

  • This drug should be administered by IV bolus injection into the venous line of the dialysis circuit at the end of each HD treatment; see administration advice for additional information on administration.
  • Dose is determined by patient's target dry body weight.
  • Not studied in patients on peritoneal dialysis and is therefore not recommended for use in this population.

Use: For the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing HD.

Renal Dose Adjustments

For use in patients undergoing HD

Liver Dose Adjustments

Mild to moderate hepatic impairment: No adjustment recommended
Severe hepatic impairment: Not recommended

Precautions

CONTRAINDICATIONS: None

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Hemodialysis: See Adult Dosing: Administer after blood is no longer circulating through dialyzer as this drug is removed by the dialyzer membrane
Peritoneal dialysis: Not recommended

Other Comments

Administration advice:

  • Administer by IV bolus into the venous line of the dialysis circuit at the end of each HD treatment
  • As this drug is removed by the dialyzer membrane, it must be administered after blood is no longer circulating through the dialyzer
  • May be given either during or after rinse back of the dialysis circuit; if given after rinse back, follow with at least 10 mL of normal saline flush; if given during rinse back, no additional normal saline is needed to flush the line.

MISSED DIALYSIS TREATMENT: If a regularly scheduled HD treatment is missed, resume with the next HD treatment

Storage requirements:
  • Store vials at room temperature (68F to 77F [20C to 25C]); do not freeze
  • Administer within 60 minutes of syringe preparation; syringe should be stored at room temperature until dosing

Reconstitution/preparation techniques:
  • Do not mix or dilute prior to administration; dose should be administered within 60 minutes of syringe preparation
  • Single dose vial; discard unused product
  • Injection volume is determined by patient's target dry body weight; consult the manufacturer's product information for a chart providing injection volume per dry body weight

General:
  • This drug has not been studied in patients on peritoneal dialysis and is not recommended for use in this population.

Patient advice:
  • Patients should be instructed to read the US FDA-approved patient labeling.
  • Patients should understand that this drug may cause dizziness, somnolence, mental status changes, and gait disturbances, including falls.
  • Patients should be advised to avoid performing potentially hazardous activities, such as driving, until they know how they will react to this drug.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.