difelikefalin

Absorption: IV administration results in complete bioavailability.

Distribution: Well distributed to tissues.

Metabolism/Excretion: Not metabolized by CYP450 isoenzymes. Primarily excreted in feces (59%), with 20% excreted into dialysate fluid, and 11% excreted in urine.

Half-Life: 23–31 hr.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
IV	rapid	end of infusion	unknown

Contraind./Precautions ⬆ ⬇

Contraindicated in:

None.

Use Cautiously in:

OB: Safety not established in pregnancy;
Lactation: Safety not established in breastfeeding;
Pedi: Safety and effectiveness not established in children;
Geri: ↑risk of sedation in older adults.

Adv. Reactions/Side Effects ⬆ ⬇

F and E: hyperkalemia

GI: diarrhea, nausea

Neuro: dizziness, gait disturbances, headache, mental status changes, sedation

Interactions ⬆ ⬇

Drug-drug:

Use with benzodiazepines or other CNS depressants, including other opioids, nonbenzodiazepine sedative/hypnotics, anxiolytics, antihistamines, and alcohol, may ↑ risk of sedation, dizziness, gait disturbances, and mental status changes.

Route/Dosage ⬆ ⬇

Dose should be based on target dry body weight.

IV (Adults ): 0.5 mcg/kg administered into the venous line of the dialysis circuit at the end of each hemodialysis treatment.

Availability ⬆ ⬇

Solution for injection: 50 mcg/mL

Assessment ⬆ ⬇

Perform baseline neurologic status; then monitor for dizziness, somnolence, mental status changes, and gait disturbances, including falls.

Lab Test Considerations:

May cause hyperkalemia.

Implementation ⬆ ⬇

Total injection volumes are based on target dry body weight; for patient with target dry weight outside of the ranges provided, use the formula: total injection volume = patient target dry body weight (kg) × 0.01, rounded to the nearest tenth.

IV Administration:

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of difelikefalin to patient. Advise patient to read Patient Information before starting therapy and periodically during therapy in case of changes.
May cause dizziness. Driving or operating machinery not recommended until effects are understood.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other medications.
Rep: Advise patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

Evaluation/Desired Outcomes ⬆ ⬇

Reduced severity of itching in patients receiving hemodialysis.

US Brand Names ⬆ ⬇

Code ⬆

NDC Code

13612- Wisdom Pharmaceutical Co.,Ltd
- 13612-0028-
  - 13612-0028-0- 15 g in 1 BAG (13612-0028-0)

52076- Chunghwa Chemical Sysnthsis & Biotech Co.,Ltd.
- 52076-6273-
  - 52076-6273-1- 50 kg in 1 DRUM (52076-6273-1)

52919- Siegfried Hameln GmbH
- 52919-028-
  - 52919-028-15- 230 VIAL, GLASS in 1 CARTON (52919-028-15) / 1.3 mL in 1 VIAL, GLASS (52919-028-01)

59162- PolyPeptide Laboratories France
- 59162-0002-
  59162-0002-1- 500 g in 1 BOTTLE, PLASTIC (59162-0002-1)

59353- Vifor (International), Inc.
- 59353-065- Korsuva
  59353-065-12- 12 VIAL, SINGLE-USE in 1 TRAY (59353-065-12) / 1.3 mL in 1 VIAL, SINGLE-USE (59353-065-01)

63552- Patheon Manufacturing Services LLC
- 63552-191-
  - 63552-191-00- 208 VIAL in 1 CASE (63552-191-00) / 1.3 mL in 1 VIAL

68225- Patheon Italia S.p.A.
- 68225-122-
  68225-122-00- 247 VIAL, SINGLE-USE in 1 CONTAINER (68225-122-00) / 1.5 mL in 1 VIAL, SINGLE-USE

69766- MSN Life Sciences Private Limited
- 69766-115-
  69766-115-06- 1 kg in 1 DRUM (69766-115-06)

section name header

Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇