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Odevixibat Dosage

Medically reviewed by Drugs.com. Last updated on Sep 13, 2021.

Applies to the following strengths: 200 mcg; 400 mcg; 600 mcg; 1200 mcg

Usual Adult Dose for Pruritus

Initial dose: 40 mcg/kg orally once a day (in the morning)
Maintenance dose: 40 to 120 mcg/kg orally once a day (in the morning)
Maximum dose: 6 mg/day

Comments:

  • Patients should be given oral pellet formulations if they weigh less than 19.5 kg; those who weigh 19.5 kg or more should be given capsule formulations.
  • The dose may be increased in 40 mg/kg increments after 3 months if pruritus does not improve.

Use: Treatment of pruritus in patients with progressive familial intrahepatic cholestasis (PFIC)

Usual Adult Dose for Pruritus of Partial Biliary Obstruction

Initial dose: 40 mcg/kg orally once a day (in the morning)
Maintenance dose: 40 to 120 mcg/kg orally once a day (in the morning)
Maximum dose: 6 mg/day

Comments:

  • Patients should be given oral pellet formulations if they weigh less than 19.5 kg; those who weigh 19.5 kg or more should be given capsule formulations.
  • The dose may be increased in 40 mg/kg increments after 3 months if pruritus does not improve.

Use: Treatment of pruritus in patients with progressive familial intrahepatic cholestasis (PFIC)

Usual Pediatric Dose for Pruritus

3 months and older:

  • Initial dose: 40 mcg/kg orally once a day (in the morning)
  • Maintenance dose: 40 to 120 mcg/kg orally once a day (in the morning)
  • Maximum dose: 6 mg/day

Comments:
  • Patients should be given oral pellet formulations if they weigh less than 19.5 kg; those who weigh 19.5 kg or more should be given capsule formulations.
  • The dose may be increased in 40 mg/kg increments after 3 months if pruritus does not improve.

Use: Treatment of pruritus in patients with PFIC

Usual Pediatric Dose for Pruritus of Partial Biliary Obstruction

3 months and older:

  • Initial dose: 40 mcg/kg orally once a day (in the morning)
  • Maintenance dose: 40 to 120 mcg/kg orally once a day (in the morning)
  • Maximum dose: 6 mg/day

Comments:
  • Patients should be given oral pellet formulations if they weigh less than 19.5 kg; those who weigh 19.5 kg or more should be given capsule formulations.
  • The dose may be increased in 40 mg/kg increments after 3 months if pruritus does not improve.

Use: Treatment of pruritus in patients with PFIC

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Patients with PFIC and clinically significant portal hypertension or with decompensated cirrhosis: Data not available; frequent monitoring recommended.

Prior to treatment: Liver function tests (e.g., ALT, AST, direct bilirubin, total bilirubin, INR) should be taken

During treatment:

  • Treatment should be interrupted if new onset liver function test abnormalities occur OR clinical hepatitis symptoms are observed.
  • If abnormalities return to baseline OR stabilized at a new baseline value, providers may consider restarting this drug at 40 mcg/kg orally once a day, and increasing the dose if needed; patients who develop recurring liver test abnormalities should permanently discontinue treatment.
  • Patients who develop portal hypertension or hepatic decompensation events (e.g., ascites, hepatic encephalopathy, variceal hemorrhage) should permanently discontinue treatment.

Dose Adjustments

Diarrhea:

  • Patients should be monitored for dehydration and should be treated promptly.
  • Treatment should be interrupted if persistent diarrhea occurs.
  • This drug should be restarted at 40 mcg/kg orally once a day once diarrhea resolves, and the dose may be increased if needed.
  • Patients who develop persistent diarrhea without an identifiable alternative etiology should discontinue treatment.

Fat-Soluble Vitamin (FSV) Deficiency:
  • Treatment should be discontinued if FSV deficiencies persist or worsen despite appropriate supplementation.

Precautions

CONTRAINDICATIONS:

  • None.

Safety and efficacy have not been established in patients younger than 3 months.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

  • This drug should be taken with a meal.
  • Capsules should not be crushed or chewed.
  • This drug should be taken at least 4 hours before or after taking bile acid binding resins (if needed).

Reconstitution/preparation techniques: The manufacturer product information should be consulted.

General:
  • LIMITATION OF USE: This drug may not be effective in patients with PFIC type 2 with ABCB11 gene variants that result in the functional/complete absence of bile salt export pump protein (BSEP-3).

Monitoring:
  • HEMATOLOGIC: INR at baseline and then throughout treatment
  • HEPATIC: Liver function tests prior to starting and then throughout treatment
  • METABOLIC: FSV levels at baseline and then throughout treatment

Patient advice:
  • Advise patients to speak to their healthcare provider if they become pregnant, intend to become pregnant, or are breastfeeding.

Further information

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