Odevixibat

Odevixibat is a prescription medication used to treat pruritus in patients with progressive familial intrahepatic cholestasis (PFIC).

• Odevixibat is available under the following different brand names: Bylvay

Common side effects of Odevixibat include:

• diarrhea,
• abdominal pain, and
• vomiting

Serious side effects of Odevixibat include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• severe dizziness,
• decreased urination,
• unusual dry mouth,
• increased thirst,
• fast heartbeat, and
• lightheadedness

Rare side effects of Odevixibat include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out. 

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Capsules

• 400 mcg
• 1200 mcg

Oral pellets

• 400 mcg
• 1200 mcg

Cholestasis

Adult dosage

• 40 mcg/kg orally every morning

Pediatric dosage

• Less than 3 months: Safety and efficacy not established
• Above 3 months
  • 40 mcg/kg orally every morning
  • Recommended for 40 mcg/kg/day
  • Less than 7.4 kg: 200 mcg/day
  • 7.5-12.4 kg: 400 mcg/day
  • 12.5-17.4 kg: 600 mcg/day
  • 17.5-25.4 kg: 800 mcg/day
  • 25.5-35.4 kg: 1200 mcg/day
  • 35.5-45.4 kg: 1600 mcg/day
  • 45.5-55.4 kg: 2000 mcg/day
• More than 55.5 kg: 2400 mcg/day
  • If no improvement in pruritus after 3 months, may increase the dose in 40 mcg/kg-increments up to 120 mcg/kg/day; not to exceed 6 mg/day

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Odevixibat has severe interactions with no other drugs.
• Odevixibat has serious interactions with no other drugs.
• Odevixibat has moderate interactions with the following drugs:
  • cholestyramine
  • colesevelam
  • colestipol
• Odevixibat has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Odevixibat?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Odevixibat?”

Cautions

• Liver test abnormalities
  • Patients enrolled in the clinical trial had abnormal LFTs at baseline, including elevated AST, ALT, TB, and DB
  • Treatment interruption days ranged from 3-124 days
  • Obtain baseline LFTs and monitor during treatment
  • Not evaluated in PFIC patients with cirrhosis; closely monitor for liver test abnormalities
  • Permanently discontinue if a patient progresses to portal hypertension or experiences a hepatic decompensation event
• Diarrhea
  • Diarrhea reported
    • If diarrhea occurs, monitor for dehydration, and treat it promptly
    • Interrupt dosing if a patient experiences persistent diarrhea
    • Restart at 40 mcg/kg/day once resolved; may increase the dose as tolerated if appropriate
    • If diarrhea persists and no alternate etiology is identified, stop treatment
• FSV deficiency
  • PFIC patients can have FSV deficiency at baseline
  • Therapy may affect the absorption of fat-soluble vitamins
  • Obtain serum FSV levels at baseline and monitor them during treatment, along with any clinical manifestations
  • If FSV deficiency is diagnosed, supplement with FSV. Discontinue BYLVAY if FSV deficiency persists or worsens despite adequate FSV supplementation
• Drug interaction overview
  • Substrate of P-glycoprotein but not a substrate of breast cancer resistance protein
• Bile acid binding resins
  • Separate bile acid-binding resins (eg, cholestyramine, colesevelam, or colestipol) at least 4 hr before or after odevixibat
  • Bile acid binding resins may bind odevixibat in the gut, which may reduce odevixibat efficacy

Pregnancy and Lactation

• There are no human data on use in pregnant females to establish a drug-associated risk of major birth defects, miscarriage, or adverse developmental outcomes
• Lactation
  • Odevixibat has low absorption following oral administration, and breastfeeding is not expected to result in the exposure of an infant
  • No data are available on its presence in human milk, its effects on breastfed infants, or its effects on milk production
  • Odevixibat may reduce the absorption of FSV
  • Monitor FSV levels and increase FSV intake, if FSV deficiency occurs during lactation