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BYLVAY (odevixibat)
- itching in progressive familial intrahepat. cholestasis
200 mcg oral pellet
- Dosage information is not available
600 mcg oral pellet
- Dosage information is not available
1,200 mcg capsule
- Dosage information is not available
400 mcg capsule
- Dosage information is not available
- None
Contraindicated
- None
Severe
Moderate
- None
- None
Contraindicated
- Abnormal hepatic function tests
- Diarrhea
- Pregnancy
Severe
Moderate
- Vitamin A deficiency
- Vitamin D deficiency
- Vitamin E deficiency
- Vitamin K deficiency
BYLVAY (odevixibat)
- itching in progressive familial intrahepat. cholestasis
- Abnormal hepatic function tests
- Diarrhea
- Increased alanine transaminase
- Increased aspartate transaminase
- Acute abdominal pain
- Vitamin A deficiency
- Vitamin D deficiency
- Vitamin E deficiency
- Vitamin K deficiency
More Frequent
Severe
Less Severe
- Dehydration
- Biliary calculus
- Hyperbilirubinemia
- Splenomegaly
- Vomiting
Less Frequent
Severe
Less Severe
Rare / Very Rare
Severe
- None
Less Severe
- Fracture
Contraindicated
None
Severe Precaution
None
Management or Monitoring Precaution
Odevixibat
Safety and effectiveness not established in pediatric patients < 3 months.
- 1 Day – 89 Days
- Safety and effectiveness not established in pediatric patients < 3 months.
Odevixibat
- Severity Level:
D
- Additional Notes: Based on animal data, fetal harm may occur
Contraindicated
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Precaution Exists
Odevixibat
Insufficient human data available
| General | Excretion Potential | Effect on Infant | Notes |
| Evaluate use carefully | Unknown | Not known; no or inclusive data | Insufficient human data available |
No Known Risk
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Contraindicated
None
Precaution Exists
None
No Known Risk
None
- None
| Cholestatic pruritus in patients with alagille syndrome | |
| L29.8 | Other pruritus |
| Pruritus in progressive familial intrahepat. cholestasis | |
| K83.1 | Obstruction of bile duct |
| 0-9 | A-Z |
|---|---|
| K83.1 | Obstruction of bile duct |
| L29.8 | Other pruritus |
Formulary Reference Tool