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Drug overview for BYLVAY (odevixibat):
Generic name: ODEVIXIBAT (OH-de-VIX-i-bat)
Drug class: Ileal Bile Acid Transporter (IBAT) Inhibitor
Therapeutic class: Hepatobiliary System Treatment Agents
Odevixibat sesquihydrate is an ileal bile acid transporter (IBAT) inhibitor.
No enhanced Uses information available for this drug.
Generic name: ODEVIXIBAT (OH-de-VIX-i-bat)
Drug class: Ileal Bile Acid Transporter (IBAT) Inhibitor
Therapeutic class: Hepatobiliary System Treatment Agents
Odevixibat sesquihydrate is an ileal bile acid transporter (IBAT) inhibitor.
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for BYLVAY (odevixibat) have been approved by the FDA:
Indications:
Cholestatic pruritus in patients with Alagille syndrome
Pruritus due to progressive familial intrahepatic cholestasis
Professional Synonyms:
Cholestatic pruritus in patients with ALGS
Pruritus due to PFIC
Indications:
Cholestatic pruritus in patients with Alagille syndrome
Pruritus due to progressive familial intrahepatic cholestasis
Professional Synonyms:
Cholestatic pruritus in patients with ALGS
Pruritus due to PFIC
The following dosing information is available for BYLVAY (odevixibat):
Dosage of odevixibat sesquihydrate is expressed in terms of odevixibat.
Administer odevixibat orally once daily in the morning with a meal. Odevixibat is commercially available as capsules and pellets for oral administration. The oral pellets are intended for use by patients weighing <19.5
kg and the capsules are intended for use by patients weighing >=19.5 kg. The drug should be taken with food. Odevixibat should be administered at least 4 hours before or after administration of bile acid sequestrants.
kg and the capsules are intended for use by patients weighing >=19.5 kg. The drug should be taken with food. Odevixibat should be administered at least 4 hours before or after administration of bile acid sequestrants.
No dosing information available.
No generic dosing information available.
The following drug interaction information is available for BYLVAY (odevixibat):
There are 0 contraindications.
There are 0 severe interactions.
There are 1 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| Maralixibat; Odevixibat/Bile Acid Sequestrants SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Bile acid sequestrants may bind to maralixibat and odevixibat in the gut, resulting in decreased absorption of maralixibat or odevixibat.(1,2) CLINICAL EFFECTS: Coadministration of bile acid sequestrants with maralixibat or odevixibat may cause reduced efficacy of maralixibat or odevixibat.(1,2) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The US manufacturers states to administer bile acid sequestrants (cholestyramine, colesevelam, and colestipol) at least 4 hours before or 4 hours after administration of maralixibat or odevixibat.(1,2) DISCUSSION: Bile acid sequestrants are known to bind to drugs when given concurrently. Administration with maralixibat or odevixibat may result in decreased systemic absorption.(1,2) |
CHOLESTYRAMINE, CHOLESTYRAMINE LIGHT, CHOLESTYRAMINE RESIN, COLESEVELAM HCL, COLESTID, COLESTIPOL HCL, PREVALITE, QUESTRAN, QUESTRAN LIGHT, WELCHOL |
The following contraindication information is available for BYLVAY (odevixibat):
Drug contraindication overview.
*None.
*None.
There are 0 contraindications.
There are 4 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Bleeding esophageal varices |
| Diarrhea |
| Hepatic encephalopathy |
| Pregnancy |
There are 5 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Disease of liver |
| Vitamin A deficiency |
| Vitamin D deficiency |
| Vitamin E deficiency |
| Vitamin K deficiency |
The following adverse reaction information is available for BYLVAY (odevixibat):
Adverse reaction overview.
Most common adverse reactions (>2%) reported in patients with PFICreceiving odevixibat include liver test abnormalities, diarrhea, abdominal pain, vomiting, and fat-soluble vitamin deficiency. Most common adverse reactions (>5%) reported in patients with ALGSreceiving odevixibat include diarrhea, abdominal pain, hematoma, and weight loss.
Most common adverse reactions (>2%) reported in patients with PFICreceiving odevixibat include liver test abnormalities, diarrhea, abdominal pain, vomiting, and fat-soluble vitamin deficiency. Most common adverse reactions (>5%) reported in patients with ALGSreceiving odevixibat include diarrhea, abdominal pain, hematoma, and weight loss.
There are 5 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Abnormal hepatic function tests Diarrhea Increased alanine transaminase Increased aspartate transaminase |
None. |
| Rare/Very Rare |
|---|
|
Dehydration |
There are 16 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Acute abdominal pain Vitamin A deficiency Vitamin D deficiency Vitamin E deficiency Vitamin K deficiency |
Hematoma Hyperbilirubinemia Splenomegaly Vomiting Weight loss |
| Rare/Very Rare |
|---|
|
Anemia Biliary calculus Epistaxis Fracture Gastrointestinal hemorrhage Gingival bleeding |
The following precautions are available for BYLVAY (odevixibat):
Safety and efficacy of odevixibat have been established in pediatric patients 3 months to 17 years of age for the treatment of pruritus due to PFIC. Use of odevixibat in this age group is supported by data from a 24-week, randomized, double-blind, placebo-controlled trial conducted in 62 patients with a confirmed diagnosis of PFIC type 1 or type 2 (Trial 1) and an open-label, 72-week, extension trial in patients with PFIC (Trial 2). Safety and efficacy of odevixibat have been established in pediatric patients 12 months to 17 years of age for the treatment of pruritus due toALGS.
Use of odevixibat in this age group is supported by data from a randomized, double-blind, placebo-controlled trial conducted in 52patients with a confirmed diagnosis of ALGS and one open-label extension trial in ALGS patients. Safety and efficacy of odevixibat for the treatment of pruritus inpediatric patients <3 months of age with PFIC have not been established. Safety and efficacy of odevixibat for the treatment of pruritus inpediatric patients <12 months of age with ALGS have not been established.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Use of odevixibat in this age group is supported by data from a randomized, double-blind, placebo-controlled trial conducted in 52patients with a confirmed diagnosis of ALGS and one open-label extension trial in ALGS patients. Safety and efficacy of odevixibat for the treatment of pruritus inpediatric patients <3 months of age with PFIC have not been established. Safety and efficacy of odevixibat for the treatment of pruritus inpediatric patients <12 months of age with ALGS have not been established.
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
There are no available data on use of odevixibat in pregnant women. In animal studies, increased incidence of malformations in fetal heart, great blood vessels, and other vascular sites were reported in pregnant rabbits receiving odevixibat at all dosages during organogenesis; maternal systemic exposure at the lowest dose was 2.1 times the maximum recommended human dosage.
A pregnancy safety study that monitorsoutcomes in women exposed to odevixibat during pregnancy is available. Pregnant women exposed to odevixibat, or their healthcare providers, should report odevixibat exposure by calling 1-855-252-4736.
A pregnancy safety study that monitorsoutcomes in women exposed to odevixibat during pregnancy is available. Pregnant women exposed to odevixibat, or their healthcare providers, should report odevixibat exposure by calling 1-855-252-4736.
Odevixibat is minimally absorbed following oral administration; therefore, breast-feeding is not expected to result in exposure to the infant at the recommended dosage. It is not known whether odevixibat is distributed into human milk. The effects of the drug on breast-fed infants or on milk production are unknown.
Consider the developmental and health benefits of breast-feeding along with the mother's need for odevixibat and any potential adverse effects on the breast-fed child from the drug or underlying maternal condition. Patients with PFIC or ALGSmay also have concomitant fat-soluble vitamin deficiency. Because odevixibat may further reduce absorption of fat-soluble vitamins, monitor fat-soluble vitamin levels and provide supplementation if a deficiency is diagnosed during lactation.
Consider the developmental and health benefits of breast-feeding along with the mother's need for odevixibat and any potential adverse effects on the breast-fed child from the drug or underlying maternal condition. Patients with PFIC or ALGSmay also have concomitant fat-soluble vitamin deficiency. Because odevixibat may further reduce absorption of fat-soluble vitamins, monitor fat-soluble vitamin levels and provide supplementation if a deficiency is diagnosed during lactation.
The manufacturer states thatPFIC and ALGS are largely diseases of pediatric and young adult patients. Clinical studies with odevixibat did not includepatients >=65 years of age.
The following prioritized warning is available for BYLVAY (odevixibat):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for BYLVAY (odevixibat)'s list of indications:
| Cholestatic pruritus in patients with alagille syndrome | |
| L29.8 | Other pruritus |
| L29.81 | Cholestatic pruritus |
| Q44.71 | Alagille syndrome |
| Pruritus in progressive familial intrahepat. cholestasis | |
| K83.1 | Obstruction of bile duct |
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