Odevixibat

What is Odevixibat?

• Odevixibat (Bylvay) is an ileal bile acid transporter (IBAT) inhibitor used for the treatment of pruritus in patients with progressive familial intrahepatic cholestasis (PFIC).

Odevixibat structure

What are the uses of this medicine?

• Odevixibat (Bylvay) used for the treatment of pruritus in patients 3 months of age and older with progressive familial intrahepatic cholestasis (PFIC).

How does this medicine work?

• Odevixibat is a reversible inhibitor of the ileal bile acid transporter (IBAT).
• It decreases the reabsorption of bile acids (primarily the salt forms) from the terminal ileum.
• Pruritus is a common symptom in patients with PFIC and the pathophysiology of pruritus in patients with PFIC is not completely understood.
• Although the complete mechanism by which odevixibat improves pruritus in PFIC patients is unknown, it may involve inhibition of the IBAT, which results in decreased reuptake of bile salts, as observed by a decrease in serum bile acids.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Bile acid binding resins may bind odevixibat in the gut, which may reduce Bylvay efficacy. Administer bile acid binding resins (e.g., cholestyramine, colesevelam, or colestipol) at least 4 hours before or 4 hours after administration of Bylvay.

Is this medicine FDA approved?

• Odevixibat was approved for medical use in the United States and in the European Union in July 2021.

How should this medicine be used?

Recommended dosage:

• The recommended dosage of Bylvay is 40 mcg/kg once daily in the morning with a meal.
• If there is no improvement in pruritus after 3 months, the dosage may be increased in 40 mcg/kg increments up to 120 mcg/kg once daily not to exceed a total daily dose of 6 mg.

Administration:

• Administer Bylvay in the morning with a meal.
• Do not crush or chew capsules.
• Do not mix Bylvay with liquids.

Oral Pellets:

• Mix the contents of the shell containing oral pellet(s) into soft food. Do not mix Bylvay in liquids.
• Do not swallow the shell containing oral pellets whole.
• Patients who are exclusively on liquid food should not use Bylvay.

Capsules:

• Take in the morning with a meal.
• Swallow the capsule whole with a glass of water.
• Alternatively, for patients unable to swallow the capsules whole, Bylvay capsules may be opened, and sprinkled and mixed with a small amount of soft food.

• For patients taking bile acid binding resins, take Bylvay at least 4 hours before or 4 hours after taking a bile acid binding resin.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Oral Pellets: 200 mcg, 600 mcg
• Capsules: 400 mcg, 1200 mcg

This medicine is available in fallowing brand namesː

• Bylvay

What side effects can this medication cause?

The most common side effects of this medicine include:

• liver test abnormalities
• diarrhea
• abdominal pain
• vomiting
• fat-soluble vitamin deficiency

What special precautions should I follow?

• Elevations in liver tests (for example, AST, ALT, TB) have been observed with use of Bylvay. Advise patients that their healthcare provider will obtain liver tests before starting Bylvay and periodically during treatment with Bylvay. Advise patients to report any symptoms of liver problems (for example, nausea, vomiting, skin or the whites of eyes turn yellow, dark or brown urine, pain on the right side of the abdomen, loss of appetite).
• Abdominal pain, vomiting, diarrhea, and dehydration have been reported with the use of Bylvay. Advise patients to contact their healthcare provider if they experience new onset or worsening of diarrhea.
• Bylvay may impair absorption of fat-soluble vitamins (FSV), which include vitamins A, D, E and K (vitamin K is assessed by measuring INR). Advise patients that their healthcare provider will obtain serum levels of vitamins A, D, E, and INR (for vitamin K) at baseline and periodically during treatment to assess for worsening of FSV deficiency.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• There are no human data on Bylvay use in pregnant persons to establish a drug-associated risk of major birth defects, miscarriage, or adverse developmental outcomes.
• Based on findings from animal reproduction studies, Bylvay may cause cardiac malformations when a fetus is exposed during pregnancy.

Can this medicine be used in children?

• The safety and effectiveness of Bylvay have been established in pediatric patients 3 months to 17 years of age for the treatment of pruritus in PFIC.
• The safety and effectiveness of Bylvay for the treatment of pruritus in PFIC in pediatric patients less than 3 months of age have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: odevixibat.
• Inactive ingredients: hypromellose and microcrystalline cellulose.

Who manufactures and distributes this medicine?

Manufactured for:

• Albireo Pharma, Inc.
• 10 Post Office Square
• Boston, MA

What should I know about storage and disposal of this medication?

• Store Bylvay at room temperature between 68°F to 77°F (20°C to 25°C).

• Dailymed label info on Odevixibat
• FDA Odevixibat

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