Brand Name
Bylvay
Generic Name
Odevixibat
View Brand Information FDA approval date: July 20, 2021
Classification: Ileal Bile Acid Transporter Inhibitor
Form: Capsule
What is Bylvay (Odevixibat)?
BYLVAY is an ileal bile acid transporter inhibitor indicated for: Progressive Familial Intrahepatic Cholestasis the treatment of pruritus in patients 3 months of age and older with progressive familial intrahepatic cholestasis .
Approved To Treat
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Related Clinical Trials
Registry to Document Treatment Effectiveness, Safety, Including Prospective Long-term Outcomes in Participants With Progressive Familial Intrahepatic Cholestasis (PFIC) Who Take Odevixibat (Bylvay)
Summary: This study will collect information from people with Progressive Familial Intrahepatic Cholestasis (PFIC) as they use odevixibat in their daily lives. Odevixibat is a medicine that helps people with PFIC, a type of rare disease that makes their liver not work well and causes itching and yellow skin. Odevixibat was first allowed to be used for PFIC in babies older than 6 months by the European Medi...
Odevixibat Pregnancy and Lactation Surveillance Program: A Post-marketing, Long-term, Observational, Descriptive Study to Assess the Risk of Pregnancy and Maternal Complications and Adverse Effects on the Developing Fetus, Neonate, and Infant Among Individuals Exposed to Odevixibat During Pregnancy and/or Lactation
Summary: The participants of this study will be of any age who are exposed to at least 1 dose of odevixibat at any time during pregnancy (from 1 day prior to conception to pregnancy outcome) and/or at any time during lactation (up to 12 months of infant age or weaning, whichever comes first. This study will collect data obtained via a variety of sources, including enrolled pregnant or lactating participant...
An Open Label Study to Evaluate the Long-term Safety and Efficacy of Odevixibat (A4250) in Patients With Alagille Syndrome (ASSERT-EXT)
Summary: The purpose of this study is to assess the long-term safety and effectiveness of odevixibat in participants with Alagille syndrome (ALGS). The participants of this study will have ALGS a rare genetic disorder that can affect multiple organ systems of the body including the liver, heart, skeleton, eyes and kidneys. Common symptoms, which often develop during the first three months of life, include ...
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Brand Information
Bylvay (odevixibat)
1DOSAGE FORMS AND STRENGTHS
- Oral Pellets:
- Capsules:
2CONTRAINDICATIONS
IBAT inhibitors, including BYLVAY, are contraindicated in patients with prior or active hepatic decompensation events (e.g., variceal hemorrhage, ascites, hepatic encephalopathy)
3ADVERSE REACTIONS
The following adverse reactions are discussed in greater detail in other sections of the label:
- Hepatotoxicity [
- Diarrhea
- Fat-Soluble Vitamin Deficiency
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
3.2Postmarketing Experience
The following adverse reactions have been identified during post-approval use of BYLVAY. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Gastrointestinal disorders: gastrointestinal hemorrhage, gingival hemorrhage, liver transplant
Investigations: gamma-glutamyltransferase increased, hemoglobin decreased
Nervous system disorders: extra-axial hemorrhage (subdural hemorrhage)
Respiratory, thoracic, and mediastinal disorders: epistaxis
4DESCRIPTION
The active ingredient in BYLVAY (odevixibat) capsules and BYLVAY (odevixibat) oral pellets, an ileal bile acid transporter (IBAT) inhibitor, is (2S)-2-{[(2R)-2-(2-{[3,3-dibutyl-7-(methylsulfanyl)-1,1-dioxo-5-phenyl-2,3,4,5-tetrahydro-1H-1λ
The molecular formula is C
BYLVAY is available for oral administration as oral pellets containing odevixibat sesquihydrate equivalent to 200 mcg or 600 mcg of odevixibat, and as capsules containing odevixibat sesquihydrate equivalent to 400 mcg or 1200 mcg of odevixibat, and the following excipients: hypromellose and microcrystalline cellulose.
The capsule shells for the oral pellets contain hypromellose, titanium dioxide and yellow iron oxide.
The capsule shells for the capsules contain hypromellose, red iron oxide, titanium dioxide and yellow iron oxide.
The imprinting ink contains ferrosoferric oxide/black iron oxide and shellac glaze.
5PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Instructions for Use).
6Instructions For Use BYLVAY [bil-vay] (odevixibat) Capsules, for oral use Oral Pellets
This Instructions for Use contains information on how to give BYLVAY Capsules and Oral Pellets. This information does not take the place of talking to your healthcare provider about your child's medical condition or their treatment.
Important information you need to know before giving or taking BYLVAY
- Give BYLVAY
- Mix BYLVAY in a small amount of soft food (up to 2 tablespoons [30 mL]), such as apple sauce, oatmeal, banana or carrot puree, chocolate or rice pudding, in a bowl. You may also mix BYLVAY with an age-appropriate liquid and give through an oral syringe.
- If your child is taking bile acid binding resins (for example, cholestyramine, colestipol), give them BYLVAY at least 4 hours before or 4 hours after they take the bile acid binding resin.
Preparing to Give BYLVAY
You will be provided with the number of BYLVAY Capsules or Oral Pellets prescribed by your child's healthcare provider in a child-resistant closure.
Giving BYLVAY Oral Pellets with soft food:
- The shell containing Oral Pellets are to be opened and sprinkled.
- Mix the contents of the Oral Pellets with soft food as shown in
Giving BYLVAY Oral Pellets with liquids (Using an oral dosing syringe):
- The shell containing the Oral Pellets are to be opened.
- Mix the Oral Pellets with liquid as shown in
- Dispose of (throw away) the emptied shells.
Taking BYLVAY Capsules
- Take BYLVAY Capsules
- For children unable to swallow BYLVAY Capsules whole, follow instructions under
How should I store BYLVAY Capsules or Oral Pellets?
Store BYLVAY at room temperature between 68°F to 77°F (20°C to 25°C).
Disposing (throwing away) of BYLVAY Capsules or Oral Pellets shells.
Dispose of (throw away) the empty BYLVAY Capsule or Oral Pellets shells in the household trash.
What are the ingredients in BYLVAY?
Active ingredient: odevixibat.
Inactive ingredients: hypromellose and microcrystalline cellulose.
Manufactured for:
Ipsen Biopharmaceuticals, Inc.
© 2024 Ipsen Biopharmaceuticals, Inc. All rights reserved.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
7PRINCIPAL DISPLAY PANEL - 200 mcg Capsule Bottle Carton
NDC 15054-3301-1
Bylvay
ORAL PELLETS
200 mcg
RX ONLY
8PRINCIPAL DISPLAY PANEL - 400 mcg Capsule Bottle Carton
NDC 15054-3302-1
Bylvay
CAPSULES
400 mcg
RX ONLY
9PRINCIPAL DISPLAY PANEL - 600 mcg Capsule Bottle Carton
NDC 15054-3303-1
Bylvay
ORAL PELLETS
600 mcg
RX ONLY
10PRINCIPAL DISPLAY PANEL - 1,200 mcg Capsule Bottle Carton
NDC 15054-3304-1
Bylvay
CAPSULES
1,200 mcg
RX ONLY
