FAQs for PFIC | Bylvay® (odevixibat) - Patient site

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This site is intended for US residents only

Frequently asked questions about Bylvay and PFIC

What is progressive familial intrahepatic cholestasis?

Progressive familial intrahepatic cholestasis (PFIC) is a spectrum of rare, genetic disorders that can cause liver damage. The way PFIC affects the liver can cause itch (pruritus), which can be severe in some patients.

What is pruritus?

Doctors may describe the itch from PFIC using this term. Pruritus (pronounced proo-rahy-tuhs) is a medical term for itching.

What is Bylvay?

Bylvay is a medicine to treat cholestatic pruritus (itch) in patients with Alagille syndrome as young as 12 months of age and in patients with progressive familial intrahepatic cholestasis (PFIC) as young as 3 months of age.

Limitation of Use:  
BYLVAY is not recommended for some PFIC type 2 patients who have specific ABCB11 gene changes. Talk with your healthcare provider if you have questions.

How is Bylvay thought to work?

Bylvay is a type of medication called an ileal bile acid transporter (IBAT) inhibitor. While the exact way Bylvay reduces itch isn’t fully understood, IBAT inhibition may reduce bile acid buildup as measured by bile acid in the blood. The buildup of bile acids in the liver and the bloodstream is believed to be the cause of itch in PFIC.

What resources can help me access/afford Bylvay?

IPSEN CARES^® patient support program can help you get access to your Bylvay^® (odevixibat) prescription with the information and support you need.

To learn more about IPSEN CARES:

Monday-Friday, 8:00 AM – 8:00 PM ET

support@ipsencares.com

What is BYLVAY (odevixibat)?

IMPORTANT SAFETY INFORMATION

What is BYLVAY (odevixibat)?

BYLVAY is a prescription medicine for the treatment of itching in:

Patients 12 months of age and older with Alagille syndrome (ALGS)
Patients 3 months of age and older with progressive familial intrahepatic cholestasis (PFIC)

Limitation of Use:
BYLVAY is not recommended for some PFIC type 2 patients who have specific ABCB11 gene changes. Talk with your healthcare provider if you have questions.

IMPORTANT SAFETY INFORMATION

What are the possible side effects of BYLVAY?

BYLVAY can cause serious side effects, including:

You should not use BYLVAY if you have had or have an advanced stage of liver disease. Talk with your healthcare provider if you have any liver conditions.
Abnormal liver tests have been observed with use of BYLVAY. Liver tests should be obtained before starting and periodically during therapy to monitor for liver injury. Immediately report to your healthcare provider any signs or symptoms of liver injury, such as nausea, vomiting, skin or the whites of eyes turn yellow, dark or brown urine, pain on the right side of the abdomen, or loss of appetite.
Notify your healthcare provider if you experience new onset or worsening of diarrhea.
BYLVAY may decrease the absorption of certain vitamins, which include vitamins A, D, E, and K (FSV or fat-soluble vitamins). Your blood levels of these vitamins should be measured before starting and periodically during treatment to assess for FSV deficiency. You may bleed more easily, may bleed longer, or experience a bone fracture. Call your healthcare provider if you have any signs or symptoms of bleeding.

The most common side effects of BYLVAY include:

The most common side effects of BYLVAY treatment in patients with ALGS are diarrhea, abdominal pain, abnormal bleeding, such as bruising, and decreased weight.
The most common side effects of BYLVAY in patients with PFIC are diarrhea, liver test abnormalities, vomiting, abdominal pain, and FSV deficiency.
Do not swallow the 200 mcg or 600 mcg capsule(s) containing Oral Pellets whole. These are intended to be opened and the contents mixed into 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.
There is a pregnancy safety study that collects outcome data in women taking BYLVAY during pregnancy. Pregnant women exposed to BYLVAY should report if they have used BYLVAY during pregnancy by calling 1-855-463-5127 and contact your doctor immediately.

You are encouraged to report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. You may also report side effects to Ipsen Biopharmaceuticals, Inc. at 1-855-463-5127.

Please see full Prescribing Information and Instructions for Use for BYLVAY.