About Bylvay

Bylvay Can Help Reduce Itching in PFIC Patients

Because of the severe itching it causes, PFIC can disrupt activities like going for a swim or relaxing at home.

Until recently, there have been no medical treatments approved for pruritus in PFIC. Patients often have been treated with surgeries, such as biliary diversion and liver transplantation, which all have significant risks.^1-4

Bylvay may change that. Bylvay is:

The first non-surgical treatment FDA-approved for pruritus in PFIC
Approved in patients as young as 3 months old
Oral medicine that is taken once a day*

While it is not known exactly how Bylvay works, it is thought that by reducing bile acids in the blood, Bylvay may reduce the amount of itching PFIC patients experience.

*Take in the morning with a meal.

First-hand Experiences with Bylvay

Watch our educational videos to learn more from patients and caregivers who have experience with Bylvay. Find out out how Bylvay works from PFIC specialists. And get an overview of Albireo Assist from the support program's Care Coordinators.

What to Expect with Bylvay

Bylvay was studied in the largest clinical trial program completed in PFIC patients.

Many patients had improvements in scratching after 4 weeks on Bylvay, and many patients eventually had little or no scratching
- Some patients respond more slowly; if the itching isn’t reduced after 3 months on Bylvay, your doctor may increase the dose
In the clinical trial, 83% of Bylvay patients and 85% of placebo patients experienced side effects
- The most common side effects during the trial were diarrhea, liver test changes, vomiting, stomach pain and fat-soluble vitamin problems

The pruritus (itchiness) in PFIC is all-encompassing. As a doctor, my biggest concern is relieving it. In the long term, you want the patient to grow to be a normal adult. But when they're standing in front of you, you want to relieve the pruritus.

Pediatric Hepatologist

Find out how to take Bylvay and how to fit it into your day

1. Bjørnland K et al. Eur J Pediatr Surg. 2020.
2. Stapelbroek JM et al. J Hepatol. 2010;52(2):258-271.
3. Bull LN et al. Hepatol Commun. 2018;2:515-518.
4. Singh S et al. Mayo Clin Proc. 2012;87:779-790.

IMPORTANT SAFETY INFORMATION AND INDICATIONS

IMPORTANT SAFETY INFORMATION

Speak with your healthcare provider if you experience abdominal pain, vomiting, diarrhea, hematoma, decreased weight, or dehydration as these have been reported with the use of Bylvay. Patients should contact their healthcare provider if they experience new onset or worsening of diarrhea
Elevations in liver tests (for example, AST, ALT, TB) have been observed with use of Bylvay. The patient’s healthcare provider will obtain liver tests before starting Bylvay and periodically during treatment with Bylvay. Patients should report to their healthcare provider 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)
Bylvay may impair absorption of fat-soluble vitamins (FSV), which include vitamins A, D, E and K (vitamin K is assessed by measuring INR). The patient’s 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
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. Take Bylvay in the morning with a meal
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 exposure registry that monitors pregnancy outcomes in women exposed to Bylvay during pregnancy. For more information, please call 1-855-252-4736

Indications and Usage

Bylvay is an ileal bile acid transporter (IBAT) inhibitor indicated for the treatment of cholestatic pruritus 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 may not be effective in a subgroup of PFIC type 2 patients with specific ABCB11 variants resulting in non-functional or complete absence of the bile salt export pump protein

Please see full Prescribing Information.

IMPORTANT SAFETY INFORMATION AND INDICATIONS

IMPORTANT SAFETY INFORMATION

Speak with your healthcare provider if you experience abdominal pain, vomiting, diarrhea, hematoma, decreased weight, or dehydration as these have been reported with the use of Bylvay. Patients should contact their healthcare provider if they experience new onset or worsening of diarrhea
Elevations in liver tests (for example, AST, ALT, TB) have been observed with use of Bylvay. The patient’s healthcare provider will obtain liver tests before starting Bylvay and periodically during treatment with Bylvay. Patients should report to their healthcare provider 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)
Bylvay may impair absorption of fat-soluble vitamins (FSV), which include vitamins A, D, E and K (vitamin K is assessed by measuring INR). The patient’s 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
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. Take Bylvay in the morning with a meal
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 exposure registry that monitors pregnancy outcomes in women exposed to Bylvay during pregnancy. For more information, please call 1-855-252-4736

Indications and Usage

Bylvay is an ileal bile acid transporter (IBAT) inhibitor indicated for the treatment of cholestatic pruritus 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 may not be effective in a subgroup of PFIC type 2 patients with specific ABCB11 variants resulting in non-functional or complete absence of the bile salt export pump protein

Please see full Prescribing Information.