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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.

What to Expect with Bylvay

Bylvay was studied in the largest clinical trial 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
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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.
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Pediatric Hepatologist

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

IMPORTANT SAFETY INFORMATION AND INDICATION

IMPORTANT SAFETY INFORMATION

Speak with your healthcare provider if you experience: abdominal pain, vomiting, diarrhea, and 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 health care 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 health care 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 mix Bylvay with liquids.

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.

INDICATIONS AND USAGE

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

Limitation of Use

Bylvay may not be effective in PFIC type 2 patients with ABCB11 variants resulting in non-functional or complete absence of bile salt export pump protein (BSEP-3).

Please see full Prescribing Information.

IMPORTANT SAFETY INFORMATION AND INDICATION

IMPORTANT SAFETY INFORMATION

Speak with your healthcare provider if you experience: abdominal pain, vomiting, diarrhea, and 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 health care 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 health care 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 mix Bylvay with liquids.

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.

INDICATIONS AND USAGE

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

Limitation of Use

Bylvay may not be effective in PFIC type 2 patients with ABCB11 variants resulting in non-functional or complete absence of bile salt export pump protein (BSEP-3).

Please see full Prescribing Information.