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Taking Bylvay

Everyday Help with Bylvay

As you or your child starts treatment with Bylvay, it’s important to incorporate your new medication into your daily routine.

Bylvay should be taken once a day in the morning with a meal. Your doctor will prescribe the right dose based on weight.

  • Bylvay can be swallowed as a capsule or opened and mixed in a small amount (up to 30mL or 2 tablespoons) of apple sauce, oatmeal, banana or carrot puree, chocolate pudding, or rice pudding in a bowl
  • Food should be at or below room temperature
  • Bylvay should not be mixed with liquid
  • Patients who only take liquid food should not use Bylvay
  • Bylvay does not need to be refrigerated.

Patients taking bile acid binding resins should take Bylvay at least 4 hours before or 4 hours after the bile acid binding resin.

For complete instructions on taking Bylvay, download the Instructions for Use.

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.