IMPORTANT SAFETY INFORMATION
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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
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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)
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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
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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
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For patients taking bile acid binding resins, take Bylvay at least
4 hours before or 4 hours after taking a bile acid binding resin
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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:
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Patients 12 months of age and older with Alagille syndrome (ALGS)
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Patients 3 months of age and older with progressive familial
intrahepatic cholestasis (PFIC)
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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.
