• Speak with your healthcare provider if you experience: abdominal pain, vomiting, diarrhea, and dehydration as these have been reported with the use of Bylvay. Contact your healthcare provider if you experience new or worsening diarrhea, or dehydration.
• Increases in the amounts of some liver enzymes (for example, AST, ALT, TB) have been seen with use of Bylvay. Your healthcare provider will run liver tests before and during treatment with Bylvay. You should report to your 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 reduce the body’s ability to absorb fat-soluble vitamins (FSV), which include vitamins A, D, E and K. Your healthcare provider will measure blood levels of these vitamins before and during treatment with Bylvay.
• 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.

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

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).