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Forms & Applications
Complete this Patient Consent Form to enroll in Albireo Assist. Your doctor will also need to complete an Enrollment Form and provide supporting materials for you to sign up.
Complete this Patient Assistance Program application if your Care Coordinator determines you are eligible for the program.
Download this brochure for patients and caregivers for information on Albireo Assist.
Indication and Important Safety Information
Indication and Usage
Bylvay is indicated for the treatment of pruritus in patients 3 months of age and older with progressive familial intrahepatic cholestasis (PFIC).
Limitations 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).
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 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 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.