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Brochure for Patients
This booklet for patients and caregivers is designed to help them better understand Albireo Assist and the services offered.
Patient Consent Form
Patients or their caregivers will need to complete, sign, and return this form to Albireo Assist as part of the enrollment process. Learn more on the How to Enroll page.
Patient Assistance Program Application
Patients enrolled in Albireo Assist who lack financial means or insurance coverage to pay for treatment may qualify for the Patient Assistance Program. Learn more on the Support Services page or from your Care Coordinator.
Help Others Understand PFIC With the PFIC Snapshot
PFIC snapshot is a quick way to capture and personalize your or your child's information. You may fill it in with symptoms and their impact, itch triggers, nutritional needs, and any notes you may want to include. Then print and share it with friends, family, teachers, coaches – anyone in your life who could use more information.
Reflecting on Your Strengths
Take a moment to think about qualities within yourself that you’re proud of. Fill out this worksheet to help you reflect on those strengths.
Tips for Reducing Stress
Finding ways of making time for yourself is key to reducing stress as a caregiver. This sheet includes a link to an audio track with mindful, deep breathing exercises.
Bylvay.com is a resource designed to inform patients and those who care for them about Bylvay.
Progressive Familial Intrahepatic Cholestasis Advocacy and Resource Network (PFIC Network) aims to improve the lives of patients and families worldwide affected by PFIC.
National Organization for Rare Disorders (NORD) is a patient advocacy organization dedicated to individuals with rare diseases and the organizations that serve them. It is committed to the identification, treatment, and cure of rare disorders through programs of education, advocacy, research, and patient services.
This is not an exhaustive list of resources.
Enter your state or territory to find your dedicated Albireo Assist Care Coordinator.
- District Of Columbia
- New Hampshire
- New Jersey
- New Mexico
- New York
- North Carolina
- North Dakota
- Puerto Rico
- Rhode Island
- South Carolina
- South Dakota
- West Virginia
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.
BROCHURE FOR HEALTHCARE PROFESSIONALS
Download this brochure for healthcare professionals for information on Albireo Assist.
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 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 or liquid. 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.
Please see full Prescribing Information | Instructions for Use