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How We Help
Patients prescribed Bylvay™ (odevixibat) are eligible to enroll in Albireo Assist, a personalized support program whose focus is on helping patients and their caregivers navigate the processes required for obtaining their prescription and refills.
Click below to view each of the service areas offered under the program.
Financial & Insurance Assistance
Health insurance can be complex and overwhelming for patients and families. We’re here to help with the expertise and resources they need, including the following:
- Helping patients understand their health insurance coverage
- Financial assistance programs for eligible patients
- Assistance with identifying prior authorization and other processes/forms
Dedicated, Live Support
A dedicated Albireo Assist Care Coordinator is your patient’s primary contact with Albireo and the support program. Care Coordinators are regionally based, and take the time to get to you know your patient and their needs.
- Access to a Care Coordinator who is just a phone call away
- Personalized support from an experienced professional who knows your patient’s case and wants to help
Patients can reach their dedicated Care Coordinator at 855-ALBIREO (855-252-4736) 8am-6pm ET, or by contacting them through their direct line or email.
Locate your patient's Care Coordinator by using the purple Find Your Care Coordinator on this page.
Albireo Assist can help support patients and families in following the care plan you prescribe, even when their circumstances change due to vacation or travel, life adjustments, permanent moves, and changes in employment. To that end, we’re focused on:
- Connecting your patients with the right specialty pharmacy based on their benefits
- Helping ensure patients get their refills on time
Educational Materials & Programs
Care Coordinators can answer questions and provide patients and families with educational materials related to PFIC. They can also provide information to others involved in your patient’s life. Those enrolled in Albireo Assist have access to:
- Resources to help patients and others in their life better understand their condition and treatment
- Information about patient support groups, community resources, patient meetings
Visit the Resources page to learn more.
Enter your state to find your dedicated Albireo Assist Care Coordinator.
- District Of Columbia
- New Hampshire
- New Jersey
- New Mexico
- New York
- North Carolina
- North Dakota
- 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.
Indication and Important Safety Information
Indication and Usage
Bylvay is an ileal bile acid transporter (IBAT) inhibitor indicated for the treatment of pruritus in patients 3 months of age and older, with progressive familial intrahepactic 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).
Important Safety Information
Warnings and Precautions:
Liver Test Abnormalities
Patients enrolled in a clinical trial had abnormal liver tests at baseline. In a clinical trial, treatment-emergent elevations of liver tests or worsening of liver tests relative to baseline values were observed during the clinical trial. Most abnormalities included elevation in AST, ALT, or total and direct bilirubin. Treatment interruption days ranged from 3 days to 124 days; none of the patients in the pivotal clinical trial permanently discontinued treatment due to liver test abnormalities.
Obtain baseline liver tests and monitor during treatment. Dose reduction or treatment interruption may be required if abnormalities occur. For persistent or recurrent liver test abnormalities, consider treatment discontinuation.
Bylvay was not evaluated in PFIC patients with cirrhosis. Closely monitor for liver test abnormalities; permanently discontinue Bylvay if a patient progresses to portal hypertension or experiences a hepatic decompensation event.
In a clinical trial, diarrhea was reported in 2 (10%) placebo-treated patients, 9 (39%) Bylvay-treated 40 mcg/kg/day patients and 4 (21%) Bylvay-treated 120 mcg/kg/day patients. Treatment interruption due to diarrhea, occurred in 2 patients with 3 events during treatment with Bylvay 120 mcg/kg/day. Treatment interruption due to diarrhea ranged between 3 to 7 days. One patient treated with Bylvay 120 mcg/kg/day withdrew from the pivotal clinical trial due to persistent diarrhea.
If diarrhea occurs, monitor for dehydration and treat promptly. Interrupt Bylvay dosing if a patient experiences persistent diarrhea. Restart Bylvay at 40 mcg/kg/day when diarrhea resolves, and increase the dose as tolerated if appropriate. If diarrhea persists and no alternate etiology is identified, stop Bylvay treatment.
Fat-Soluble Vitamin (FSV) Deficiency
Fat-soluble vitamins (FSV) include vitamin A, D, E, and K (measured using INR levels). PFIC patients can have FSV deficiency at baseline. Bylvay may affect absorption of fat-soluble vitamins. In a clinical trial, new onset or worsening of existing FSV deficiency was reported in 1 (5%) placebo-treated patient, and 3 (16%) Bylvay-treated 120 mcg/kg/day patients; none of the Bylvay-treated 40 mcg/kg/day patients had new onset or worsening of existing FSV deficiency.
Obtain serum FSV levels at baseline and monitor during treatment, along with any clinical manifestations. If FSV deficiency is diagnosed, supplement with FSV. Discontinue Bylvay if FSV deficiency persists or worsens despite adequate FSV supplementation.
The most common adverse reactions for Bylvay are diarrhea, liver test abnormalities, vomiting, abdominal pain, and fat-soluble vitamin deficiency.
For patients taking bile acid binding resins, take Bylvay at least 4 hours before or 4 hours after taking a bile acid binding resin.
Use in Specific Populations
There are no human data on Bylvay use in pregnant persons to establish a drug-associated risk of major birth defects, miscarriage, or adverse developmental outcomes. Based on findings from animal reproduction studies, Bylvay may cause cardiac malformations when a fetus is exposed during pregnancy.