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Bylvay® (odevixibat)
Bylvay is a potent, once-daily, non-systemic ileal bile acid transport inhibitor (IBATi) that acts locally in the small intestine and has minimal systemic exposure. In June 2023, Bylvay was approved in the U.S. for the treatment of cholestatic pruritus in patients from 12 months of age with Alagille syndrome. Bylvay is also approved in the U.S. for the treatment of pruritus in patients three months of age and older with PFIC, where it has orphan exclusivity. 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. Bylvay was first launched as a treatment option for pruritus in patients with PFIC in the U.S. in 2021, where it is supported by a program designed to assist with access to treatment and patient support. Bylvay is also approved in the E.U. for the treatment of PFIC in patients aged six months or older. It has launched in over nine countries and has secured public reimbursement across several major markets including Germany, Italy, the U.K., France and Belgium.
Learn more about Bylvay in the U.S
- Patients and Families: https://bylvay.com/
- HCPS: https://bylvay.com/home-hcp.html
- Prescribing Information: https://bylvay.com/pdf/Bylvay_Pl.pdf
- Also attached is the IMPORTANT SAFETY INFORMATION
IMPORTANT SAFETY INFORMATION
- 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 orworsening of diarrhea
- 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)
- 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 toassess 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. 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
About Ipsen
Ipsen is a global, mid-sized biopharmaceutical company focused on transformative medicines in Oncology. Rare Disease and Neuroscience. With about 5,400 team members around the world, Ipsen sells medicines in over 100 countries. Alongside its external-innovation strategy, the Company’s resech and development efforts are focused on its innovative and differentiated technological platforms located in the heart of leading biotechnological and life-science hubs: Paris-Saclay, France; Oxford, U.K.; Cambridge, U.S.; Shanghai, China. For more information, visit ipsen.com.
Ipsen ALGS Resources
Important Links
Information for ALGS Patients and Families: https://bylvay.com/
Non-surgical treatment for pruritus (HCPCS): https://bylvay.com/home-hcp.html
Prescribing Informaiton: https://bylvay.com/pdf/Bylvay_PI.pdf