Bayfortes (Damoctocog Alfa Pegol) - Indication and Use
Bayfortes is a PEGylated recombinant factor VIII concentrate indicated for the treatment and prevention of bleeding episodes in patients with severe hemophilia A. 1
When Bayfortes is Needed
Primary Indication
- Bayfortes (BAY 94-9027, damoctocog alfa pegol) is specifically indicated for previously treated pediatric and adult patients with severe hemophilia A who require factor VIII replacement therapy 1
- The medication is an extended half-life PEGylated recombinant factor VIII product designed to reduce dosing frequency compared to standard factor VIII products 1
Clinical Situations Requiring Treatment
Prophylactic Use:
- Routine prophylaxis to prevent bleeding episodes in patients with severe hemophilia A is the primary indication 1
- Prophylactic regimens can be administered twice weekly, every 5 days, or every 7 days depending on patient needs 1
- Long-term prophylaxis has demonstrated efficacy with median annualized bleeding rates of 1.5-1.9 total bleeds in pediatric patients 1
Treatment of Acute Bleeds:
- On-demand treatment for breakthrough bleeding episodes while on prophylaxis 1
- Management of spontaneous bleeding events (median spontaneous ABR of 0.0 in the last 12 months of treatment in pediatric studies) 1
Patient Population
- Approved for previously treated patients (PTPs) who have had at least 50 exposure days to factor VIII products 1
- Demonstrated safety and efficacy in pediatric patients aged <12 years, including those <6 years of age 1
- Long-term safety data extends up to 5.9 years of continuous treatment 1
Key Safety Considerations
- No inhibitor development was observed in clinical trials, making it appropriate for patients without pre-existing factor VIII inhibitors 1
- No anti-PEG antibodies developed during long-term follow-up 1
- The extended half-life formulation allows for less frequent dosing compared to standard factor VIII products, improving adherence 1