Jivi FDA Approval History
Last updated by Judith Stewart, BPharm on Aug 31, 2018.
FDA Approved: Yes (First approved August 30, 2018)
Brand name: Jivi
Generic name: antihemophilic factor [recombinant] PEGylated-aucl
Dosage form: Injection
Company: Bayer HealthCare Pharmaceuticals Inc.
Treatment for: Hemophilia A
Jivi (antihemophilic factor (recombinant), PEGylated-aucl) is a recombinant DNA-derived, Factor VIII concentrate indicated to treat and control bleeding in patients with hemophilia A.
The extended half-life of Jivi allows for twice-weekly initial dosing, with the ability to dose every five days and further individually adjust to less or more frequent dosing based on bleeding episodes.
IMPORTANT SAFETY INFORMATION
- You should not use Jivi if you are allergic to rodents (like mice and hamsters) or to any ingredient in Jivi.
- Tell your healthcare provider about all of your medical conditions that you have or had.
- Tell your healthcare provider if you have been told that you have inhibitors to Factor VIII.
- Allergic reactions may occur with Jivi. Call your healthcare provider right away and stop treatment if you get tightness of the chest or throat, dizziness, decrease in blood pressure, or nausea.
- Allergic reactions to polyethylene glycol (PEG), a component of Jivi, are possible.
- Your body can also make antibodies, called "inhibitors," against Jivi, which may stop Jivi from working properly. Consult your healthcare provider to make sure you are carefully monitored with blood tests for the development of inhibitors to Factor VIII.
- If your bleeding is not being controlled with your usual dose of Jivi, consult your doctor immediately. You may have developed Factor VIII inhibitors or antibodies to PEG and your doctor may carry out tests to confirm this.
The common side effects of Jivi are headache, cough, nausea, and fever.
Development Timeline for Jivi
|Aug 30, 2018||Approval Bayer Receives FDA Approval for Jivi (antihemophilic factor (recombinant), PEGylated-aucl) for Prophylactic Treatment of Hemophilia A|
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.