Important Safety Information
Jivi Indications and Important Safety Information - Patients
- Jivi is an injectable medicine used to replace clotting factor (Factor VIII or antihemophilic factor) that is missing in people with hemophilia A.
- Jivi is used to treat and control bleeding in previously treated adults and adolescents (12 years of age and older) with hemophilia A. Your healthcare provider may also give you Jivi when you have surgery. Jivi can reduce the number of bleeding episodes in adults and adolescents with hemophilia A when used regularly (prophylaxis).
- Jivi is not for use in children below 12 years of age or in previously untreated patients.
- Jivi is not used to treat von Willebrand disease.
IMPORTANT SAFETY INFORMATION
- You should not use Jivi if you are allergic to rodents (like mice and hamsters) or to any ingredients 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.
- These are not all the possible side effects with Jivi. Tell your healthcare provider about any side effect that bothers you or that does not go away.
For additional important risk and use information, please see the full Prescribing Information.
You are encouraged to report side effects or quality complaints of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.