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SELECTED IMPORTANT SAFETY INFORMATION ABOUT JIVI, KOVALTRY, AND KOGENATE FS
You should not use JIVI, KOVALTRY, or KOGENATE FS if you are allergic to rodents (like mice and hamsters) or any ingredients in JIVI, KOVALTRY, or KOGENATE FS. ...Continue reading below
ISI v2 - Important Safety Information v3
Indications and Important Safety Information
JIVI®, KOVALTRY®, and KOGENATE® FS are injectable medicines used to replace clotting factor (Factor VIII or antihemophilic factor) that is missing in people with hemophilia A.
Indication For JIVI®
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.
Indication For KOVALTRY®
KOVALTRY is used to treat and control bleeding in adults and children with hemophilia A. KOVALTRY can reduce the number of bleeding episodes in adults and children with hemophilia A when used regularly (prophylaxis). Your healthcare provider may give you KOVALTRY when you have surgery.
Indication For Kogenate® FS
KOGENATE FS is used to treat and control bleeding in adults and children with hemophilia A. Your healthcare provider may give you KOGENATE FS when you have surgery. KOGENATE FS can reduce the number of bleeding episodes in adults and children when used regularly (prophylaxis). KOGENATE FS can reduce the risk of joint damage in children without pre-existing joint damage when used regularly.
JIVI, KOVALTRY, and KOGENATE FS are not indicated for the treatment of von Willebrand disease.
Important Safety Information About JIVI, KOVALTRY, and KOGENATE FS
- You should not use JIVI, KOVALTRY, or KOGENATE FS if you are allergic to rodents (like mice and hamsters) or any ingredients in JIVI, KOVALTRY, or KOGENATE FS.
- Tell your healthcare provider about all the medical conditions that you have or had or are at risk of such as heart disease.
- Allergic reactions may occur with JIVI, KOVALTRY, and KOGENATE FS. Call your healthcare provider right away and stop treatment if you get rash or hives, itching, tightness of the chest or throat, dizziness, difficulty breathing, decrease in blood pressure, and nausea.
- Allergic reactions to polyethylene glycol (PEG), a component of JIVI, are possible.
- Your body can also make antibodies, called “inhibitors,” against JIVI, KOVALTRY, and KOGENATE FS, which may stop JIVI, KOVALTRY, and KOGENATE FS 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, KOVALTRY, or KOGENATE FS consult your doctor immediately. You may have developed Factor VIII inhibitors to JIVI, KOVALTRY, or KOGENATE FS. If your bleeding is not being controlled with your usual dose of JIVI you may have developed 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.
- The common side effects of KOVALTRY are fever, headache, and rash, in addition to inhibitors in patients who were not previously treated or minimally treated with Factor VIII products.
- Other common side effects of KOGENATE FS are local injection site reactions (pain, swelling, irritation at infusion site) and infections from implanted injection device.
- These are not all the possible side effects with JIVI, KOVALTRY, and KOGENATE FS. 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 full Prescribing Information for Jivi, Kovaltry and Kogenate FS.
