SELECTED IMPORTANT SAFETY INFORMATION: You should not use Jivi if you are allergic to rodents (like mice and hamsters) or to any ingredients in Jivi. CONTINUE READING BELOW

Getting Started with Jivi®

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Hear why Zach, a Bayer patient for more than 15 years, knew Jivi was right for him.

    Jivi® is an extended-half-life rFVIII with unique step-wise dosing1,2

    Start simply. For all prophylaxis patients the recommended starting regimen is Jivi twice weekly (30-40 IU/kg). Step up. Based on bleeding episodes, less frequent dosing of Jivi every 5 days (45-60 IU/kg) can be used. Fine tune. Based on bleeding episodes, the dosing frequency may be further adjusted up or down.

    IU, international units; kg, kilograms; rFVIII, recombinant Factor VIII.

    Hear Chama, share how he was able to reduce his dosing frequency with Jivi.

    Ask your doctor about the dosing frequency that is best for you.

    Jivi® is available in a range of vial sizes.1

    500 IU Range. 1000 IU Range. 2000 IU Range. 3000 IU Range.

    Learn how to use Jivi® with Vial Adapter.

    Reconstitute and administer Jivi® with the components provided with each package. If any component of the package is opened or damaged, do not use this component. Work on a clean surface and wash hands thoroughly using soap and warm water before performing the procedures.

    Make sure to download the Instructions For Use using the link above and read for more detailed information.

    Jivi® is available with the Vial Adapter needleless reconstitution system, which contains1:

    Vial Adapter, with built-in 15-micrometer filter

    2.5-mL diluent in a 5-mL syringe

    25-gauge butterfly needle

    Hear why Stacey, share why her son, Erik, loves Jivi's packaging.

    Thermometer icon 77 degrees
    Jivi® antihemophilic factor (recombinant), PEGylated-aucl, vial adapter kit

    Store Jivi® at 36°F to 46°F for up to 24 months from the date of manufacture

    Do not freeze

    Within this period, Jivi® may be stored for a single period of up to 6 months at temperatures up to 77°F

    Record the starting date of room-temperature storage clearly on the unopened product carton

    Once stored at room temperature, do not return the product to the refrigerator

    The shelf life expires after storage at room temperature for 6 months, or after the expiration date on the product vial, whichever is earlier

    Store vials in their original carton and protect them from extreme exposure to light

    Jivi® is available with the Vial Adapter needleless reconstitution system, which contains

    Vial Adapter, with built-in 15-micrometer filter

    2.5-mL diluent in a 5-mL syringe

    25-gauge butterfly needle

    Jivi® antihemophilic factor (recombinant), PEGylated-aucl, vial adapter kit

    Hear why Stacey, share why her son, Erik, loves Jivi's packaging.

    Thermometer icon 77 degrees

    Store Jivi® at 36°F to 46°F for up to 24 months from the date of manufacture

    Do not freeze

    Within this period, Jivi® may be stored for a single period of up to 6 months at temperatures up to 77°F

    Record the starting date of room-temperature storage clearly on the unopened product carton

    Once stored at room temperature, do not return the product to the refrigerator

    The shelf life expires after storage at room temperature for 6 months, or after the expiration date on the product vial, whichever is earlier

    Store vials in their original carton and protect them from extreme exposure to light

    INDICATIONS

    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.

    References: 1. Jivi® Prescribing Information. Whippany, NJ: Bayer LLC; 2018. 2. Data on file. Tx Review 0918. Bayer; 2018.