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

Frequently asked questions about the Kogenate^® FS discontinuation.

See additional questions about general topics, Kovaltry^® and insurance below.

Questions about Jivi^®

Why might Jivi be appropriate for adult and adolescent patients currently on Kogenate FS?

Jivi is an extended half-life (EHL) product that offers previously treated adults and adolescents (12 years of age and older) with hemophilia A the potential for fewer infusions. Jivi has a twice weekly starting dose and the potential (based on bleeding episodes) to step up to every 5 days and fine tune. Kogenate FS and Jivi are both manufactured using the same type of cell line. Jivi is not for use in patients under 12 years of age or in previously untreated patients.¹ Talk to your doctor to see if Jivi may be right for you.

Does Jivi allow my doctor to tailor my treatment to meet my individual needs?

Yes, Jivi offers unique stepwise dosing with a twice weekly starting dose and, based on bleeding episodes, the potential to step up to every 5 days and fine tune.¹

Are there clinical data for Kogenate FS patients who transitioned to Jivi?

Yes, Jivi clinical studies evaluated efficacy and safety data in previously treated adult and adolescent patients, 12 years of age or older. These studies included 132 on-demand and prophylactic patients*, 48 of whom were previously on Kogenate FS^†. Click here to learn more about these patients.^1,2

How long has Jivi been available to patients?

Jivi was approved by the FDA in 2018 based on efficacy and safety data in the treatment and control of bleeding in previously treated adults and adolescents (12 years of age and older) with hemophilia A. Jivi is not for use in patients under 12 years of age or in previously untreated patients.¹ Ask your doctor if Jivi is right for you.

Jivi is manufactured using the same type of cell line as Kogenate FS.^1,3

Does my dosing frequency change if my doctor decides that Jivi is right for me?

Jivi offers patients a twice weekly starting dose and the potential (based on bleeding episodes) to step up to every 5 days and fine tune.¹ Talk to your doctor to determine if Jivi is right for you.

Does Jivi have the same reconstitution system as Kogenate FS?

Yes, both Jivi and Kogenate FS use the same Vial Adapter reconstitution system.^1,3

Can patients pool multiple Jivi vials in one syringe?

If your dose requires more than one vial, first reconstitute each vial as described in the Jivi Vial Adapter instructions with the diluent syringe provided. Then, to combine the contents of the vials, use a larger plastic syringe (not provided) to pool the solution into the syringe and administer as usual.

Does Jivi come with a butterfly needle?

Yes, Jivi is packaged with a 25-gauge butterfly needle.¹

How long can patients keep Jivi at room temperature?

Store Jivi under refrigeration at 36°F to 46°F. Do not freeze. Jivi may be stored for a single period of up to 6 months at temperatures up to 77°F. Once stored at room temperature, do not return the product to the refrigerator. The shelf-life then expires after storage at room temperature for 6 months, or after the expiration date on the product vial, whichever is earlier.¹ Visit the Jivi website for the full details on storing Jivi.

Is PK testing required to transition from Kogenate FS to Jivi?

No, PK testing is not required to transition from Kogenate FS to Jivi.

How do the PK parameters of Jivi compare to those of other extended half-life (EHL) products?

Visit UnderstandingPK.com to learn about the pharmacokinetic properties of Jivi. This website also includes data from a head-to-head study comparing the pharmacokinetic characteristics of Jivi vs. Eloctate. Talk to your doctor about the PK data in head-to-head studies comparing Jivi vs. Eloctate and Jivi vs. another EHL.

Can Jivi be used for surgery in adult and adolescent patients 12 years of age or older?

Yes, your healthcare provider can also give you Jivi when you have surgery.¹ Speak with your doctor about any upcoming medical procedures.

Additional FAQs

*Two patients enrolled in Protect VIII left the main study prematurely during the run-in period.
†Also includes patients who transitioned from Helixate FS. Kogenate FS and Helixate FS contain the same factor (active pharmaceutical ingredient and formulation).
‡Patients who are enrolled in any type of government insurance are not eligible. Bayer reserves the right to rescind, revoke, or amend this offer without notice at any time.
§Co-pay program support is available for up to 1 year. Can include any out-of-pocket prescription costs, such as co-pay and co-insurance. Up to 20,000 in co-pay assistance available per year. Eligible patients will be auto-enrolled every January.

1. Jivi Prescribing Information. Bayer HealthCare LLC, Whippany, NJ; 2018. 2. Data on file. Jivi Protect VIII Subgroup Analysis. Bayer HealthCare LLC, Whippany, NJ. 3. Kogenate Prescribing Information. Bayer HealthCare LLC, Whippany, NJ.

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.

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

Site last modified 08/2024

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Frequently asked questions about the Kogenate® FS discontinuation.

Questions about Jivi®

Additional FAQs

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