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, Jivi^® and insurance below.

Questions about Kovaltry^®

Why might Kovaltry be appropriate for a Kogenate FS patient?

Like Kogenate FS, Kovaltry is an unmodified, full-length, standard half-life (SHL) rFVIII product. Kovaltry offers patients currently on Kogenate FS a cell bank derived from the Kogenate FS cell line, advancements to the manufacturing process including the removal of human – and animal – derived raw materials from the cell culture and the addition of the 20nm filtration step, and the potential to stay on the same dose and frequency, or the potential to reduce their dosing frequency.¹Talk to your doctor to see if Kovaltry may be right for you.

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

Yes, Kovaltry offers patients currently on Kogenate FS the potential to reduce their dosing frequency or stay on the same dose and frequency depending on individual treatment needs.¹ Ask your doctor about the dose and frequency that is best for you.

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

Yes. Kovaltry clinical studies evaluated efficacy and safety in previously treated pediatric, adult and adolescent patients. Kovaltry clinical studies with adult and adolescent patients included 142 on-demand and prophylactic patients, 48 of whom were previously on Kogenate FS.* Kovaltry clinical studies with pediatric patients included 51 patients, 25 of whom were previously on Kogenate FS.*^1,2,3 Click here to learn more about these patients.

How long has Kovaltry been available to patients?

Kovaltry was approved by the FDA in 2016 based on efficacy and safety data in pediatric, adolescent and adult patients.¹Click here for more details.

Kovaltry is manufactured with a cell bank derived from the Kogenate FS cell line. The Kovaltry manufacturing process incorporates advancements to the Kogenate FS manufacturing process, which includes the removal of human – and animal – derived raw materials from the cell culture and the addition of 20nm filtration step.^1,4

Does my dosing frequency have to change if my doctor decides that Kovaltry is right for me?

Kovaltry offers patients currently on Kogenate FS the potential to stay on the same dosing frequency.¹ Ask your doctor about the dose and frequency that is best for you.

Does Kovaltry have the same reconstitution system as Kogenate FS?

Yes, both Kovaltry and Kogenate FS have the same Vial Adapter reconstitution device. Click here for more information on Kovaltry’s Vial Adapter reconstitution device.¹

Can patients pool multiple Kovaltry vials in one syringe?

If a dose requires more than one vial, first, reconstitute each vial as described in the Kovaltry Vial Adapter instructions with the diluent syringe provided. Then, use a larger plastic syringe (not provided) to combine the content of the vials into the syringe. Work with your doctor if you have any additional questions.

Does Kovaltry come with a butterfly needle?

Yes, Kovaltry comes with a 25-gauge butterfly needle.¹

How long can patients keep Kovaltry at room temperature?

Store Kovaltry under refrigeration at 36°F to 46°F for up to 30 months from the date of manufacture. Do not freeze. Within this period, Kovaltry may be stored for a single period of up to 12 months at temperatures up to +25°C or 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 12 months, or after the expiration date on the product vial, whichever is earlier.¹ Visit the Kovaltry website for the full details on storing Kovaltry.

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

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

How do the half-life and other PK parameters of Kovaltry compare to those of Advate?

The PK profiles of Kovaltry and Advate were compared in a head-to-head PK study. Click here to review the study data, and talk to your doctor about the PK data.

Can Kovaltry be used for surgery?

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

Additional FAQs

*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. Kovaltry Prescribing Information. Bayer HealthCare LLC, Whippany, NJ; 2021. 2. Data on file. Leopold I (12954) prior Kogenate FS/Helixate FS cohort. 3. Data on file. LEOPOLD Kids Subgroup Analysis. Bayer HealthCare LLC, Whippany, NJ. 4. 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 Kovaltry®

Additional FAQs

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