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.¹ 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

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

Yes, Jivi clinical trials evaluated efficacy and safety for on-demand treatment, perioperative management of bleeding and routine prophylaxis in 132 previously treated adult and adolescent patients ≥ 12 years during the Protect VIII clinical trial.* A post-hoc subgroup analysis was also completed to evaluate the 48 patients who transitioned from Kogenate FS to Jivi as part of these trials.^†1,2Click here for efficacy and safety data on these patients.

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

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

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 the dose requires more than one vial, your patient should 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, a patient should 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 HCP 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 for patients to transition from Kogenate FS to Jivi; however, eligible patients can receive up to $250 per year to offset out-of-pocket costs for laboratory testing of Jivi.^‡§

Click here to access the Jivi reimbursement for lab testing claim form for your patients.

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

Pharmacokinetic data for Jivi, including data from two randomized, crossover PK studies comparing Jivi to Eloctate and comparing Jivi to Adynovate, can be found by visiting JiviPK.com.

If a patient requires surgery, can Jivi be used in the perioperative setting?

Yes, Jivi is approved for perioperative management of bleeding.¹

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

Indication For KOGENATE^® FS

KOGENATE FS is an Antihemophilic Factor (Recombinant) indicated for:

On-demand treatment and control of bleeding episodes in adults and children with hemophilia A.
Perioperative management of bleeding in adults and children with hemophilia A.
Routine prophylaxis to reduce the frequency of bleeding episodes in children with hemophilia A and to reduce the risk of joint damage in children without pre-existing joint damage.
Routine prophylaxis to reduce the frequency of bleeding episodes in adults with hemophilia A.

Indication For KOVALTRY^®

KOVALTRY Antihemophilic Factor (Recombinant) is a recombinant human DNA sequence derived, full length Factor VIII concentrate indicated for use in adults and children with hemophilia A for:

On-demand treatment and control of bleeding episodes
Perioperative management of bleeding
Routine prophylaxis to reduce the frequency of bleeding episodes

Indication For JIVI^®

JIVI antihemophilic factor (recombinant), PEGylated-aucl, is a recombinant DNA-derived, Factor VIII concentrate indicated for use in previously treated adults and adolescents (12 years of age and older) with hemophilia A (congenital Factor VIII deficiency) for:

On-demand treatment and control of bleeding episodes
Perioperative management of bleeding
Routine prophylaxis to reduce the frequency of bleeding episodes

Limitations of Use For JIVI:

JIVI is not indicated for use in children
less than 12 years of age due to a greater risk for hypersensitivity reactions.
JIVI is not indicated for use in previously untreated patients (PUPs).

KOGENATE FS, KOVALTRY, and JIVI are not indicated for the treatment of von Willebrand disease.

Important Safety Information About KOGENATE FS, KOVALTRY, and JIVI

KOGENATE FS, KOVALTRY, and JIVI are contraindicated in patients who have a history of hypersensitivity reactions to the active substance, to any of the excipients, or to mouse or hamster proteins. JIVI is also contraindicated in patients who have a history of hypersensitivity reactions to polyethylene glycol (PEG).
Hypersensitivity reactions, including severe allergic reactions, are possible with KOGENATE FS, KOVALTRY, and JIVI. Monitor patients for hypersensitivity symptoms.
Early signs of hypersensitivity reactions, which can progress to anaphylaxis, may include chest or throat tightness, dizziness, mild hypotension and nausea. Discontinue KOGENATE
FS, KOVALTRY, or JIVI if symptoms occur and seek immediate emergency treatment.
KOGENATE FS, KOVALTRY, and JIVI may contain trace amounts of mouse and hamster proteins. Patients treated with KOGENATE FS, KOVALTRY, or JIVI may develop hypersensitivity to these non-human mammalian proteins.
Neutralizing antibodies (inhibitors) have occurred following administration of KOGENATE FS, KOVALTRY, and JIVI predominately in previously untreated patients. Carefully monitor patients for the development of Factor VIII inhibitors, using appropriate clinical observations and laboratory tests. If expected plasma Factor VIII activity levels are not attained, or if bleeding is not controlled with an expected dose, suspect the presence of an inhibitor.
For JIVI, a clinical immune response associated with IgM anti-PEG antibodies, manifested as symptoms of acute hypersensitivity and/or loss of drug effect, has been observed primarily in patients < 6 years of age. The symptoms of the clinical immune response were transient. Anti-PEG IgM titers decreased over time to undetectable levels. No immunoglobulin class switching was observed. In case of clinical suspicion of loss of drug effect, conduct testing for Factor VIII inhibitors and Factor VIII recovery.
For JIVI, a low post-infusion Factor VIII level in the absence of detectable Factor VIII inhibitors indicates that loss of drug effect is likely due to anti-PEG antibodies. Discontinue JIVI and switch patients to a previously effective Factor VIII product.
Hemophilic patients with cardiovascular risk factors or diseases may be at the same risk to develop cardiovascular events as non-hemophilic patients when clotting has been normalized by treatment with Factor VIII.
Catheter-related infections may occur when KOVALTRY is administered via central venous access devices (CVADs). These infections have not been associated with the product itself.

In clinical trials with:

KOGENATE FS – the most common adverse reactions (≥4%) observed were inhibitor formation in previously untreated and minimally treated patients, skin-related hypersensitivity reactions, infusion site reactions, and CVAD-associated infections.
KOVALTRY – the most frequently reported adverse reactions in clinical trials (≥5%) were inhibitors in previously untreated patients (PUPs)/minimally treated patients (MTPs), and pyrexia, headache, and rash.
JIVI – the most frequently (≥5%) reported adverse reactions in previously treated patients (PTPs) ≥12 years of age were headache, cough, nausea, and fever.

For additional important risk and use information, please see the full Prescribing Information for KOGENATE FS, KOVALTRY, and JIVI.

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Frequently asked questions about the Kogenate® FS discontinuation.

Questions about Jivi®

Additional FAQs

ISI v2 - Important Safety Information v3