SELECTED 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). ...Continue reading below

Frequently asked questions about the Kogenate^® FS discontinuation.

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

Insurance Questions

Can you tell me more about the insurance coverage of Kovaltry^® and Jivi^®?

Jivi and Kovaltry are covered by the majority of insurance plans and for 99% of patients nationally.*^† Please check with your patient’s insurance plan administrator for specific plan details. Access Services by Bayer can also assist you in the process required to get your patients started on Kovaltry or Jivi. Please call Access Services by Bayer at 1-800-288-8374.

Will my patients’ out-of-pocket costs change?

Bayer offers patients the same $0 Co-Pay Program for Kogenate FS, Kovaltry, and Jivi. By enrolling in the $0 Co-Pay Program, most commercially insured patients can receive Jivi or Kovaltry for as little as $0 per prescription, regardless of income (up to $20,000 in out-of-pocket cost assistance is available per year).^‡§ Click here to learn more about how to enroll your patients, or call Access Services by Bayer at 1-800-288-8374.

Can Bayer assist with any costs associated with transitioning to Kovaltry or Jivi?

Through the Free Trial Program, patients new to Kovaltry or Jivi can receive 1 month of free therapy, delivered to your patient’s home, regardless of insurance type or status.^¶#
Through the Patient Loyalty Program, Bayer is committed to helping your patients start and stay on therapy regardless of changes in their commercial health insurance coverage status. Eligible Kogenate FS patients who transition to Jivi or Kovaltry can receive product at no cost if they experience gaps or changes with insurance coverage.^‡¶
Click here to learn more about how to enroll your patients, or call Access Services by Bayer at 1-800-288-8374.

Will patients need a new prior authorization before transitioning to Kovaltry or Jivi?

A new prior authorization is likely needed when a patient transitions to another hemophilia A treatment. However, this is specific to the insurance plan requirements. Access Services by Bayer can assist in the process required to get your patients started on Kovaltry or Jivi. Please call Access Services by Bayer at 1-800-288-8374.

Additional FAQs

*Formulary status is believed to be accurate as of January 1, 2022 but cannot be guaranteed. Formulary status for national plans may not reflect plan variation at the local level. Lower co-pay costs do not necessarily reflect a cost advantage in the outcome of the condition treated because there are other variables that affect relative cost. Formulary status does not imply a comparison of efficacy, safety, or dosing.
†Jivi coverage includes pharmacy and medical lives across commercial (99%), fee-for-service Medicaid (100%), Managed Medicaid (100%) & Medicare Advantage (100%). Percentage represents the coverage within the book of business. n=1,518, 51, 369, 748. Kovaltry coverage includes pharmacy and medical lives across commercial (99%), fee-for-service Medicaid (100%), Managed Medicaid (100%) & Medicare Advantage (100%). Percentage represents the plan coverage within the book of business: n=1,798; 51; 410; 1,112.
‡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.
¶The medication provided through this program is at no cost to the patient and is not contingent on future use of this medication. Reselling or billing any third party for free product provided by this program is prohibited by law.
#Participation in the Jivi or Kovaltry Free Trial Program is limited to 1 time only per product (patients currently using Jivi or Kovaltry are not eligible for a Free Trial of their current product). The Free Trial Program includes 1 month supply up to a maximum of 40,000 IU. The Free Trial Program for Jivi is available to patients 12 years of age and older. Bayer reserves the right to rescind, revoke, or amend this offer without notice at any time.

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.

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.

Insurance Questions

Additional FAQs

ISI v2 - Important Safety Information v3