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.¹

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

Yes. Kovaltry clinical trials evaluated efficacy and safety for on-demand treatment, perioperative management of bleeding, and routine prophylaxis in 142 previously treated adult and adolescent patients age ≥ 12 years to < 65 years in the Leopold I and Leopold II clinical trials. A post-hoc subgroup analysis was also completed to evaluate the 48 patients who transitioned from Kogenate FS to Kovaltry as part of these trials.*^1,2 Click here for efficacy and safety data on these patients. Kovaltry clinical trials also evaluated efficacy and safety for routine prophylaxis and perioperative management of bleeding in 51 previously treated pediatric patients ages 12 and younger, in the Leopold Kids clinical trial. A post-hoc subgroup analysis was also completed to evaluate the 25 patients who transitioned from Kogenate FS to Kovaltry as part of this trial.*^1,3 Click here for efficacy and safety data on these patients.

How long has Kovaltry been available to patients?

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

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 HCP 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 for patients to transition from Kogenate FS to Kovaltry; however, eligible patients can receive up to $250 per year to offset out-of-pocket costs for laboratory testing of Kovaltry.^†‡

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

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 single-dose, open-label, randomized cross-over study. Click here to review the study data and PK data.

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

Yes, Kovaltry is approved for perioperative bleeding management.¹

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

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 Kovaltry®

Additional FAQs

ISI v2 - Important Safety Information v3