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

Kovaltry^®: An unmodified, full length recombinant Factor VIII treatment with a cell bank derived from the Kogenate^® FS cell line¹

Information on children.

Explore data below on Kogenate FS pediatric patients who transitioned to Kovaltry as part of a clinical trial.

Clinical study data

Kovaltry Clinical Study (51 patients)

Study Design
The multinational, open-label study evaluated efficacy and safety of routine prophylaxis either 2 times per week, 3 times per week, or every other day with Kovaltry in previously treated male patients (≤12 years) with severe hemophilia A. The primary efficacy endpoint, ABR within 48 hours after prophylactic infusion, was 0 (0.0; 4.0).¹

1. 9

bleed per year
(median ABR)

0-12 years
(n=51)¹

inhibitors

in 51 previously treated patients¹

No confirmed case of neutralizing antibodies (inhibitors) to FVIII occurred.

People with hemophilia A may develop inhibitors to rFVIII.¹

One case of transient low titer inhibitor (0.6 BU/mL (peak titer: 1.0 BU/mL)) occurred in a 13 year old PTP after 549 EDs concurrent with an acute infection and positive IgG anticardiolipin antibodies. The Factor VIII recovery was normal (2.7 IU/dL per IU/kg), annualized bleeding rate (ABR) was zero, and no change in therapy was required.¹

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.

ABR, annualized bleed rate.
*No confirmed cases of neutralizing antibodies (inhibitors) to FVIII occurred.
†People with a history of inhibitors were excluded from LEOPOLD.⁴

Kogenate FS children who transitioned to Kovaltry

18 pediatric Kogenate FS patients transitioned to Kovaltry prophylaxis as part of the Kovaltry clinical study.

In an analysis of the study data completed after the study ended, it was determined that Kogenate FS patients who transitioned to Kovaltry experienced:

A reduction in bleeds
per year⁴*

inhibitors⁴

in the subgroup analysis of 18
previously treated patients¹

People with hemophilia A may
develop inhibitors to rFVIII.^1†

	MEDIAN ABR⁴ (0-12 years)
Kogenate FS ABR prior to study enrollment	1
Kovaltry ABR during study	0

There were no drug-related adverse events in this subgroup.

ABR, annualized bleed rate.
*Self-reported bleeds in prior 12 months.⁴
†People with a history of inhibitors were excluded from LEOPOLD Kids.⁴

Dosing

Kovaltry offers Kogenate FS patients the opportunity to stay on the same dose and frequency^1,3

Children

	Kogenate FS	Kovaltry
Dose	25 IU/kg	25 IU/kg 50 IU/kg	Potential to stay on the same dose

Frequency	Every other day	Every other day 3x per week 2x per week	Potential to stay on the same infusion frequency or reduce frequency

Children

	Kogenate FS	Kovaltry
	Dose
	25 IU/kg	25 IU/kg 50 IU/kg
	Potential to stay on the same dose

	Frequency
	Every other day	Every other day 3x per week 2x per week
	Potential to stay on the same infusion frequency or reduce frequency

Summary

Kovaltry offers pediatric patients currently on Kogenate FS...

A cell bank derived from the Kogenate FS cell line²
Advancements to the Kogenate FS manufacturing process¹
- Removal of human and animal derived raw materials from the cell culture
- Addition of the 20nm filtration step
The potential to stay on the same dose and frequency¹

In a study analysis, pediatric patients who transitioned to Kovaltry from Kogenate FS prophylaxis experienced:⁴

A reduction in bleeds per year (ABR)*

inhibitors

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.

ABR, annualized bleed rate.
*Self-reported bleeds in prior 12 months.⁴

Click here to download Kovaltry prophylaxis data.

For more information about Kovaltry, visit www.Kovaltry.com.

Visit the Kovaltry website

1. Kovaltry Prescribing Information. Bayer HealthCare LLC, Whippany, NJ; 2021. 2. Data on file. Kovaltry Summary Basis for Regulatory Action. Bayer HealthCare LLC, Whippany, NJ; 2016. 3. Kogenate Prescribing Information. Bayer HealthCare LLC, Whippany, NJ. 4. Data on file. LEOPOLD Kids Subgroup Analysis. 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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Kovaltry®: An unmodified, full length recombinant Factor VIII treatment with a cell bank derived from the Kogenate® FS cell line1

Information on children.

Kovaltry Clinical Study (51 patients)

kovaltry adults - tab 4 - eficacy draw

inhibitors

inhibitors4

Kovaltry offers Kogenate FS patients the opportunity to stay on the same dose and frequency1,3

kovaltry children- tab 2 (desktop)

kovaltry children- tab 2 (mobile)

Kovaltry offers pediatric patients currently on Kogenate FS...

In a study analysis, pediatric patients who transitioned to Kovaltry from Kogenate FS prophylaxis experienced:4

Button: Visit the Kovaltry website

ISI v2 - Important Safety Information v3