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Kogenate® FS antihemophilic factor (recombinant)

IMPORTANT SAFETY INFORMATION

Kogenate^® FS Antihemophilic Factor (Recombinant) is contraindicated in patients who have life-threatening hypersensitivity reactions, including anaphylaxis to mouse or hamster protein or other constituents of the product. Continue reading below

Dear {{accTitle}} {{accFname}} {{accLname}},

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Kogenate FS is available with the Vial Adapter reconstitution system. Vial Adapter is a needleless reconstitution system that contains a sterile vial adapter with a built-in 15-micrometer filter.¹

The Kogenate FS needleless reconstitution system contains:

1	Product vial

2	Prefilled diluent syringe and separate plunger rod

3	Vial Adapter with built-in filter

4	Butterfly needle administration set

Kogenate FS needleless reconstitution system

For your patients with hemophilia A, Kogenate FS offers:

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Routine prophylaxis to reduce the frequency of bleeding episodes in adults¹

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Routine prophylaxis in children (0-16 years) with no pre-existing joint damage to help reduce the risk of joint damage¹

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On-demand treatment for active bleeds in adults and children¹

Consider Kogenate FS for your patients with hemophilia A.

Contact your Bayer Representative for more information.

INDICATIONS

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Kogenate^® FS is an Antihemophilic Factor (Recombinant) indicated for:

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On-demand treatment and control of bleeding episodes in adults and children with hemophilia A.

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Perioperative management of bleeding in adults and children with hemophilia A.

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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.

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Routine prophylaxis to reduce the frequency of bleeding episodes in adults with hemophilia A.

■

Kogenate FS is not indicated for the treatment of von Willebrand disease.

IMPORTANT SAFETY INFORMATION

■

Kogenate FS Antihemophilic Factor (Recombinant) is contraindicated in patients who have life-threatening hypersensitivity reactions, including anaphylaxis to mouse or hamster protein or other constituents of the product.

■

Hypersensitivity reactions, including anaphylaxis have been reported with Kogenate FS. Reported symptoms included facial swelling, flushing, hives, decrease in blood pressure, nausea, rash, restlessness, shortness of breath, tachycardia, tightness of the chest, tingling, urticaria, and vomiting. Discontinue Kogenate FS if symptoms occur and seek immediate emergency treatment.

■

Neutralizing antibodies (inhibitors) have been reported following administration of Kogenate FS 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, perform an assay that measures factor VIII inhibitor concentration.

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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.

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Serious adverse reactions seen with Kogenate FS are systemic hypersensitivity reactions including bronchospastic reactions and/or hypotension and anaphylaxis, and the development of high-titer inhibitors necessitating alternative treatments to factor VIII.

■

The most common adverse reactions (≥4%) observed in clinical trials were inhibitor formation in previously untreated and minimally treated patients, skin-related hypersensitivity reactions, infusion site reactions, and central venous access device (CVAD) associated infections.

For additional important risk and use information, please click here for full Prescribing Information.

You are encouraged to report negative side effects or quality complaints of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088.

{{customText[I would be glad to provide further information to help you and your hemophilia A patients with their Kogenate FS treatment. If you'd like to speak more, please feel free to contact me at the number below.|Since we haven't met in a while, I would welcome the opportunity to talk with you in person about this information. If you're interested, please feel free to contact me at the number below.|Thank you for reviewing this information on Kogenate FS. I hope it was helpful. Please don't hesitate to call me if you have any questions about the information provided, or if you need additional materials.|Since you requested this information, I want to answer any questions you may have. Please don't hesitate to call me if there is anything else I can help with.|If you have any questions, I would be happy to speak further, or to set up a visit at your convenience.]}}

Sincerely,

{{userName}}
{{user.Phone}}
Bayer Hematology

Reference: 1. Kogenate^® FS with Vial Adapter [prescribing information]. Whippany, NJ: Bayer HealthCare LLC; 2016.

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