V3 | Kogenate(R) iRep Email

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 has demonstrated efficacy as episodic (on-demand) treatment in patients with hemophilia A. Based on results shown in two studies, one involving previously treated patients (PTPs) and the other involving previously untreated patients and minimally treated patients (PUPs and MTPs), Kogenate FS demonstrated its effectiveness in controlling bleeds on demand.

Kogenate FS offers proven results for on-demand bleed control

	In PTPs, 93% of bleeds were successfully treated in 1 or 2 infusions¹

	In PUPs and MTPs, 88% of bleeds were successfully treated in 1 or 2 infusions¹
Study descriptions: A total of 73 patients with severe (<2% FVIII) hemophilia A, ages 12 to 59, who had been previously treated with other recombinant or with plasma-derived AHF products, were treated up to 54 months in open-label studies with Kogenate FS in Europe and North America. A total of 5684 bleeding episodes were treated during the study.¹ In a separate study, Kogenate FS was used in the treatment of bleeding episodes in PUPs and pediatric MTPs with severe (<2% FVIII) hemophilia A. There were 37 PUPs and 24 MTPs (defined as having equal to or less than 4 exposure days) treated with a total of 9419 infusions of Kogenate FS for a follow-up duration up to 3.1 years. A total of 1047 bleeding episodes were treated.¹ These studies also examined the safety of on-demand treatment with Kogenate FS:
	In PTPs, 0% (0 of 72 patients) developed de novo inhibitors¹*

	In PUPs and MTPs, 15% (9 of 60 patients) developed de novo inhibitors^1†

	Adverse events reported in clinical studies with PTPs or PUPs/MTPs, regardless of relationship to study drug, with a frequency of >4% included rash, pruritus, urticaria, and infusion site reactions¹
*No FVIII inhibitors developed in 72 PTPs who received Kogenate FS for up to 54 exposure months.¹ ^†In trials with PUPs and MTPs, 88% of patients (53 of 60) achieved 20 or more exposure days, and the incidence of inhibitor formation was consistent with that observed in other pediatric studies using FVIII products.²

For more information about Kogenate FS, please click here.

INDICATIONS

Kogenate^® FS antihemophilic factor (recombinant) is a recombinant factor VIII indicated for:


	Control and prevention of bleeding episodes in adults and children with hemophilia A.

	Surgical prophylaxis in adults and children with hemophilia A.

	Routine prophylactic treatment to prevent or 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 prophylactic treatment to prevent or 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.

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.

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.

{{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,

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Bayer Hematology

References: 1. Kogenate FS with BIO-SET^® [package insert]. Tarrytown, NY: Bayer HealthCare LLC; 2014. 2. Kreuz W, Gill JC, Rothschild C, et al; the International Kogenate-FS Study Group. Full-length sucrose-formulated recombinant factor VIII for treatment of previously untreated or minimally treated young children with severe haemophilia A: results of an international clinical investigation. Thromb Haemost. 2005;93(3):457-467.

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