Kogenate(R) HCP On-Demand Email

SELECTED IMPORTANT SAFETY INFORMATION
Kogenate^® FS is contraindicated in patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including mouse or hamster proteins. Continue reading below

Dear [Insert Name],

Kogenate^® FS has demonstrated results in controlling and preventing bleeding episodes in adults and children with hemophilia A. These results were shown in two studies, one involving PTPs and the other involving PUPs and MTPs.

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 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

PUP=previously untreated patient. MTP=minimally treated patient. PTP=previously treated patient.

	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 a trial with PUPs and MTPs, 88% of patients (53 of 60) achieved 20 or more exposure days.²


	INDICATIONS

	Kogenate^® FS, antihemophilic factor (recombinant), is a recombinant factor VIII treatment indicated for the control and prevention of bleeding episodes and peri-operative management in adults and children (0-16 years) with hemophilia A. Kogenate^® FS is also indicated for routine prophylaxis to reduce the frequency of bleeding episodes and the risk of joint damage in children with hemophilia A with no preexisting joint damage.
	IMPORTANT SAFETY INFORMATION

	Kogenate^® FS is contraindicated in patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including mouse or hamster proteins. The most serious adverse reactions are systemic hypersensitivity reactions and the development of high-titer inhibitors necessitating alternative treatments to AHF. The most common adverse reactions observed in clinical trials were inhibitor formation in previously untreated or minimally treated patients, skin-associated hypersensitivity reactions, infusion site reactions, and central venous access device (CVAD) line-associated infections.

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

For more information about Kogenate^® FS, please click here. If you’d like to see how Bayer may be able to help your patients with helpline support and financial assistance, visit www.factorsolutionssupport.com.

References: 1. Kogenate^® FS with BIO-SET^® [package insert]. Tarrytown, NY: Bayer HealthCare LLC; 2013. 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.