Kogenate(R) HCP Efficacy Email

SELECTED IMPORTANT SAFETY INFORMATION
Kogenate^® FS antihemophilic factor (recombinant) 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],

As you are aware, Kogenate^® FS is an antihemophilic factor (recombinant) treatment indicated for routine prophylaxis in children (0-16 years) with hemophilia A and no pre-existing joint damage. In this population, Kogenate^® FS has been shown to reduce the frequency of bleeding episodes and the risk of joint damage. The Joint Outcome Study (JOS), which studied prophylaxis in children with no pre-existing joint damage, exclusively used Kogenate^® and Kogenate^® FS.¹



			93% (25 of 27) of children with no pre-existing joint damage treated with Kogenate^® or Kogenate^® FS for routine prophylaxis up to 5.5 years had no joint damage as measured by MRI, compared with 55% (16 of 29) of children given enhanced episodic treatment with Kogenate^® or Kogenate^® FS (P=0.002).¹
			–	The difference between the 2 groups was statistically significant when using MRI but not when using x-ray alone²
			Overall, 12.5% (8 of 64) of study patients developed any level of inhibitors over the 5.5-year study²
			Two patients developed high-titer inhibitors and were withdrawn from the study^1,2
			There were no life-threatening bleeds in the routine prophylaxis group (0 of 32 patients) compared with approximately 10% (3 of 33) in the episodic group¹
			Most adverse events were associated with central venous access, and there were no statistically significant differences between the 2 study groups^1,2

Joint Outcome Study (JOS) description: A total of 65 boys <30 months of age with severe hemophilia A (FVIII level <2 IU/dL) and with <2 bleeds into each index joint and normal baseline joint imaging were observed for up to 5.5 years in a multicenter, open-label, prospective, randomized, controlled clinical study. Patients received either 25 IU/kg every other day (primary prophylaxis; n=32) or at least 3 doses totaling a minimum of 80 IU/kg at the time of a bleeding episode (enhanced episodic; n=33). Joint damage was evaluated by magnetic resonance imaging (MRI) or radiography, and the frequency of bleeding episodes was assessed.^1,2


	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. Manco-Johnson MJ, Abshire TC, Shapiro AD, et al. Prophylaxis versus episodic treatment to prevent joint disease in boys with severe hemophilia. N Engl J Med. 2007;357(6):535-544. 2. Kogenate^® FS with BIO-SET^® [package insert]. Tarrytown, NY: Bayer HealthCare LLC; 2013.