You're invited: LEOPOLD educational session


	Learn about treatment with KOVALTRY^®, Antihempholic Factor (Recombinant)

	KOVALTRY^® Antihemophilic Factor (Recombinant)

SELECTED IMPORTANT SAFETY INFORMATION

KOVALTRY^® Antihemophilic Factor (Recombinant) is contraindicated in patients who have a history of hypersensitivity reactions to the active substance, to any of the excipients, or to mouse or hamster proteins. Continue reading below

You are cordially invited to an informational session

Topic:	PROPHYLAXIS WITH KOVALTRY^®: Results from the LEOPOLD I and LEOPOLD Kids Clinical Trials

Overview:	•	The science behind KOVALTRY^®

	•	Clinical trial results for KOVALTRY^® in previously treated adults, adolescents, and children with severe hemophilia A

	•	Real-patient case studies drawn from the LEOPOLD Kids Part A clinical trial

When:	[MONTH DAY, YEAR]
	[TIME]

Where:	[LOCATION]
	[ADDRESS]
	[CITY, STATE]
	[PHONE]

Featured
Speaker:	[NAME OF SPEAKER, CREDENTIALS]
	[TITLE]

Registration:	If you'd like to attend, please RSVP at myprogramRSVP.com, enter program number (XX‑XXXX), and enter the state of the program location (XX).

This is a non-CME promotional program.

INDICATIONS

•	KOVALTRY^® Antihemophilic Factor (Recombinant) is a recombinant human DNA sequence derived, full length Factor VIII concentrate indicated for use in adults and children with hemophilia A for:

	•	On-demand treatment and control of bleeding episodes

	•	Perioperative management of bleeding

	•	Routine prophylaxis to reduce the frequency of bleeding episodes

•	KOVALTRY^® is not indicated for the treatment of von Willebrand disease.

IMPORTANT SAFETY INFORMATION

•	KOVALTRY^® is contraindicated in patients who have a history of hypersensitivity reactions to the active substance, to any of the excipients, or to mouse or hamster proteins.

•	Hypersensitivity reactions, including anaphylaxis, are possible with KOVALTRY^®. Early signs of hypersensitivity reactions, which can progress to anaphylaxis, may include chest or throat tightness, dizziness, mild hypotension and nausea. Discontinue KOVALTRY^® if symptoms occur and seek immediate emergency treatment.

•	KOVALTRY^® may contain trace amounts of mouse and hamster proteins. Patients treated with this product may develop hypersensitivity to these non-human mammalian proteins.

•	Neutralizing antibody (inhibitor) formation can occur following administration of KOVALTRY^®. Previously untreated patients (PUPs) are at greatest risk for inhibitor development with all Factor VIII products. 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 as expected with administered dose, suspect the presence of an inhibitor.

•	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.

•	Catheter-related infections may occur when KOVALTRY^® is administered via central venous access devices (CVADs). These infections have not been associated with the product itself.

•	The most frequently reported adverse reactions in clinical trials (≥3%) were headache, pyrexia, and pruritus.

For additional important risk and use information, please see 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.

Please note: This e-mail is not monitored for replies. If you would like to contact us, please visit our Contact Us section online.

1‌00 B‌ayer B‌oulevard, P‌O B‌ox 915, W‌hippany, N‌J 0‌7981-0915 U‌SA