ASH Clinical News Focus on Rare Diseases | Page 12

KOVALTRY®

TAKING THE NEXT STEP—TOGETHER

Recommended
prophylaxis dose

Regimen

Children aged ≤12 years1

25-50 IU/kg

2x/week, 3x/week, or EOD

Adolescents and adults1

20-40 IU/kg

2x/week or 3x/week

Bayer Access Solutions
If your patient’s insurance does not cover KOVALTRY®, we may be able to provide KOVALTRY®
to your patient at no cost for up to one year while insurance issues are being resolved*
Call 1-800-288-8374 from 8:00 AM-8:00 PM (ET) Monday-Friday to connect with a Case
Specialist. Spanish-speaking Case Specialists are also available
*Some restrictions apply. Please call 1-800-288-8374 to learn more.

SELECTED 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.
For additional important risk and use information, please see Brief Summary on following pages.
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.
References: 1. KOVALTRY® [prescribing information]. Whippany, NJ: Bayer HealthCare LLC; 2016. 2. Data on file.
Bayer HealthCare Pharmaceuticals, Inc; 2016. 3. Ljung R, Kenet G, Mancuso ME, et al. BAY 81-8973 safety and
efficacy for prophylaxis and treatment of bleeds in previously treated children with severe hemophilia A: results
of the LEOPOLD Kids Trial [published online December 9, 2015]. Haemophilia. doi:10.1111/hae.12866.

Bayer, the Bayer Cross, and KOVALTRY are registered trademarks of Bayer.
© 2016 Bayer. All rights reserved.
Printed in USA 05/16 PP-675-US-0202