Exploring the KOVALTRY® versus Advate® Study

In a head-to-head study of KOVALTRY® and Advate® (N=18)

FVIII levels were 121% higher for KOVALTRY at 48 hours compared to Advate^1,2

FVIII levels through 48 hours

FVIII levels in the blood
(FVIII activity, IU/dL)

KOVALTRY

Advate

KOVALTRY
10.0 IU/dL

Advate
4.5 IU/dL

Chart comparing concentration over time.

Time, h

Data are geometric means.

KOVALTRY demonstrated a 16% longer half-life than Advate¹

KOVALTRY demonstrated a 13.9-hour half-life

Advate demonstrated a 12.0-hour half-life

In a head-to-head study of KOVALTRY and Advate (N=18)

FVIII levels were 121% higher for KOVALTRY at 48 hours compared to Advate^1,2

FVIII levels in the blood (FVIII activity, IU/dL)

Time, h

Data are geometric means.

KOVALTRY demonstrated a 16% longer half-life than Advate¹

KOVALTRY demonstrated a 13.9-hour half-life

Advate demonstrated a 12.0-hour half-life

See how KOVALTRY compares to Advate in time to target threshold levels from the cross-over PK study

INDICATION FOR KOVALTRY®

KOVALTRY® is a medicine used to replace clotting factor (Factor VIII or antihemophilic factor) that is missing in people with hemophilia A.

KOVALTRY is used to treat and control bleeding in adults and children with hemophilia A. KOVALTRY can reduce the number of bleeding episodes in adults and children with hemophilia A when used regularly (prophylaxis). Your healthcare provider may give you KOVALTRY when you have surgery.

KOVALTRY is not used to treat von Willebrand Disease.

IMPORTANT SAFETY INFORMATION

You should not use KOVALTRY if you are allergic to rodents (like mice and hamsters) or any ingredients in KOVALTRY.

Tell your healthcare provider if you have heart disease or are at risk for heart disease.

The common side effects of KOVALTRY are fever, headache, and rash, in addition to inhibitors in patients who were not previously treated or minimally treated with Factor VIII products.

Your body may make antibodies, called “inhibitors” against KOVALTRY, which may stop KOVALTRY from working properly. If your bleeding is not adequately controlled, it could be due to the development of Factor VIII inhibitors. Consult with your healthcare provider to make sure you are carefully monitored with blood tests for the development of inhibitors to Factor VIII.

Allergic reactions may occur with KOVALTRY. Call your healthcare provider right away and stop treatment if you get tightness of the chest or throat, dizziness, decrease in blood pressure, and nausea.

Tell your healthcare provider about any side effect that bothers you or that does not go away.

Call your healthcare provider right away if bleeding is not controlled after using KOVALTRY.

For additional important risk and use information, please see full Prescribing Information.

References: 1. Shah A, Solms A, Garmann D, et al. Improved pharmacokinetics with BAY 81-8973 versus antihemophilic factor (recombinant) plasma/albumin-free method: a randomized pharmacokinetic study in patients with severe hemophilia A [published online December 22, 2016]. Clin Pharmacokinet. doi:10.1007/s40262-016-0492-2. 2. Data on file. Bayer Healthcare Pharmaceuticals, Inc; 2017.

Exploring the KOVALTRY® versus Advate® Study

In a head-to-head study of KOVALTRY® and Advate® (N=18)

KOVALTRY demonstrated a 16% longer half-life than Advate1

In a head-to-head study of KOVALTRY and Advate (N=18)

KOVALTRY demonstrated a 16% longer half-life than Advate1

INDICATION FOR KOVALTRY®

IMPORTANT SAFETY INFORMATION

KOVALTRY demonstrated a 16% longer half-life than Advate¹

KOVALTRY demonstrated a 16% longer half-life than Advate¹