SELECTED IMPORTANT SAFETY INFORMATION: You should not use KOVALTRY® if you are allergic to rodents (like mice and hamsters) or any ingredients in KOVALTRY®CONTINUE READING BELOW >

Exploring the KOVALTRY® versus Advate® Study

KOVALTRY® median time to minimum FVIII levels (compared to Advate®) in a population PK analysis (N=18)1*

Median Time to Minimum FVIII Levels1

Minimum FVIII Levels (%)

  • 10%
    • 34.5 hours
    • 49 hours
      14.5 hours
      more
  • 5%
    • 46.5 hours
    • 63 hours
      16.5 hours
      more
  • 3%
    • 55.5 hours
    • 73 hours
      17.5 hours
      more
  • 1%
    • 74.5 hours
    • 94.5 hours
      20 hours
      more
  • 0
  • 20
  • 40
  • 60
  • 80100

Time in Hours

  • Advate50 IU/kg (N=18)
  • KOVALTRY50 IU/kg (N=18)
  • A similar trend in median time to minimum FVIII levels was observed for 25, 30, and 40 IU/kg doses.1
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  • The minimum FVIII level is the factor concentration just above any level that may raise the risk of bleeds
  • All patients have a different minimum factor level that meets their needs
  • Ask your doctor which FVIII level is right for you.

KOVALTRY median time to minimum FVIII levels (compared to Advate) in a population PK analysis (N=18)1*

Median Time to Minimum FVIII Levels1

Light bulp
light-bulp
  • The minimum FVIII level is the factor concentration just above any level that may raise the risk of bleeds
  • All patients have a different minimum factor level that meets their needs
  • Ask your doctor which FVIII level is right for you.

Time in Hours

  • 0
  • 20
  • 40
  • 60
  • 80100
  • 10% 14.5 hours more
    • 34.5 hrs
    • 49 hrs
  • 5% 16.5 hours more
    • 46.5 hrs
    • 63 hrs
  • 3% 17.5 hours more
    • 55.5 hrs
    • 73 hrs
  • 1% 20 hours more
    • 74.5 hrs
    • 94.5 hrs

Minimum FVIII Levels (%)

  • Advate50 IU/kg (N=18)
  • KOVALTRY50 IU/kg (N=18)

A similar trend in median time to minimum FVIII levels was observed for 25, 30, and 40 IU/kg doses.1

PK = pharmacokinetics.

*Adapted from Shah et al. A population PK model was developed based on data obtained by a one-stage assay to simulate time to reach FVIII thresholds of 1, 3, 5 and 10% FVIII.1

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.