What is ADYNOVATE?

ADYNOVATE is an injectable medicine that is used to help treat and control bleeding in children and adults with hemophilia A. ADYNOVATE is not used to treat von Willebrand disease.

Proven bleed protection for children and adults

Light bulb Icon.How does prophylaxis treatment work?

Prophylaxis is a treatment you take regularly to prevent bleeds, rather than waiting for a bleed to happen and then treating it.

Study design

In adolescents and adults 12 years and older
A clinical trial of 137 previously treated patients (age 12 years and older) with severe hemophilia A evaluated how well ADYNOVATE worked over 6 months, in both twice-weekly prophylaxis and on-demand use. 120 patients received a prophylaxis dose of 40-50 IU/kg twice a week, and 17 patients received an on-demand dose of 10-60 IU/kg. The main objective of the study was to compare the annualized bleed rates in the patients receiving prophylaxis and those receiving on-demand treatment.1

Study results

Arrow pointing down.When changing from on-demand use to prophylaxis:

95%

reduction in median ABR

41.5 median ABR with on-demand treatment versus
1.9 median ABR with prophylactic treatment.1

ABR=annualized bleed rate
Median is defined as the middle number in a list of numbers arranged in numerical order.

SELECTED IMPORTANT RISK INFORMATION

What should I tell my HCP before using ADYNOVATE?

Tell your HCP if you:
  • Have or have had any medical problems.
  • Take any medicines, including prescription and non-prescription medicines, such as over-the-counter medicines, supplements or herbal remedies.
  • Have any allergies, including allergies to mice or hamsters.
  • Are breastfeeding. It is not known if ADYNOVATE passes into your milk and if it can harm your baby.
  • Are or become pregnant. It is not known if ADYNOVATE may harm your unborn baby.
  • Have been told that you have inhibitors to factor VIII (because ADYNOVATE may not work for you).

See Detailed Important Risk Information below.

Light bulb Icon.What is median ABR?

ABR is an acronym for Annualized Bleed Rate. This is a measurement of how many total bleeds a person had over one year's time. Median ABR refers to the middle value in a list of annual bleed rates.

“I strive for zero bleeds, so my doctor called me to talk about ADYNOVATE.” —Brett, actual patient”

Find out how people like you are living with hemophilia A and treating with ADYNOVATE.
See their stories

This is Brett's experience, not everyone will have the same experience on ADYNOVATE.

Get better organized by tracking your
bleeds and infusions all in one place.

Icon of pointing down arrow.Download bleed and infusion tracker worksheet

Go for it! Set and track your treatment,
lifestyle, and overall health goals.

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Prophylaxis with ADYNOVATE has helped some patients stay bleed free

In these ADYNOVATE clinical studies, patients receiving twice-weekly prophylaxis, ADYNOVATE demonstrated 2 bleeds or less per year in children and adults.

Data presented here are from 2 different trials and are based on median overall annualized bleed rate results.

Study description

Children under 12 years old
The pediatric study (N=73) evaluated the efficacy, PK, and safety of ADYNOVATE® twice-weekly prophylaxis and determined the ability to treat bleeding episodes for 6 months. Sixty-six children (32 aged <6 years and 34 aged 6 to <12 years) received 40-60 IU/kg of ADYNOVATE prophylactically, twice-weekly. The primary goal of the study was to assess development of inhibitors to ADYNOVATE.1,2

Adolescents and adults 12 years and older
A clinical trial of 137 previously treated patients (age 12 years and older) with severe hemophilia A evaluated how well ADYNOVATE worked over 6 months, in both twice-weekly prophylaxis and on-demand use. 120 patients received a prophylaxis dose of 40-50 IU/kg twice a week, and 17 patients received an on-demand dose of 10-60 IU/kg. The primary goal of the study was to compare the annualized bleed rates in the patients receiving prophylaxis and those receiving on-demand treatment.1

Study results

Water drop.In children under 12 years old

38%

(25 out of 66) of patients experienced zero bleeding episodes1

  • 73% of patients (48 of 66) experienced zero joint bleeds1
  • 67% of patients (44 of 66) experienced zero spontaneous bleeds1

Water drop.In adolescents and adults 12 years and older

40%

(40 out of 101 in the per-protocol group) of patients experienced zero bleeding episodes1

  • 57% of patients (68 of 120) experienced zero joint bleeds1
  • 57% of patients (69 of 120) experienced zero spontaneous bleeds3

Clock Icon.Twice-weekly prophylaxis was proven to reduce Annual Bleed Rate (ABR)

Children under 12 years old (n=66)
experienced a

2.0

median overall ABR1

  • ZERO median ABR for joint bleeds with prophylaxis (n=66)1
  • ZERO median ABR for spontaneous bleeds with prophylaxis (n=66)1

In adolescents and adults 12 years and older
(n=120) experienced a

1.9

median overall ABR1

  • ZERO median ABR for joint bleeds with prophylaxis (n=120) versus 38.1 (n=17) with on-demand1
  • ZERO median ABR for spontaneous bleeds with prophylaxis (n=120) versus 21.6 (n=17) with on-demand1

SELECTED IMPORTANT RISK INFORMATION

What are possible side effects of ADYNOVATE?

  • The common side effects of ADYNOVATE are headache and nausea. These are not all the possible side effects with ADYNOVATE. Tell your HCP about any side effects that bother you or do not go away.

See Detailed Important Risk Information below.

Treating on-demand

Learn how ADYNOVATE performed as an on-demand treatment in clinical trials

See the data
How to use ADYNOVATE

See dosing schedule examples and how to reconstitute
ADYNOVATE using the BAXJECT® System.

get the results