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.
Helping with bleed control when you need it
Let's face it, when you're living with hemophilia A, bleeds happen. Some may be more serious than others, but what's important is that you have a treatment that's there for you.
In a clinical trial, over 85% of bleeds in adolescents and adults 12 years and older controlled with 1 infusion
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 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
During the clinical study,
96%
(567 of 591) bleeding episodes were controlled with 1 to 2 infusions of ADYNOVATE.1
95%
(561 of 591) controlled bleeding episodes were rated as Excellent or Good1
SELECTED IMPORTANT RISK INFORMATION
Who should not use ADYNOVATE?
Do not use ADYNOVATE if you:
Are allergic to mice or hamster protein
Are allergic to any ingredients in ADYNOVATE or ADVATE [Antihemophilic Factor (Recombinant)]
Tell your HCP if you are pregnant or breastfeeding because ADYNOVATE may not be right for you.
See Detailed Important Risk Information below.
What do 'Excellent' and 'Good' mean?
In these ADYNOVATE clinical studies, an EXCELLENT rating means there was a full relief of pain and objective signs that bleeding has stopped. A GOOD rating means there was definite pain relief and/or improvement in bleeding.
In a clinical trial over 82% of bleeds in children under 12 years old controlled with 1 infusion
Study design
In 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
Study results
During the clinical study,
91%
(64 of 70) bleeding episodes were controlled with 1 to 2 infusions of ADYNOVATE.1
90%
(63 of 70) controlled bleeding episodes were rated as Excellent or Good1
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.
Get better organized by tracking your bleeds and infusions all in one place.
Do not use ADYNOVATE if you are allergic to mice or hamster protein or are allergic to any ingredients in ADYNOVATE or ADVATE® [Antihemophilic Factor (Recombinant)]. Tell your HCP if you are pregnant or breastfeeding because ADYNOVATE may not be right for you.
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During the clinical study,
What do 'Excellent' and 'Good' mean?
Download bleed and infusion tracker worksheet
