For U.S. healthcare professionals only
Takeda is committed to advancing care and providing continued support for the hemophilia A community.
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For U.S. healthcare professionals only
Takeda is committed to advancing care and providing continued support for the hemophilia A community.
See how
For U.S. healthcare professionals only
Indications and Limitation of Use: ADYNOVATE is indicated for use in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) for on-demand treatment and control of bleeding episodes, perioperative management, and routine prophylaxis to reduce the frequency of bleeding episodes. ADYNOVATE is not indicated for the treatment of von Willebrand disease.1
study design
In children under 12 years old: This prospective open-label, uncontrolled pivotal phase 3 study evaluated the efficacy, PK, and safety of 40–60 IU/kg ADYNOVATE twice-weekly prophylaxis and determined the ability to treat bleeding episodes for 6 months in 66 previously treated children under 12 years old with severe hemophilia A. The primary endpoint was to assess the development of FVIII inhibitors.1
In adolescents and adults 12 years and older: This open-label, nonrandomized, pivotal phase 2/3 study evaluated the efficacy, PK, and safety of ADYNOVATE twice-weekly prophylaxis vs on-demand treatment and determined hemostatic efficacy in the treatment of bleeding episodes for 6 months in 137 previously treated patients 12 years and older with severe hemophilia A. The primary study goal was to compare the ABR between the prophylaxis vs on-demand treatment regimens.1
CONTRAINDICATIONS: ADYNOVATE is contraindicated in patients who have had prior anaphylactic reaction to ADYNOVATE, to the parent molecule (ADVATE [Antihemophilic Factor (Recombinant)]), mouse or hamster protein, or excipients of ADYNOVATE (e.g. Tris, mannitol, trehalose, glutathione, and/or polysorbate 80).
See Detailed Important Risk Information below.
study results
†Data presented here are from 2 different trials and are based on median overall annualized bleed rate results.
CONTRAINDICATIONS: ADYNOVATE is contraindicated in patients who have had prior anaphylactic reaction to ADYNOVATE, to the parent molecule (ADVATE [Antihemophilic Factor (Recombinant)]), mouse or hamster protein, or excipients of ADYNOVATE (e.g. Tris, mannitol, trehalose, glutathione, and/or polysorbate 80).
See Detailed Important Risk Information below.
had zero total bleeding episodes1
had zero spontaneous bleeding episodes1
had zero joint bleeding episodes1
‡n=40/101, results from per-protocol group
had zero total bleeding episodes1
had zero spontaneous bleeding episodes3
had zero joint bleeding episodes1
| Overall median abr | ||
|---|---|---|
| Prophylaxis | On-demand | |
| In children <12Results from full analysis set | 2.0 (IQR, 3.9) (n=66)1,3 |
N/A |
| In adolescents and adults ≥12 |
1.9 (IQR 5.9) (n=120)1,3 |
41.5 (IQR, 19.4) (n=17)1,3 |
| Spontaneous median abr | ||
|---|---|---|
| Prophylaxis | On-demand | |
| In children <12Results from full analysis set | 0.0 (IQR, 1.9) (n=66)1,3 |
N/A |
| In adolescents and adults ≥12 |
0.0 (IQR 2.2) (n=120)1,3 |
21.6 (IQR, 22.0) (n=17)1,3 |
| Joint median abr | ||
|---|---|---|
| Prophylaxis | On-demand | |
| In children <12Results from full analysis set | 0.0 (IQR, 1.9) (n=66)1,3 |
N/A |
| In adolescents and adults ≥12 |
0.0 (IQR 2.0) (n=120)1,3 |
38.1 (IQR, 20.1) (n=17)1,3 |
ABR=annualized bleeding rate; IQR=interquartile range
Hypersensitivity Reactions: Hypersensitivity reactions, including anaphylaxis, have been reported with ADYNOVATE. Hypersensitivity reactions that can progress to anaphylaxis may include angioedema, chest tightness, dyspnea, wheezing, urticaria, pruritus, and nausea and vomiting. Immediately discontinue administration and initiate appropriate treatment if hypersensitivity reactions occur.
See Detailed Important Risk Information below.
study design
A retrospective, observational, U.S.-based analysis was conducted from November 2015 to September 2017 to describe the clinical profiles of 56 patients with hemophilia A, between the ages of 5 and 88, who transitioned from prophylaxis with any rFVIII to ADYNOVATE prophylaxis. Some of the measured endpoints before and after switching from a previous rFVIII to ADYNOVATE included ABR (calculated for patients receiving ADYNOVATE greater than or equal to 3 months) and qualitative adherence.4
Limitations:
The limitations of this retrospective, observational study include: Patients were not randomized, observers were not blinded, and some subgroups (eg, patients <12 years of age, patients treated with a prior EHL rFVIII) were small in sample size. In addition, bleeding rates were patient reported.4
Since these data are from a retrospective, observational chart review, they have less evidentiary value than prospective, controlled studies. Further confirmatory studies are required to draw any conclusions from these data.
See the safety data for ADYNOVATE
Neutralizing Antibodies: Formation of neutralizing antibodies (inhibitors) to factor VIII can occur following administration of ADYNOVATE. Monitor patients regularly for the development of factor VIII inhibitors by appropriate clinical observations and laboratory tests. Perform an assay that measures factor VIII inhibitor concentration if the plasma factor VIII level fails to increase as expected, or if bleeding is not controlled with expected dose.
See Detailed Important Risk Information below.
study results
In a retrospective, observational, real world study, it was reported that ADYNOVATE has shown:
median ABR for overall study population4
of patients (20 out of 51) reported ZERO bleeding episodes4
Neutralizing Antibodies: Formation of neutralizing antibodies (inhibitors) to factor VIII can occur following administration of ADYNOVATE. Monitor patients regularly for the development of factor VIII inhibitors by appropriate clinical observations and laboratory tests. Perform an assay that measures factor VIII inhibitor concentration if the plasma factor VIII level fails to increase as expected, or if bleeding is not controlled with expected dose.
See Detailed Important Risk Information below.
With my current schedule, I have better control over my condition. I feel empowered about my condition now. I definitely feel that we made a good decision moving on to ADYNOVATE.
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See ADYNOVATE bleed control data in children and adults from an on-demand clinical trial
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ADYNOVATE has a twice-weekly dosing regimen that you can tailor to each patient
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IMPORTANT RISK INFORMATION
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CONTRAINDICATIONS: ADYNOVATE is contraindicated in patients who have had prior anaphylactic reaction to ADYNOVATE, to the parent molecule (ADVATE [Antihemophilic Factor (Recombinant)]), mouse or hamster protein, or excipients of ADYNOVATE (e.g. Tris, mannitol, trehalose, glutathione, and/or polysorbate 80).
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