Adynovate

Name: Adynovate

Adynovate Overview

Adynovate is a prescription medication used to control and reduce the number of bleeding episodes in patients with hemophilia A.

Adynovate belongs to a group of drugs called clotting factor replacement treatments. These work by replacing clotting factor that is missing in people with hemophilia.

This medication comes as a dry powder to be mixed into a solution and injected into a vein (IV) by a healthcare provider. Many people with hemophilia A learn to infuse their Adynovate by themselves or with the help of a family member.

Common side effects of Adynovate include headache and nausea.

 

Adynovate Drug Class

Adynovate is part of the drug class:

  • Blood coagulation factors

Inform MD

Before taking Adynovate, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

  • are allergic to Adynovate or to any of its ingredients
  • have or have had any medical problems
  • have any allergies, including allergies to mice or hamsters
  • are breastfeeding
  • are pregnant or plan to become pregnant
  • have been told that you have inhibitors to factor VIII (because Adynovate may not work for you)

Tell your doctor about all medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Adynovate and Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant.

There are no studies that have been done in humans or animals with Adynovate. It is not known if Adynovate can harm an unborn baby. Adynovate should only be used in pregnant women if it is clearly needed.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Side effects

Common adverse reactions ( ≥ 1% of subjects) reported in the clinical studies were headache and nausea.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not refl ect the rates observed in practice.

The safety of ADYNOVATE was evaluated in 169 previously treated patients (PTPs) with severe hemophilia A (factor VIII less than 1% of normal), who received at least one dose of ADYNOVATE in 2 multi-center, prospective, open label clinical studies and 3 ongoing clinical studies. The median duration of participation per subject was 333 (min-max: 1-593) days and the median number of exposure days to ADYNOVATE per subject was 96 (min-max: 1-170). Table 2 lists the adverse reactions reported during clinical studies.

Table 2: Adverse Reactions Reported for ADYNOVATE

MedDRA System Organ Class MedDRA Preferred Term Number of Subjects n (%)
(N=169)
Percent of Infusion
(N=13579)
Gastrointestinal Disorders Diarrhea 1 (0.6%) 0.01%
Nausea 2 (1.2%) 0.01%
Nervous System Disorders Headache 5 (3.0%) 0.06%
Vascular Disorders Flushing 1 (0.6%) 0.01%

No events of hypersensitivity were reported.

Two cases of acute pancreatitis, with no precipitating cause identified in one case, were reported in adults during an extension study of the clinical trial which evaluated 137 subjects. Administration of ADYNOVATE continued and both cases resolved.

Immunogenicity

The risk of the development of factor VIII inhibitors with the use of ADYNOVATE was evaluated in 2 completed and 3 ongoing clinical trials. Study subjects consisted of adult (n= 143 with ≥ prior 150 EDs) and pediatric PTPs [( < 6 years of age with ≥ 50 prior EDs (n= 3), ≥ 6 years of age with ≥ 150 prior EDs (n= 23)]. In 120 adult and pediatric PTPs who were treated for at least 50 exposure days with ADYNOVATE, the factor VIII inhibitor frequency was 0 (95% CI of 0 to 0.03). None of the 169 individual subjects who received at least one infusion of ADYNOVATE developed neutralizing antibodies to factor VIII.

Immunogenicity also was evaluated by measuring the development of binding IgG and IgM antibodies against factor VIII, PEGylated (PEG)-factor VIII, PEG and Chinese hamster ovary (CHO) protein using validated ELISA assays. None of the 169 treated subjects with at least one infusion of ADYNOVATE developed a persistent binding antibody response to any of these antigens. Thirteen subjects in total showed pre-existing antibodies to factor VIII (n=1), PEG-factor VIII (n=12) and/or PEG (n=3) prior to the first exposure to ADYNOVATE. Eight subjects who tested negative at screening developed transient IgG antibodies against factor VIII (n= 5), or PEG-FVIII (n= 3) at one or two consecutive study visits. Binding antibodies that were detected prior to exposure to ADYNOVATE or that transiently developed during the study could not be correlated to any impaired treatment efficacy, altered PK parameters, or adverse reactions. No subject had pre-existing or treatment-emergent antibodies to CHO protein.

The detection of antibodies that are reactive to factor VIII is highly dependent on many factors, including: the sensitivity and specificity of the assay, sample handling, timing of sample collection, concomitant medications and underlying disease. For these reasons, comparison of the incidence of antibodies to ADYNOVATE with the incidence of antibodies to other products may be misleading.

Read the entire FDA prescribing information for Adynovate (Antihemophilic Factor (Recombinant), PEGylated for Injection)

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