Adynovate

Last updated on RxList: 3/17/2021
Adynovate Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Adynovate?

Adynovate [antihemophilic factor (recombinant), PEGylated] is a human antihemophilic factor indicated in adolescent and adult patients (12 years and older) with hemophilia A (congenital factor VIII deficiency) for on-demand treatment and control of bleeding episodes and routine prophylaxis to reduce the frequency of bleeding episodes. Adynovate is not indicated for the treatment of von Willebrand disease.

What Are Side Effects of Adynovate?

Common side effects of Adynovate include:

  • headache,
  • nausea,
  • diarrhea, and
  • flushing

Allergic reactions, including anaphylaxis, are possible.

Dosage for Adynovate

The dose of Adynovate for routine prophylaxis is 40-50 IU per kg body administered weight 2 times per week. The dose is adjusted based on the patient's clinical response.

What Drugs, Substances, or Supplements Interact with Adynovate?

Adynovate may interact with other drugs. Tell your doctor all medications and supplements you use.

Adynovate During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant while using Adynovate. It is unknown if Adynovate would affect a fetus. It is unknown if Adynovate passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Adynovate [antihemophilic factor (recombinant), PEGylated] Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

Anemia Symptoms and Signs, Types, Treatment and Causes See Slideshow
Adynovate Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives, itching, rash, numbness, tingling; fever, dizziness, nausea; fast heartbeats, chest tightness, wheezing, difficult breathing; pale skin, cold sweat, feeling light-headed, fainting; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • increased bleeding episodes;
  • any bleeding that will not stop;
  • chest pain; or
  • a light-headed feeling, like you might pass out.

Common side effects may include:

  • nose bleeds;
  • nausea, vomiting, diarrhea;
  • headache, dizziness;
  • muscle or joint pain;
  • rash;
  • flushing (sudden warmth, redness, or tingly feeling);
  • fever, chills;
  • cough;
  • weakness; or
  • pain, swelling, itching, or redness where the injection was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Adynovate (Antihemophilic Factor (Recombinant), PEGylated for Injection)

QUESTION

What is hemophilia? See Answer
Adynovate Professional Information

SIDE EFFECTS

The most 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 reflect the rates observed in practice.

The safety of ADYNOVATE was evaluated in 237 previously treated patients (PTPs) and 6 previously untreated patients (PUPs) with severe hemophilia A (factor VIII less than 1% of normal), who received at least one dose of ADYNOVATE in 3 completed multi-center, prospective, open label clinical studies and 4 ongoing clinical studies. The median duration of participation per subject was 401 (min-max: 3-1034) days and the median number of exposure days to ADYNOVATE per subject was 111 (min-max: 1-322).

Table 3: Adverse Reactions Reported for ADYNOVATE

MedDRA System
Organ Class
MedDRA Preferred Term Number of Subjects
n (%)
(N=243)
Rate of AEs per 100 Infusions
(N=30865)
Gastrointestinal Disorders Diarrhea 1 (0.4%) 0.003
Nausea 2 (0.8%) 0.006
Immune System Disorder Hypersensitivity* 1 (0.4%) 0.003
Nervous System Disorders Headache 5 (2.1%) 0.026
Skin and Subcutaneous Tissue Disorders Rash 1 (0.4%) 0.003
Vascular Disorders Flushing 1 (0.4%) 0.003
* The event of hypersensitivity was a mild transient non-serious rash, occurring in one 2-year old patient who had developed a previous rash while on ADYNOVATE.

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 3 completed and 4 ongoing clinical trials. Subjects consisted of adolescent and adult (n= 148 with ≥150 prior EDs) and pediatric PTPs [(<6 years of age with ≥50 prior EDs (n= 32), ≥6 years of age with ≥150 prior EDs (n= 57)], and pediatric PUPs (n=6). In 191 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 0.019). One PUP subject from an ongoing study, 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. The majority of subjects (238/243) with at least one infusion of ADYNOVATE did not develop a persistent binding antibody response to any of these antigens. Twenty-eight subjects in total showed pre-existing antibodies to factor VIII (n=3), PEG-factor VIII (n=25) and/or PEG (n=3) prior to the first exposure to ADYNOVATE. Thirteen subjects who tested negative at screening developed transient antibodies against factor VIII (n= 6), PEG-FVIII (n= 8) at one or two consecutive study visits. Antibodies were transient and not detectable at subsequent visits. Five subjects showed positive results for binding antibodies at study completion or at the time of data cutoff. Binding antibodies that were detected prior to exposure to ADYNOVATE, that transiently developed during the trial or were still detectable at study completion or data cutoff could not be correlated to any impaired treatment efficacy or altered PK parameters. There was no causal relationship between observed adverse events and binding antibodies except in one subject where a causal relationship cannot be ruled out based on available data. 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.

DRUG INTERACTIONS

No Information Provided

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

© Adynovate Patient Information is supplied by Cerner Multum, Inc. and Adynovate Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

Health Solutions From Our Sponsors