Slideshows Images Quizzes

Copyright © 2018 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment. See additional information.

Adynovate

Last reviewed on RxList: 2/16/2021
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

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)

Related Resources for Adynovate

© 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.

SLIDESHOW

Anemia Symptoms and Signs, Types, Treatment and Causes See Slideshow

Health Solutions From Our Sponsors

CONTINUE SCROLLING FOR RELATED SLIDESHOW