Esperoct

Last updated on RxList: 3/7/2019
Esperoct Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 3/7/2019

Esperoct [antihemophilic factor (recombinant), glycopegylated-exei] is a coagulation Factor VIII concentrate indicated for use in adults and children with hemophilia A for on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes. Esperoct is not indicated for the treatment of von Willebrand disease. Common side effects of Esperoct include:

  • rash,
  • redness,
  • itching, and
  • injection site reactions

The dose of Esperoct depends on the usage. Esperoct may interact with other drugs. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Esperoct; it is unknown how it would affect a fetus. It is unknown if Esperoct passes into breast milk or if it would affect a nursing infant. Consult your doctor before breastfeeding.

Our Esperoct [antihemophilic factor (recombinant), glycopegylated-exei] Lyophilized Powder for Solution, for Intravenous Use 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.

QUESTION

What is hemophilia? See Answer
Esperoct 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 Esperoct ([antihemophilic factor (recombinant), glycopegylated-exei] Injection)

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Esperoct Professional Information

SIDE EFFECTS

The most frequently reported adverse reactions (incidence ≥1%) in clinical trials were rash, redness, itching (pruritus), and injection site reactions.

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 clinical practice.

The safety of ESPEROCT has been evaluated in 270 subjects (202 adolescents/adults and 68 children) in five prospective, multi-center clinical studies in previously treated patients (PTPs) with severe hemophilia A (<1% endogenous Factor VIII activity) and no history of inhibitors. All subjects received at least one dose of ESPEROCT. A previously treated patient was defined as a subject with a history of at least 150 exposure days to other Factor VIII products (adolescent/adult subjects) or 50 exposure days to other Factor VIII products (pediatric subjects). Total exposure to ESPEROCT was 80,425 exposure days corresponding to 889 patient years of treatment.

During the clinical trials in PTPs, adverse reactions occurred at a rate of 0.10 events per patient year of exposure. The most frequently reported adverse reactions were rash (5.2%), injection site reaction (2.6%), redness (1.9%), and itching (pruritus) (1.5%).

Immunogenicity

Subjects were monitored for neutralizing and non-neutralizing antibodies to Factor VIII, polyethylene glycol (PEG), and CHO host cell protein. One previously treated subject developed confirmed neutralizing antibodies to Factor VIII (13.5 Bethesda Units). In addition, two subjects had transient low titer FVIII antibody (<5 Bethesda Units) test results at a single occasion. Anti-PEG antibodies of no clinical consequence were detected in 45 subjects, 32 of whom had pre-existing anti-PEG antibodies. Nine subjects developed anti-CHO host cell protein antibodies of no clinical consequence.

The detection of antibodies is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease.

Read the entire FDA prescribing information for Esperoct ([antihemophilic factor (recombinant), glycopegylated-exei] Injection)

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

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