Eloctate

Last updated on RxList: 4/5/2018
Eloctate Side Effects Center

Last reviewed on RxList 4/5/2018

Eloctate [Antihemophilic Factor (Recombinant), Fc Fusion Protein] used in adults and children with Hemophilia A (congenital Factor VIII deficiency) to control and prevent bleeding episodes, for perioperative management (surgical prophylaxis), and routine prophylaxis to prevent or reduce the frequency of bleeding episodes. Eloctate is not indicated for the treatment of von Willebrand disease. Common side effects of Eloctate include:

Dose and duration of treatment with Eloctate depend on the severity of the Factor VIII deficiency, the location and extent of bleeding, and the patient's clinical condition. Eloctate may interact with other drugs. Tell your doctor all medications and supplements you use. During pregnancy, Eloctate should be administered only if prescribed. It is unknown if it will harm a fetus. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Eloctate [Antihemophilic Factor (Recombinant), Fc Fusion Protein] 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.

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Eloctate 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 Eloctate (Antihemophilic Factor (Recombinant), Fc Fusion Protein for Intravenous Infusion)

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Eloctate Professional Information

SIDE EFFECTS

Common adverse reactions ( ≥ 1% of subjects) reported in clinical trials were arthralgia and malaise.

Clinical Trials Experience

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

In the multi-center, prospective, open-label, clinical trial of ELOCTATE, 164 adolescent and adult, previously treated patients (PTPs, exposed to a Factor VIII containing product for ≥ 150 exposure days) with severe Hemophilia A ( < 1% endogenous FVIII activity or a genetic mutation consistent with severe Hemophilia A) received at least one dose of ELOCTATE as part of either routine prophylaxis, on-demand treatment of bleeding episodes or perioperative management. A total of 146 (89%) subjects were treated for at least 26 weeks and 23 (14%) subjects were treated for at least 39 weeks.

Adverse reactions (ARs) (summarized in Table 3) were reported for nine (5.5 %) subjects treated with routine prophylaxis or episodic (on-demand) therapy.

Two subjects were withdrawn from study due to adverse reactions of rash and arthralgia. In the study, no inhibitors were detected and no events of anaphylaxis were reported.

Table 3: Adverse Reactions Reported for ELOCTATE (N=164)

MedDRA System Organ Class MedDRA Preferred Term Number of Subjects n (%)
General disorders and administration site conditions Malaise 2 (1.2)
Chest pain 1 (0.6)
Feeling cold 1 (0.6)
Feeling hot 1 (0.6)
Nervous systemdisorders Dizziness 1 (0.6)
Dysgeusia 1 (0.6)
Headache 1 (0.6)
Musculoskeletaldisorders Arthralgia 2 (1.2)
Joint swelling 1 (0.6)
Myalgia 1 (0.6)
Gastrointestinaldisorders Abdominal pain, lower 1 (0.6)
Abdominal pain, upper 1 (0.6)
Vascular disorders * Angiopathy 1 (0.6)
Hypertension 1 (0.6)
Cardiac disorders Bradycardia 1 (0.6)
Injury, poisoning, and procedural complications Procedural hypotension 1 (0.6)
Respiratory, thoracic, and mediastinal disorders Cough 1 (0.6)
Skin and subcutaneous tissue disorders Rash 1 (0.6)
*Investigator term: vascular pain after injection of study drug

Immunogenicity

Clinical trial subjects were monitored for neutralizing antibodies to Factor VIII. No subjects developed confirmed, neutralizing antibodies to Factor VIII. One 25 year old subject had a transient, positive, neutralizing antibody of 0.73 BU at week 14, which was not confirmed upon repeat testing 18 days later and thereafter.

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.

Read the entire FDA prescribing information for Eloctate (Antihemophilic Factor (Recombinant), Fc Fusion Protein for Intravenous Infusion)

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

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