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  • Antihemophillic Factor (Human), Hemofil M, Method M, Monoclonal Purified
    / Takeda

    Active Ingredient

    Status in Israel

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft


    Low: 10 ml

    full basket chart 35265 8383


    Mid: 10 ml

    full basket chart 35267 8384


    High: 10 ml

    full basket chart 35263 8382


    This product is to be administered only intravenously. Each bottle  is labeled with the AHF activity expressed in IU per bottle. This potency assignment is referenced to the World Health Organization International Standard. The purity of this product has been thought to influence the difficulty of producing an accurate potency measurement. Experiments have shown that to achieve accurate activity levels, such a potency assay should be conducted using plastic test tubes and pipets as well as substrate containing normal levels of von Willebrand’s factor. The expected in vivo peak AHF level, expressed as IU/dL of plasma or % (percent) of normal, can be calculated by multiplying the dose administered per kg body weight (IU/kg) by two. This calculation is based on the clinical finding by Abildgaard, et al, 2 which is supported by data from the collaborative study of in vivo recovery and survival with 15 different lots of this product on 56 hemophiliacs that demonstrated a mean peak recovery point above the mean pre-infusion baseline of about 2.0 IU/dL per infused IU/kg body weight.
    Example: (1) A dose of 1750 IU AHF administered to a 70 kg patient, i.e. 25 IU/kg (1750/70), should be expected to cause a peak post-infusion AHF increase of 25 x 2 = 50 IU/dL (50% of normal). (2) A peak level of 70% is required in a 40 kg child. In this situation the dose would be 70/2 x 40 = 1400 IU.
    For full details see prescribing information.


    Hemophilia A (classical hemophilia) for prevention and control of hemorrhaging episodes. Not indicated in von Willebrand


    This product is contraindicated in patients with a known hypersensitivity to the active substance, to excipients, or to mouse proteins.

    Special Precautions

    General Certain components used in the packaging of this product contain natural rubber latex. Identification of the clotting defect as a Factor VIII deficiency is essential before the administration of  this product, Antihemophilic Factor (Human) (AHF), Method M, Monoclonal Purified, is initiated. The processing of  this product, Antihemophilic Factor (Human) (AHF), Method M, Monoclonal Purified significantly reduces the presence of blood group specific antibodies in the final product. Factor VIII Inhibitors Patients should be evaluated for the development of Factor VIII inhibitors if the expected plasma Factor VIII activity levels are not attained, or if bleeding is not controlled with an appropriate dose. No benefit may be expected from this product in treating other deficiencies. Formation of Antibodies to Mouse Protein Although no hypersensitivity reactions have been observed, because  this product contains trace amounts of mouse protein (less than 0.1 ng/AHF activity units), the possibility exists that patients treated with this product may develop hypersensitivity to the mouse proteins. There have been no cases of hypersensitivity to the mouse proteins reported. Increase in Pulse Rate The pulse rate should be determined before and during administration of  this product. Should a significant increase occur, reducing the rate of administration or temporarily halting the injection usually allows the symptoms to disappear promptly. Latex Sensitivity Certain components used in the packaging of this product contain natural rubber latex which may cause allergic reactions. Use precaution when treating patients with sensitivity to natural rubber latex.
    For full details see prescribing information.

    Side Effects

    IMMUNE SYSTEM DISORDERS: Anaphylaxis, Hypersensitivity reactions.
    EYE DISORDERS: Visual impairment, Ocular hyperemia.
    CARDIAC DISORDERS: Cyanosis, Bradycardia, Tachycardia.
    VASCULAR DISORDERS: Hypotension, Flushing.
    RESPIRATORY, THORACIC, AND MEDIASTINAL DISORDERS: Bronchospasm, Dyspnea, Cough, Hyperventilation.
    GASTROINTESTINAL DISORDERS: Diarrhea, Vomiting, Nausea, Abdominal pain.
    SKIN AND SUBCUTANEOUS TISSUE DISORDERS: Urticaria, Rash, Pruritus, Hyperhidrosis.
    GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS: Facial edema, Edema, Chills, Fatigue, Chest pain, Musculoskeletal pain, Irritability.
    For full details see prescribing information.

    Pregnancy and Lactation

    Pregnancy: Pregnancy Category C. Animal reproduction studies have not been conducted with this product, Antihemophilic Factor (Human) (AHF), Method M, Monoclonal Purified. It is not known whether  this product can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.  this product should be given to a pregnant woman only if clearly needed.
    Nursing Mothers: The safety of  this product for use in nursing mothers has not been established. It is not known whether this drug is excreted into human milk. Physicians should carefully consider the potential risks and benefits for each specific patient before prescribing  this product.  this product should be given to nursing mothers only if clinically indicated.

    Baxter Healthcare Corp. USA
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