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  • Bleomycin PFI
    / Megapharm


    Active Ingredient
    Bleomycin Sulphate 15000 IU/vial

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Vial

    10 X 15000 IU/vial

    partial basket chart 26707 2207

    Related information


    Dosage

    Bleomycin is administered parenterally as intramuscular injection, intravenous
    injection/infusion, intraarterial injection/infusion, subcutaneous injection,
    intratumoral injection or intracavitary instillation.
    See prescribing information for full details.


    Indications

    1) Squamous cell carcinoma affecting the mouth, nasopharynx and paranasal
    sinuses, larynx, esophagus, cervix, vagina, penis and skin. Well-differentiated
    tumors usually respond better than anaplastic ones.
    2) Hodgkin’s disease and other malignant lymphomas, including mycosis
    fungoides.
    3) Testicular carcinoma (seminoma and non-seminomas).
    4) Malignant effusions of serous cavities (pleura and peritoneum).
    5) Additional indications in which Bleomycin has been shown to be of some
    value include metastatic malignant melanoma, carcinoma of the thyroid, lung
    and bladder.
    Local treatment of refractory warts.
    Bleomycin can be used as a single agent, but is generally used in combination
    with other cytotoxics and/or with radiation therapy.


    Contra-Indications

    Bleomycin is contra-indicated in patients with acute pulmonary infection,
    severely impaired lung function or circulatory disturbances in the lungs and in
    patients who have demonstrated a hypersensitive or an idiosyncratic reaction to
    the drug.


    Special Precautions

    Patients with significant impairment of renal function or compromised pulmonary function. A severe idiosyncratic reaction consisting of hypotension, mental confusion, fever, chills and wheezing has been reported in 1% of lymphoma patients treated, usually after the first or second dose. Therefore, careful monitoring is essential after these doses. Pregnancy and lactation: If used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard to the fetus. Women should be advised to avoid becoming pregnant during therapy. It is recommended that nursing be discontinued during therapy.
    See prescribing information for full details.


    Side Effects

    CYSTS AND POLYPS): Tumor pain, Tumor lysis syndrome
    BLOOD AND LYMPHATIC SYSTEM DISORDERS: Febrile neutropenia, Neutropenia, Thrombocytopenia, Hemolytic uremic syndrome, Thrombotic microangiopathy, Granulocytopenia, Leukopenia
    METABOLISM AND NUTRITION DISORDERS: Anorexia
    PSYCHIATRIC DISORDERS: Confusional state
    NERVOUS SYSTEM DISORDERS: Cerebral arteritis, Cerebrovascular accident
    CARDIAC DISORDERS: Myocardial infarction, Pericarditis
    VASCULAR DISORDERS: Hypotension, Phlebitis, Raynaud’s phenomenon, Thrombophlebitis, Arterial thrombosis, deep vein thrombosis.
    RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS: Respiratory failure, pulmonary embolism, Dyspnoea, Interstitial lung disease, Pulmonary fibrosis, Pulmonary toxicity, Rales, Wheezing, Acute respiratory distress syndrome.
    GASTROINTESTINAL DISORDERS: Nausea, Stomatitis, Vomiting
    SKIN AND SUBCUTANEOUS TISSUE DISORDERS: Alopecia, Blister, Erythema, Hyperkeratosis, Nail disorder, Pruritis, Rash, Rash vesicular, Skin hyperpigmentation, Skin striae, Skin toxicity, Dermatitis, Drug eruption.
    MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS: Arthralgia, Myalgia, Scleroderma
    GENERAL DISORDERS AND ADMINISTRATIVE SITE CONDITIONS: Chest pain, Chills, Induration, Injection site pain, Local reaction, Mucosal inflammation, Mucosal ulceration, Oedema, Oedema peripheral, Pyrexia, Tenderness, Idiosyncratic drug reaction


    Drug interactions

    When Bleomycin is used as one of the drugs in multiple chemotherapy regimens the toxicity of Bleomycin should be borne in mind in the selection and dosage of drugs with a similar toxic potential.
    An increased risk of pulmonary toxicity has been described with concomitant
    use of BCNU, mitomycin-C, cyclophosphamide, methotrexate and gemcitabine.
    Previous or concurrent radiotherapy to the chest is an important factor in increasing the incidence and severity of lung toxicity.
    Because of the potential of Bleomycin to sensitize the lung tissue, the risk of developing pulmonary toxicity is increased in patients who have received Bleomycin when oxygen is being administered at surgery. A reduction in inspired oxygen during operation and postoperatively is therefore recommended.
    In patients treated for testicular cancer with a combination of Bleomycin and vinca alkaloids a syndrome has been reported corresponding to morbus Raynaud, ischemia which may lead to necrosis of the peripheral parts of the
    body (fingers, toes, nose tip).
    In patients treated with a triple combination regimen of cisplatin, vinblastine
    and Bleomycin, a positive correlation between GFR (glomerular filtration rate)
    and pulmonary function was observed. Therefore, Bleomycin should be used
    cautiously in patients with severely impaired renal function. Another study showed that an increase of the cisplatin dose was associated with a decrease
    of the creatinine clearance and the Bleomycin elimination.
    The increase in neutrophil counts and the stimulation of the ability to produce
    superoxide radicals after the use of granulocyte-colony stimulating factor may
    potentiate lung injury.
    The rate and extent of absorption of oral acetyldigoxin and of phenytoin could
    be reduced by Bleomycin treatments.


    Pregnancy and Lactation

    Pregnancy: The use of Bleomycin should be avoided whenever possible during pregnancy particularly during the first trimester.
    Lactation: Bleomycin should not be given to mothers who are breast feeding.
    See prescribing information for full details.


    Overdose

    Observations indicate that it is difficult to eliminate Bleomycin from the body by dialysis.The acute reaction following an overdosage of Bleomycin would probably include hypotension, fever, rapid pulse and general symptoms of shock. Treatment is purely symptomatic. In the event of respiratory problems the patient should be treated with a corticosteroid and a broad-spectrum antibiotic.


    Manufacturer
    Baxter Oncology, Germany
    Licence holder
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