DBL Bleomycin Sulfate

DBL Bleomycin Sulfate





Zuellig Pharma


Concise Prescribing Info
Bleomycin sulfate
Squamous cell carcinoma of skin, head, neck & oesophagus, larynx, penis & uterine cervix, bronchus. Choriocarcinoma & embryonal cell carcinoma of the testis. Advanced Hodgkin's disease & other lymphomas. Mycosis fungoides.
Dosage/Direction for Use
IM, IV or SC 10,000-20,000 IU/m2 wkly or twice wkly. Alternatively, 15,000 IU daily for 7 days followed by 3 wk off-treatment & repeat twice so total dose of approx 300,000 IU is administered. Intra-arterial 30,000-60,000 IU once or twice wkly until total recommended dose of 300,000 IU is reached. Repeat treatment: 150,000 IU may be commenced after min of 3-4 wk following completion of 1st course.
Hypersensitivity. Patients w/ acute pulmonary infection or greatly reduced lung function. Repeat course of therapy in patients who have shown any signs of pneumonitis or decreased pulmonary function.
Special Precautions
Discontinue use if pulmonary changes are noted & if forced vital capacity decreases rapidly. Perform baseline & subsequent mthly evaluation of carbon monoxide diffusion capacity & wkly chest x-rays which should be continued up to 4 wk after treatment completion. Anaesth, pneumonitis, lung cancer, compromised pulmonary function, smoking, lymphoma. Previous cytotoxic drug therapy or radiation therapy (especially chest irradiation). Concomitant cisplatin & granulocyte colony stimulating factor (G-CSF) & administration as combination therapy. Cumulative total dose >400,000 IU. Hepatic & severe renal impairment. Pregnancy. Not to be used during lactation. Patients >70 yr.
Adverse Reactions
Subacute or chronic pneumonitis; hypersensitivity; MI, CVA, thrombotic microangiopathy (haemolytic-uremic syndrome) or cerebrovascular arteritis, acute chest pain syndrome, acute pericarditis, fulminant fatal hyperpyrexia & angioedema. Fever, chills, headache; anorexia, nausea, vomiting, tiredness; hypoesthesia which may progress to hyperesthesia, urticaria, erythematous swelling, tenderness, pruritis, hyperpigmentation, patchy hyperkeratosis, alopecia, ichthyosis, rash, striae, vesiculation, peeling & bleeding, stomatitis, tongue & lips ulcerations; dermal lesions (intra-arterial administration).
Drug Interactions
Sensitisation of lung tissue to O2. Increased toxicity w/ radiation therapy & concurrent antineoplastic agents. Pulmonary toxicity w/ lower doses of bleomycin when administered as combination therapy & w/ concurrent G-CSF. Delayed clearance & increased toxicity w/ cisplatin. Reduced digoxin serum levels. Decreased phenytoin serum conc.
MIMS Class
Cytotoxic Chemotherapy
ATC Classification
L01DC01 - bleomycin ; Belongs to the class of other cytotoxic antibiotics. Used in the treatment of cancer.
DBL Bleomycin Sulfate powd for inj 15,000 IU
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