DBL Bleomycin Sulfate

DBL Bleomycin Sulfate

bleomycin

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Bleomycin sulfate
Indications/Uses
Squamous cell carcinoma of skin, head, neck & oesophagus, larynx, penis & uterine cervix, bronchus. Choriocarcinoma & embryonal cell carcinoma of testis. Advanced Hodgkin's disease & other lymphomas. Mycosis fungoides.
Dosage/Direction for Use
IM/IV/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: Approx 300,000 IU is administered. Intra-arterial 30,000-60,000 IU once or twice wkly until total recommended dose: 300,000 IU is reached. Repeat treatment: 150,000 IU may be commenced after min 3-4 wk following completion of 1st course.
Contraindications
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
Anaphylaxis. Discontinue use if pulmonary changes are noted & if forced vital capacity decreases rapidly. Pneumonitis; lung cancer; compromised pulmonary function; smoking, lymphoma. Perform baseline & subsequent mthly evaluation of carbon monoxide diffusion capacity & wkly chest X-rays up to 4 wk after treatment completion. Cumulative total dose >400,000 IU. Concomitant use w/ anaesth, cisplatin, granulocyte colony stimulating factor; administration as combination therapy. Previous cytotoxic drug therapy or radiation therapy (especially chest irradiation). 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 & pericarditis, fulminant fatal hyperpyrexia & angioedema. Fever, chills, headache; anorexia, nausea, vomiting, tiredness; hypoesthesia which may progress to hyperesthesia, urticaria, erythematous swelling, tenderness, pruritus, hyperpigmentation, patchy hyperkeratosis, alopecia, ichthyosis, rash, striae, vesiculation, peeling & bleeding, mucositis, stomatitis, tongue & lips ulcerations; dermal lesions (intra-arterial administration).
Drug Interactions
Lung tissue sensitisation to O2. Increased toxicity w/ radiation therapy, antineoplastic agents. Pulmonary toxicity when used as combination therapy & w/ G-CSF. Delayed clearance & increased toxicity w/ cisplatin. Reduced serum digoxin levels. Decreased serum phenytoin conc.
MIMS Class
Cytotoxic Chemotherapy
ATC Classification
L01DC01 - bleomycin ; Belongs to the class of other cytotoxic antibiotics. Used in the treatment of cancer.
Presentation/Packing
Form
DBL Bleomycin Sulfate powd for inj 15,000 IU
Packing/Price
1's
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