DBL Bleomycin Sulfate

DBL Bleomycin Sulfate Dosage/Direction for Use





Zuellig Pharma


Full Prescribing Info
Dosage/Direction for Use
Bleomycin may be given by the intramuscular, intravenous, subcutaneous or intra-arterial routes.
Note: Because of the possibility of an anaphylactoid reaction, lymphoma patients should receive test doses of between 1-5 units, for the first two treatments. If no acute allergic reaction occurs within 4-6 hours, the balance of the dose may be given. Thereafter the regular dosage schedule may be followed, if no reaction occurs.
Adult dose: Initial Treatment (intramuscular, intravenous or subcutaneous administration): Total doses of over 300,000 IU should be given with great caution.
10,000 to 20,000 IU/m2 of body surface area given weekly or twice weekly.
Alternatively, give 15,000 IU daily for 7 days followed by three weeks off-treatment and repeat twice so that a total dose of approximately 300,000 IU is administered.
Improvement of lymphomas and testicular tumours is prompt ie. within two weeks while response by squamous cell cancers may take as long as three weeks.
A therapeutic response should be observed as the total dose approaches 150,000 IU, if this is not seen, consideration should be given to other therapy.
Note: When bleomycin is used in combination with other antineoplastic agents, pulmonary toxicities may occur at lower doses (see Pulmonary Toxicity under Precautions, Interactions).
Intra-arterial administration: Intra-arterial infusion/perfusion is employed when increased drug concentrations at the cancer site are desired. The suggested dosage schedule is 30,000 to 60,000 IU once or twice a week until the total recommended dose of 300,000 IU is reached.
Repeat treatment: In patients for whom a course of bleomycin treatment provides an initial but incomplete response, a repeat course is suggested. Patients who show superficial improvement after one course eg. in cases of squamous cell carcinoma, may benefit from a second course of treatment to prevent recurrence.
A repeat course may be commenced after a minimum of 3-4 weeks following completion of the first course, providing no sign of pulmonary toxicity have been observed (see Contraindications). A total dose of 150,000 IU for repeat treatment is recommended.
Paediatric dose: No information available.
Geriatric dose: Adult dose should be used with caution, particularly in patients over 70 years (see Pulmonary Toxicity under Adverse Reactions).
In impaired liver function: Use adult dose with caution.
In impaired renal function: As bleomycin is mostly excreted unchanged and as there is a high correlation between renal bleomycin clearance and creatinine clearance, impairment of function may require reduction in dosage and careful monitoring for toxicity. Dosage reductions of 40-75% have been recommended for patients with creatinine clearance values of ≤40 mL/min.
Directions for reconstitution: For intramuscular or subcutaneous injection: dissolve the contents of the vial in 1-5mL of Sterile Water for Injection or Sodium Chloride Intravenous Infusion 0.9%.
For intravenous or intra arterial injection: dissolve the contents of the vial in 5-10mL of diluent and administer slowly over a period of 10 minutes.
Suitable diluents are Water for Injections, Bacteriostatic Water for Injection and Sodium Chloride Intravenous Infusion 0.9%. Although Glucose Intravenous Infusion 5% has been used in the past, recent data suggests that it is not the diluent of choice, as over the concentration range of 300 to 15,000 IU /mL the content of Bleomycin A2 + B2 was consistently lower when Glucose Intravenous Infusion 5% was used.
Reconstituted solutions containing 150 to 15,000 IU /mL bleomycin prepared using the recommended diluents remain stable for periods of at least 24 hours when stored in the dark, at temperatures of 2-8°C or 25°C. Solutions of bleomycin sulfate in Sodium Chloride Intravenous 0.9% stored in the dark at 2-8°C for 10 days were chemically stable. However, in order to reduce the possibility of microbiological contamination, reconstituted injections should be used as soon as practicable after preparation. If storage of the reconstituted solution is necessary, store at 2-8° C for no more than 24 hours. Any unused portions must be discarded in compliance with acceptable procedures for the disposal of anticancer medicines.
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