DBL Bleomycin Sulfate

DBL Bleomycin Sulfate Special Precautions





Zuellig Pharma


Full Prescribing Info
Special Precautions
It is recommended that Bleomycin be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of therapy and complications is possible only when adequate diagnostic and treatment facilities are readily available. Patients receiving bleomycin must be observed carefully and frequently during and after therapy.
After injection, bleomycin is readily absorbed and distributed in the body, particularly in the skin, lungs and any susceptible tumour tissue, leading to possible skin and pulmonary toxicity, as well as antitumour activity.
Pulmonary Toxicity: No single predictive monitoring test for bleomycin-induced pulmonary toxicity has been identified. Frequent physical examinations should be undertaken. Cough, basal rales and pleuritic chest pain are frequent first signs of toxicity. Dyspnoea is usually the first symptom. If pulmonary changes are noted, treatment should be discontinued until it can be determined whether the cause is drug-related. Pulmonary function tests [especially total lung volume (TLV) and forced vital capacity (FVC)] may be of value in detecting early lung changes, although these are not always predictive of subsequent toxicity. It has been suggested that bleomycin should be discontinued if FVC decreases rapidly. Baseline and subsequent monthly evaluation of carbon monoxide diffusion capacity (DLCO) are also recommended, and bleomycin should be discontinued when the DLCO is less than 30-35% of the pretreatment value.
The most commonly recommended method of monitoring the onset of pulmonary toxicity is weekly chest x-rays, which should be continued up to 4 weeks after completion of treatment. However, high resolution computer tomography is a more sensitive method of detection.
Other proposed methods of monitoring pulmonary toxicity include 99m-Technetium scans and measurement of ESR, which has been found to increase prior to the development of symptomatic toxicity. However, the usefulness of these methods as predictors of development of toxicity have not been proven in clinical practice.
Anaesthesia: Because of bleomycin's effects on lung tissue, patients who have received the drug are at increased risk of developing pulmonary toxicity when oxygen is administered during surgery. Long exposure to very high concentrations of oxygen is a known cause of lung damage, but after administration of bleomycin, lung damage can occur at oxygen concentrations lower than those usually considered safe. Therefore to minimize the risk in patients undergoing surgery who have received bleomycin the following is recommended: FI O2 concentration should be maintained at approximately that of room air (25%) during surgery and the post-operative period.
Fluid replacement should be carefully monitored, with emphasis on administration of colloid rather than crystalloid.
Pneumonitis: Pneumonitis due to bleomycin has been treated with corticosteroids in a effort to prevent progression to pulmonary fibrosis.
Infectious pneumonitis should receive appropriate antibiotic therapy.
Lung cancer: Bleomycin should be used with extreme caution in patients with lung cancer as these patients show an increased incidence of pulmonary toxicity.
Compromised pulmonary function due to disease other than malignancy: Bleomycin should be used with extreme caution in patients with compromised pulmonary function as pulmonary toxicity may be particularly dangerous in these patients (see Contraindications).
Previous cytotoxic or radiation therapy (especially chest irradiation); smokers.
Bleomycin should be used with caution in patients who have had previous cytotoxic drug therapy or radiation therapy (especially chest irradiation), and in patients who smoke, since the risk of pulmonary toxicity may be increased in these patients.
Cisplatin: Cisplatin-induced renal function impairment may result in delayed clearance and bleomycin toxicity even at low doses. An increased incidence of bleomycin-induced pulmonary toxicity has been observed when these two agents are administered as part of an antineoplastic treatment regimen. Dosage reduction may be required (see Interactions).
Granulocyte colony stimulating factor (G-CSF): It has been suggested that concomitant administration of G-CSF and bleomycin may increase the risk of bleomycin-induced pulmonary toxicity, especially at higher doses, although this has not been confirmed in clinical trials. If G-CSF is added to bleomycin-containing treatment regimens, patients should be closely observed for signs of pulmonary toxicity (see Interactions).
Combination therapy: Pulmonary toxicity may be observed at lower doses of bleomycin when bleomycin is administered as part of a multi-drug treatment regimen. Patients should be closely monitored for signs of pulmonary toxicity (see Interactions).
Age related: Patients over 70 years of age should be closely observed for signs of pulmonary toxicity due to bleomycin therapy (see Adverse Reactions).
Cumulative dose: Pulmonary toxicity is more common in patients receiving a total dose of more than 400,000 IU.
Idiosyncratic reactions: Idiosyncratic reactions similar to anaphylaxis have been reported in 1% of patients treated with Bleomycin (5% of lymphoma patients). Since these usually occur after the first or second dose, careful monitoring is essential after these doses.
Lymphoma patients: All lymphoma patients should receive test doses of bleomycin before initiating full-dose therapy (see Adverse Reactions).
Carcinogenicity, mutagenicity and impairment of fertility: Bleomycin is mutagenic in both in vitro and in vivo test systems.
It is not known whether bleomycin is carcinogenic in humans. However, an increased incidence of nodular hyperplasia was noted in F344/N male rats with lung cancer induced by nitrosamines, after bleomycin treatment. In another study where bleomycin was administered subcutaneously to rats at a dose of 0.35mg/kg weekly (or about 30% the recommended human dose), necropsy findings included dose related injection site fibrosarcomas and various renal tumours.
The effects of bleomycin on fertility are not known.
Renal or hepatic toxicity: Renal or hepatic toxicity, beginning as a deterioration in renal or liver function tests, have been reported infrequently. These toxicities may occur, however, at any time after initiation of therapy.
Use in renally impaired patients: Bleomycin should be used with extreme caution in patients with severely impaired renal function (see Impaired Renal Function under Dosage & Administration).
Use in pregnancy: Bleomycin has caused, is suspected to have caused or may be expected to cause, an increase incidence of human fetal malformations or irreversible damage. It may also have adverse pharmacological effects.
Use in lactation: It is not known whether bleomycin is excreted in breast milk. Due to the potential for serious adverse effects in infants, it is recommended that breastfeeding is discontinued prior to administration of bleomycin sulfate to the mother.
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