Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Bm_squib
BLENOXANE Injection SCHEDULING STATUS: S4 PROPRIETARY NAME (and dosage form): BLENOXANE Injection COMPOSITION Each vial contains bleomycin sulphate equivalent to 15 units of bleomycin . PHARMACOLOGICAL CLASSIFICATION A 26 - Cytostatic agents. PHARMACOLOGICAL ACTION BLENOXANE (bleomycin sulphate) is a water soluble glycopeptide antitumour antibiotic. BLENOXANE has a strong affinity for squamous cell carcinomas. BLENOXANE has not been shown to have an immunosuppressive effect in vitro and no significant inhibition of immune response has been observed to date in patients treated with BLENOXANE. When given parenterally, BLENOXANE reaches high concentrations in the skin, lungs, kidneys, peritoneum, lymphatics and tumour tissue, if present. Tissue concentrations are particularly high in the skin and lungs. BLENOXANE is not readily metabolized or inactivated following parenteral administration. BLENOXANE possesses antitumour activity although the mechanisms of antitumour action are not completely understood. It is known that BLENOXANE inhibits the synthesis of DNA (deoxyribonucleic acid) in tumour cells. The major route of excretion of bleomycin is the kidney with 60 to 70 percent of an administered dose recovered in the urine as active bleomycin. Renal dysfunction can significantly prolong excretion. In patients with creatinine clearance of <35 mL per minute, the plasma or serum terminal elimination half-life increases exponentially as the creatinine clearance decreases. An association between the decreased renal function and enhanced bleomycin-related toxicities has been reported. Pharmacokinetic/pharmacodynamic relationships suggest that enhancement of toxicity is the consequence of reduced renal clearance of bleomycin resulting in prolonged elimination half-life and increased area-under-the-plasma- Read the complete document