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Bleomycin: Mechanism of Action, Side Effects, Contraindications and Dosage

Mechanism of Action

Bleomycin is a cytostatic agent (glycopeptid antibiotic) from the bacterium Streptomyces verticillus. Bleomycin forms a pseudoenzyme complex with iron, which generates reactive oxygen species that damage DNA and probably other macromolecules as well.

Urologic Indications for Bleomycin

Metastatic germ cell tumors of the testes or extragonadal germ cell tumors. See treatment of seminoma and treatment of nonseminoma.

Pharmacokinetics of Bleomycin

Parenteral administration as a short intravenous infusion, bolus injection, or intramuscular injection. Renal elimination, half-life 2–4 hours. A dosage adjustment is necessary in patients with chronic kidney disease.

Side Effects of Bleomycin

The most common side effects affect the gastrointestinal tract. The most serious side effects occur in the lungs and affect about 10% of patients.

Pulmonary Side Effects:

Bleomycin may cause a subacute or chronic pneumonia (interstitial plasmacellular pneumonia) with fibrosis. In 1% of treated patients, pulmonary side effects are severe and potentially leathal. Risk factors: advanced age, pulmonary disease and cumulative bleomycin dosage more than 300 mg.

Signs and symptoms of bleomycin pneumonia: cough, shortness of breath and fever. Diagnosis is possible with chest X-ray or CT scan and pulmonary functions tests. At the first signs of interstitial pneumonia, further bleomycin treatment is contraindicated.

Allergy:

Chills, fever, hypotension, and shock are rarely possible (<0.5%), and fatal outcomes have been reported, particularly in patients with lymphoma. A test dose of 1 mg (followed by observation for 4 hours) is recommended in the product information, but its necessity is questioned in patients with testicular tumors (Lam et al., 2005). Treatment consists of infusions, corticosteroids, antihistamines, paracetamol, and vasopressors, depending on the severity.

Other Side Effects of Bleomycin

• Skin: eruptions of the skin, nail changes, hair loss, skin necrosis
• Gastrointestinal tract: nausea and vomiting, diarrhea, loss of appetite
• Joint and muscle pain
• Raynaud syndrome, mycardial infarction or cerebrovascular events possible

Drug Interactions with Bleomycin

Avoide nephrotoxic or myelosuppressive agents. No live vaccines.

Contraindications of Bleomycin

• Maximum cumulative total dose 400 units (USP)
• Allergy or intolerance to bleomycin
• Lung fibrosis
• Pregnancy
• Relative contraindications (depending on the severity): restrictive or obstructive lung diseases, thoracic irradiation, kidney or liver insufficiency.

Dosage of Bleomycin

The dosage information for bleomycin is based on standardized biological activity, expressed in international units (IU) or units according to USP or milligrams of active bleomycin. 1,000 IU correspond to 1 unit (USP) and 1 mg of active bleomycin.

PEB-Chemotherapy Regimen

Bleomycin (30 Units) on day 1, 8, and 15 as an i.v. bolus. One cycle of PEB regimen lasts 21 days. Maximum dosage is 3–4 cycles.

References

Lam, M. S. H. The need for routine bleomycin test dosing in the 21st century.
Ann Pharmacother, 2005, 39, 1897-1902
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M. G. Kier et al., “Prognostic Factors and Treatment Results After Bleomycin, Etoposide, and Cisplatin in Germ Cell Cancer: A Population-based Study.,” Eur Urol, vol. 71, no. 2, pp. 290–298, 2017, doi: 10.1016/j.eururo.2016.09.015.

  Deutsche Version: Nebenwirkungen und Dosierung von Bleomycin

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