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Bleomycin (as sulphate) 15mg/ampoule (powder for reconstitution): Injection.
Though the exact mechanism of action is not fully established, Bleomycin mainly inhibits DNA synthesis, with minor effects on RNA and protein synthesis. It induces single-strand and some double-strand DNA breaks and arrests the cell cycle at the G2 and mitosis phases. When administered intrapleurally, it acts as a sclerosing agent.
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✅ Description:
Bleocin is primarily used as a palliative treatment and has demonstrated efficacy either alone or in combination with other approved chemotherapeutic agents in the management of the following malignancies:
- Squamous Cell Carcinomas: Including tumors of the head and neck (e.g., mouth, tongue, tonsils, nasopharynx, oropharynx, sinuses, palate, lips, buccal mucosa, gingivae, epiglottis, skin, and larynx), as well as cancers of the penis, cervix, and vulva. Patients previously treated with radiotherapy for head and neck cancers may show a reduced response.
- Lymphomas: Both Hodgkin’s disease and non-Hodgkin lymphoma.
- Testicular Cancers: Effective against embryonal carcinoma, choriocarcinoma, and teratocarcinoma.
- Malignant Pleural Effusion: Administered as an intrapleural sclerosing agent.
Note: Use only as directed by a registered physician.
✔️ Dosage & Administration
- Initial Testing Dose (Lymphoma): ≤2 units for the first two doses to monitor for anaphylactoid reactions.
- Standard Regimen (Squamous Cell Carcinoma, Testicular Cancer, Non-Hodgkin’s Lymphoma):
0.25–0.50 units/kg (10–20 units/m²) via IV, IM, or SC weekly or twice weekly. - Hodgkin’s Disease:
Same initial dosing; if 50% response is achieved, continue with 1 unit daily or 5 units weekly (IV or IM) as maintenance.
Malignant Pleural Effusion:
60 units via single-dose intrapleural bolus.
⚠️ Cumulative doses exceeding 400 units significantly increase the risk of pulmonary toxicity and must be administered with caution, especially in combination regimens.
Pediatrics: Safety and efficacy not established.
Geriatrics: Higher incidence of pulmonary toxicity in patients >70 yea
✔️ Overdose Management
Symptoms include hypotension, fever, tachycardia, and shock-like symptoms. Treatment is symptomatic; respiratory complications should be addressed with corticosteroids and broad-spectrum antibiotics.
✔️ Side Effects
- Common: Injection site reactions, fever, chills, nausea, appetite and weight loss, skin discoloration, nail changes, and tumor-site pain.
- Serious: Pulmonary fibrosis, particularly with high cumulative doses.
✔️ Reconstitution Guidelines
- IM/SC: Add 1–5 mL (15 IU) or 2–10 mL (30 IU) of sterile water, NaCl 0.9%, or bacteriostatic water to achieve 3–15 IU/mL.
- IV: Reconstitute with 5 mL (15 IU) or 10 mL (30 IU) of NaCl 0.9% for ≤3 IU/mL. Administer slowly over 10 minutes.
- Intrapleural: Dissolve 60 IU in 50–100 mL of NaCl 0.9%.
✔️ Drug Interactions
- Increased pulmonary toxicity when used before or after chest radiotherapy.
- Vinca alkaloids may precipitate Raynaud 's-like ischemia, potentially leading to peripheral necrosis.
- May impair phenytoin absorption.
- Co-administration with clozapine increases the risk of agranulocytosis.
✔️ Contraindications
- Acute pulmonary infections or severely impaired lung function.
- Concomitant use with brentuximab, cisplatin, or high-concentration oxygen therapy.
- Breastfeeding is contraindicated.
✔️ Use in Pregnancy & Lactation
Pregnancy Category D: Known risk to the fetus.
Unknown if excreted in breast milk. Due to potential risks, breastfeeding should be avoided during treatment.
✔️ Precautions & Warnings
Use with caution in patients with renal impairment, cardiovascular disease, the elderly, or those who are pregnant.
✔️ Storage
Store at 2–8°C.
Protect from light and do not use beyond the expiration date.
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