Bleomycin Sulfate is indicated for the treatment and palliative management of several types of malignant tumors. It may be used alone or as an adjunct to surgery and radiation therapy in the management of the following cancers:

• Squamous cell carcinoma of the skin, head and neck, and esophagus (primary indication)
• Squamous cell carcinoma of the larynx, penis, and uterine cervix
• Squamous cell carcinoma of the bronchus (responses are less frequent)
• Choriocarcinoma and embryonal carcinoma of the testis
• Advanced Hodgkin’s disease and other lymphomas
• Mycosis fungoides

Although the exact mechanism of action of Bleomycin Sulfate is not completely understood, it is believed to exert its antitumor activity by causing single-strand and double-strand breaks in DNA. This damage interferes with DNA synthesis, resulting in inhibition of cell division and tumor growth. Bleomycin is most effective against cells in the M phase and G2 (premitotic) phase of the cell cycle. Unlike many other anticancer agents, Bleomycin has not demonstrated significant immunosuppressive activity in laboratory studies and generally does not cause major suppression of the immune response in treated patients. An enzyme capable of inactivating Bleomycin has been identified in both normal and malignant cells and is particularly abundant in the liver. However, this enzyme is largely absent in the lungs and skin, which may explain why these tissues are more susceptible to Bleomycin-related toxicity.

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 i.e. 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.

Bleomycin may be given by the intramuscular, intravenous, subcutaneous or intra-arterial routes. 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.

Bleomycin Sulfate may interact with several medications and treatment modalities. Previous or concurrent radiotherapy to the chest may increase both the incidence and severity of pulmonary toxicity associated with Bleomycin. When Bleomycin is used in combination with vinca alkaloids, it may lead to a syndrome resembling Raynaud’s phenomenon, which can cause severe peripheral ischemia and may progress to tissue necrosis affecting the fingers, toes, or the tip of the nose. Bleomycin may also reduce the absorption of phenytoin, potentially decreasing its therapeutic effect. In addition, concomitant use with clozapine may increase the risk of agranulocytosis.

Bleomycin Sulfate is contraindicated in patients with a known hypersensitivity or allergic reaction to Bleomycin. It is also contraindicated in patients with acute pulmonary infections or significantly impaired lung function. Furthermore, repeat treatment with Bleomycin should not be administered to patients who have previously developed pneumonitis or reduced pulmonary function during therapy.

Common adverse effects associated with Bleomycin Sulfate include injection site reactions, such as pain, redness, warmth, itching, or swelling at the site of administration. Other commonly reported side effects include fever, chills, nausea, vomiting, loss of appetite, and weight loss. Patients may also experience skin changes, including darkening or discoloration of the skin, as well as alterations in fingernails or toenails. In some cases, itching or localized pain near the tumor site may occur.

Bleomycin Sulfate is classified as Pregnancy Category D, indicating evidence of potential risk to the fetus. It is not known whether Bleomycin is excreted in human breast milk. Because many drugs are excreted in breast milk and there is a possibility of serious adverse reactions in nursing infants, breastfeeding should be discontinued during treatment with Bleomycin Sulfate.

Bleomycin should only be administered under the supervision of a qualified physician experienced in cancer chemotherapy. Effective management of treatment and potential complications requires access to appropriate diagnostic and medical facilities. Patients receiving Bleomycin should be carefully monitored both during and after therapy. Following injection, Bleomycin is rapidly absorbed and distributed throughout the body, particularly in the skin, lungs, and susceptible tumor tissues. This distribution may result in skin toxicity and pulmonary toxicity, in addition to its antitumor activity. If signs of pulmonary toxicity or lung changes appear, treatment should be discontinued until it is determined whether these effects are related to Bleomycin therapy.

Cytotoxic Chemotherapy

Store at a temperature between 2°C and 8°C. Protect from light and do not use the product after the expiration date.