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🏅 FDA Orphan Designation

Blenoxane

Bleomycin sulfate

Manufacturer: Bristol-Myers Squibb Pharmaceutical Research Institute

Indicated for:
Malignant peritoneal mesotheliomaOrphanEmbryonal carcinomaNon-Hodgkin lymphomaSquamous cell carcinoma of head and neckTesticular teratomaSquamous cell carcinoma of the cervix uteriSquamous cell carcinoma of the penis
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Black Box Warning (Boxed Warning)

A Boxed Warning is the FDA's strongest safety warning — it indicates serious or life-threatening risks identified during clinical trials or post-market surveillance. It does not mean the medication is unsafe for all patients; your prescriber weighs these risks against the benefits for your specific situation. Source: FDA-approved prescribing information.

View full prescribing information on DailyMed (NLM) ↗

FDA-Approved Indications (7)

Treatment of malignant pleural effusion.

management of Testicular Carcinoma, embryonal cell

Population: all ages

management of non-Hodgkin's lymphoma

Population: all ages

management of Squamous Cell Carcinoma of head and neck (including mouth, tongue, tonsil, nasopharynx, oropharynx, sinus, palate, lip, buccal mucosa, gingivae, epiglottis, skin, larynx)

Population: all ages

management of Testicular Carcinoma, teratocarcinoma

Population: all ages

management of Squamous Cell Carcinoma of cervix

Population: all ages

Squamous Cell Carcinoma: penis

Population: all ages

Indications & Usage

INDICATIONS AND USAGE Bleomycin for Injection, USP should be considered a palliative treatment. It has been shown to be useful in the management of the following neoplasms either as a single agent or in proven combinations with other approved chemotherapeutic agents: Squamous Cell Carcinoma: Head and neck (including mouth, tongue, tonsil, nasopharynx, oropharynx, sinus, palate, lip, buccal mucosa, gingivae, epiglottis, skin, larynx), penis, cervix, and vulva. The response to Bleomycin for Injection, USP is poorer in patients with previously irradiated head and neck cancer. Lymphomas: Hodgkin's disease, non-Hodgkin's lymphoma. Testicular Carcinoma: Embryonal cell, choriocarcinoma, and teratocarcinoma. Bleomycin for Injection, USP has also been shown to be useful in the management of: Malignant Pleural Effusion: Bleomycin for Injection, USP is effective as a sclerosing agent for the treatment of malignant pleural effusion and prevention of recurrent pleural effusions.

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Medical disclaimer: This information is for educational purposes only. Always consult a qualified healthcare provider before making treatment decisions. Data sourced from FDA and current as of our last update.