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Blenoxane (BLEOMYCIN)
Bleomycin works by binding to DNA and causing strand breaks, which ultimately leads to cell death.
Blenoxane (Bleomycin) is a cytoprotective agent used to treat various types of cancer, including non-Hodgkin's lymphoma, Hodgkin's disease, and vulvar carcinoma. It was originally developed by Bristol Myers Squibb in 1973 and is still owned by the company. Bleomycin targets the enzyme aspartyl/asparaginyl beta-hydroxylase and has been approved for several indications. The drug is available as a generic product and is off-patent, with multiple manufacturers offering their versions. Key safety considerations include its potential to cause pulmonary toxicity and nephrotoxicity.
At a glance
| Generic name | BLEOMYCIN |
|---|---|
| Sponsor | Bristol-Myers Squibb |
| Drug class | Cytoprotective Agent |
| Target | Aspartyl/asparaginyl beta-hydroxylase |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 1973 |
Mechanism of action
Mechanism of Action. Although the exact mechanism of action of bleomycin is unknown, available evidence indicates that the main mode of action is the inhibition of DNA synthesis with some evidence of lesser inhibition of RNA and protein synthesis.Bleomycin is known to cause single, and to lesser extent, double-stranded breaks in DNA. In in vitro and in vivo experiments, bleomycin has been shown to cause cell cycle arrest in G2 and in mitosis.When administered into the pleural cavity in the treatment of malignant pleural effusion, bleomycin acts as sclerosing agent.
Approved indications
- Diffuse non-Hodgkin's lymphoma, large cell
- Follicular non-Hodgkin's lymphoma
- Hodgkin's disease
- International Federation of Gynecology and Obstetrics stage finding for vulvar carcinoma
- Malignant tumor of cervix
- Malignant tumor of head and/or neck
- Malignant tumor of penis
- Non-Hodgkin's lymphoma
- Pleural Malignant Effusions
- Squamous cell carcinoma
- Testicular Germ Cell Tumor
Boxed warnings
- WARNING It is recommended that Bleomycin for Injection, USP be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of therapy and complications is possible only when adequate diagnostic and treatment facilities are readily available. Pulmonary fibrosis is the most severe toxicity associated with bleomycin. The most frequent presentation is pneumonitis occasionally progressing to pulmonary fibrosis. Its occurrence is higher in elderly patients and in those receiving greater than 400 units total dose, but pulmonary toxicity has been observed in young patients and those treated with low doses. A severe idiosyncratic reaction consisting of hypotension, mental confusion, fever, chills, and wheezing has been reported in approximately 1% of lymphoma patients treated with bleomycin.
Common side effects
- Pulmonary fibrosis
- Pleuropericarditis
- Interstitial fibrosis
- Hyaline membrane formation
- Bronchiolar squamous metaplasia
- Reactive macrophages
- Atypical alveolar epithelial cells
- Fibrinous edema
- Capillary changes
- Fibrinous exudation
- Hamman-Rich syndrome
- Pneumocystic pneumonitis
Key clinical trials
- Brentuximab Vedotin and Combination Chemotherapy in Treating Children and Young Adults With Stage IIB, Stage IIIB, IVA, or IVB Hodgkin Lymphoma (PHASE3)
- Electrochemotherapy of Posterior Resection Surface for Lowering Disease Recurrence Rate in Pancreatic Cancer (PanECT Study) (NA)
- Primary RPLND Versus Systemic Chemotherapy in Good-prognosis Metastatic Testicular Cancer (NA)
- A Study to Compare Standard Therapy to Treat Hodgkin Lymphoma to the Use of Two Drugs, Brentuximab Vedotin and Nivolumab (PHASE3)
- Electrochemotherapy for Recurrent Vulvar Cancer (PHASE2)
- A Frontline Therapy Trial in Participants With Advanced Classical Hodgkin Lymphoma (PHASE3)
- Active Surveillance, Bleomycin, Etoposide, Carboplatin or Cisplatin in Treating Pediatric and Adult Patients With Germ Cell Tumors (PHASE3)
- Pediatric Classical Hodgkin Lymphoma Consortium Study: cHOD17 (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |