Last reviewed · How we verify
BLEOMYCIN SULFATE
At a glance
| Generic name | BLEOMYCIN SULFATE |
|---|---|
| Phase | FDA-approved |
| First approval | 1973 |
Approved indications
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
- Pneumonitis
- Dyspnea
- Fine rales
Serious adverse events
- Pulmonary fibrosis
- Death from pulmonary fibrosis
- Pleuropericarditis
- Anaphylaxis-like idiosyncratic reaction
- Pulmonary toxicity
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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- BLEOMYCIN SULFATE CI brief — competitive landscape report
- BLEOMYCIN SULFATE updates RSS · CI watch RSS