Bleomycin

Overview

A complex of related glycopeptide antibiotics from Streptomyces verticillus consisting of bleomycin A2 and B2 (B2 CAS # 9060-10-0). It inhibits DNA metabolism and is used as an antineoplastic, especially for solid tumors. Bleomycin A2 is used as the representative structure for Bleomycin.

Indication

For palliative treatment in the management malignant neoplasm (trachea, bronchus, lung), squamous cell carcinoma, and lymphomas.

Associated Conditions

Hodgkin's Lymphoma
Malignant Pleural Effusion
Non-Hodgkin's Lymphomas
Squamous Cell Carcinoma (SCC)
Teratocarcinoma
Testicular Choriocarcinoma
Testicular Embryonal Carcinoma

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Microneedling Alone Versus Microneedling Coupled With Either Bleomycin or 5flourouracil in the Treatment of Plantar Warts	2025/06/27	NCT07041749	Not Applicable	Not yet recruiting	Assiut University
ECT STUDY High-grade or Initially Invasive Vulva - GinOnc-ECT Study	2024/12/04	NCT06715592	Phase 2	Active, not recruiting	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
GISEL:Registry of Breast Cancer Patients Treated With ECT	2024/11/11	NCT06683404	N/A	Completed	Istituto Oncologico Veneto IRCCS
The Effect of Reduced Bleomycin in Electrochemotherapy Treatment	2024/10/17	NCT06647342	Phase 4	Recruiting	Julie Gehl
Use of Bleomycin in the Sclerotherapy of Lymphatic Malformations for Pediatric Patients	2024/05/31	NCT06437158	Phase 2	Recruiting	West China Hospital
Treatment of Low-flow Venous Malformations With Electrosclerotherapy. Prospective Observational Study	2024/01/03	NCT06189092	N/A	Recruiting	Istituto Ortopedico Rizzoli
Electrochemotherapy for the Treatment of Vulvar Cancer	2023/06/23	NCT05916690	Not Applicable	Recruiting	Institute of Oncology Ljubljana
A Study to Compare Standard Therapy to Treat Hodgkin Lymphoma to the Use of Two Drugs, Brentuximab Vedotin and Nivolumab	2023/01/09	NCT05675410	Phase 3	Recruiting	National Cancer Institute (NCI)
Electrochemotherapy With Carboplatinum Plus Bleomycin Versus Bleomycin Alone in Vulvar Cancer	2022/05/27	NCT05395962	Phase 2	Recruiting	IRCCS Azienda Ospedaliero-Universitaria di Bologna
Role of Propranolol as Compared to Bleomycin in Management of Hemangioma	2022/04/14	NCT05327309	Not Applicable	Completed	Shaheed Zulfiqar Ali Bhutto Medical University

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Bleomycin	Hospira, Inc.	61703-323	INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, INTRAPLEURAL	30 [USP'U] in 1 1	8/25/2022
Bleomycin	Fresenius Kabi USA, LLC	63323-136	INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, INTRAPLEURAL	15 [USP'U] in 1 1	12/31/2019
Bleomycin	NorthStar Rx LLC	16714-908	INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, INTRAPLEURAL	30 [USP'U] in 1 1	11/20/2018
Bleomycin	Hospira, Inc.	0409-0323	INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, INTRAPLEURAL	30 [USP'U] in 1 1	8/25/2022
Bleomycin	Amneal Pharmaceuticals LLC	70121-1567	INTRA-ARTERIAL, INTRAMUSCULAR, INTRAVENOUS	15000 [iU] in 1 1	12/23/2023
Bleomycin	Hospira, Inc.	0409-0332	INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, INTRAPLEURAL	15 [USP'U] in 1 1	8/25/2022
Bleomycin	Fresenius Kabi USA, LLC	63323-137	INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, INTRAPLEURAL	30 [USP'U] in 1 1	12/31/2019
Bleomycin	Hikma Pharmaceuticals USA Inc.	0143-9240	INTRAMUSCULAR, INTRAPLEURAL, INTRAVENOUS, SUBCUTANEOUS	15 [USP'U] in 1 1	4/19/2022
Bleomycin	NorthStar Rx LLC	16714-886	INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, INTRAPLEURAL	15 [USP'U] in 1 1	11/20/2018
Bleomycin	Meitheal Pharmaceuticals Inc.	71288-107	INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, INTRAPLEURAL	30 [USP'U] in 1 1	6/24/2021

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
DBL BLEOMYCIN SULFATE FOR INJECTION 15000 iu/vial	Zydus Hospira Oncology Private Limited (ZHOPL)	SIN08426P	INJECTION, POWDER, FOR SOLUTION	15000 iu/vial	10/26/1995

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
CIPLA BLEOMYCIN 15K bleomycin sulfate 15000 IU powder for injection vial	220440	Cipla Australia Pty Ltd	Medicine	A	3/19/2015
BLEO 15K bleomycin sulfate 15000 IU powder for injection vial	157341	Juno Pharmaceuticals Pty Ltd	Medicine	A	9/30/2010
Hospira Bleomycin Sulphate for Injection, USP 15 U, vial	126045	Hospira Australia Pty Ltd	Medicine	A	3/10/2006
Hospira Bleomycin for Injection, USP 30 units vial	80566	Hospira Australia Pty Ltd	Medicine	A	10/10/2001
Hospira Bleomycin 15,000 IU Powder for Injection, vial	125600	Hospira Australia Pty Ltd	Medicine	A	2/15/2006
DBL BLEOMYCIN 15000 IU powder for injection	42569	Pfizer Australia Pty Ltd	Medicine	A	9/12/1994
Hospira Bleomycin for Injection, USP 15 units vial	42878	Hospira Australia Pty Ltd	Medicine	A	11/19/1992

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
BLENOXANE PWS 15UNIT	bristol labs division of bristol-myers squibb	00258482	Powder For Solution - Intramuscular , Intravenous	15 UNIT / AMP	12/31/1973

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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