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.
Bleomycin for Injection, USP is a mixture of cytotoxic glycopeptide antibiotics isolated from a strain of
. It is freely soluble in water.
Bleomycin for Injection, USP is provided as a sterile lyophilized powder for reconstitution containing 15 units per vial and 30 units per vial, which are intended for intramuscular, intravenous, subcutaneous or intrapleural administration.
Its chemical name is N-[3-(dimethylsulphonio)propyl]bleomycin-amide (bleomycin A2) and N-[4-(guaniodobutyl)]bleomycin-amide (bleomycin B2).
BLEOMYCIN is indicated for the following:
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 is poorer in patients with previously irradiated head and neck cancer.
Hodgkins disease, non-Hodgkins lymphoma.
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 is effective as a sclerosing agent for the treatment of malignant pleural effusion and prevention of recurrent pleural effusions.
Published Studies Related to Bleomycin
[A systematic review of talc compared with bleomycin for patients with malignant pleural effusion.] [2009.03.20]
BACKGROUND: Malignant pleural effusions are a common complication in advanced malignancy. Talc, bleomycin and the tetracyclines are the three most frequently used sclerosants. The aim of this study is to evaluate the efficacy and adverse effects of patients with malignant pleural effusions treated with talc and bleomycin... CONCLUSIONS: Current evidence indicate that talc is super to bleomycin for patients with malignant pleural effusions in terms of improving treatment success and reducing recurrence rate, there is no significant difference between the two group with regard to case fatality rate, fever, pain, the results mentioned above still need to be confirmed by high quality, large sample, multicenter randomized controlled trial.
Early versus late intensification for patients with high-risk Hodgkin lymphoma-3 cycles of intensive chemotherapy plus low-dose lymph node radiation therapy versus 4 cycles of combined doxorubicin, bleomycin, vinblastine, and dacarbazine plus myeloablative chemotherapy with autologous stem cell transplantation: five-year results of a randomized trial on behalf of the GOELAMS Group. [2008.12.15]
BACKGROUND: The 5-year freedom from treatment failure (FFTF) rate, with treatment failure defined as the lack of post-treatment complete remission (CR), recurrence, or death, ranges from 60% to 70% after 6 to 8 cycles of combined doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD), which is the reference treatment for patients with advanced Hodgkin lymphoma (HL). In this randomized, phase 2 study, the authors tested 2 intensive chemotherapy regimens in 158 patients with clinical stage (CS) IIB through IV HL accompanied by high-risk factors who were recruited between May 1997 and December 2004... CONCLUSIONS: Early intensification (Arm V) and late intensification (Arm A) were equally effective for treating patients with high-risk/advanced HL.
Randomized trial comparing bleomycin/etoposide/cisplatin with alternating cisplatin/cyclophosphamide/doxorubicin and vinblastine/bleomycin regimens of chemotherapy for patients with intermediate- and poor-risk metastatic nonseminomatous germ cell tumors: Genito-Urinary Group of the French Federation of Cancer Centers Trial T93MP. [2008.01.20]
PURPOSE: Two chemotherapy regimens for intermediate- and poor-risk metastatic nonseminomatous germ cell tumors were compared for efficacy and toxicity... CONCLUSION: Because of equivalent efficacy and lesser toxicity, the standard treatment for patients with intermediate- and poor-risk metastatic nonseminomatous germ cell tumors remains four cycles of BEP.
Two cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine plus extended-field radiotherapy is superior to radiotherapy alone in early favorable Hodgkin's lymphoma: final results of the GHSG HD7 trial. [2007.08.10]
PURPOSE: To investigate whether combined-modality treatment (CMT) with two cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) followed by extended-field radiotherapy (EF-RT) is superior to EF-RT alone in patients with early favorable Hodgkin's lymphoma (HL)... CONCLUSION: CMT consisting of two cycles of ABVD plus EF-RT is more effective than EF-RT alone.
Patterns of failure in patients with locally advanced head and neck cancer treated postoperatively with irradiation or concomitant irradiation with Mitomycin C and Bleomycin. [2007.03.01]
PURPOSE: The long term results and patterns of failure in patients with squamous cell head and neck carcinoma (SCHNC) treated in a prospective randomized trial in which concomitant postoperative radiochemotherapy with Mitomycin C and Bleomycin (CRT) was compared with radiotherapy only (RT), were analyzed... CONCLUSION: With concomitant radiochemotherapy, locoregional control and disease free survival were significantly improved. Second primary malignancies in the CRT arm compared to RT arm were significantly less frequent. The high probability of post treatment hypothyroidism in both arms warrants regular laboratory evaluation.
Clinical Trials Related to Bleomycin
Dose Escalating Study for Amphinex-based PCI of Bleomycin. [Completed]
The primary goal of this extension study is to further investigate the tolerability and
efficacy in a phase I setting in order to see whether lower doses than the initial study
dose of 0. 25 mg/kg bw Amphinex in Amphinex-based PCI of bleomycin will show a comparable or
improved safety and tolerability profile in combination with comparable signs of efficacy.
Study Using the Medpulser Electroporation System With Bleomycin to Treat Head and Neck Cancer [Completed]
The purpose of the trial is to study the safety and efficacy of the Medpulser
Electroporation System with bleomycin in the treatment of head and neck cancer.
Study of a-Interferon With Adriamycin, Bleomycin, Velban, and Dacarbazine (ABVD) With Hodgkin's Disease [Completed]
This is a clinical research study of interferon (IFN) plus chemotherapy with the standard
combination of Adriamycin, Bleomycin, Velban, and Dacarbazine (ABVD). The treatment will be
given to patients with Hodgkin's disease. The study will look at whether adding IFN to ABVD
improves the immune response against Hodgkin's disease, and will determine whether the
toxicity of ABVD is increased by adding IFN.
Medpulser Electroporation With Bleomycin Study to Treat Posterior Head and Neck Squamous Cell Carcinoma [Suspended]
The purpose of the study is to evaluate Medpulser electroporation (EPT) with bleomycin with
regard to local tumor recurrence, disease-free survival, and overall survival rates versus
surgery in recurrent or secondary primary squamous cell carcinoma (SCC) of the base of the
tongue, posterior lateral pharyngeal wall, hypopharynx or larynx.
Paclitaxel, Ifosfamide and Cisplatin (TIP) Versus Bleomycin, Etoposide and Cisplatin (BEP) for Patients With Previously Untreated Intermediate- and Poor-risk Germ Cell Tumors [Recruiting]
The purpose of this study is to learn about the safety and effectiveness of two different
drug combinations in patients who have intermediate- and poor-risk germ cell tumors (GCT).
One combination of drugs, paclitaxel, ifosfamide and cisplatin (TIP), is experimental. The
other combination of drugs, bleomycin, etoposide and cisplatin (BEP), is the standard of
care treatment for intermediate- and poor-risk germ cell tumors. However, BEP does not cure
every patient and therefore newer treatments are needed.
Reports of Suspected Bleomycin Side Effects
Respiratory Disorder (8),
Pulmonary Toxicity (5),
Gastrointestinal Haemorrhage (3),
Blood Creatinine Increased (3),
Bronchopulmonary Aspergillosis (2),
Histiocytosis Haematophagic (2), more >>
Page last updated: 2010-10-05