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Brand Name
Bleomycin
View Brand InformationFDA approval date: April 10, 2000
Classification: Cytoprotective Agent
Form: Injection, Powder
What is Bleomycin?
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 , penis, cervix, and vulva. The response to Bleomycin for Injection 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 is effective as a sclerosing agent for the treatment of malignant pleural effusion and prevention of recurrent pleural effusions.
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Brand Information
Bleomycin (BLEOMYCIN)
WARNING
It is recommended that Bleomycin for Injection 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 for Injection.
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 for Injection.
1DESCRIPTION
Bleomycin for Injection, USP is a mixture of cytotoxic glycopeptide antibiotics isolated from a strain of
It is available as a lyophilized powder for intramuscular, intravenous or subcutaneous injection. Each vial contains sterile bleomycin sulphate equivalent to 15 units or 30 units of bleomycin.
Sulfuric acid or Sodium hydroxide used, if necessary to adjust the pH.
Bleomycins are a group of related basic glycopeptides which differ in the terminal amine substituent of the common structural unit, bleomycin acid. The main components of Bleomycin for Injection are bleomycins A
The molecular formula of bleomycin A
Note: A unit of bleomycin is equal to the formerly used milligram activity. The term milligram activity is a misnomer and was changed to units to be more precise.
2INDICATIONS AND USAGE
Bleomycin for Injection 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 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 has also been shown to be useful in the management of:
Malignant Pleural Effusion
Bleomycin is effective as a sclerosing agent for the treatment of malignant pleural effusion and prevention of recurrent pleural effusions.
Bleomycin is effective as a sclerosing agent for the treatment of malignant pleural effusion and prevention of recurrent pleural effusions.
3CONTRAINDICATIONS
Bleomycin for Injection is contraindicated in patients who have demonstrated a hypersensitive or an idiosyncratic reaction to it.
4WARNINGS
Patients receiving bleomycin must be observed carefully and frequently during and after therapy. It should be used with extreme caution in patients with significant impairment of renal function or compromised pulmonary function.
Pulmonary toxicities occur in 10% of treated patients. In approximately 1%, the nonspecific pneumonitis induced by bleomycin progresses to pulmonary fibrosis and death. Although this is age and dose related, the toxicity is unpredictable. Frequent roentgenograms are recommended (see
A severe idiosyncratic reaction (similar to anaphylaxis) consisting of hypotension, mental confusion, fever, chills, and wheezing has been reported in approximately 1% of lymphoma patients treated with bleomycin. Since these reactions usually occur after the first or second dose, careful monitoring is essential after these doses (see
Renal or hepatic toxicity, beginning as a deterioration in renal or liver function tests, have been reported. These toxicities may occur at any time after initiation of therapy.
4.1Usage in Pregnancy
Bleomycin can cause fetal harm when administered to a pregnant woman. It has been shown to be teratogenic in rats. Administration of intraperitoneal doses of 1.5 mg/kg/day to rats (about 1.6 times the recommended human dose on a unit/m
There have been no studies in pregnant women. If Bleomycin for Injection is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant during therapy with Bleomycin for Injection.
5DOSAGE AND ADMINISTRATION
Because of the possibility of an anaphylactoid reaction, lymphoma patients should be treated with 2 units or less for the first 2 doses. If no acute reaction occurs, then the regular dosage schedule may be followed.
The following dose schedule is recommended:
Squamous cell carcinoma, non-Hodgkin's lymphoma, testicular carcinoma - 0.25 to 0.50 units/kg (10 to 20 units/m2) given intravenously, intramuscularly, or subcutaneously weekly or twice weekly.
Hodgkin's Disease - 0.25 to 0.50 units/kg (10 to 20 units/m2) given intravenously, intramuscularly, or subcutaneously weekly or twice weekly. After a 50% response, a maintenance dose of 1 unit daily or 5 units weekly intravenously or intramuscularly should be given.
Pulmonary toxicity of bleomycin appears to be dose-related with a striking increase when the total dose is over 400 units. Total doses over 400 units should be given with great caution.
Note: When Bleomycin for Injection is used in combination with other antineoplastic agents, pulmonary toxicities may occur at lower doses.
Improvement of Hodgkin's disease and testicular tumors is prompt and noted within 2 weeks. If no improvement is seen by this time, improvement is unlikely. Squamous cell cancers respond more slowly, sometimes requiring as long as 3 weeks before any improvement is noted.
Malignant Pleural Effusion—60 units administered as a single-dose bolus intrapleural injection (see Administration: Intrapleural).
5.1Use in Patients with Renal Insufficiency
The following dosing reductions are proposed for patients with creatinine clearance (CrCL) values of less than 50 mL/min:
- CrCL can be estimated from the individual patient's measured serum creatinine (Scr) values using the Cockcroft and Gault formula:
5.2Administration
Bleomycin for Injection may be given by the intramuscular, intravenous, subcutaneous or intrapleural routes.
5.2.1Administration Precautions
Caution should be exercised when handling Bleomycin for injection. Procedures for proper handling and disposal of anticancer drugs should be utilized. Several guidelines on this subject have been published.
5.2.2Intramuscular or Subcutaneous
The Bleomycin for Injection, USP 15 units vial should be reconstituted with 1 to 5 mL of Sterile Water for Injection, USP, Sodium Chloride for Injection, 0.9%, USP, or Sterile Bacteriostatic Water for Injection, USP. The Bleomycin for Injection, USP 30 units vial should be reconstituted with 2 to 10 mL of the above diluents.
5.2.3Intravenous
The contents of the 15 units or 30 units vial should be dissolved in 5 mL or 10 mL, respectively of Sodium Chloride for Injection, 0.9%, USP, and administered slowly over a period of 10 minutes.
5.2.4Intrapleural
Sixty units of Bleomycin are dissolved in 50 to 100 mL Sodium Chloride for Injection, 0.9%, USP, and administered through a thoracostomy tube following drainage of excess pleural fluid and confirmation of complete lung expansion. The literature suggests that successful pleurodesis is, in part, dependent upon complete drainage of the pleural fluid and reestablishment of negative intrapleural pressure prior to instillation of a sclerosing agent. Therefore, the amount of drainage from the chest tube should be as minimal as possible prior to instillation of Bleomycin. Although there is no conclusive evidence to support this contention, it is generally accepted that chest tube drainage should be less than 100 mL in a 24-hour period prior to sclerosis. However, Bleomycin instillation may be appropriate when drainage is between 100 to 300 mL under clinical conditions that necessitate sclerosis therapy. The thoracostomy tube is clamped after Bleomcyin instillation. The patient is moved from the supine to the left and right lateral positions several times during the next four hours. The clamp is then removed and suction reestablished. The amount of time the chest tube remains in place following sclerosis is dictated by the clinical situation.
The intrapleural injection of topical anesthetics or systemic narcotic analgesia is generally not required.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
6HOW SUPPLIED
Bleomycin for Injection, USP contains sterile bleomycin sulfate equivalent to 15 units or 30 units of bleomycin.
6.1Stability
The sterile powder is stable under refrigeration 2°C to 8°C (36°F to 46°F) and should not be used after the expiration date is reached.
Bleomycin for Injection should not be reconstituted or diluted with 5% Dextrose Injection or other dextrose containing diluents. When reconstituted in 5% Dextrose Injection and analyzed by HPLC, Bleomycin for Injection demonstrates a loss of A
Bleomycin for Injection, USP is stable for 24 hours at room temperature in Sodium Chloride.
7REFERENCES
- NIOSH Alert: Preventing occupational exposures to antineoplastic and other hazardous drugs in healthcare settings. 2004. U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 2004 165.
- OSHA Technical Manual, TED 1-0.15A, Section VI: Chapter 2. Controlling occupational exposure to hazardous drugs. OSHA, 1999. http://www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html
- American Society of Health-System Pharmacists. ASHP guidelines on handling hazardous drugs.
- Polovich M, White JM, Kelleher LO, eds. 2005. Chemotherapy and biotherapy guidelines and recommendations for practice. 2nd ed. Pittsburgh, PA: Oncology Nursing Society.
8PRINCIPAL DISPLAY PANEL - 30 unit Vial Label
1 single-dose vial
Bleomycin for Injection, USP
30 units per vial
For Intravenous, Intramuscular,
Caution: Cytotoxic - Special Handling Procedures
novaplus
Novaplus is a registered
9PRINCIPAL DISPLAY PANEL - 30 unit Vial Carton
VIAL
1 single-dose vial
Bleomycin for
30 units per vial
For Intravenous,
novaplus
Caution: Cytotoxic -
10PRINCIPAL DISPLAY PANEL - 15 unit Vial Label
1 single-dose vial
Bleomycin for Injection, USP
15 units per vial
For Intravenous, Intramuscular,
Caution: Cytotoxic - Special Handling Procedures
novaplus
11PRINCIPAL DISPLAY PANEL - 15 unit Vial Carton
VIAL
1 single-dose vial
Bleomycin for
15 units per vial
For Intravenous,
novaplus
Caution: Cytotoxic -
