Bleomycin
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Questions & Answers
Side Effects & Adverse Reactions
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 ADVERSE REACTIONS, Pulmonary).
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 ADVERSE REACTIONS, Idiosyncratic Reactions).
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.
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/m2 basis) on days 6 to 15 of gestation caused skeletal malformations, shortened innominate artery and hydroureter. Bleomycin is abortifacient but not teratogenic in rabbits at intravenous doses of 1.2 mg/kg/day (about 2.4 times the recommended human dose on a unit/m2 basis) given on gestation days 6 to 18.
There have been no studies in pregnant women. If bleomycin 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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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:
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.
Hodgkin's Disease, non-Hodgkin's lymphoma.
Embryonal cell, choriocarcinoma, and teratocarcinoma.
Bleomycin for injection has also been shown to be useful in the management of:
Bleomycin for injection is effective as a sclerosing agent for the treatment of malignant pleural effusion and prevention of recurrent pleural effusions.
History
There is currently no drug history available for this drug.
Other Information
Bleomycin for Injection USP is a mixture of cytotoxic glycopeptide antibiotics isolated from a strain of Streptomyces verticillus. It is freely soluble in water. Bleomycin for Injection USP contains sterile bleomycin sulfate equivalent to 15 units or 30 units of bleomycin. Sulfuric acid or sodium hydroxide can be used, if necessary, to adjust pH.
Bleomycin for Injection USP may be given by the intramuscular, intravenous or subcutaneous routes.
Its chemical name is N’-[3-(dimethylsul-phonio)propyl]bleomycin-amide (bleomycin A2) and N’-[4-(guaniodobutyl)]bleomycin-amide (bleomycin B2). (Main component: Bleomycin A2, in which R is [CH3]2S+CH2CH2CH2-)
The molecular formula of bleomycin A2 is C55H84N17O21S3 and a calculated molecular weight of 1414. The molecular formula of bleomycin B2 is C55H84N20O21S2 and a calculated molecular weight of 1425. The structural formula of bleomycins A2 and B2 are shown below.
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.
Sources
Bleomycin Manufacturers
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Teva Parenteral Medicines, Inc.
![Bleomycin Injection, Powder, Lyophilized, For Solution [Teva Parenteral Medicines, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Bleomycin | Teva Parenteral Medicines, Inc.
BECAUSE OF THE POSSIBILITY OF AN ANAPHYLACTOID REACTION, LYMPHOMA PATIENTS SHOULD BE TREATED WITH 2 UNITS OR LESS FOR THE FIRST TWO 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 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).
Use in Patients with Renal InsufficiencyThe following dosing reductions are proposed for patients with creatinine clearance (CrCL) values of less than 50 mL/min:
Patient CrCL
(mL/min)Bleomycin for Injection, USP
Dose (%) 50 and above 100 40 to 50 70 30 to 40 60 20 to 30 55 10 to 20 45 5 to 10 40CrCL can be estimated from the individual patient’s measured serum creatinine (Scr) values using the Cockcroft and Gault formula:
Males CrCL = [weight x (140 – Age)]/(72 x Scr)
Females CrCL = 0.85 x [weight x (140 – Age)]/(72 x Scr)
Where CrCL in mL/min/1.73m2, weight in kg, age in years, and Scr in mg/dL.
AdministrationBleomycin for injection may be given by the intramuscular, intravenous, subcutaneous, or intrapleural routes.
Administration 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.1-4 To minimize the risk of dermal exposure, always wear impervious gloves when handling vials containing bleomycin for injection. If bleomycin for injection contacts the skin, immediately wash the skin thoroughly with soap and water. If contact with mucous membranes occurs, the membranes should be flushed immediately and thoroughly with water. More information is available in the references listed below.
Intramuscular or Subcutaneous
The bleomycin for injection USP 15 units vial should be reconstituted and dissolved with 1 to 5 mL of sterile water for injection, USP, sodium chloride injection, 0.9%, USP, or bacteriostatic water for injection, USP. The bleomycin for injection USP 30 units vial should be reconstituted and dissolved with 2 to 10 mL of the above diluents.
Intravenous
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.
Intrapleural
60 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 bleomycin 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.
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Hospira Worldwide, Inc.
Bleomycin | Hospira Worldwide, Inc.
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).
Use in Patients with Renal Insufficiency
The following dosing reductions are proposed for patients with creatinine clearance (CrCL) values of less than 50 mL/min:
Patient CrCL
(mL/min) Bleomycin for Injection, USP
Dose (%) 50 and above 100 40 to 50 70 30 to 40 60 20 to 3055
10 to 20
45
5 to 10 40 CrCL can be estimated from the individual patient’s measured serum creatinine (Scr) values using the Cockcroft and Gault formula:Males CrCL = [weight x (140 - Age)]/(72 x Scr)
Females CrCL = 0.85 x [weight x (140 - Age)]/(72 x Scr)
Where CrCL in mL/min/1.73m2, weight in kg, age in years, and Scr in mg/dL.
Administration
Bleomycin for Injection may be given by the intramuscular, intravenous, subcutaneous or intrapleural routes.
Administration 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.1-4 To minimize the risk of dermal exposure, always wear impervious gloves when handling vials containing Bleomycin for injection. If Bleomycin for injection contacts the skin, immediately wash the skin thoroughly with soap and water. If contact with mucous membranes occurs, the membranes should be flushed immediately and thoroughly with water. More information is available in the references listed below.
Intramuscular 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.
Intravenous
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.
Intrapleural
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 thenremoved 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.
-
Fresenius Kabi Usa, Llc
Bleomycin | Fresenius Kabi Usa, Llc
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 0.5 units/kg (10 to 20 units/m2) given intravenously, intramuscularly, or subcutaneously weekly or twice weekly.
Hodgkin’s Disease – 0.25 to 0.5 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 for Injection, USP 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, USP 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).
Use in Patients with Renal Insufficiency
The following dosing reductions are proposed for patients with creatinine clearance (CrCL) values of less than 50 mL/min:
Patient CrCL
(mL/min)
Bleomycin
for Injection, USP
Dose (%)
50 and above
100
40 to 50
70
30 to 40
60
20 to 30
55
10 to 20
45
5 to 10
40
CrCL can be estimated from the individual patient’s measured serum creatinine (Scr) values using the Cockcroft and Gault formula:
Males CrCL = [weight x (140 – Age)]/(72 x Scr)
Females CrCL = 0.85 x [weight x (140 – Age)]/(72 x Scr)
Where CrCL in mL/min/1.73m2, weight in kg, age in years, and Scr in mg/dL.
![Bleomycin (Bleomycin Sulfate) Injection, Powder, Lyophilized, For Solution [Hospira Worldwide, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=905e0984-2ce3-481c-b1a0-0ef0a616479a&name=bleomycin-for-injection-usp1-figure-2-jCA-434083.jpg)
![Bleomycin (Bleomycin Sulfate) Injection, Powder, Lyophilized, For Solution [Fresenius Kabi Usa, Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=b5806c40-12ce-48e3-8abd-9f8997ef4428&name=bleomycin-for-injeciton-usp-figure-3-103610-vial.jpg)
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