Bleomycin sulfate

What is Bleomycin sulfate?

• Bleomycin sulfate is a mixture of cytotoxic glycopeptide antibiotics isolated from a strain of Streptomyces verticillus.

Bleomycin R

Bleomycin mechanism

Bleomycin ball-and-stick

What are the uses of this medicine?

• Bleomycin sulfate used to treat many types of cancer, including squamous cell carcinoma of the cervix, head and neck, and vulva , Hodgkin’s disease, non-Hodgkin’s lymphoma , Testicular Carcinoma, Malignant Pleural Effusion.

How does this medicine work?

• Although the exact mechanism of action of bleomycin is unknown, available evidence indicates that the main mode of action is the inhibition of DNA synthesis with some evidence of lesser inhibition of RNA and protein synthesis.
• Bleomycin is known to cause single, and to a lesser extent, double-stranded breaks in DNA.
• When administered into the pleural cavity in the treatment of malignant pleural effusion, bleomycin acts as a sclerosing agent.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• have demonstrated a hypersensitive or an idiosyncratic reaction to it.

What drug interactions can this medicine cause?

• No formal drug interaction studies have been conducted with Bleomycin sulfate.

Is this medicine FDA approved?

• Bleomycin was first discovered in 1962 when the Japanese scientist Hamao Umezawa found anticancer activity while screening culture filtrates of Streptomyces verticillus.
• Umezawa published his discovery in 1966.
• The drug was launched in Japan by Nippon Kayaku in 1969. In the US, bleomycin gained FDA approval in July 1973.

How should this medicine be used?

Recommended dosage: Squamous cell carcinoma, non-Hodgkin’s lymphoma, testicular carcinoma:

• 0.25 to 0.5 units/kg (10 to 20 units/m 2) given intravenously, intramuscularly, or subcutaneously weekly or twice weekly.

Hodgkin’s Disease:

• 0.25 to 0.5 units/kg (10 to 20 units/m 2) 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.

Malignant Pleural Effusion:

• 60 units administered as a single dose bolus intrapleural injection.

Administration:

• Bleomycin for Injection may be given by the intramuscular, intravenous, subcutaneous, or intrapleural routes.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Bleomycin for Injection, USP is provided as a sterile lyophilized powder for reconstitution containing 15 units per vial and 30 units per vial

This medicine is available in fallowing brand namesː

• Bleomycin

What side effects can this medication cause?

The most common side effects of this medicine include:

• Fever, chills, and vomiting have been reported.
• Anorexia and weight loss have been reported and may persist long after termination of this medication.
• Pain at tumor site, phlebitis, and other local reactions have been reported.
• Malaise has been reported.

• The most serious side effects are pulmonary adverse reactions.

What special precautions should I follow?

• Patients with creatinine clearance values of less than 50 mL/min should be treated with caution and their renal function should be carefully monitored during the administration of bleomycin.
• 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. Frequent roentgenograms are recommended.
• A severe idiosyncratic reaction (similar to anaphylaxis) consisting of hypotension, mental confusion, fever, chills, and wheezing has been reported. Since these reactions usually occur after the first or second dose, careful monitoring is essential after these doses.
• 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.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Bleomycin can cause fetal harm when administered to a pregnant woman.
• There have been no studies in pregnant women.

Can this medicine be used in children?

• Safety and effectiveness of bleomycin in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredients include:

• BLEOMYCIN SULFATE

Inactive ingredients include:

• none

Who manufactures and distributes this medicine?

• Packager: Fresenius Kabi USA, LLC

What should I know about storage and disposal of this medication?

• 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 is stable for 24 hours at room temperature in Sodium Chloride.
• The container closure is not made with natural rubber latex.

• Dailymed label info on Bleomycin sulfate
• FDA Bleomycin sulfate

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