Bleomycin

What is Bleomycin?

• Bleomycin (Blenoxane) is a mixture of cytotoxic glycopeptide antibiotics isolated from a strain of Streptomyces verticillus.
• It damages the cell’s DNA and may kill cancer cells.
• It is a type of antineoplastic antibiotic.
• Bleomycins are a group of related basic glycopeptides which differ in the terminal amine substituent of the common structural unit, bleomycin acid.

Bleomycin

Bleomycin A2

Bleomycin ball-and-stick

What are the uses of this medicine?

• Bleomycin for Injection (Blenoxane) should be considered a palliative treatment.
• Bleomycin for Injection is used for the treatment of fallowing conditions:

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.

Lymphomas:

• Hodgkin's disease, non-Hodgkin's lymphoma

Testicular Carcinoma:

• Embryonal cell, choriocarcinoma, and teratocarcinoma

Malignant Pleural Effusion:

• It is also used to treat pleural effusions (a condition when fluid collects in the lungs) that are caused by cancerous tumors.

How does this medicine work?

• The bleomycins are a group of glycopeptide antibiotics that were initially derived from Streptomyces verticillus and later found to have antitumor activity in vitro and in vivo.
• Bleomycin (blee” oh mye’ sin) is actually a mixture of water soluble glycopeptides that have similar chemical structures and metabolic activities. The cytotoxic effects of bleomycin appear to be due to oxidative damage to DNA, leading to single and double stranded breaks.
• Bleomycin is concentrated in skin and lung tissue and has significant cutaneous and pulmonary toxicity, but has only mild myelo- and immunosuppressive activities which allows it to be added to regimens that are otherwise limited by these toxicities.
• 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?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Is this medicine FDA approved?

• Bleomycin was approved for use in the United States in 1973 and current formal indications include testicular and ovarian germ cell tumors, head and neck cancers, Hodgkin and non-Hodgkin lymphomas and malignant pleural effusions.
• It is usually given in combination with other anticancer agents, most frequently with cisplatin, vinblastine, etoposide, adriamycin or dacarbazine.

How should this medicine be used?

Recommended dosage: 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.

Malignant Pleural Effusion:

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

Administration:

• Bleomycin comes as a powder to be mixed with liquid and injected intravenously, intramuscularly, or subcutaneously by a doctor or nurse in a medical facility.
• It is usually injected once or twice a week.
• When bleomycin is used to treat pleural effusions, it is mixed with liquid and placed in the chest cavity through a chest tube.
• Caution should be exercised when handling Bleomycin for injection.
• Procedures for proper handling and disposal of anticancer drugs should be utilized.
• 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.

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

This medicine is available in fallowing doasage form:

• As a lyophilized powder for intramuscular, intravenous or subcutaneous injection.

This medicine is available in fallowing brand namesː

• Blenoxane

What side effects can this medication cause?

The most common side effects of this medicine include:

• nausea
• vomiting
• diarrhea
• headache
• dizziness
• alopecia
• fatigue
• weakness
• darkened skin color
• redness, blistering, tenderness, or thickening of the skin
• loss of appetite
• weight loss
• sores on the mouth or tongue

• Uncommon, but serious toxicities of bleomycin include interstitial pneumonitis, hypersensitivity reactions and malignant hyperthermia that can be fatal.

What special precautions should I follow?

• 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 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. 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.
• Bleomycin can cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be advised to avoid becoming pregnant during therapy with Bleomycin for Injection.
• It is not known whether the drug is excreted in human milk.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are receiving bleomycin.
• Therapy with bleomycin in combination with other agents is often associated with mild-to-moderate serum enzyme elevations, but is a rare cause of clinically apparent liver injury.

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.
• Women of childbearing potential should be advised to avoid becoming pregnant during therapy with Bleomycin for Injection.

Can this medicine be used in children?

• Safety and effectiveness of Bleomycin for Injection in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active Ingredients:

• bleomycin sulfate

Inactive Ingredients:

• sulfuric acid
• sodium hydroxide

Who manufactures and distributes this medicine?

• Distributed by Hospira Inc., Lake Forest, IL, USA

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, USP is stable for 24 hours at room temperature in Sodium Chloride.

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• Dailymed label info on Bleomycin
• FDA Bleomycin

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