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Bleomycin (Bleomycin) - Indications and Dosage

 
 



INDICATIONS AND USAGE

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.

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.

DOSAGE 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 0.5 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.

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 Subcutaenous

The Bleomycin for Injection 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 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 for Injection 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 re-establishment 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 for Injection.  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 for Injection 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 for Injection 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 re-established.  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.

HOW SUPPLIED

Bleomycin for Injection, USP is available as follows:


Product

No.

NDC

No.


103610

63323-136-10 

15 units per vial, individually packaged.

103720

63323-137-20

30 units per vial, individually packaged.


Stability

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 D5W or other dextrose containing diluents.  When reconstituted in D5W and analyzed by HPLC, Bleomycin for Injection demonstrates a loss of A2 and B2 potency that does not occur when Bleomycin for Injection is reconstituted in Sodium Chloride for Injection, 0.9%, USP.

Bleomycin for Injection is stable for 24 hours at room temperature in Sodium Chloride.

This container closure is not made with natural rubber latex.

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