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Blenoxane

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Blenoxane

Blenoxane

INDICATIONS

BLENOXANE (bleomycin sulfate 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 BLENOXANE (bleomycin sulfate 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.

BLENOXANE (bleomycin sulfate injection) has also been shown to be useful in the management of:

Malignant Pleural Effusion

BLENOXANE (bleomycin sulfate 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 0.50 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 BLENOXANE (bleomycin sulfate injection) 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 BLENOXANE (bleomycin sulfate 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) BLENOXANE Dose (%)
50 and above 100
40-50 70
30-40 60
20-30 55
10-20 45
5-10 40

CrCL can be estimated from the individual patient's measured serum creatinine (Scr) values using the Cockcroft and Gault formula:

Males CrCL = [weight (140 – Age)]/(72 Scr)

Females CrCL = 0.85 [weight (140 – Age)]/(72 Scr)

Where CrCL in mL/min/1.73m², weight in kg, age in years, and Scr in mg/dL.

Administration

BLENOXANE (bleomycin sulfate injection) may be given by the intramuscular, intravenous, subcutaneous, or intrapleural routes.

Administration Precautions

Caution should be exercised when handling BLENOXANE (bleomycin sulfate injection) 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 BLENOXANE (bleomycin sulfate injection) for injection. If BLENOXANE (bleomycin sulfate injection) 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 BLENOXANE (bleomycin sulfate 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 BLENOXANE (bleomycin sulfate 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 BLENOXANE (bleomycin sulfate 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 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 BLENOXANE (bleomycin sulfate 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, BLENOXANE (bleomycin sulfate 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 BLENOXANE (bleomycin sulfate 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 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.

HOW SUPPLIED

BLENOXANE® (bleomycin sulfate for injection, USP) is available as follows:

NDC 0015-3010-20, 15 units per vial as bleomycin sulfate for injection, USP.
NDC 0015-3063-01, 30 units per vial as bleomycin sulfate for injection, USP.

Stability

The sterile powder is stable under refrigeration 2°C (36°F) to 8°C (46°F) and should not be used after the expiration date is reached.

BLENOXANE (bleomycin sulfate injection) should not be reconstituted or diluted with D5W or other dextrose containing diluents. When reconstituted in D5W and analyzed by HPLC, BLENOXANE (bleomycin sulfate injection) demonstrates a loss of A2 and B2 potency that does not occur when BLENOXANE (bleomycin sulfate injection) is reconstituted in Sodium Chloride for Injection, 0.9%, USP.

BLENOXANE (bleomycin sulfate injection) is stable for 24 hours at room temperature in Sodium Chloride.

REFERENCES

1. 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.

2. 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

3. American Society of Health-System Pharmacists. ASHP guidelines on handling hazardous drugs. Am J Health-Syst Pharm. 2006;63:1172-1193.

4. Polovich M, White JM, Kelleher LO, eds. 2005. Chemotherapy and biotherapy guidelines and recommendations for practice. 2nd ed. Pittsburgh, PA: Oncology Nursing Society.

Manufactured by: Nippon Kayaku Co., Ltd. Tokyo, Japan. Distributed by: Bristol-Myers Squibb Company Princeton, NJ 08543 USA. Rev April 2010

Last reviewed on RxList: 6/22/2010
This monograph has been modified to include the generic and brand name in many instances.

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