DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Blenoxane (Bleomycin Sulfate) - Indications and Dosage

 
 



INDICATIONS AND USAGE

BLENOXANE 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 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 has also been shown to be useful in the management of:

Malignant Pleural Effusion

BLENOXANE 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 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 BLENOXANE 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 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)
BLENOXANE
Dose (%)
50 and above100
40-5070
30-4060
20-3055
10-2045
5-10 40

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

MalesCrCL = [weight × (140 – Age)]/(72 × Scr)
FemalesCrCL = 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 may be given by the intramuscular, intravenous, subcutaneous, or intrapleural routes.

To minimize the risk of dermal exposure, always wear impervious gloves when handling vials containing BLENOXANE for injection. This includes all handling activities in clinical settings, pharmacies, storerooms, and home healthcare settings, including during unpacking and inspection, transport within a facility, and dose preparation and administration.

Intramuscular or Subcutaneous

The BLENOXANE 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 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 are dissolved in 50–100 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. 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 instillation may be appropriate when drainage is between 100–300 mL under clinical conditions that necessitate sclerosis therapy. The thoracostomy tube is clamped after BLENOXANE 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 should not be reconstituted or diluted with D5W or other dextrose containing diluents. When reconstituted in D5W and analyzed by HPLC, BLENOXANE demonstrates a loss of A2 and B2 potency that does not occur when BLENOXANE is reconstituted in Sodium Chloride for Injection, 0.9%, USP.

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

Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published.1-8 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017