Bleoz

Bleoz

Bleomycin Sulphate

Strength: 15 IU

Pack Size: 1 vial

Drug Class: antineoplastic agent

Dosage and Administration:

DOSAGE AND ADMINSTRATION

Because of the possibility of an anaphylactiod 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 doses 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, 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 maintenancedose of 1 unit daily or 5 units weekly intravenously or intram

Pulmonary toxicity of BLEOZ appear 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 BLEOZ is used in combination with other antineoplastic agent, pulmonary toxicities may occur at lower doses.

Improvement of Hodgkin’s disease and testicular turnover is prompt and noted within 20 weeks. If no improvement is seen by this time, improvement is unlikely. Squamous cell cancer 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 reduction are proposed for patients with creatinine clearance (CRCL) value of les than 50 ml/min

Patient CRCL (mL/min)	BLEOZ 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 patients measured serum creatinine (Scr) value using the Cockcroft and Gault formula:

Males CrCL =	[weight × (140 – Age)]/(72 x Scr)
Females CrCL =	0.85 x [weight × (140 – Age)]/(72 x Scr)
Where CrCL in mL/min/1.73m2, weight in kg, age in years, and Scr in mg/dL.

Administration

BLEOZ may be given by the intramuscular, intravenous, subcutaneous, or intrapleural routes.

Administration Precautions

Caution should be exercised when handling BLEOZ 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 BLEOZ for injection. If BLEOZ for injection contacts 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 BLEOZ 15 units vial should be reconstituted with 1 to 5ml of Sterile Water for Injection, IP, Sodium Chloride for Injection, 0.9%, USP, or Sterile Bacteriostatic Water for Injection, USP. The BLEOZ 30 units vial should be reconstituted with 2 to 10ml 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 10minutes.

Intrapleural

Sixty units of BLEOZ are dissolved in 50 to 100ml Sodium Chloride for Injection, 0.9%, USP, and administered through a thoracostomy tube following drainage of excess pleural fluid and confirmation of complete lung exapansion. 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 sclerosis. However, BLEOZ 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 BLEOZ 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.

Cold Storage: yes