Bleoz- Bleomycin Inj

Bleoz- Bleomycin Inj

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

Bleomycin for Injection, USP is a mixture of cytotoxic glycopeptide antibiotics isolated from a strain of Streptomyces verticillus and is freely soluble in water.

It is available as a lyophilized powder for intramuscular, intravenous or subcutaneous injection. Each vial contains sterile bleomycin sulfate equivalent to 15 units or 30 units of bleomycin. Sulfuric acid or Sodium hydroxide used, if necessary to adjust the pH.

Bleomycins are a group of related basic glycopeptides which differ in the terminal amine substituent of the common structural unit, bleomycin acid. The main components of Bleomycin for Injection are bleomycins A2 and B2. Chemically, bleomycin A2 is N1-[3-(dimethylsulfonio)propyl]-bleomycinamide and bleomycin B2 is N1-[4-(aminoiminomethyl)amino]butyl]-bleomycinamide.

The molecular formula of bleomycin A2 is C55H84N17O21S3 and a calculated molecular weight of 1414. The molecular formula of bleomycin B2 is C55H84N20O21S2 and a calculated molecular weight of 1425. The structural formula of bleomycins A2 and B2 are shown below.

BLEOZ 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, plate, lip, buccal mucosa, gingivae, skin, larynx), Penis, cervix, and vulva. The response to BLEOZ is poorer in patients with previously irradiated head neck cancer.

Lymphomas

Hodgkin’s diseases, non-Hodgkin’s lymphoma

Testicular Carcinoma

Embryonal cell, choriocarcinoma and teratocarcinoma.

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

Malignant Pleural Effusion

BLEOZ is effective as ascierosing agent for the treatment of malignant pleural effusion and prevention of recurrent pleural effusions.

Although the exact mechanism of action of BLENOXANE (bleomycin sulfate injection) is unknown, available evidence indicates that the main mode of action is the inhibition of DNA synthesis with some evidence of lesser inhibition of RNA and protein synthesis.

Bleomycin is known to cause single, and to a lesser extent, double-stranded breaks in DNA. In in vitro and in vivo experiments, bleomycin has been shown to cause cell cycle arrest in G2 and in mitosis.

When administered into the pleural cavity in the treatment of malignant pleural effusion, BLENOXANE (bleomycin sulfate injection) acts as a sclerosing agent.

BLEOZ 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, plate, lip, buccal mucosa, gingivae, skin, larynx), Penis, cervix, and vulva. The response to BLEOZ is poorer in patients with previously irradiated head neck cancer.

Lymphomas

Hodgkin’s diseases, non-Hodgkin’s lymphoma

Testicular Carcinoma

Embryonal cell, choriocarcinoma and teratocarcinoma.

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

Malignant Pleural Effusion

BLEOZ is effective as ascierosing agent for the treatment of malignant pleural effusion and prevention of recurrent pleural effusions.

Because Bleomycin sulfate may contain inactive ingredients, it may cause allergic reactions or other problems. Also, tell your doctor or pharmacist if you have any medical history, especially immune system problems (e.g. chemotherapy, bone marrow problems), illness. kidney, liver disease, lung problems.