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Product
Anti-cancer Products (Bleocip)
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Anti-cancer Products (Bleocip)
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Bleocip
Bleocip Injection
COMPOSITION
Each vial contains Bleomycin Sulphate IP equivalent to bleomycin 15 units as a sterile, freeze dried powder for reconstitution.
Indications
Bleocip 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 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 has also been shown to be useful in the management of: Malignant Pleural Effusion: Bleocip is effective as a sclerosing agent for the treatment of malignant pleural effusion and prevention of recurrent pleural effusions.
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Dosage and Administration
Squamous cell carcinoma, non-Hodgkin’s lymphoma, testicular
carcinoma - 0.25 to 0.5 units/kg (10 to 20 units/m 2 ) given intravenously, intramuscularly, or subcutaneously weekly or twice weekly.
Hodgkin’s Disease - 0.25 to 0.50 units/kg (10 to 20 units/m 2 ) 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.
Total dose over 400 units should be given with great care since pulmonary
toxicity may appear over that dose.
Note: When Bleocip is used in combination with other antineoplastic agents,
pulmonary toxicities may occur at lower doses.
Improvement of Hodgkin’s disease and testicular tumour is prompt and
noted within two weeks. If no improvement is seen by this time, improvement
is seen by this time, improvement is unlikely. Squamous cell cancers
respond more slowly, sometimes requiring as long as three weeks before
any improvement is noted.
Malignant Pleural Effusion: 60 units administered as a single dose bolus
intrapleural injection.
Bleocip may be given by the intramuscular, intravenous, subcutaneous or
intrapleural routes.
Intramuscular or subcutaneous: The Bleocip 15 units vial should be
reconstituted with 1 to 5 ml of sterile water for Injection; Sodium Chloride
for Injection, 0.9%; or Sterile Bacteriostatic Water for Injection. The Bleocip
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% and
administered slowly over a period of 10 minutes.
Intrapleural: 60 units of Bleocip is dissolved in 50-100 ml Sodium Chloride
injection 0.9%, 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 Bleocip. 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, Bleocip instillation may be appropriate when drainage is between
100-300 ml under clinical conditions that necessitate sclerosis therapy.
The thoracostomy tube is clamped after Bleocip 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.
Contraindications
Bleocip is contraindicated in patients who have demonstrated a
hypersensitive or an idiosyncratic reaction to it.
Presentation
Bleocip Injection Vial of 3 ml
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