Blenamax

Generic Name: Bleomycin sulfate
Product Name: Blenamax

Indication

Bleomycin can be used in combination with surgery or radiotherapy, or in the palliative treatment of a number of cancers.

The main indication is squamous cell carcinoma of the skin, head and neck and oesophagus. Some response is seen in squamous cell carcinoma of the penis, larynx and uterine cervix. Squamous cell carcinoma of the bronchus has shown little response.

Bleomycin can also be used in the treatment of choriocarcinoma and embryonal cell carcinoma of the testis.It has also been used successfully in the treatment of Hodgkin’s disease and other lymphomas of the non-Hodgkin’s type, as well as mycosis fungoides.

Bleomycin is bone marrow sparing, so can be used in cases where other cytotoxic agents are contraindicated.When used in conjunction with radiotherapy, it is more effective when given before the radiation than after.

Bleomycin is also useful as a sclerosing agent (leads to hardening and fibrosis) in the treatment of malignant pleural effusion. It should be used only once for this indication.

Action

Bleomycin is an antineoplastic antibiotic. Instead of having activity against microorganisms such as bacteria, Bleomycin attacks the DNA of dividing cells, which are found in large numbers in cancers. The exact mechanism by which Bleomycin works is not fully known, but it is thought to create breaks in the DNA, which then inhibit further production of DNA and cell division. Because it mainly affects dividing cells, Bleomycin is known as a “cell cycle specific” chemotherapeutic agent.

Bleomycin is useful in the treatment of pleural effusion related to cancer, and its mechanism of action here is also not fully understood. It is thought to create a local inflammatory effect, the healing of which is followed by formation of a fibrous adhesion, clearing the effusion. However, a cytotoxic (cell killing) effect could also have a role here

.Cancer can develop resistance to Bleomycin, as Bleomycin-inactivating enzyme has been found in normal and malignant cells, especially liver cells.

Dose advice

Bleomycin can be injected via intravenous, intramuscular, subcutaneous, intra-arterial or intrapleural routes. Dose should always be determined based on patient response.

Adults

Initial treatment:

• 10,000-20,000IU/m2 body surface area given weekly or twice weekly
• alternatively, give 15,000IU daily for seven days followed by 3 weeks off treatment and repeat twice
• therapeutic response should be seen as cumulative dose reaches 150,000IU, and if this does not occur other therapy should be considered
• care should be taken in administering total cumulative doses larger than 300,000IU- 30,000
• 60,000IU can be given once or twice a week (to maximum of 300,000IU) via the intra-arterial route if greater concentrations at the cancer site are required

Repeat treatment:

• this is suitable in patients who have had a past but incomplete response
• minimum of 3-4 weeks is required between courses
• treatment cannot be repeated if the patient has suffered pulmonary toxicity

Renal impairment:

• dose reductions of 40-75% are recommended for patients with a creatinine clearance of ?´0ml/min

Reconstitution:

• for IM or SC injection, dissolve contents of vial in 1-5ml water for injection
• for IV or intra-arterial injection, use 5-10ml of diluent and inject slowly (over 10 minutes)
• reconstituted solutions are stable for 24 hours at 25??C, but should be used as soon as possible, as Bleomycin contains no antibacterial agent

Malignant pleural effusion:

• 60,000IU administered as single bolus intrapleural injection
• 60,000IU should be dissolved in 50-100ml sodium chloride 0.9% and administered through a thoracotomy tube.

Schedule

S4

Common side effects

Mucocutaneous toxicity is seen in up to 50% of patients and consists of:

• skin rash
• hives
• changes in skin sensation
• hyperpigmentation (darkening of skin and nails)
• hair loss
• mouth ulcers
• hard patches on skin

Other effects that occur commonly with use of Bleomycin include:

• nausea
• vomiting
• loss of appetite
• weight loss
• fever
• chills
• headache
• tiredness

Uncommon side effects

Pulmonary toxicity may occur, and consists of the following:

• shortness of breath
• cough
• fever
• fine crackles heard in chest
• chest x-ray changes – Chest x-ray should be performed every 1-2 weeks during therapy and for 4 weeks after cessation of therapy.

Other adverse effects that occur uncommonly include:

• renal toxicity
• haematuria
• bladder irritation
• hepatic toxicity
• central nervous system toxicity
• disorientation
• aggressive behaviour
• decrease in number of blood cells, which may increase bleeding risk or risk of infection
• bleeding in the eye
• pain at tumour site
• inflammation of vein used for injection

For further information talk to your doctor.