Cipla Bleomycin 15 units Solution

CIPLA BLEOMYCIN is an antitumour antibiotic with cytotoxic activity, which means that it is a medicine that is used to treat cancer. It acts by inhibiting the growth tumours.

CIPLA BLEOMYCIN is used to treat several types of cancer, including:

• Squamous cell (a flat cell resembling a scale) skin cancers.
• Squamous cell cancers of the head and neck, including the oesophagus.
• Squamous cell cancer of the penis and uterine (womb) cervix.
• Choriocarcinoma (a cancer arising from the placenta).
• Embryonal carcinoma of the testes.
• Certain lymphomas (cancers of the lymph tissue).

CIPLA BLEOMYCIN should not be administered to you:

• If you are hypersensitive (allergic) to bleomycin or any of the other ingredients of CIPLA BLEOMYCIN (listed in section 6).
• If you are pregnant or breastfeeding (see pregnancy and breastfeeding).

Warnings and precautions

Tell your doctor or health care provider before being given the injection:

• If you are receiving or have received radiation therapy for your lungs or chest area.
• If you suffer from impaired kidney function, as you may require a reduced dose.
• If you are sexually active as you will require reliable contraception during therapy and up to 6 months after therapy.
• If you suffer from impaired lung function, especially after previous therapy with CIPLA BLEOMYCIN, or if you smoke and are often short of breath or cough frequently.
• There is a risk that you may develop diseases that cause scarring of the lungs while on treatment with CIPLA BLEOMYCIN. Therefore, you will likely have to undergo frequent chest x-rays and measurements of lung function. These tests will continue for up to 4 weeks after completion of therapy and you will be kept under review for approximately 2 months.
• If you develop lung disease as mentioned above, your treatment with CIPLA BLEOMYCIN will stop immediately and you will be treated with antibiotics and corticosteroids (anti-inflammatory medicines).
• If you are older than 70 years of age, as you are then more likely to develop lung complications from treatment with CIPLA BLEOMYCIN.
• If you are scheduled for any kind of surgery, you must tell your doctor or dentist that you are receiving, or have received, CIPLA BLEOMYCIN, since patients receiving oxygen as part of general anaesthesia have an increased risk of lung complications from CIPLA BLEOMYCIN therapy.
• If you are experiencing shortness of breath, as treatment with CIPLA BLEOMYCIN may cause damage to the lung walls.
• If you are receiving, or have received, radiation therapy for cancer, as this may increase your risk to develop complications, such as low white and red blood cell counts, mouth ulcers or lung complications. CIPLA BLEOMYCIN may also become less effective.
• If you have severe heart disease or liver disease as you may be at risk of greater toxicity while on treatment with CIPLA BLEOMYCIN.
• If you have AIDS, as treatment with CIPLA BLEOMYCIN may need to be stopped if you develop side effects affecting the skin.
• If you are currently undergoing treatment with cisplatin, as your dose of CIPLA BLEOMYCIN may need to be reduced.
• Treatment with CIPLA BLEOMYCIN may cause an allergic reaction, therefore your doctor should initially give you a test dose and only administer the full dose if there is no reaction.
• If you are currently taking other anti-cancer medicines as there is a risk of developing a heart attack.

You will not be expected to give yourself CIPLA BLEOMYCIN. It will be given to you by a person who is qualified to do so.

CIPLA BLEOMYCIN will be administered either into your veins, muscles or under the skin in a dosage calculated by your treating doctor. You will usually receive treatment with CIPLA BLEOMYCIN either once a week or twice a week.

There is a possibility of having an allergic reaction to CIPLA BLEOMYCIN. This would usually occur after either your first or second dose. You could experience symptoms such as rash, low blood pressure, mental confusion, fever, chills or wheezing. If you suffer from lymphoma, your doctor will give you a lower dose for your first two treatments with CIPLA BLEOMYCIN to ensure that you are not allergic to it.

Your doctor will decide how long treatment with CIPLA BLEOMYCIN will last.

If you have the impression that CIPLA BLEOMYCIN is too strong or too weak for you, please discuss this with your doctor.

If you receive more CIPLA BLEOMYCIN than you should

Symptoms of overdose with CIPLA BLEOMYCIN include low blood pressure, fever, fast heartbeat and generalised shock. Since a health care provider will administer CIPLA BLEOMYCIN, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

If you forget to take CIPLA BLEOMYCIN

Since a health care provider will administer CIPLA BLEOMYCIN, it is unlikely that the dose will be missed.

CIPLA BLEOMYCIN can have side effects. Not all side effects reported for CIPLA BLEOMYCIN are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking CIPLA BLEOMYCIN, please consult your health care provider for advice.

If any of the following happens, stop taking CIPLA BLEOMYCIN and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Severe shortness of breath, which may be an indication of lung problems, which are potentially the most serious side effects of CIPLA BLEOMYCIN therapy and may result in lung toxicity and death. These may include lung failure, scarring of the lungs blood clots in the lungs etc.
• Pneumonia – fever, chills, cough, shortness of breath.
• Allergic reactions, which may present with confusion, fever, chills, wheezing, shortness of breath, skin rash and swelling, difficulty in swallowing.
• Chest pain, radiating into the jaw or down the left arm, accompanied by shortness of breath, weakness and nausea, as this may indicate a heart attack.
• Weakness or paralysis affecting one side of the body, confusion or loss of consciousness, difficulty speaking, or any other symptoms related to a stroke.
• Blue discolouration of the fingers or toes, as this may indicate occlusion of blood vessels due to small blood clots.

These are all very serious side effects. If you have them, you may have had a serious reaction to CIPLA BLEOMYCIN. You may need urgent medical attention or hospitilisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice the following:

• Severe headache.
• Increased or decreased frequency of urination, discolouration of urine, inability to pass urine, swelling and confusion, as this may indicate damage to the kidneys.
• Heart attack and chest pain.

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• Swelling.
• Rash and reddening of the skin.
• Itching.
• Painful ulceration particularly at pressure points such as fingertips and elbows.
• Blistering.
• Darkening and tenderness of skin.
• Nail changes and hair loss.
• Ulcers in the mouth and corners of the mouth.

Less frequent side effects:

• Tumour pain.
• Decreased red and white blood cell count.
• Bleeding.
• Dizziness and confusion.
• Diarrhoea.
• Loss of appetite and weight loss, which may persist long after treatment with CIPLA BLEOMYCIN has been discontinued.
• Dizziness or fatigue due to low blood pressure.
• Raynaud’s phenomenon (discolouration of fingers or toes after exposure to heat or cold or in response to emotional stress).
• Pain following injection of CIPLA BLEOMYCIN into the cavity surrounding the lungs.
• Nausea and vomiting.
• Muscle and joint pain.
• Fever and chills. You may develop transient fever 3 to 5 hours after injection of CIPLA BLEOMYCIN into your veins.
• Inflammation and pain at the site of injection.

Side effects with unknown frequency:

• Sepsis (the extreme reaction of the body to infection).
• Impaired or insufficient blood supply to the body tissue.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of CIPLA BLEOMYCIN. You may also report any suspected side effects to Cipla Medpro (Pty) Ltd., by e-mail: [email protected] or telephone: 080 222 6662 (toll free).

The centre where you receive treatment will store and dispose of CIPLA BLEOMYCIN on your behalf. The lyophilised product should be stored between 2 and 8 °C. Store vials in carton until required for use. The reconstituted product is for single use only. Discard any unused portion. Store all medicines out of reach of children.