Bicnu 100 Mg-Powder And Solvent For Solution For Infusion
Package leaflet: Information for the user
BiCNU 100 mg-Powder and solvent for solution for infusion
carmustine
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, pharmacist or nurse.
- If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What BiCNU is and what it is used for
2. What you need to know before you use BiCNU
3. How to use BiCNU
4. Possible side effects
5. How to store BiCNU
6. Contents of the pack and other information
1. What BiCNU is and what it is used for
BiCNU is a medicine which contains carmustine. Carmustine belongs to a group of anticancer substances known as nitrosourea that act by slowing the growth of cancer cells.
BiCNU is used as palliative therapy (relieving and preventing the suffering of patients) as a single agent or in established combination therapy with other approved anticancer substances in certain types of cancers, like:
• Brain tumors- glioblastoma, medulloblastoma, astrocytoma and metastatic brain tumors
• Multiple myeloma (malignant tumor developing from bone marrow)
• Hodgkin’s disease (lymphoid tumor)
• Non-Hodgkin’s lymphomas (lymphoid tumor)
2. What you need to know before you use BiCNU Do not use BiCNU
- if you are allergic to carmustine, other nitrosourea medicines or any of the other ingredients of this medicine (listed in section 6).
BiCNU should not be used in patients who have reduced number of blood platelets (thrombocytes), the white blood cells (leucocytes) or the red blood cells (erythrocytes), either as a consequence of chemotherapy or even out of other causes.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using BiCNU.
Since the major toxicity is delayed bone marrow suppression, your doctor will monitor blood counts weekly for at least 6 weeks after a dose. At the recommended dosage, courses of BiCNU would not be given more frequently than every 6 weeks. The dosage will be confirmed with the blood count.
Before treatment, your liver and kidney function would be tested and observed regularly during the treatment.
Since the use of BiCNU can lead to lung damages, your X-ray of the chest region and the lung function tests would be conducted (Please also see the section “Possible side effects”).
Your doctor will counsel about the possibility of lung damaging effect of BiCNU and allergic reactions and their symptoms. If such symptoms occur, your doctor has to be consulted (see section 4).
Other medicines and BiCNU
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without prescription, such as:
• Phenytoin, used in epilepsy
• Cimetidine, used for stomach problems like indigestion
• Digoxin, used if you have abnormal heart rythm
• Melphalan, an anticancer drug
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy and fertility
BiCNU should not be used during pregnancy because it may harm an unborn baby. Therefore BiCNU should not normally be administered to pregnant women. If used during pregnancy, the patient must be aware of the potential risk to the foetus. Women of childbearing potential are advised to avoid becoming pregnant.
Male patients should use adequate contraceptives measures during treatment with BiCNU for at least 6 months.
Breast-feeding
You should not breast-feed while taking this medicine.
Driving and using machines
Effect on ability to drive and use machines is not known. You must check with your doctor before driving or operating any tools or machines because the amount of alcohol in this medicine may impair your ability to drive or use machines.
BiCNU contains ethanol (alcohol)
This medicinal product contains 0.57 vol% ethanol (alcohol), which means 7.68 g per dose. This corresponds to 11.32 ml of beer or 4.72 ml wine, per dose. This may be harmful for those suffering from alcoholism, liver disease or epilepsy (fits)
3. How to use BiCNU
BiCNU will always be given to you by a healthcare professional with experience in the use of anticancer agents.
Adults
Dosage is based on your medical condition, body size and response to treatment. It is usually given at least every 6 weeks.The recommended dose of BiCNU as a single agent in previously untreated patients is 150 to 200 mg/m2 intravenously every 6 weeks. This may be given as a single dose or divided into two daily injections such as 75 to 100 mg/m2 on two successive days. Dosage will also depend if BiCNU is given with other anti-cancer drugs.
Doses will be adjusted according to how you respond to the treatment.
Your blood count will be monitored frequently to avoid toxicity in your bone marrow and adjust the dose if necessary.
Route of administration
Intravenous administration should be conducted as an infusion.
BiCNU is given into a vein by a drip over a one to two hour period. The time of infusion should not be less than one hour to avoid burning and pain at the injected area. The injected area will be monitored during the administration.
The duration of the treatment is determined by the doctor and may vary for each patient.
Use in children
BiCNU can be used with extreme caution in children due to high risk of lung toxicity.
Use in elderly
BiCNU can be used with caution in elderly patients. The kidney function will be carefully monitored. If you use more BiCNU than you should
As a doctor or nurse will be giving you this medicine, it is unlikely that you will receive an incorrect dose. Tell your doctor or nurse if you have any concerns about the amount of medicine that you receive.
If you have any further questions on the use of this product, ask your doctor or pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor or nurse immediately if you notice any of the following:
Any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body), and feeling you are going to faint. These may be signs of severe allergic reaction.
Very common (may affect more than 1 in 10 people)
• Delayed myelosuppression (decrease in blood cells in bone marrow);
• Ataxia (lack of voluntary coordination of muscle movements);
• Dizziness;
• Headache;
• Transient redness in the eye, blurred vision, retinal bleeding;
• Hypotension (fall in blood pressure) in high-dose therapy;
• Phlebitis (inflamation of the veins);
• Respiratory disorders (lung related disorders) with breathing problems;
• Severe nausea and vomiting; beginning within 2-4 hours of administration and lasting for 4-6 hours;
• When used on the skin, inflammation of the skin (dermatitis)
• Accidental contact with skin may cause transient hyperpigmentation (darkening of an area of skin or nails)
Common (may affect up to 1 in 10 people)
• Acute leukemias and bone marrow dysplasias (abnormal development of the bone marrow) following long term use;
• Anaemia (decrease in the amount of red blood cells in the blood);
• Encephalopathy (disorder of brain) in high-dose therapy;
• Anorexia;
• Constipation;
• Diarrhoea;
• Inflammation of the mouth and lips;
• Reversible liver toxicity in high-dose therapy, delayed up to 60 days after administration. This can be manifested by increased liver enzymes and bilirubin;
• Alopecia (loss of hair);
• Flushing of the skin;
• Reactions on the injection site
Rare (may affect up to 1 in 1,000 people)
• Veno-occlusive disease (progressive blockage of the veins) in high-dose therapy;
• Breathing problems caused by interstitial fibrosis (with lower doses);
• Kidneys toxicity;
• Gynecomastia (breast growth in males)
Not known (frequency cannot be estimated from the available data)
• Muscular pain;
• Seizures (fits) including status epilepticus;
• Tissue damage due to leakage in injection area;
• Infertility;
• BiCNU has been shown to adversely affect the development of unborn babies Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and carton after statement “can be used up to’. The expiry date refers to the last day of that month.
This medicine will be stored by your doctor or health care professional.
The unopened vial of the dry drug must be stored in a refrigerator (2°-8°C). After reconstitution as recommended, BiCNU is stable for 24 hours under refrigeration (2°-8°C) in a glass container and must be protected from light.
The reconstituted solution further diluted with 500 ml sodium chloride for injection or 5% glucose for injection, in glass or polypropylene containers, results in a solution which should be utilized within 8 hours at room temperature and be protected from light. These solutions are also stable 24 hours under refrigeration (2-8°C) and an additional 6 hours at room temperature protected from light.
An indication of the decomposition is the appearance of an oil film at the bottom of the vial. This medicine should not be used any further. When you are not clear about the fact whether the product is adequately cooled, then you should immediately inspect each and every vial in the carton. For verification, hold the vial in bright light. Carmustine appears with small quantities of dried flakes or dried rigid mass.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist or doctor how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What BiCNU contains
The active substance is carmustine.
A 30 ml vial contains 100 mg carmustine and a 5 ml vial contains 3 ml sterile diluent (dehydrated alcohol).
What BiCNU looks like and contents of the pack
Powder and solvent for solution for infusion.
Yellowish powder for reconstitution.
Appearance of solution: colorless to light yellow
Powder: Type I amber glass vial (30 ml) sealed with a dark grey bromo butyl lyo rubber stopper and aluminium seal having polypropylene cap.
Diluent: Type I glass vial (5 ml) sealed with a grey bromo butyl rubber stopper with an aluminium seal having polypropylene cap.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder Creative Pharma Solutions, s.r.o.,
Italska 17 120 00 Prague 2 Czech Republic
Manufacturer
Tillomed Laboratories Limited 3 Howard Road, Eaton Socon St. Neots,
Cambridgeshire PE19 8ET,
United Kingdom
Emcure Pharma UK Limited
Devonshire house
582 Honeypot lane
Stanmore
HA71JS,
United Kingdom
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This leaflet was last revised in {MM/YYYY}
07/2015