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CARMUSTINE 100 MG-POWDER AND SOLVENT FOR SOLUTION FOR INFUSION

Active substance(s): CARMUSTINE

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Package leaflet: Information for the user

BiCNU ® 100 mg-Powder and
solvent for solution for infusion
carmustine

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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

Pregnancy and fertility
BiCNU should not be used during pregnancy because it
may harm your unborn baby. Therefore this medicine
should not normally be administered to pregnant women.
If used during pregnancy, the patient must be aware of the
potential risk to the unborn baby. Women of childbearing
potential are advised to avoid becoming pregnant whilst
being treated with this medicine.
Male patients should use adequate contraceptives
measures during treatment with BiCNU for at least 6
months to prevent their partners becoming pregnant.
Breast-feeding
You should not breast-feed while taking this medicine.

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)

Driving and using machines
The effect of this medicine on your 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.
This medication is for intravenous infusion.

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), white blood
cells (leucocytes) or red blood cells (erythrocytes), either
as a result of chemotherapy or from other causes.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using
BiCNU.
Since the major side effects of this medicine 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 will be
tested and observed regularly during the treatment.
Since the use of BiCNU can lead to lung damage, an X-ray
of the chest region and the lung function tests will be
conducted (Please also see the section “Possible side
effects”).
Your doctor will talk to you about the possibility of lung
damage and allergic reactions and their symptoms. If such
symptoms occur, you should contact your doctor
immediately (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 rhythm
• Melphalan, an anticancer drug

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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.

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 on whether 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 the dose adjusted if
necessary.
Route of administration
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.

Front

stated on the label and carton after statement “can be used
up to'. The expiry date refers to the last day of that month.

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.
BiCNU may cause the following side effects:
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 (inflammation 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 result in
increased liver enzymes and bilirubin (detected by
blood tests) ;
• 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);
• Kidney problems;
• 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

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.
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
Emcure Pharma UK Limited
3 Howard Road
Eaton Socon, St Neots
Cambridgeshire PE19 8ET
United Kingdom
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
This medicinal product is authorised in the Member
States of the EEA under the following names:
Spain:

BiCNU polvo y disolvente
para solucion para perfusion

This leaflet was last revised in 11/2015

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
d i r e c t l y v i a t h e Ye l l o w C a r d S c h e m e a t :
www.mhra.gov.uk/yellowcard. By reporting side effects
you can help provide more information on the safety of
this medicine.
5. How to store BiCNU
Keep this medicine out of the sight and reach of children.

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Do not use this medicine after the expiry date which is

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4. Possible side effects

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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