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TOPOTECAN 1MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): TOPOTECAN HYDROCHLORIDE

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ways feeling unwell.
(also see section 4 ‘Possible side effects’)
Package leaflet: Information for the user

Tell your doctor if any of these applies to you.

Topotecan

Other medicines and Topotecan 1 mg/ml
concentrate for solution for infusion
Tell your doctor or pharmacist if you are taking
have recently taken or might take any other
medicines.

Topotecan 1 mg/ml
concentrate for solution
for infusion
Read all of this leaflet carefully before you start
taking this medicine because it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have further questions, ask your doctor,
pharmacist or nurse.
- If you get any side effects, talk to your
doctor,pharmacist or nurse. This includes any
possible side effects not listed in this leaflet see
section 4.
What is in this leaflet:
1. What Topotecan 1 mg/ml concentrate for
solution for infusion is and what it is used for
2. What you need to know before you are given
Topotecan 1 mg/ml concentrate for solution for
infusion
3. How to use Topotecan 1 mg/ml concentrate for
solution for infusion
4. Possible side effects
5. How to store Topotecan 1 mg/ml concentrate
for solution for infusion
6. Contents of the pack and other information

1. What Topotecan 1 mg/ml
concentrate for solution for
infusion is and what it is
used for
What Topotecan 1 mg/ml concentrate for
solution for infusion is:
Topotecan 1 mg/ml concentrate for solution for
infusion helps to destroy tumours. A doctor or a
nurse will give you the medicine as an infusion
into a vein (a drip) in hospital.
What Topotecan 1 mg/ml concentrate for
solution for infusion is used for:
Topotecan 1 mg/ml concentrate for solution for
infusion is used to treat:
- ovarian cancer or small cell lung cancer that
has come back after chemotherapy
- advanced cervical cancer if surgery or
radiotherapy treatment is not possible. When
treating cervical cancer, Topotecan 1 mg/ml
concentrate for solution for infusion is
combined with another drug called cisplatin.
Your doctor will decide with you whether
Topotecan 1 mg/ml concentrate for solution for
infusion therapy is better than further treatment
with your initial chemotherapy.

2. What you need to know before
you are given Topotecan
1 mg/ml concentrate for
solution for infusion
Do not take Topotecan 1 mg/ml concentrate
for solution for infusion :
- if you are allergic (hypersensitive) to topotecan
or any of the other ingredients of Topotecan
1 mg/ml concentrate for solution for infusion
(listed in section 6).
- if you are breast feeding
- if your blood cell counts are too low. Your doctor
will tell you, based on the results of your last
blood test.
Tell your doctor if any of these applies to you.
Warning and precautions
Talk to your doctor or pharmacist or nurse before
you are given this medicine:
- if you have any kidney or liver problems. Your
dose of Topotecan 1 mg/ml concentrate for
solution for infusion may need to be adjusted.
- if you are pregnant or plan to become pregnant
- if you plan to father a child
Topotecan 1 mg/ml concentrate for solution for
infusion may harm a baby conceived before,
during or soon after treatment. You should use an
effective method of contraception. Ask your
doctor for advice.
Topotecan 1 mg/ml concentrate for solution for
infusion may harm your lung. The risk of damage
to your lung increases if you had a lung disease,
lung cancer, received radiation treatment of the
lungs or drugs which can cause lung damage or
have a so-called smoker’s lung.
Your treating doctor will examine your lung
function in regular intervals and might decide to
stop treatment if you develop symptoms like
cough, fever and/or breathing problems.
Topotecan 1 mg/ml concentrate for solution for
infusion may cause a decrease in the number of
blood clotting cells (platelets). This can lead to
severe bleeding from relatively small injuries
such as a small cut. Rarely, it can lead to more
severe bleeding (hemorrhage).
If your general health status is not very good, it is
more likely that you experience side effects
during the treatment with Topotecan Infusion. The
treatment might also be less effective.
Tell your doctor if any of these applies to you.
The doctor will evaluate your general health
during the treatment and you should tell him/her
in case you have fever, infection or are in some

The following information is intended for
medical or healthcare professionals only
Instructions on how to prepare, store and
dispose of Topotecan Accord
Instructions for dilution
The concentrate is clear yellow colour solution
and contains 1 mg per ml of Topotecan. Further
dilution of the appropriate volume of the
concentrate with sodium chloride 9 mg/ml, (0.9
%) solution for injection or glucose 50 mg/ml
(5%) solution for injection to reach a final
Topotecan concentration of between 25 and 50
microgram/ml in the solution for infusion.

Topotecan 1 mg/ml concentrate for solution
for infusion with food, drink and alcohol
There is no known interaction between Topotecan
1 mg/ml concentrate for solution for infusion and
alcohol. However, you should check with your
doctor whether drinking alcohol is advisable for you.
Pregnancy breast-feeding and fertility
Topotecan 1 mg/ml concentrate for solution for
infusion is not recommended for pregnant
women. It may harm the baby if conceived
before, during or at least six months after
treatment. You should use an effective method of
contraception. Ask your doctor for advice. Do not
try and become pregnant/father a child until a
doctor advises you it is safe to do so.
Male patients who may wish to father a child,
should ask their doctor for family planning advice
or treatment. If pregnancy occurs during
treatment, tell your doctor immediately.
Do not breast-feed if you are being treated with
Topotecan 1 mg/ml concentrate for solution for
infusion . Do not restart breast-feeding until the
doctor tells you it is safe to do so.
Driving and using machines
Topotecan 1 mg/ml concentrate for solution for
infusion can make people feel tired.
If you feel tired or weak, do not drive and do not
use machines.

3. How to use Topotecan
1 mg/ml concentrate for
solution for infusion
The dose of Topotecan 1 mg/ml concentrate for
solution for infusion you are given will be worked
out by your doctor, based on:
- your body size (surface area measured in
square meters)
- the results of blood tests carried out before
treatment
- the disease being treated.
The recommended dose
• For ovarian and small cell lung cancer: 1.5 mg
per square meters of body surface area per day.
• For cervical cancer: 0.75 mg per square meters
of body surface area per day.
When treating cervical cancer, Topotecan 1 mg/ml
concentrate for solution for infusion is combined
with another medicine, called cisplatin. Your
doctor will advise you about the correct dose of
cisplatin.
How Topotecan 1 mg/ml concentrate for
solution for infusion is prepared
Topotecan is supplied as a concentrate for
solution for infusion. The concentrate must be
diluted before administration.
How Topotecan 1 mg/ml concentrate for
solution for infusion is given
A doctor or nurse will give you a suitable dose of
Topotecan 1 mg/ml concentrate for solution for
infusion as an infusion (a drip). It is usually
dripped into your arm over about 30 minutes.
• For ovarian and small cell lung cancer, you will
have treatment once a day for 5 days.
• For cervical cancer, you will have treatment
once a day for 3 days.
This pattern of treatments will normally be
repeated every three weeks, for all cancers.
The treatment may vary, depending on the
results of your regular blood tests.
If you stop taking Topotecan 1 mg/ml
concentrate for solution for infusion
Your doctor will decide when to stop the
treatment.

4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Contact your doctor immediately if you
experience any of the following symptoms
after taking this medicine as they can be
serious:
Very common: (may affect more than 1 in 10
people)
Signs of infections: Topotecan 1 mg/ml
concentrate for solution for infusion may reduce
the number of white blood cells and lower your
resistance to infection. This can even be life
threatening. Signs include:
- fever
- serious deterioration of your general condition
- local symptoms such as sore throat or urinary
problems (for example, a burning sensation
when urinating, which may be a urinary
infection)
- occasionally severe stomach pain, fever and
possibly diarrhoea (rarely with blood) can be
signs of bowel inflammation (colitis)
- Feeling generally weak and tired (temporary

Storage of the diluted solution
Chemical and physical in-use stability has been
demonstrated for 30 days at 25°C under normal
light conditions and at 2-8°C when protected from
light. From a microbiological point of view, the
product should be used immediately. If not used
immediately, in-use storage times and conditions
prior to use are the responsibility of the user and
would normally not be longer 24 hours at 2 to
8°C, unless dilution has taken place in controlled
and validated aseptic conditions.

anaemia). In some cases you may need a blood
transfusion.
- Abnormally low white blood cell count
(neutropenia) which may be accompanied with
fever and signs of infections (febrile
neutropenia).
- Unusual bruising or bleeding, caused by a
decrease in the number of clotting cells in the
blood. This can lead to severe bleeding from
relatively small injuries such as a small cut.
Rarely, it can lead to more severe bleeding
(haemorrhage). Talk to your doctor for advice on
how to minimize the risk of bleeding.
- Weight loss and loss of appetite (anorexia);
tiredness; weakness; feeling unwell.
- Feeling sick (nausea), being sick (vomiting);
diarrhoea; stomach pain; constipation
- Inflammation and ulcers of the mouth tongue or
gums
- High body temperature (fever)
- Hair loss.
Common: (may affect up to 1 in 10 people)
- Allergic or hypersensitivity reactions (including
rash)
- Yellow skin
- Itching sensation
- Muscle pain
- Severe infection (sepsis).
- Feeling unwell (malaise)

6. Contents of the pack and
other information
What Topotecan 1 mg/ml concentrate for
solution for infusion contains
- The active substance is topotecan
hydrochloride. Each 1 ml vial of concentrate
contains 1 mg topotecan (as hydrochloride)
Each 4 ml vial of concentrate contains 4 mg
topotecan (as hydrochloride)
- The other ingredients are: tartaric acid (E334),
water for injections and hydrochloric acid
(E507) or sodium hydroxide (for pH
adjustment).
What Topotecan 1 mg/ml concentrate for
solution for infusion looks like and contents
of the pack
This medicine is a concentrate for solution for
infusion.
The concentrate is a clear yellow colour solution.
It is filled in an amber colour glass vial sealed
with flurotec rubber stoppers and aluminium
flip-off seals.
Each vial of 1 ml contains 1 mg topotecan (as
hydrochloride).
Each vial of 4 ml contains 4 mg topotecan (as
hydrochloride).

Rare: (may affect up to 1 in 1,000 people)
- Lung inflammation (interstitial lung disease):
You are most at risk if you have existing lung
disease, had radiation treatment to your lungs,
or have previously taken medicines that caused
lung damage. Signs include:
- difficulty in breathing
- cough
- fever

This medicinal product is available in two pack
sizes, containing either 1 vial or 5 vials.

The risk of developing this severe condition
(interstitial lung disease) is higher if you currently
have lung problems, or if you have received
previous radiation treatment or medicines that
affected your lungs.

Manufacturer:
Accord Healthcare Limited,
Sage House, 319 Pinner Road, North Harrow
HA1 4HF, United Kingdom

- Severe allergic or anaphylactic reactions
causing swelling of the lips, face or neck
leading to severe difficulty in breathing, skin
rash or hives, anaphylactic shock (a severe
reduction in blood pressure, paleness, agitation,
weak pulse, decreased consciousness.
- Swelling caused by fluid build up (angioedema)
- Mild pain and inflammation at the site of injection
- Itchy rash (or hives).

Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Accord Healthcare Limited,
Sage House, 319 Pinner Road, North Harrow
HA1 4HF, United Kingdom

Or
Cemelog-BRS Ltd.,
H-2040 Budaors, Vasut u. 13, Hungary
This leaflet was last revised in 08/2015.

Tell your doctor immediately if you get any
symptoms of these conditions, as hospitalisation
may be necessary.
Very rare: (may affect up to 1 in 10,000 people)
- Discharge of blood into tissues (extravasation).
If you are being treated for cervical cancer,
you may get side effects from the other medicine
(cisplatin) that you will be given along with
Topotecan 1 mg/ml concentrate for solution for
infusion. Those effects are described in the
cisplatin patient information.
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 in 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 Topotecan
1 mg/ml concentrate for
solution for infusion
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 vial and carton after EXP.
The expiry date refers to the last day of that
month.
“Store below 25°C”
Keep the container in the outer carton in order to
protect from light.
This medicine is for single use only. After
opening, the product should be used immediately
for dilution.
Chemical and physical in-use stability after
dilution has been demonstrated for 30 days at
25°C under normal light conditions and at 2-8°C
when protected from light.
From a microbiological point of view, the product
after dilution should be used immediately. If not
used immediately, in-use storage times and
conditions prior to use are the responsibility of
the user and would normally not be longer 24
hours at 2 to 8°C, unless dilution has taken place
in controlled and validated aseptic conditions.
Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer used. These
measures will help to protect the environment.

Handling and disposal
The normal procedures for proper handling and
disposal of anti-tumour medicinal products should
be adopted:
- Staff should be trained to dilute the medicinal
product.
- Pregnant staff should be excluded from working
with this medicinal product.
- Staff handling this medicinal product during
dilution should wear protective clothing
including mask, goggles and gloves.
- All items for administration or cleaning,
including gloves, should be placed in high-risk,
waste disposal bags for high-temperature
incineration.

- Accidental contact with the skin or eyes should
be treated immediately with copious amounts of
water.

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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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