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TOPOTECAN 4 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): TOPOTECAN / TOPOTECAN HYDROCHLORIDE / TOPOTECAN HYDROCHLORIDE

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Topotecan 4 mg - Pack Insert - GBR+IRL - (Bordon) - TYPE-IB Variation
PACKAGE LEAFLET: INFORMATION FOR THE USER

Topotecan 4 mg powder for
concentrate for solution for infusion

Do not breast-feed if you are being treated with Topotecan. Do not restart breastfeeding until the doctor tells you it is safe to do so.
Driving and using machines
Topotecan can make people feel tired.
If you feel tired or weak, do not drive and do not use machines.

topotecan
Read all of this leaflet carefully before you start using this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor.
- If any of the side effects get serious, or if you notice any side effects not listed in
this leaflet, please tell your doctor.
In this leaflet:
1. What Topotecan is and what it is used for
2. Before you are given Topotecan
3. How to use Topotecan
4. Possible side effects
5. How to store Topotecan
6. Further information

3. How Topotecan is used
The dose of Topotecan you are given will be worked out by your doctor, based on:
• your body size (surface area measured in square metres)
• the results of blood tests carried out before treatment
• the disease being treated.
The usual dose
• For ovarian and small cell lung cancer: 1.5 mg per square metres of body surface
area per day.
• For cervical cancer: 0.75 mg per square metres of body surface area per day.
When treating cervical cancer, Topotecan is combined with another medicine,
called cisplatin. Your doctor will advise you about the correct dose of cisplatin.

1. What Topotecan is and what it is used for
Topotecan helps to destroy tumours. A doctor or a nurse will give you the medicine as
an infusion into a vein (a drip) in hospital.
Topotecan 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 is combined with another drug called
cisplatin.
Your doctor will decide with you whether Topotecan therapy is better than further
treatment with your initial chemotherapy.
2. Before you are given Topotecan
You should not receive Topotecan:
• if you are allergic (hypersensitive) to topotecan or any of the other ingredients of
Topotecan.
• 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.
Take special care with Topotecan
Your doctor needs to know before you are given this medicine:
• if you have any kidney or liver problems. Your dose of Topotecan may need to
be adjusted.
• if you are pregnant or plan to become pregnant
• if you plan to father a child
Topotecan may harm a baby conceived before, during or soon after treatment.
You should use an effective method of contraception.
Ask your doctor for advice.
→Tell your doctor if any of these applies to you.
Using other medicines
Please tell your doctor if you are taking or have recently taken any other medicines,
including any herbal products or medicines obtained without a prescription.
Remember to tell your doctor if you start to take any other medicines while you're on
Topotecan.
Using Topotecan with food and drink
There is no known interaction between Topotecan and alcohol. However, you should
check with your doctor whether drinking alcohol is advisable for you.
Pregnancy and breast feeding
Topotecan is not recommended for pregnant women. It may harm the baby if
conceived before, during or soon 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.

How Topotecan is given
A doctor or nurse will give you a suitable dose of Topotecan 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.
Stopping treatment
Your doctor will decide when to stop the treatment.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Topotecan can cause side effects, although not everybody gets
them.
Serious side effects: tell your doctor
These very common side effects may affect more than 1 in 10 people treated with
Topotecan .
• Signs of infections. Topotecan 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)
This rare side effect may affect up to 1 in 1000 treated with Topotecan.
• 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
→ Tell your doctor immediately if you get any symptoms of these conditions, as
hospitalisation may be necessary.
Very common side effects
These may affect more than 1 in 10 people treated with Topotecan:
• Feeling generally weak and tired (temporary anaemia). In some cases you may
need a blood transfusion.
• 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.

Black

Times New Roman 9 pt.

Reason for the Artwork* : Text revised

Dimension

Artwork No.

Supersedes No. : 7220131386

Prepared
By
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Checked
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PDD

: 7220131436

: 290 x 280 mm

Approved By
PDD

Marketing

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Form No.: SOP/PDD/003-03 Rev. 03

RA

FD

CRMS

IPR

Production

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NA

Approved
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QA

* Attached separate sheet if required

15-12-2012 Ver 08

The following information is
intended for medical or healthcare
professionals only:
Instructions on how to reconstitute,
store and dispose of Topotecan
Reconstitution
Topotecan 4 mg powder for concentrate
for solution for infusion should be
reconstituted with 4 ml of water for
injections to provide 1 mg per ml of
Topotecan. Further dilution is
required. The appropriate volume of
the reconstituted solution should be
diluted with either 0.9 % w/v sodium
chloride intravenous infusion or 5 %
w/v glucose intravenous infusion, to a
final concentration of between 25 and
50 microgram per ml.
Storage of the prepared solution
Reconstituted solutions
The product should be used
immediately after reconstitution as it
contains no antibacterial preservative.
Diluted solutions
The physiochemical stability of the drug
product after dilution in the
recommended solutions for infusion
(see section 6.6) has been demonstrated
for 48 hours at 2 °C to 8 °C and 25 °C.
From a microbiological point of view,
the product should be used immediately.
If not used Immediately, in-use storage
time and conditions prior to use are the
responsibility of the user and would
normally not be longer than 24 hours
at 2 °C to 8 °C, unless reconstitution/
dilution has taken place in controlled
and validated aseptic condition.
Handling and disposal
The normal procedures for proper
handling and disposal of anti-tumour
medicinal products should be adopted:
- Staff should be trained to reconstitute
the medicinal product.
- Pregnant staff should be excluded
from working with this medicinal
product.
- Staff handling this medicinal product
during reconstitution 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.

Dimension: 290 x 280 mm

Topotecan 4 mg - Pack Insert - GBR+IRL - (Bordon) - TYPE-IB Variation
• 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 side effects
These may affect up to 1 in 10 people treated with Topotecan
• Allergic or hypersensitivity reactions (including rash)
• Yellow skin
• Itching sensation
• Muscle pain
Rare side effects
These may affect up to 1 in 1000 people treated with Topotecan .
• Severe allergic or anaphylactic reactions
• Swelling caused by fluid build up (angioedema)
• Mild pain and inflammation at the site of injection
• Itchy rash (or hives).
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. Those effects are
described in the cisplatin patient information.
If you get side effects
→ Tell your doctor or pharmacist if any of the side effects become severe or
troublesome, or if you notice any side effects not listed in this leaflet.
5. How to store Topotecan
Keep out of the reach and sight of children.
Do not use Topotecan after the expiry date which is stated on the carton and vial. The
expiry date refers to the last day of that month.
Keep the container in the outer carton in order to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will
help to protect the environment.
Do not use Topotecan if certain visible signs of deterioration occur upon
reconstitution/ dilution.
6. Further information
What Topotecan contains
The active substance is topotecan. Each vial contains topotecan hydrochloride
equivalent to 4 mg of topotecan.
The other ingredients are: mannitol (E421), tartaric acid (E334), hydrochloric acid
(E507) (for pH adjustment), sodium hydroxide (E524) (for pH adjustment).
What Topotecan looks like and contents of the pack
Topotecan comes as a light yellow to greenish lyophilized powder in a type I clear,
colourless, tubular glass vials closed with a flurotec lyotec rubber stoppers and sealed
with aluminium flip-off overseal.
Topotecan is available in packs containing 1 vial or 5 vials. Each vial may be shrink
wrapped and may/ may not be packed in a plastic container.
Not all pack sizes may be marketed.
Each vial contains Topotecan hydrochloride equivalent to 4 mg Topotecan.
The powder needs to be reconstituted and diluted before infusion.
The powder in the vial provides 1 mg per ml of active substance when reconstituted
as recommended.

This medicinal product is authorised in the Member States of the EEA under
the following names:
Austria

Topotecan Kabi 4 mg Pulver zur Herstellung einer
Infusionslösungskonzentrats
Belgium
Topotecan Fresenius Kabi 4 mg poeder voor concentraat voor
oplossing voor infusie
Bulgaria
Topotecan Kabi 4 mg Πpax зa концентpaт зa инфyзионен
paзвop
Cyprus
Topotecan Kabi 4 mg κόνις για πυκνό διάλυμα για παρασκευή
διαλύματος προς έγχυση
Czech Republic Topotecan Kabi 4 mg, prášek pro koncentrát pro přípravu
infuzního roztoku
Germany
Topotecan Kabi 4 mg Pulver zur Herstellung einer
Infusionslösungskonzentrats
Denmark
Topotecan Fresenius Kabi
Estonia
Topotecan Kabi 4 mg
Greece
Topotecan Kabi 4 mg κόνις για πυκνό διάλυμα για παρασκευή
διαλύματος προς έγχυση
Spain
Topotecan Kabi 4 mg polvo para concentrado para solución
para perfusión
Finland
Topotecan Fresenius Kabi 4 mg kuiva-aine välikonsentraatiksi
infuusionestettä varten, liuos
France
Topotecan Kabi 4 mg poudre pour solution á diluer pour
perfusion
Hungary
Topotecan Kabi 4 mg por oldatos infúzióhoz való
koncentrátumhoz
Ireland
Topotecan 4 mg powder for concentrate for solution for
infusion
Italy
Topotecan Kabi 4 mg polvere per concentrato per soluzione per
infusione
Latvia
Topotecan Kabi 4 mg pulveris infuziju šķīduma koncentrāta
pagatavošanai
Luthuania
Topotecan Kabi 4 mg milteliai koncentratui infuziniam tirpalui
Luxemburg
Topotecan Kabi 4 mg Pulver zur Herstellung einer
Infusionslösungskonzentrats
The Netherlands Topotecan Fresenius Kabi, 4 mg poeder voor concentraat voor
oplossing voor infusie
Norway
Topotecan Fresenius Kabi 4 mg pulver til konsentrat til
infusjonsvæske, opplØsning
Poland
Topotecan Kabi
Portugal
Topotecano Kabi
Romania
Topotecan Kabi 4 mg pulbere pentru concentrat pentru soluţie
perfuzabilă
Sweden
Topotecan Fresenius Kabi 4 mg pulver till koncentrat till
infusionsvätska, lösning
Slovenia
Topotekan Kabi 4 mg prašek za koncentrat za raztopino za
infundiranje
Slovak Republic Topotecan Kabi 4 mg, prášok na infúzny koncentrát
United Kingdom Topotecan 4 mg powder for concentrate for solution for
infusion
This leaflet was last revised on 10/2012

XXXXXXXXX

XXXXXX

V003/BO

Marketing Authorisation Holder and Manufacturer
Fresenius Kabi Oncology Plc.
Lion Court, Farnham Road, Bordon
Hampshire, GU35 0NF, United Kingdom

Black

Times New Roman 9 pt.

Reason for the Artwork* : Text revised

Dimension

Artwork No.

Supersedes No. : 7220131386

Prepared
By
PDD

Checked
By
PDD

: 7220131436

: 290 x 280 mm

Approved By
PDD

Marketing

NA

Form No.: SOP/PDD/003-03 Rev. 03

RA

FD

CRMS

IPR

Production

NA

NA

NA

Approved
online

CONFIDENTIAL

QA

* Attached separate sheet if required

15-12-2012 Ver 08

Dimension: 290 x 280 mm

Expand view ⇕

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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