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TOPOTECAN LOGENEX 1MG/ML POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Topotecan Logenex 1mg/ml
powder for concentrate for solution for infusion
topotecan
Pack Size 1 mg/vial
Pack Size 4 mg/vial
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 gets serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor.
IN THIS LEAFLET
1. What Topotecan Logenex is and what it is used for
2. Before you are given Topotecan Logenex
3. How Topotecan Logenex is used
4. Possible side effects
5. How to store Topotecan Logenex
6. Further information

1. WHAT TOPOTECAN LOGENEX 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 Logenex 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 Logenex is combined with another drug called cisplatin.
Your doctor will decide with you whether Topotecan Logenex therapy is better than further
treatment with your initial chemotherapy.

2. BEFORE YOU ARE GIVEN TOPOTECAN LOGENEX
You should not receive Topotecan Logenex:
• if you are allergic (hypersensitive) to topotecan or any of the other ingredients of Topotecan
Logenex.
• 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 Logenex

Your doctor needs to know before you are given this medicine:
• if you have any kidney or liver problems. Your dose of Topotecan Logenex may need to be
adjusted.
• if you are pregnant or plan to become pregnant
• if you plan to father a child
Topotecan Logenex 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.
Taking 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 are being
given Topotecan Logenex.
Using Topotecan Logenex with food and drink
There is no known interaction between Topotecan Logenex and alcohol. However, you should
check with your doctor whether drinking alcohol is advisable for you.
Pregnancy and breast feeding
Topotecan Logenex 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.
Do not breast-feed if you are being treated with Topotecan Logenex. Do not restart
breast-feeding until the doctor tells you it is safe to do so.
Driving and using machines
Topotecan Logenex can make people feel tired. If you feel tired or weak, do not drive and do
not use any tools or machines.

3. HOW TOPOTECAN LOGENEX IS USED
The dose of Topotecan Logenex 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 metre of body surface area per
day.
• For cervical cancer: 0.75 mg per square metre of body surface area per day.
When treating cervical cancer, Topotecan Logenex is combined with another medicine,
called cisplatin. Your doctor will advise you about the correct dose of cisplatin.
How Topotecan Logenex is given

A doctor or nurse will give you a suitable dose of Topotecan Logenex 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 Logenex can cause side effects, although not everybody gets
them.
These side effects may occur with certain frequencies, which are defined as follows:
-

very common: affects more than 1 user in 10
common: affects 1 to 10 users in 100
uncommon: affects 1 to 10 users in 1,000
rare: affects 1 to 10 users in 10,000
very rare: affects less than 1 user in 10,000
not known: frequency cannot be estimated from the available data

Serious side effects: tell your doctor
Very common side effects
• Signs of infections. Topotecan Logenex 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 diarrhea (rarely with blood) can be
signs of bowel inflammation (colitis).
Rare side effect
• 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 of these, as hospitalisation may be necessary.
Very common side effects
• 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
• A decrease in white blood cells in your blood (neutropenia), sometimes with a fever and
signs of infection (febrile neutropenia)
• 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)
• Infections
• Hair loss.
Common side effects
• Allergic or hypersensitivity reactions (including rash)
• Yellow skin
• Itching sensation
• Serious blood infection (sepsis)• A decrease in several types of blood cells in your blood
(red blood cells, white blood cells and platelets)
• Muscle pain
Rare side effects
• 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 Logenex. 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 LOGENEX
Keep out of the reach and sight of children.
Do not use Topotecan Logenex after the expiry date which is stated on the carton and the vial
after ‘EXP:’. The expiry date refers to the last day of that month.
This medicinal product does not require any special temperature storage conditions. Keep the
container in the outer carton in order to protect from light.
Medicines should not be disposed of via wastewater or household waste. Your doctor will
dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION
What Topotecan Logenex contains

The active substance is topotecan. Each vial contains 1 mg or 4 mg topotecan (as
hydrochloride) depending on the pack size. The powder must be reconstituted and diluted
before infusion. The powder in the vial provides 1 mg per ml of topotecan when reconstituted
as recommended.
The other ingredients are: tartaric acid (E334), mannitol (E421), hydrochloric acid (E507) and
sodium hydroxide (E524). The last two substances are used for pH adjustment.
What Topotecan Logenex looks like and contents of the pack
Topotecan Logenex is a light to yellow to greenish powder for concentrate for solution for
infusion. The reconstituted solution is a pale yellow to greenish clear solution.
Topotecan Logenex is supplied in colourless glass vials closed with a rubber stopper and
sealed with an aluminium seal and a polypropylene flip-off cap. It is available in packs
containing either 1 or 5 vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder is:
Logenex Pharm GmbH
Kleine Johannisstr. 10
20457 Hamburg
Germany
The Manufacturer is:
Venus Pharma GmbH
Am Bahnhof 1-3
59368 Werne
Germany
This leaflet was last approved in MM/YYYY
PL 36801/0001
----------------------------------------------------------------------------------------------------------------Prescriber Information leaflet
PREPARATION GUIDE FOR USE WITH TOPOTECAN LOGENEX 1 mg per ml
POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
(Please note this is a Prescriber Information Leaflet NOT the SPC. For full details
regarding this product please refer to the SPC.)
The following information is intended for medical or healthcare professionals only:
INSTRUCTIONS ON HOW TO RECONSTITUTE; STORE AND DISPOSE OF
TOPOTECAN LOGENEX 1 mg per ml POWDER FOR CONCENTRATE FOR
SOLUTION FOR INFUSION
Reconstitution

Topotecan Logenex 1 mg per ml powder for concentrate for solution for infusion in pack size
1 mg/vial should be reconstituted with 1.1 ml of water for injections to provide 1 mg per ml
of topotecan.
Topotecan Logenex 1mg/ml mg powder for concentrate for solution for infusion in pack size
4 mg/vial 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 5 % dextrose and 0.9 % w/v sodium chloride intravenous infusion or 5 %
w/v dextrose intravenous infusion, to a final concentration of between 25 and 50 microgram
per ml.
Do not use the reconstituted product if there are particles in the solution.
----------------------------------------------------------------------------------------------------------------Storage of the prepared solution
The product should be used immediately after it is prepared for infusion. If reconstitution and
dilution is performed under strict aseptic conditions Topotecan Logenex infusion may be
completed within 12 hours at room temperature (or 24 hours if stored at 2-8°C).
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.
• Liquid waste may be flushed with large amounts of water.
• Accidental contact with the skin or eyes should be treated immediately with copious
amounts of water.
Any unused product or waste material should be disposed of in accordance with local
requirements.

Expand Transcript

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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