Topotecan 4 Mg Powder For Concentrate For Solution For Infusion
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Topotecan 4 mg Powder for Concentrate for Solution for Infusion
Topotecan
Read all of this leaflet carefully before you start taking this
medicine
- Keep this leaflet. You may need to read it again.
- If you have further questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their sign of illness are the same as yours
- If you get any side effects talk to your doctor your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet see section 4.
In this leaflet:
1. What Topotecan powder for solution for Infusion is and what it is used for
2. Before you use Topotecan powder for for solution for Infusion
3. How to take Topotecan powder for solution for Infusion
4. Possible side effects
5. How to store Topotecan powder for solution for Infusion
6. Contents of the pack and other information
1. What Topotecan powder for solution for Infusion is and what it is used for
The name of your medicine is ‘Topotecan 4 mg Powder for concentrate for solution for Infusion' but in the rest of the leaflet it will be called “Topotecan powder for solution for Infusion”.
What Topotecan powder for solution for Infusion is:
Topotecan powder 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 powder for solution for Infusion is used for:
Topotecan powder 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 powder for solution for Infusion is combined with another drug called cisplatin. Your doctor will decide with you whether Topotecan powder for solution for Infusion therapy is better than further treatment with your initial chemotherapy.
2. What you need to know Bbefore you use Topotecan for Infusion Topotecan powder for solution for Infusion
Do not take Topotecan powder for solution for Infusion:
- if you are allergic (hypersensitive) to topotecan or any of the other ingredients of Topotecan powder for solution for Infusion.
- 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 taking this medicine
- if you have any kidney or liver problems. Your dose of Topotecan powder 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 powder 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.
Tell your doctor if any of these applies to you.
Other medicines and Topotecan powder for solution for Infusion
Tell your doctor or pharmacist if you are taking ,have recently taken or might take any other medicines
Using Topotecan powder for solution for Infusion with food and drink
There is no known interaction between Topotecan powder 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 powder for solution for Infusion 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 powder 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 powder 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 take Topotecan powder for solution for Infusion
The dose of Topotecan powder 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 usual 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 powder for solution for Infusion is combined with another medicine, called cisplatin. Your doctor will advise you about the correct dose of cisplatin.
How Topotecan powder for solution for Infusion is given
A doctor or nurse will give you a suitable dose of Topotecan powder 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.
The following information is intended for medical or healthcare professionals only
Instructions on how to reconstitute store and dispose of Topotecan powder for solution for Infusion
Reconstitution
Topotecan powder 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
The product should be used immediately after it is prepared for infusion. If reconstitution is performed under strict aseptic conditions (e.g. an LAF bench) the product should be used (infusion completed) within 12 hours at room temperature or
24 hours if stored at 2-8°C after the first puncture of the vial. 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.
Stopping treatment
Your doctor will decide when to stop the treatment.
4. Possible side effects
Like all medicines, Topotecan powder for solution for Infusionthis medicine can cause side effects, although not everybody gets them.
Serious effects: tell your doctor
Very common side effects: (more than 1 in 10 patientsTopotecan powder for solution for Infusion).
• Signs of infections. Topotecan powder 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)
Rare side effect(more than 1 in 10,000 but less than 1 in 1000 patients):
• Lung inflammation (interstitial lung disease that some cases can even be life threatening): 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: (more than 1 in 10 patients):
• 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.
• 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: (less than 1 in 10 patients):
• Allergic or hypersensitivity reactions (including rash)
• Yellow skin
• Itching sensation
• Muscle pain
Rare side effects: (more than I in 10,000 but less than 1 in 1,000 patients)
• 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 powder 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 powder for solution for Infusion
Keep out of the reach and sight of children.
Do not use Topotecan powder for solution for Infusionthis medicine after the expiry date, which is stated on the carton. 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 throw away medicines you no longer used. These measures will help to protect the environment
6. Contents of the pack and other information
What Topotecan powder for solution for Infusion contains
- The active substance is topotecan hydrochloride. Each vial contains 4 mg topotecan.
- The other ingredients are: tartaric acid, mannitol (E421), hydrochloric acid (for pH adjustment) and sodium hydroxide (for pH adjustment).
What Topotecan powder for solution for Infusion looks like and contents of the pack
Topotecan powder for solution for Infusion comes as a yellow lyophilized powder in a clear glass vial for concentrate for solution for intravenous infusion.
It is available in pack containing 1 vial.
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.
Marketing Authorisation Holder:
Accord Healthcare Limited,
Sage House, 319 Pinner Road, North Harrow HA1 4HF, United Kingdom
Manufacturer:
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 The leaflet was last revised in 01/2015
- 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.
