Patient leaflet - Hycamtin
1. What Hycamtin is and what it is used for
Hycamtin helps to destroy tumours. A doctor or a nurse will give you the medicine as an infusion into a vein in hospital.
Hycamtin 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, Hycamtin is combined with another medicine called cisplatin.
Your doctor will decide with you whether Hycamtin therapy is better than further treatment with your initial chemotherapy.
2. What you need to know before you are given Hycamtin
You should not receive Hycamtin
- if you are allergic to topotecan or any of the other ingredients of this medicine (listed in
section 6).
- if you are breast-feeding.
- if your blood cell counts are too low. Your doctor will tell you whether this is the case, based on
the results of your last blood test.
Tell your doctor if any of these applies to you.
Warnings and precautions
Before you are given this medicine your doctor needs to know:
- if you have any kidney or liver problems. Your dose of Hycamtin may need to be adjusted.
- if you are pregnant or plan to become pregnant. See section “Pregnancy and breast-feeding”
below.
- if you plan to father a child. See section “Pregnancy and breast-feeding” below.
Tell your doctor if any of these applies to you.
Other medicines and Hycamtin
Tell your doctor if you are taking, have recently taken, or might take 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 on Hycamtin.
Pregnancy and breast-feeding
Hycamtin is not recommended for pregnant women. It may harm a baby conceived before, during or soon after treatment. You should use an effective method of contraception. Ask your doctor for advice. Do not try to become pregnant until a doctor advises you it is safe to do so.
Male patients who wish to father a child should ask their doctor for family planning advice or treatment. If your partner becomes pregnant during your treatment, tell your doctor immediately.
Do not breast-feed if you are being treated with Hycamtin. Do not restart breast-feeding until the doctor tells you it is safe to do so.
Driving and using machines
Hycamtin can make people feel tired. If you feel tired or weak, do not drive or use machines.
Hycamtin contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium free”. If your doctor uses a solution of common salt to dilute Hycamtin, the dose of sodium received would be larger.
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3. How Hycamtin is used
The dose of Hycamtin 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
- Ovarian and small cell lung cancer: 1.5 mg per square metre of body surface area per day.
You will have treatment once a day for 5 days. This pattern of treatment will normally be repeated every 3 weeks.
- Cervical cancer: 0.75 mg per square metre of body surface area per day. You will have
treatment once a day for 3 days. This pattern of treatment will normally be repeated every 3 weeks.
When treating cervical cancer, Hycamtin is combined with another medicine, called cisplatin.
Your doctor will determine the correct dose of cisplatin.
The treatment may vary, depending on the results of your regular blood tests.
How Hycamtin is given
A doctor or nurse will administer Hycamtin as an infusion into your arm lasting about 30 minutes.
4. Possible side effects
Like all medicines, this medicine 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 Hycamtin:
- Signs of infections: Hycamtin 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 1,000 people treated with Hycamtin:
- Lung inflammation (interstitial lung disease): You are most at risk if you have existing lung
disease, have had radiation treatment to your lungs, or have previously taken medicines that caused lung damage. Signs include: – difficulty 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 Hycamtin:
- 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 minimise the risk of bleeding.
- Weight loss and loss of appetite (anorexia); tiredness; weakness.
- 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 Hycamtin:
- Allergic or hypersensitivity reactions (including rash).
- Yellow skin.
- Feeling unwell.
- Itching sensation.
Rare side effects
These may affect up to 1 in 1,000 people treated with Hycamtin:
- 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).
Side effects with frequency not known
The frequency of some side effects is not known (events from spontaneous reports and the frequency cannot be estimated from the available data):
- Severe stomach pain, nausea, vomiting of blood, black or bloody stools (possible symptoms of
gastrointestinal perforation).
- Mouth sores, difficulty swallowing, abdominal pain, nausea, vomiting, diarrhoea, bloody stools
(possible signs and symptoms of inflammation of the inner lining of the mouth, stomach and/or gut [mucosal inflammation]).
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 Hycamtin. Those effects are described in the cisplatin patient leaflet.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Hycamtin
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 carton.
Keep the vial 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. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user. If reconstitution and dilution are performed under strict aseptic conditions (e.g. an LAF bench) the product should be used (infusion completed) within 24 hours if stored at 2°C – 8°C after the first puncture of the vial.
Any unused product or waste material should be disposed of in accordance with local requirements for cytotoxic material.
6. Contents of the pack and other information
What Hycamtin contains
- The active substance is topotecan. Each vial contains 1 mg or 4 mg of topotecan (as
hydrochloride).
- The other ingredients are: tartaric acid (E334), mannitol (E421), hydrochloric acid (E507) and
sodium hydroxide.
What Hycamtin looks like and contents of the pack
Hycamtin comes as a powder for concentrate for solution for intravenous infusion.
It is available in packs containing either 1 or 5 glass vials; each vial contains 1 mg or 4 mg of 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
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland
Manufacturer
Novartis Farmacéutica S.A.
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain
Novartis Pharma GmbH
Roonstrasse 25
90429 Nuremberg
Germany
GlaxoSmithKline Manufacturing S.p.A.
Strada Provinciale Asolana 90
43056 San Polo di Torrile
Parma
Italy
For any information about this medicine, please
Authorisation Holder:
België/Belgique/Belgien
Novartis Pharma N.V.
Tél/Tel: +32 2 246 16 11
Et^rapuH
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Tea: +359 2 489 98 28
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Novartis s.r.o.
Tel: +420 225 775 111
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contact the local representative of the Marketing
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This leaflet was last revised in
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency web site:.
The following information is intended for healthcare professionals only:
Instructions on how to reconstitute, store and dispose of Hycamtin
Reconstitution
Hycamtin 1 mg powder for concentrate for solution for infusion should be reconstituted with 1.1 ml of water for injections to provide 1 mg per ml of topotecan.
Hycamtin 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
The product should be used immediately after it is prepared for infusion. If reconstitution is performed under strict aseptic conditions Hycamtin infusion may be completed within 12 hours at room temperature (or 24 hours if stored at 2–8oC).
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