Patient leaflet - Topotecan 1 mg/ml concentrate for solution for infusion
1. WHAT TOPOTECAN CONCENTRATE FOR SOLUTION FOR INFUSION IS AND WHAT IT IS USED FOR
Topotecan 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 in hospital.
Topotecan 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 concentrate for solution for infusion is combined with another medicine called cisplatin.
Your doctor will decide with you whether Topotecan 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 CONCENTRATE FOR SOLUTION FOR INFUSION
You should not receive Topotecan concentrate for solution for infusion:
- 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.
Warning and precautions
Talk to your doctor or pharmacist or nurse before you are given this medicine your doctor needs to know:
- 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. See section “Pregnancy, breast-feeding and fertility” below.
- if you plan to father a child. See section “Pregnancy, breast-feeding and fertility” below.
- Tell your doctor if any of these applies to you.
Other medicines and Topotecan concentrate for solution for infusion
Tell your doctor or pharmacist 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 Topotecan concentrate for solution for infusion.
Pregnancy breast-feeding and fertility
Topotecan concentrate for solution for infusion 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 Topotecan 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 concentrate for solution for infusion can make people feel tired.
If you feel tired or weak, do not drive or use machines.
Topotecan concentrate for solution for infusion 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 Topotecan concentrate for solution for infusion, the
dose of sodium received would be larger.
3. HOW TO USE TOPOTECAN CONCENTRATE FOR SOLUTION FOR INFUSION
The dose of Topotecan 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 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 meter 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 meter 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, Topotecan concentrate for solution for infusion is combined with another medicine, called cisplatin. Your doctor will determine the correct dose of cisplatin.
How Topotecan concentrate for solution for infusion is given
A doctor or nurse will administer Topotecan concentrate for solution for infusion as an infusion into your arm lasting about 30 minutes.
The treatment may vary, depending on the results of your regular blood tests.
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 Topotecan concentrate for solution for infusion:
- Signs of infections: Topotecan 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)
This rare side effects may affect up to 1 in 1,000 people treated with Topotecan concentrate for solution for infusion:
- 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.
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 Topotecan concentrate for solution for infusion:
- Feeling generally weak and tired (temporary 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 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 Topotecan concentrate for solution for infusion:
- Allergic or hypersensitivity reactions (including rash)
- Yellow skin
- Itching sensation
- Feeling unwell (malaise)
- Deficiency of all three cellular components (red cells, white cells, and platelets) of the blood (pancytopenia).
Rare side effects
These may affect up to 1 in 1,000 people treated with Topotecan concentrate for solution for infusion:
- 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).
Very rare: (may affect up to 1 in 10,000 people)
- Discharge of blood into tissues (extravasation).
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20.09.24[3]
The following information is intended for medical or healthcare professionals only
Instructions on how to prepare, store and dispose of Topotecan concentrate for solution for infusion
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.
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.
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 Topotecan concentrate for solution for infusion. Those effects are described in the cisplatin patient leaflet.
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 Website:
www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
5. HOW TO STORE TOPOTECAN 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.
- Do not store above 25°C.
- Keep the vial in the original container 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.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Topotecan 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 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 supplied in an amber glass vial closed with a rubber stopper and sealed with aluminium with a flip off royal blue seal.
This medicinal product is available in a pack size of 1x1ml vial and 1x4ml vial.
Manufacturer and product licence holder
Manufactured by Accord Healthcare Polska Sp.z o.o., ul. Lutomierska 50, 95-200 Pabianice, Poland.
Procured from within the EU by product licence holder Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, Middlesex HA1 1XD. Repackaged by Servipharm Ltd.
Leaflet revision and issue date (Ref.) 20.09.24[3]
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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.