Topotecan 1mg/Ml Concentrate For Solution For Infusion
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ways feeling unwell.
(also see section 4 'Possible side effects')
Package leaflet: Information for the user
Topotecan 1 mg/ml concentrate for solution for infusion
Topotecan
Read all of this leaflet carefully before you start
taking this medicine because it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have further questions, ask your doctor, pharmacist or nurse.
- If you get any side effects, talk to your doctor,pharmacist or nurse. This includes any possible side effects not listed in this leaflet see section 4.
What is in this leaflet:
1. What Topotecan 1 mg/ml concentrate for solution for infusion is and what it is used for
2. What you need to know before you are given Topotecan 1 mg/ml concentrate for solution for infusion
3. How to use Topotecan 1 mg/ml concentrate for solution for infusion
4. Possible side effects
5. How to store Topotecan 1 mg/ml concentrate for solution for infusion
6. Contents of the pack and other information
1. What Topotecan 1 mg/ml concentrate for solution for infusion is and what it is used for
What Topotecan 1 mg/ml concentrate for solution for infusion is:
Topotecan 1 mg/ml 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 (a drip) in hospital.
What Topotecan 1 mg/ml concentrate for solution for infusion is used for:
Topotecan 1 mg/ml 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 1 mg/ml concentrate for solution for infusion is combined with another drug called cisplatin.
Your doctor will decide with you whether Topotecan 1 mg/ml 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 1 mg/ml concentrate for solution for infusion
Do not take Topotecan 1 mg/ml concentrate for solution for infusion :
- if you are allergic (hypersensitive) to topotecan or any of the other ingredients of Topotecan
1 mg/ml concentrate for solution for infusion (listed in section 6).
- 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 you are given this medicine:
- 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
- if you plan to father a child
Topotecan 1 mg/ml concentrate 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.
Topotecan 1 mg/ml concentrate for solution for infusion may harm your lung. The risk of damage to your lung increases if you had a lung disease, lung cancer, received radiation treatment of the lungs or drugs which can cause lung damage or have a so-called smoker's lung.
Your treating doctor will examine your lung function in regular intervals and might decide to stop treatment if you develop symptoms like cough, fever and/or breathing problems.
Topotecan 1 mg/ml concentrate for solution for infusion may cause a decrease in the number of blood clotting cells (platelets). This can lead to severe bleeding from relatively small injuries such as a small cut. Rarely, it can lead to more severe bleeding (hemorrhage).
If your general health status is not very good, it is more likely that you experience side effects during the treatment with Topotecan Infusion. The treatment might also be less effective.
Tell your doctor if any of these applies to you. The doctor will evaluate your general health during the treatment and you should tell him/her in case you have fever, infection or are in some
Tell your doctor if any of these applies to you.
Other medicines and Topotecan 1 mg/ml concentrate for solution for infusion
Tell your doctor or pharmacist if you are taking have recently taken or might take any other medicines.
Topotecan 1 mg/ml concentrate for solution for infusion with food, drink and alcohol
There is no known interaction between Topotecan 1 mg/ml concentrate 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 1 mg/ml concentrate for solution for infusion is not recommended for pregnant women. It may harm the baby if conceived before, during or at least six months 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 1 mg/ml 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 1 mg/ml concentrate 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 use Topotecan 1 mg/ml concentrate for solution for infusion
The dose of Topotecan 1 mg/ml 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 meters)
- the results of blood tests carried out before treatment
- the disease being treated.
The recommended 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 1 mg/ml concentrate for solution for infusion is combined with another medicine, called cisplatin. Your doctor will advise you about the correct dose of cisplatin.
How Topotecan 1 mg/ml concentrate for solution for infusion is prepared
Topotecan is supplied as a concentrate for solution for infusion. The concentrate must be diluted before administration.
How Topotecan 1 mg/ml concentrate for solution for infusion is given
A doctor or nurse will give you a suitable dose of Topotecan 1 mg/ml concentrate 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.
If you stop taking Topotecan 1 mg/ml concentrate for solution for infusion
Your doctor will decide when to stop the treatment.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately if you experience any of the following symptoms after taking this medicine as they can be serious:
Very common: (may affect more than 1 in 10 people)
Signs of infections: Topotecan 1 mg/ml 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)
- Feeling generally weak and tired (temporary
The following information is intended for medical or healthcare professionals only
Instructions on how to prepare, store and dispose of Topotecan Accord
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.
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 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: (may affect up to 1 in 10 people)
- Allergic or hypersensitivity reactions (including rash)
- Yellow skin
- Itching sensation
- Muscle pain
- Severe infection (sepsis).
- Feeling unwell (malaise)
Rare: (may affect up to 1 in 1,000 people)
- 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
The risk of developing this severe condition (interstitial lung disease) is higher if you currently have lung problems, or if you have received previous radiation treatment or medicines that affected your lungs.
- 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.
- Swelling caused by fluid build up (angioedema)
- Mild pain and inflammation at the site of injection
- Itchy rash (or hives).
Tell your doctor immediately if you get any
symptoms of these conditions, as hospitalisation may be necessary.
Very rare: (may affect up to 1 in 10,000 people)
- Discharge of blood into tissues (extravasation).
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 1 mg/ml concentrate 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.
6. Contents of the pack and other information
What Topotecan 1 mg/ml 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 1 mg/ml 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. It is filled in an amber colour glass vial sealed with flurotec rubber stoppers and aluminium flip-off seals.
Each vial of 1 ml contains 1 mg topotecan (as hydrochloride).
Each vial of 4 ml contains 4 mg topotecan (as hydrochloride).
This medicinal product is available in two pack sizes, containing either 1 vial or 5 vials.
Not all pack sizes may be marketed.
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
This leaflet was last revised in 04/2016.
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5. How to store Topotecan 1 mg/ml 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.
“Store below 25°C”
Keep the container 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 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.
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.