Topotecan 4 Mg Powder For Concentrate For Solution For Infusion
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 being given this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any 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 is and what it is used for
2. What you need to know before you are given Topotecan
3. How Topotecan is used
4. Possible side effects
5. How to store Topotecan
6. Contents of the pack and other information
1. What Topotecan is and what it is used for
This medicine contains topotecan, which 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 is used to treat:
• ovarian cancer or small cell lung cancer that has come back after chemotherapy
• cervical cancer where the disease is advanced (Stage IVB) or has returned after radiotherapy. When treating cervical cancer, topotecan is combined with another drug called cisplatin.
Your doctor will decide with you whether topotecan therapy is better than further treatment with your initial chemotherapy.
2. What you need to know before you are given Topotecan You must not be given Topotecan:
• 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, based on the results of your last blood test.
^ Tell your doctor if any of these applies to you.
Warnings and precautions
Your doctor needs to know before you are given this medicine:
• if you have any kidney or liver problems. Your dose of Topotecan may need to be adjusted.
• a history of lung problems such as lung inflammation (interstitial lung disease), scarring of the lungs (pulmonary fibrosis), lung cancer, had radiation treatment to your lungs or have previously taken medicines that caused lung damage or increase the production of white blood cells (see section 4)
• if you have bleeding problems or have an increased risk of bleeding
• if you are pregnant or plan to become pregnant
• if you plan to father a child
Topotecan 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
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Remember to tell your doctor if you start to take any other medicines whilst you are on Topotecan.
Topotecan with alcohol
There is no known interaction between topotecan and alcohol. However, you should check with your doctor whether drinking alcohol is advisable for you.
Pregnancy, breast-feeding and fertility
Topotecan 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. Do not restart breast-feeding until the doctor tells you it is safe to do so.
Driving and using machines
Topotecan can make people feel tired. If you feel tired or weak, do not drive and do not use machines.
Topotecan contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodium-free’.
3. How Topotecan is used
The dose of Topotecan 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 recommended dose
• For ovarian and small cell lung cancer: 1.5 mg per square metres of body surface area per day.
• For cervical cancer: 0.75 mg per square metres of body surface area per day.
When treating cervical cancer, topotecan is combined with another medicine, called cisplatin. Your doctor will advise you about the correct dose of cisplatin.
How Topotecan is given
A doctor or nurse will give you a suitable dose of Topotecan 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 are given too much Topotecan
If you think you have been given too much Topotecan contact your doctor or nurse. The symptoms of an overdose are similar to the side effects you may have with topotecan therapy (see section 4). You may get a sore throat, fever or infection, feel tired or experience bruising and bleeding (bone marrow suppression), inflammation and ulcers of the mouth, tongue or gums and increased liver enzymes (as seen on a blood test).
Stopping treatment with Topotecan
Your doctor will decide when to stop the treatment.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop your treatment and tell your doctor or nurse straight away or go to the nearest hospital emergency department if you notice any of the following serious side effects:
Very common (may affect more than 1 in 10 people)
• Signs of infections: topotecan 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, this may cause severe stomach pain, fever and possibly diarrhoea (rarely with blood) can be signs of bowel inflammation (colitis).
Common (may affect up to 1 in 10 people)
• A severe infection with whole-body inflammatory response which can even be life-threatening (sepsis often called “blood poisoning”). Signs include:
- fever, chills and shivering
- a fast heartbeat
- fast breathing
• Reduction in blood cells (pancytopenia). Signs include:
- feeling generally weak and tired, look pale or you notice yellowing of the skin or eyes. 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. It can lead to more severe bleeding (haemorrhage). Talk to your doctor for advice on how to minimise the risk of bleeding
- frequent infections (see signs of infections)
• Allergic or hypersensitivity reactions (including rash) (common). In rare cases (may affect up to 1 in 1,000 people) this may be severe allergic (anaphylactic) reactions or swelling caused by fluid build-up (angioedema). Symptoms include:
- red, itchy rash (hives)
- swelling of the face, lips, tongue or throat
- difficulty breathing or swallowing.
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.
Other side effects include:
Very common (may affect more than 1 in 10 people)
Weight loss and loss of appetite (anorexia)
• Feeling sick (nausea), being sick (vomiting), constipation
• Inflammation and ulcers of the mouth tongue or gums
• Hair loss.
Common (may affect up to 1 in 10 people)
• Feeling unwell.
Very rare (may affect up to 1 in 10,000 people)
• Mild pain and inflammation at the site of injection.
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. 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 at: 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
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 and vial after {EXP}. The expiry date refers to the last day of that month.
As packaged for sale: This medicine does not require any special temperature storage conditions. Keep the vial in the outer carton in order to protect from light.
After reconstitution and dilution: For single use only. This medicine should be used immediately after reconstitution and dilution as it contains no antibacterial preservative.
Chemical and physical in-use stability of the reconstituted solution and the further diluted solution has been demonstrated for 24 hours when stored between 2°C and 25°C.
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 than 24 hours at 2 to 8°C, unless reconstitution and dilution has taken place in controlled and validated aseptic conditions.
6. Contents of the pack and other information What Topotecan contains
- The active substance is topotecan. Each vial contains topotecan hydrochloride equivalent to 4 mg of topotecan.
- The other ingredients are tartaric acid (E334), mannitol (E421), hydrochloric acid (for pH adjustment) (E507) and sodium hydroxide (for pH adjustment) (see section 2, ‘Topotecan contains sodium’).
What Topotecan looks like and contents of the pack
Topotecan comes as a light yellow to greenish powder or plug for concentrate for solution for intravenous infusion.
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. The reconstituted solution is clear and yellow to yellow-green in colour.
This medicine comes in glass vials, together with bromobutyl rubber stoppers and aluminium seals with flip-off seals. It is available in packs containing either 1 or 5 vials; each vial contains 4 mg of topotecan.
Not all pack sizes may be marketed.
Marketing authorisation holder
Mylan
Potters Bar, Hertfordshire EN6 1TL United Kingdom
Manufacturer
Agila Specialties Polska Sp. z o.o. 10, Daniszewska Str 03-230 Warsaw Poland
This leaflet was last revised in 03/2016.
The following information is intended for healthcare professionals only Instructions on how to reconstitute, store and dispose of Topotecan Reconstitution
Topotecan 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. The reconstituted solution is clear and yellow to yellow-green in colour (pH between 2.5 and 3.5). Do not use this medicine if you notice any particulate matter and / or discolouration.
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
For single use only. The product should be used immediately after reconstitution and dilution as it contains no antibacterial preservative.
Chemical and physical in-use stability of the reconstituted solution and the further diluted solution has been demonstrated for 24 hours when stored between 2°C and 25°C.
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 than 24 hours at 2 to 8°C, unless reconstitution and dilution has taken place in controlled and validated aseptic conditions.
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.
• Remnants of the medicinal product as well as the materials that have been used for reconstitution, for dilution and administration must be destroyed according to hospital standard procedures applicable to cytotoxic agents with due regard to current laws related to the disposal of hazardous waste.
• Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
• Accidental contact with the skin or eyes should be treated immediately with copious amounts of water.