1 mg/ml concentrate for infusion solution
topotecan
Read this leaflet carefully before you start using this medicine. It contains information that is important to you.
- Save this information. You may need to read it again.
- If you have further questions, ask your doctor, pharmacist or nurse.
- If you get side effects , talk to your doctor, pharmacist or nurse. This also applies to any side effects that are not mentioned in this information. See section 4.
In this leaflet you will find information on:
1. What Topotecan Accord is and what it is used for
2. What you need to know before you receive Topotecan Accord
3. How to use Topotecan Accord
4. Possible side effects
5. How to store Topotecan Accord
6. Contents of the packaging and other information
1. What Topotecan Accord is and what it is used for
Topotecan Accord helps destroy tumors . A doctor or nurse will give you the medicine as an infusion into a vein (drip) in the hospital.
Topotecan Accord is used to treat:
- ovarian cancer or small cell lung cancer that has come back after chemotherapy
- advanced cervical cancer where surgery or radiotherapy is not possible. For the treatment of cervical cancer, Topotecan Accord solution for infusion is given in combination with another medicine called cisplatin.
The doctor will decide together with you whether treatment with Topotecan Accord is better than further treatment with the chemotherapy you were initially treated with.
The topotecan contained in Topotecan Accord may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist or other healthcare professional if you have any further questions and always follow their instructions.
2. What you need to know before you receive Topotecan Accord
You should not receive Topotecan Accord:
- if you are allergic to topotecan or any of the other ingredients of this medicine (listed in section 6).
- if you are breastfeeding.
- if your blood levels are too low. Your doctor will then inform you if this is the case based on the test results of your last blood test.
Tell your doctor if any of these apply to you.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before receiving this medicine:
- if you have any kidney or liver problems. Your dose of Topotecan Accord may need to be adjusted.
- if you are pregnant or planning to become pregnant. See section “Pregnancy, breastfeeding and fertility” below.
- if you are a man and planning to have children. See section “Pregnancy, breastfeeding and fertility” below.
Other medicines and Topotecan Accord
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including over-the-counter and herbal medicines.
Remember to tell your doctor if you start taking any other medicine while you are using Topotecan Accord.
Topotecan Accord with food, drink and alcohol
There is no known interaction between Topotecan Accord and alcohol, but you should check with your doctor if it is advisable to drink alcohol.
Pregnancy, breastfeeding and fertility
Topotecan Accord is not recommended for pregnant women. It can harm a fetus if you or your partner have become pregnant before, during or at least six months after treatment. You must use an effective method of contraception. Ask your doctor for advice. Do not try to get pregnant until your doctor says it is safe to do so.
Male patients who wish to have a child should ask their doctor for family planning advice or treatment. If your partner becomes pregnant during treatment, you must tell your doctor immediately.
Do not breast-feed if you are treated with Topotecan Accord. Do not start breastfeeding again until your doctor tells you that it is safe to breastfeed.
Driving ability and use of machinery
Topotecan Accord can make you feel tired. If you feel tired or weak, do not drive or use machines.
You yourself are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects . Description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Topotecan Accord contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose , i.e. it is almost “sodium-free”.
However, if your doctor uses normal saline for dilution, the sodium dose will be higher.
3. How to use Topotecan Accord
The dose of Topotecan Accord you receive is decided by your doctor and is based on:
- the size of your body surface area (measured as square meters)
- the results of the blood samples taken before the treatment
- which disease is being treated.
Recommended dose
- Ovarian cancer and small cell lung cancer: 1.5 mg per square meter of body surface per day. You will be treated once a day for 5 days. Usually this treatment schedule is repeated every three weeks.
- Cervical cancer: 0.75 mg per square meter of body surface per day. You will be treated once a day for 3 days. Usually this treatment schedule is repeated every three weeks.
In the treatment of cervical cancer, Topotecan Accord is combined with another medicine called cisplatin. The doctor decides what dose of cisplatin you will receive.
How Topotecan Accord is prepared
Topotecan is supplied as a concentrate for infusion , solution. The concentrate must be diluted before administration .
How Topotecan Accord is given
A doctor or nurse will give you the appropriate dose of Topotecan Accord as an infusion into a vein (drip), usually in the arm over about 30 minutes.
The treatment schedule may vary depending on the results of your regular blood tests.
If you stop using Topotecan Accord
Your doctor will decide when to stop treatment.
4. Possible side effects
Like all medicines, this medicine can cause side effects , although not everybody gets them.
Serious side effects: tell your doctor
Very common (may affect more than 1 in 10 users)
- Signs of infection: Topotecan Accord can reduce the number of white blood cells and reduce your resistance to infection . This can lead to life-threatening conditions. Signs of this can be:
- fever
- severe deterioration of the general condition
- local symptoms such as a sore throat or difficulty urinating (for example, a burning sensation when you urinate, which may be due to a urinary tract infection)
- Sometimes severe abdominal pain, fever and possible diarrhea (in rare cases bloody) can be signs of inflammation of the intestines ( colitis ).
Rare (may affect up to 1 in 1,000 users
- Severe allergic or anaphylactic reaction that causes swelling of the lips, face or throat that makes it difficult to breathe, skin rash or hives, anaphylactic shock (severe drop in blood pressure, paleness, restlessness, weak pulse , reduced level of consciousness).
- Pneumonia (interstitial lung disease): You are most at risk if you have an existing lung disease, have received radiation therapy to your lungs, or if you have previously taken medications that caused lung damage. Signs of this can be:
- breathing difficulties
- cough
- fever
Contact your doctor immediately if you develop symptoms of any of these conditions as hospitalization may be necessary.
Other side effects:
Very common (may affect more than 1 in 10 people)
- Feeling of general weakness and tiredness (temporary anemia [lack of blood]). In some cases, you may need a blood transfusion .
- Abnormally low white blood cell count ( neutropenia ), which may be accompanied by fever and signs of infection (febrile neutropenia )
- Easier to bruise and bleed, due to a reduction in the number of cells that make the blood clot ( platelets ). This can lead to major bleeding from relatively small injuries, such as small cuts. In rare cases, this can lead to severe bleeding ( hemorrhage ). Talk to your doctor for advice on how to minimize the risk of bleeding.
- Weight loss and loss of appetite ( anorexia ), fatigue, weakness
- Nausea, vomiting, diarrhoea, stomach pain, constipation
- Inflammation and sores on the tongue or gums
- Fever
- Hair loss
Common (may affect up to 1 in 10 users)
- Allergic or hypersensitivity reactions (including skin rash)
- Yellowish skin
- Itchy skin
- Feeling of illness
- Lack of all three cell types ( red blood cells , white blood cells and platelets ) in the blood (pancytopenia).
Rare (may affect up to 1 in 1,000 users)
- Swelling due to fluid retention ( angioedema )
- Mild pain and inflammation at the injection site
- Itchy rash (or hives)
Very rare (may affect up to 1 in 10,000 users)
- leakage of blood into surrounding tissue (extravasation)
Has been reported (occurring in an unknown number of users)
The frequency of some side effects is not known (derived from spontaneous reports and the frequency cannot be calculated from the available data)
- Severe stomach pain, nausea, vomiting blood, black or bloody stools (possible symptoms of a hole in the gastrointestinal tract [gastrointestinal perforation]).
- Mouth ulcers, difficulty swallowing, abdominal pain, nausea, vomiting, diarrhea, bloody stools (possible signs and symptoms of inflammation of the lining of the mouth, stomach and/or intestine [mucositis]).
If you are being treated for cervical cancer , you may have side effects from the other medicine (cisplatin) that you receive together with Topotecan. These side effects are described in the package insert for cisplatin.
Reporting of side effects
If you get side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Swedish Medicines Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase information about drug safety.Postal address
5. How to store Topotecan Accord
Store out of sight and reach of children.
Use before the expiry date which is stated on the carton and vial after EXP or EXP. The expiration date is the last day of the specified month.
Store below 25 °C.
Store the vial in the outer carton. Light sensitive.
This medicine is for single use only. Once opened, it should be diluted immediately.
Chemical and physical in-use stability of the medicinal product has been demonstrated for 30 days at 25°C under normal light conditions and at 2-8°C when protected from light.
For microbiological reasons, 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°C to 8°C unless dilution has taken place under controlled and validated aseptic conditions.
Medicines must not be thrown into the drain or among household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
6. Contents of the packaging and other information
Contents declaration
– 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)
– Other ingredients are: tartaric acid (E334), water for injection and hydrochloric acid (E507) or sodium hydroxide (for pH adjustment.
Appearance and package sizes of the medicine
This medicine is a concentrate for infusion .
This concentrate is a clear solution that is yellow in color. It is supplied in an amber colored glass vial closed with a fluorotek rubber stopper and an aluminum flip-off cap.
Each 1 ml vial contains 1 mg topotecan (as hydrochloride)
Each 4 ml vial contains 4 mg topotecan (as hydrochloride)
This medicine is available in two pack sizes containing 1 or 5 vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Accord Healthcare BV
Winthontlaan 200
3526 KV Utrecht
Netherlands
Manufacturer
Accord Healthcare Limited
Sage House, 319 Pinner Road
North Harrow HA1 4 HF, Middlesex
UK
Accord Healthcare Polska Sp.z o.o
ul. Lutomirska 50
95-200 Pabianice
Poland
Accord Healthcare BV
Winthontlaan 200
3526 KV Utrecht
The Netherlands