1 mg/ml concentrate for infusion solution
topotecan
What Topotecan Ebewe is and what it is used for
Topotecan Ebewe helps destroy tumors. A doctor or nurse will give you the medicine as an infusion into a vein in the hospital.
Topotecan Ebewe is used to treat
- ovarian cancer or small cell lung cancer that has come back after chemotherapy.
- advanced cervical cancer where treatment with surgery or radiotherapy is not possible. In the treatment of cervical cancer, Topotecan Ebewe is given in combination with another medicine called cisplatin.
Your doctor will decide together with you whether Topotecan Ebewe treatment is better than continuing treatment with the chemotherapy you were treated with initially.
The topotecan contained in Topotecan Ebewe may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you receive Topotecan Ebewe
You should not receive Topotecan Ebewe
- 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 tell you if this is the case, based on the results of your last blood test.
Tell your doctor if any of these apply to you.
Warnings and precautions
Before starting treatment, your doctor must know:
- if you have problems with your kidneys or liver. The dose of Topotecan Ebewe may need to be adjusted.
- if you are pregnant or planning to become pregnant. See the section “Pregnancy and breastfeeding” below.
- if you are a man and planning to have children. See the section “Pregnancy and breastfeeding” below.
Tell your doctor if any of these apply to you.
Other medicines and Topotecan Ebewe
Tell your doctor if you are taking, have recently taken, or may be taking 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 Ebewe.
Pregnancy and breastfeeding
Topotecan Ebewe is not recommended for pregnant women. It can harm the fetus if conception occurs before, during, or shortly after treatment. You must use an effective contraceptive method. Consult your doctor. Do not try to get pregnant until your doctor says it is safe to do so.
Male patients who wish to have children should ask their doctor for family planning advice or treatment. If your partner becomes pregnant during treatment, tell the doctor immediately.
Do not breastfeed if you are treated with Topotecan Ebewe. Do not start breastfeeding again until your doctor tells you it is safe to do so.
Driving ability and use of machinery
Topotecan Ebewe makes you feel tired. If you feel tired or weak, do not drive or use machines.
You 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. A 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.
How Topotecan Ebewe is used
The dose of Topotecan Ebewedo you receive is determined by your doctor and is based on:
- your body surface area (measured as square meters)
- results from blood tests taken before treatment
- what disease you are being treated for
Usual 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 Ebewe is combined with another medicine called cisplatin. Your doctor will decide which dose of cisplatin you will receive.
The treatment schedule may vary depending on the results of your regular blood tests.
How Topotecan Ebewe is given
A doctor or nurse will give you Topotecan Ebewe as an infusion into your arm for about 30 minutes.
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:
- Signs of infections: topotecan can reduce the number of white blood cells and reduce your resistance to infection. This can lead to life-threatening conditions. Symptoms include:
- fever
- severe deterioration of your 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 intestinal inflammation ( colitis )
This rare side effect may affect up to 1 in 1,000 users treated with topotecan:
- Pneumonia ( interstitial lung disease ): You are most at risk if you have an existing lung disease, have had radiation treatment of your lungs, or have previously taken medications that caused damage to the lungs. 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.
Very common side effects are
These may affect more than 1 in 10 users treated with topotecan:
- Feeling of general weakness and tiredness (temporary anemia [lack of blood]). In some cases, you may need a blood transfusion.
- Unusual bruising or bleeding is caused by a reduced number of clotting cells in the blood. This can lead to more bleeding from relatively small wounds such as small cuts. In rare cases, this can lead to serious bleeding ( hemorrhage ). Talk to your doctor for advice on how to minimize the risk of bleeding.
- Weight loss and loss of appetite, fatigue, and weakness.
- Nausea (nausea), vomiting, diarrhea, abdominal pain, constipation.
- Inflammation and sores in the mouth, tongue, or gums.
- Fever.
- Hair loss.
Common side effects are
These may occur in up to 1 in 10 users treated with topotecan:
- Allergic or hypersensitivity reactions ( including skin rash).
- Yellow skin.
- A general feeling of discomfort.
- Itchy skin.
Rare side effects ar
These may occur in up to 1 in 1,000 users treated with topotecan:
- A severe allergic or anaphylactic reaction.
- Swelling is caused by fluid retention ( angioedema ).
- Mild pain and inflammation at the injection site.
- Itchy rash (or hives ).
Has been reported
The frequency of some side effects is not known (derived from spontaneous reports and occurring in an unknown number of users).
- 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, and 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 Ebewe. These side effects are described in the package insert for cisplatin.
How to store Topotecan Ebewe
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the carton and vial after the Issue date. or EXP. The expiration date is the last day of the specified month.
Store in a refrigerator (2 °C–8 °C).
Store the vial in the outer carton. Light sensitive.
Do not freeze.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
The active substance is topotecan.
One milliliter of concentrate for infusion solution contains 1 mg of topotecan (as hydrochloride).
Each 1 ml vial contains 1 mg of topotecan (as hydrochloride).
Each 3 ml vial contains 3 mg of topotecan (as hydrochloride).
Each 4 ml vial contains 4 mg topotecan (as hydrochloride).
Other ingredients are: tartaric acid, dilute hydrochloric acid, and water for injections.
Appearance and package sizes of the medicine
This medicine is supplied as a concentrate for infusion, and solution.
The concentrate is a clear, yellow solution, practically free of visible particles, in a colorless type 1 glass vial with a gray rubber stopper and an aluminum seal with a plastic snap cap with or without plastic protection (Onco-Safe or protective film). Once-Safe and protective foil are not in contact with the drug and provide increased safety during transport, which increases the safety of pharmacy and healthcare personnel. The vials are sealed with aluminum shrink caps.
Package sizes:
1 x 1 ml, 5 x 1 ml, 10 x 1 ml
1 x 3 ml, 5 x 3 ml, 10 x 3 ml
1 x 4 ml, 5 x 4 ml, 10 x 4 ml
Not all pack sizes may be marketed.
Ebewe Pharma Ges.mbH Nfg. KG, Mondseestraße 11, A-4866 Unterach, Austria