4 mg/4 ml concentrate for infusion solution, solution
topotecan
What Topotecan Hospira is and what it is used for
Topotecan Hospira helps destroy tumors. A doctor or nurse will give you the medicine as an infusion into a vein in the hospital.
Topotecan Hospira is used to treat:
• ovarian cancer or small cell lung cancer that has recurred after chemotherapy.
• advanced cervical cancer where treatment with surgery or radiotherapy is not possible. In the treatment of cervical cancer, Topotecan Hospira is given in combination with another medicine called cisplatin.
Your doctor will decide together with you whether treatment with Topotecan Hospira is better than continuing treatment with the chemotherapy you were initially treated with.
What you need to know before you receive Topotecan Hospira
You should not receive Topotecan Hospira:
- 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 cell count is too low. Your doctor will 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
Before starting treatment, your doctor must know:
- if you have kidney or liver problems. Your dose of Topotecan Hospira may then 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 Hospira
Tell your doctor if you are taking, have recently taken, or maybe 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 Hospira.
Pregnancy and breastfeeding
Topotecan is not recommended for pregnant women. It can harm the fetus if it occurs before, during, or shortly after the treatment. You must use effective 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 breastfeed if you are treated with topotecan. Do not start breastfeeding again until your doctor tells you that it is safe to breastfeed.
Driving ability and use of machinery
Topotecan can make you feel tired. If you feel tired or weak, do not drive or use machines.
Topotecan Hospira contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose unit, i.e. it is almost ‘sodium-free’. However, if your doctor uses normal saline when diluting Topotecan Hospira, the sodium dose will be higher.
How Topotecan Hospira is used
The topotecan dose you receive is determined by your doctor and is based on:
• your body surface area (measured as square meters (m 2 ))
• the results of the blood samples taken before the treatment.
• which disease is being treated.
Usual dosage
- For 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.
- For 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 Hospira is combined with another drug 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 is given
A doctor or nurse will give you Topotecan Hospira as an infusion into your arm, over about 30 minutes.
If you have further questions about this medicine, contact your doctor or pharmacist.
Possible side effects
Like all medicines, Topotecan Hospira 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 Hospira.
- Signs of infection. 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/health
- 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 ).
This rare side effect may occur in up to 1 in 1,000 people treated with Topotecan Hospira.
- 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 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.
Very common side effects are
These may occur in more than 1 in 10 people treated with Topotecan Hospira:
- Feeling of general weakness and fatigue (temporary anemia ). In some cases, you may need a blood transfusion.
- Easier to bruise and bleed, due to a reduction in the 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 ( anorexia ), fatigue, and weakness.
- Nausea, vomiting, diarrhea, stomach ache, constipation.
- Inflammation and sores in the mouth, tongue, or gums.
- High body temperature ( fever ).
- Hair loss.
Common side effects are
These may occur in up to 1 in 10 people treated with Topotecan Hospira:
- Allergic or hypersensitivity reaction (including skin rash).
- Yellowish skin (jaundice)
- A general feeling of discomfort
- Itching
Rare side effects ar
These may occur in up to 1 in 1,000 people treated with Topotecan Hospira:
- Severe allergic or anaphylactic reactions.
- Swelling is caused by fluid retention ( angioedema ).
- • Mild pain and inflammation at the injection site.
- Itchy rash (or hives )
Side effects are without known frequency
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, 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 Hospira. These side effects are described in the package insert for cisplatin.
How to store Topotecan Hospira
Keep this medicine out of the sight and reach of children.
Do not use before the expiry date which is stated on the vial label and the carton after EXP.
Store in a refrigerator (2ºC–8ºC). Do not freeze.
Store the vial in the outer carton. Light sensitive.
This medicine is for single use only. After opening, the product must be used immediately. If the medicine is not used immediately, Topotecan Hospira can be used for up to 24 hours if stored in a refrigerator (protected from light) or at room temperature (under normal light conditions).
If visible particles are observed, the product should not be given.
The medicine should not be thrown down the drain. 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 in Topotecan Hospira is topotecan (as hydrochloride). 1 ml concentrate for infusion, the solution contains 1 mg topotecan (as hydrochloride) Each vial of 4 ml concentrate contains 4 mg topotecan (as hydrochloride).
- The other ingredients are tartaric acid (E334), water for injections, and hydrochloric acid (E507) or sodium hydroxide (to adjust the pH ).
Appearance and package sizes of the medicine
Topotecan Hospira is a clear yellow to yellow-green concentrate for infusion, a solution supplied in clear glass vials containing 4 ml of concentrate. Topotecan Hospira is available in two pack sizes, 1 or 5 vials. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium
Manufacturer
Pfizer Service Company BV
Hoge Wei 10
1930 Zaventem
Belgium
Contact the representative of the Marketing Authorization Holder if you would like to know more about this medicine:
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