Topotecan medac

Package Leaflet: Information for the User

Topotecan medac, 1 mg/ml, concentrate for solution for infusion

Topotecan

Read all of this leaflet carefully before using 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 or pharmacist.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

• 1. What Topotecan medac is and what it is used for
• 2. Before you are given Topotecan medac
• 3. How Topotecan medac is given
• 4. Possible side effects
• 5. How to store Topotecan medac
• 6. Contents of the pack and other information

1. What Topotecan medac is and what it is used for

Topotecan medac helps to destroy cancer cells. It is given in a hospital by a doctor or nurse, as an infusion into a vein.

Topotecan medac is used to treat:

• Ovarian cancer and small cell lung cancerthat has come back after chemotherapy
• Advanced cancer of the cervix, when surgery and/or radiotherapy are not possible. During treatment of cervical cancer, Topotecan medac is used in combination with another medicine called cisplatin.

Your doctor will decide with you whether to use Topotecan medac or further chemotherapy treatment.

2. Before you are given Topotecan medac

When not to use Topotecan medac:

• 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 count is too low. Your doctor will tell you about this based on your latest blood test results. You must tell your doctorif any of these apply to you.

Warnings and precautions

Before starting treatment with Topotecan medac, you should discuss this with your doctor.

• if you have any kidney or liver problems. Your dose of Topotecan medac may need to be adjusted.
• if you are pregnant or planning to become pregnant. See below under “Pregnancy, breast-feeding and fertility”.
• if you are planning to become a father. See below under “Pregnancy, breast-feeding and fertility”. You must tell your doctorif any of these apply to you.

Topotecan medac and other medicines

Tell your doctor about all medicines you are taking now or have taken recently, and about any medicines you plan to take, including herbal preparations and medicines that can be bought without a prescription. Remember to tell your doctor if you start taking other medicines while being treated with Topotecan medac.

Pregnancy, breast-feeding and fertility

Topotecan medac is not recommended during pregnancy. It may harm your unborn child, before, during or after birth. You must use effective contraception. Ask your doctor for advice. Women should use effective contraception to prevent pregnancy during treatment and for at least 6 months after treatment. Men should ensure that their partner does not become pregnant during and for at least 3 months after treatment. Genetic counselling is recommended if you wish to have children after treatment. If you plan to become a father, you should consult your doctor about family planning and the possibility of sperm conservation before starting treatment. If your partner becomes pregnant while you are being treated with topotecan, you must tell your doctor immediately. You must not breast-feed while being treated with Topotecan medac. You must not start breast-feeding again until your doctor tells you it is safe to do so.

Driving and using machines

Topotecan medac may cause fatigue. If you feel tired or weak, do not drive or use machines.

Topotecan medac contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per vial (1 ml/2 ml/4 ml), i.e. it is essentially sodium-free.

3. How Topotecan medac is given

The dose of Topotecan medac is decided by your doctor based on:

• your body size (in square metres)
• the results of your blood tests before starting treatment
• the disease being treated

Recommended dose:

• Ovarian cancer and small cell lung cancer: 1.5 mg per square metre of body surface area per day. The medicine is given once a day for 5 days. This treatment cycle is usually repeated every 3 weeks.
• Cervical cancer: 0.75 mg per square metre of body surface area per day. The medicine is given once a day for 3 days. This treatment cycle is usually repeated every 3 weeks. During treatment of cervical cancer, Topotecan medac is used in combination with another medicine called cisplatin. Your doctor will decide on the right dose of cisplatinfor you. The way you are treated may be changed based on the results of regular blood tests.

How Topotecan medac is given

Topotecan medac is given by a doctor or nurse as an infusion into a vein, over about 30 minutes.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Severe side effects: tell your doctor immediately

The following very commonside effects may occur in more than 1 in 10 patientsreceiving Topotecan medac:

• Infection symptoms:Topotecan medac can lower the number of white blood cells and reduce your resistance to infections. This can be life-threatening. Symptoms include
• fever
• serious worsening of your general condition
• local symptoms such as sore throat or urinary problems (e.g. burning sensation while urinating, which may be a sign of a urinary tract infection)
• Rarely, severe abdominal pain, fever and possibly diarrhoea (rarely bloody), which can be symptoms of inflammation of the bowel (colitis)

The following rareside effects may occur in less than 1 in 1,000 patientsreceiving Topotecan medac:

• Pneumonia(interstitial lung disease): The greatest risk is for patients with existing lung disease, who have undergone previous radiotherapy to the lungs, or who have been treated with medicines that have caused lung damage. Symptoms include:
• difficulty breathing
• cough
• fever

Tell your doctor immediatelyif you get any of the symptoms described above, as you may need to be treated in hospital.
Very common side effects:may occur in more than 1 in 10 patients

• General weakness and tiredness (transient anaemia). In some cases, a blood transfusion may be necessary.
• Unusual bruising or bleeding due to a decrease in the number of blood cells responsible for clotting. This can lead to increased bleeding after relatively minor injuries, such as small cuts. Rarely, more severe bleeding (haemorrhage) can occur. Ask your doctor how to minimise the risk of bleeding.
• Weight loss and loss of appetite (anorexia); tiredness; weakness.
• Nausea (feeling sick), vomiting, diarrhoea, abdominal pain, constipation.
• Inflammation and ulcers of the mouth, tongue or gums.
• High temperature (fever).
• Hair loss.

Common side effects:may occur in less than 1 in 10 patients

• Allergic reactions or hypersensitivity (including rash).
• Yellowing of the skin.
• Feeling unwell.
• Itching.

Rare side effects:may occur in less than 1 in 1,000 patients

• Severe allergic reactions or anaphylaxis.
• Swelling due to fluid accumulation (angioedema).
• Mild pain and inflammation at the injection site.
• Itchy rash (or hives).

Side effects with unknown frequency:frequency cannot be estimated from the available data

• Sudden stomach pain, nausea, vomiting blood, black or bloody stools (possible symptoms of perforation of the digestive tract).
• Ulcers of the mouth, problems with swallowing, abdominal pain, nausea, vomiting, diarrhoea, bloody stools (possible symptoms of inflammation of the mucous membranes of the mouth, stomach and/or intestines).

During treatment of cervical cancer, side effects of the other medicine (cisplatin) used at the same time as Topotecan medac may occur. These side effects are described in the patient information leaflet for cisplatin.

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 national reporting system listed in the “Further information” section below. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Topotecan medac

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. Store the vial in the outer carton in order to protect from light. Store in a refrigerator (2°C – 8°C).

6. Contents of the pack and other information

What Topotecan medac contains

• The active substance is topotecan. Each vial contains topotecan hydrochloride equivalent to 1 mg, 2 mg or 4 mg of topotecan.
• The other ingredients are water for injections, hydrochloric acid and sodium hydroxide.

What Topotecan medac looks like and contents of the pack

Topotecan medac is a concentrate for solution for infusion. The medicine is available in packs containing 1 vial or 5 vials; each vial contains 1 mg, 2 mg or 4 mg of topotecan. Before infusion, the concentrate must be diluted. The concentrate in the vial provides 1 mg of active substance in 1 ml.

Marketing Authorisation Holder and Manufacturer

medac
Gesellschaft für klinische
Spezialpräparate mbH
Theaterstr. 6
22880 Wedel
Germany
Tel.:
+49 4103 8006-0
Fax: +49 4103 8006-100

Date of last revision of the leaflet: 06/2023

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Information intended for healthcare professionals only:

Instructions for dilution, storage and disposal of Topotecan medac

Dilution
A further dilution with 0.9 % sodium chloride infusion solution or 5 % glucose infusion solution is required to achieve a final concentration of 25 to 50 micrograms/ml.
Shelf-life after first opening of the container
Chemical and physical stability have been demonstrated for 48 hours at 2 °C – 8 °C or at room temperature. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.
Shelf-life of the ready-to-use infusion solution
Chemical and physical stability have been demonstrated for 96 hours at 2 °C – 8 °C and for 48 hours at room temperature. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions before use are the responsibility of the user. Normally, the storage time should not be longer than 24 hours at 2 °C – 8 °C, unless dilution has been carried out under controlled and validated aseptic conditions.
Disposal of Topotecan medac and handling of waste

• Pregnant women should be excluded from working with this medicinal product.
• Personnel handling the medicinal product during dilution should wear appropriate protective clothing, including a mask, protective glasses and gloves.
• All items used for administration or cleaning, including gloves, should be placed in high-risk waste disposal bags for incineration at high temperatures.
• Any unused product or waste material should be disposed of in accordance with local requirements.
• In case of accidental contact with the skin or eyes, flush with plenty of water.