Topotecan Accord 1 mg/ml concentrate for solution for infusion

Patient Information Leaflet

Introduction

Package leaflet: Information for the user

Topotecan Accord 1 mg/ml concentrate for solution for infusion

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if it is a side effect not listed in this leaflet. See section 4.

Leaflet contents:

1. What Topotecan Accord is and what it is used for
2. What you need to know before you use Topotecan Accord
3. How to use Topotecan Accord
4. Possible side effects
5. How to store Topotecan Accord
6. Contents of the pack and other information

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

Topotecan Accord helps to destroy tumors. A doctor or nurse will administer the medicine by intravenous infusion in the hospital.

Topotecan Accord is used to treat:

• ovarian cancer or small cell lung cancer that has recurred after chemotherapy.
• advanced cervical cancer when surgery and radiotherapy are not possible. When treating cervical cancer, Topotecan Accord is used in combination with another medicine called cisplatin.

Your doctor will decide with you whether Topotecan Accord is preferable to continuing treatment with initial chemotherapy.

2. What you need to know before using Topotecan Accord

Do not receive Topotecan Accord

• if you are allergic to topotecan or to 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 applies, based on the results of your most recent blood test.

Inform your doctor if you are in any of these situations.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before being administered this medicine:

• if you have kidney or liver problems. A dose adjustment of Topotecan Accord may be necessary.
• if you are pregnant or planning to become pregnant. See the section “Pregnancy, breastfeeding and fertility” below.
• if you are a man and plan to father a child. See the section “Pregnancy, breastfeeding and fertility” below.

Inform your doctor if you are in any of these situations.

Other medicines and Topotecan Accord

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription or any herbal medicines.

Pregnancy, breastfeeding and fertility

Administration of Topotecan Accord to pregnant women is not recommended. It may harm the fetus before, during or after treatment. You must use effective contraceptive methods during treatment with topotecan and for 6 months after completion of treatment. Ask your doctor for advice. Do not attempt to become pregnant until your doctor confirms it is safe to do so.

Men are advised to use effective contraception and to avoid fathering a child while receiving topotecan and for 3 months after completion of treatment. Male patients who wish to have children should seek advice from their doctor regarding family planning or treatment. If your partner becomes pregnant during your treatment, inform your doctor immediately.

Avoid breastfeeding if you are being treated with Topotecan Accord. Do not resume breastfeeding until your doctor advises it is safe to do so.

Driving and operating machinery

Topotecan Accord may cause fatigue.

If you feel tired or weak, do not drive or operate machinery.

Topotecan Accord contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose; hence, it is essentially "sodium-free". If your doctor uses a saline solution to dilute Topotecan Accord, the amount of sodium received will be higher.

3. How to use Topotecan Accord

Your doctor will calculate the dose of Topotecan Accord to be administered to you based on:

• your body size (surface area measured in square meters)
• the results of blood tests performed before treatment
• the condition being treated

The usual dose is

• Ovarian cancer and small cell lung cancer: 1.5 mg per square meter of body surface area per day. You will receive treatment once daily for 5 days. This treatment schedule is normally repeated every 3 weeks.
• Cervical cancer: 0.75 mg per square meter of body surface area per day. You will receive treatment once daily for 3 days. This treatment schedule is normally repeated every 3 weeks.

When treating cervical cancer, Topotecan Accord is combined with another medicine called cisplatin. Your doctor will determine the correct dose of cisplatin for you.

How Topotecan Accord is administered

A doctor or nurse will administer Topotecan Accord to you as an intravenous infusion into your arm over approximately 30 minutes.

Treatment may vary depending on the results of periodic blood tests.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Serious adverse effects: inform your doctor

These very common adverse effects may affect more than 1 in every 10 people treated with topotecan:

• Signs of infections: Topotecan Accord may reduce the number of white blood cells and decrease your resistance to infection. This can even be fatal. Signs include:

  • fever
  • severe deterioration in your general condition
  • local symptoms such as sore throat or urinary tract problems (e.g., burning sensation when urinating, which may indicate a urinary tract infection)

• Occasionally, the presence of severe stomach pain, fever, and possibly diarrhea (rarely with blood) may indicate intestinal inflammation (colitis).

These rare adverse effects may affect up to 1 in every 1,000 people treated with topotecan:

• Severe allergic or anaphylactic reactions causing swelling of the lips, face, or neck and leading to severe breathing difficulties, skin rash or hives, anaphylactic shock (a severe drop in blood pressure, paleness, restlessness, weak pulse, reduced level of consciousness).
• Lung inflammation (interstitial lung disease): your risk is higher if you have pre-existing lung disease, have received lung radiotherapy, or have previously taken medications that may cause lung damage. Signs include:
  • difficulty breathing
  • cough
  • fever

Inform your doctor immediately if you experience any of these symptoms, as hospitalization may be required.

Very common adverse effects

May affect more than 1 in every 10 people treated with topotecan:

• General feeling of weakness and fatigue (transient anemia). In some cases, you may require a blood transfusion.
• Abnormally low count of white blood cells (neutropenia), which may be accompanied by fever and signs of infection (febrile neutropenia).
• Unusual bruising or bleeding, caused by a reduction in blood-clotting cells. This may result in severe bleeding from relatively minor injuries such as a small cut. Rarely, it may lead to more serious bleeding. Consult your doctor for advice on how to minimize the risk of bleeding.
• Weight loss and loss of appetite (anorexia), fatigue, weakness.
• Nausea, vomiting, diarrhea, stomach pain, constipation.
• Inflammation and ulcers in the mouth, tongue, or gums.
• High body temperature (fever).
• Hair loss.

Frequent adverse effects

Can affect up to 1 in every 10 people treated with topotecan:

• Allergic reactions or hypersensitivity (including rash)
• Yellowing of the skin
• Itching sensation
• Feeling of malaise
• Deficiency of all three blood cell components (red blood cells, white blood cells, and platelets) (pancytopenia)

Uncommon adverse effects

Can affect up to 1 in every 1,000 people treated with topotecan:

• Severe allergic reactions or anaphylactic reactions
• Swelling due to fluid accumulation (angioedema)
• Mild pain and inflammation at the injection site
• Itchy skin rash (or wheals)

Very rare adverse effects

Can affect up to 1 in every 10,000 people treated with topotecan:

• Leakage of blood into tissues (extravasation)

Adverse effects of unknown frequency

The frequency of some adverse effects is unknown (effects from spontaneous reports and frequency cannot be estimated from the available data):

• Severe stomach pain, nausea, vomiting blood, black or bloody stools (possible symptoms of gastrointestinal perforation)
• Mouth sores
• Difficulty swallowing
• Abdominal pain
• Nausea
• Vomiting
• Diarrhea
• Blood in stools (possible signs and symptoms of inflammation of the inner lining of the mouth, stomach, and/or intestine [mucositis])

If you are being treated for cervical cancer, you may experience adverse effects related to the other medicine (cisplatin) that will be administered together with Topotecan Accord. These effects are described in the cisplatin package leaflet.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor, hospital pharmacist, or nurse, even if they are effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Topotecan Accord

• Keep out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the container following EXP. The expiry date refers to the last day of the month indicated.
• Store below 25°C.
• Keep the vial in the outer packaging to protect it from light.
• This medicine is for single use only. It must be diluted immediately after opening.
• In-use physicochemical stability of the medicine has been demonstrated for 30 days at 25°C under normal light conditions and at 2-8°C when protected from light. From a microbiological standpoint, the product should be used immediately. If not used immediately, the storage times and conditions prior to use shall be the user's responsibility and normally should not exceed 24 hours at 2-8°C, unless the dilution has taken place under controlled, aseptic, and validated conditions.
• Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the container and additional information

Composition of Topotecan Accord

• The active substance is topotecan hydrochloride. Each 1 ml vial contains 1 mg of topotecan (as hydrochloride). Each 4 ml vial contains 4 mg of topotecan (as hydrochloride).
• The other components (excipients) are: tartaric acid (E334), water for injections, hydrochloric acid (E507), and sodium hydroxide (for pH adjustment).

Appearance of the product and contents of the pack

This medicine is a concentrate for solution for infusion.

The concentrate is a pale yellow solution. It is supplied in an amber glass vial sealed with a flurotec rubber stopper and an aluminium tamper-evident cap.

Each 1 ml vial contains 1 mg of topotecan (as hydrochloride).

Each 4 ml vial contains 4 mg of topotecan (as hydrochloride).

This medicine is available in packs containing 1 vial or 5 vials.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Accord Healthcare S.L.U.

World Trade Center

Moll de Barcelona, s/n

Edifici Est, 6th floor

08039 Barcelona

Spain

Manufacturer

Accord Healthcare Polska Sp. z o.o.,

ul. Lutomierska 50, 95-200 Pabianice,

Poland

or

Accord Healthcare Single Member S.A.

64th Km National Road Athens, Lamia, Schimatari, 32009,

Greece

This medicine is authorized in the European Economic Area member states under the following names

Date of the latest review of this summary: September 2025.

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

This information is intended for healthcare professionals only

Instructions on how to prepare, store, and dispose of Topotecan Accord

Dilution instructions

The concentrate is a clear yellow solution containing 1 mg per ml of Topotecan. Dilution is required with an appropriate volume of 9 mg/ml (0.9%) sodium chloride injection solution or 50 mg/ml (5%) glucose injection solution to obtain a final topotecan concentration between 25 and 50 micrograms/ml in the infusion solution.

Storage of the prepared solution

The in-use physicochemical 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. From a microbiological standpoint, the product should be used immediately. If not used immediately, the storage times and conditions prior to use shall be the responsibility of the user and normally should not exceed 24 hours at 2–8°C, unless the dilution was carried out under controlled and validated aseptic conditions.

Handling and disposal

Standard procedures should be followed for the proper handling and disposal of cytotoxic anticancer agents:

• Personnel should be trained in the dilution of the medicine.
• Healthcare personnel must not handle this medicine during pregnancy.
• Healthcare personnel handling this medicine during dilution must wear protective clothing, including mask, goggles, and gloves.
• All materials used for administration or cleaning, including gloves, must be placed in high-risk waste disposal bags for high-temperature incineration.

In case of accidental contact with skin or eyes, immediately rinse thoroughly with plenty of water.