Topotecanum Accord

Leaflet accompanying the packaging: patient information

Topotecanum Accord, 1 mg/ml, concentrate for solution for infusion

Topotecanum

You should read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• You should consult a doctor, pharmacist, or nurse if you have any further doubts.
• If any of the side effects worsen or if any side effects not mentioned in the leaflet occur, you should tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Topotecanum Accord and what is it used for
• 2. Important information before using Topotecanum Accord
• 3. How to use Topotecanum Accord
• 4. Possible side effects
• 5. How to store Topotecanum Accord
• 6. Contents of the packaging and other information

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

What is Topotecanum Accord:

Topotecanum Accord helps destroy cancer cells. The medicine is administered in a hospital by a doctor or nurse, in the form of an intravenous infusion.

What is Topotecanum Accord used for

Topotecanum Accord is used to treat:

• ovarian cancer and small cell lung cancerin case of recurrence after chemotherapy
• advanced cervical cancerwhen surgical or radiation therapy is not possible. During the treatment of cervical cancer, Topotecanum Accord is used in combination with another medicine called cisplatin.

The doctor will decide with the patient whether to use Topotecanum Accord therapy or continue the initial chemotherapy.

2. Important information before using Topotecanum Accord

When NOT to use Topotecanum Accord

• if the patient is allergic to topotecan or any of the other ingredients of this medicine (listed in section 6),
• if the patient is breastfeeding,
• if the patient has a low blood cell count. The doctor will provide information on this based on the results of the latest blood test.

You should inform your doctorif any of these circumstances apply to you.

Warnings and precautions

Before starting Topotecanum Accord, you should tell your doctor if:

• you have kidney or liver disease. There may be a need to adjust the dose of Topotecanum Accord,
• you are pregnant or plan to become pregnant. See the section "Pregnancy, breastfeeding, and fertility" below.
• you plan to become a father. See the section "Pregnancy, breastfeeding, and fertility" below. You should inform your doctorif any of these circumstances apply to you.

Topotecanum Accord and other medicines

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take, including herbal preparations and medicines available without a prescription.
You should inform your doctor if you plan to take other medicines during treatment with Topotecanum Accord.

Pregnancy, breastfeeding, and fertility

Topotecanum Accord is not recommended for pregnant women, as it may harm the unborn child. Effective contraception should be used. You should consult your doctor. You should not try to become pregnant until your doctor says it is safe.
If a man plans to become a father, he should consult his doctor about family planning or treatment. If the patient's partner becomes pregnant during treatment, the doctor should be informed immediately.
You should not breastfeed while using Topotecanum Accord. You should not restart breastfeeding until your doctor says it is safe.

Driving and using machines

Topotecanum Accord may cause fatigue.
You should not drive or operate machinery if you feel tired or weak.

Topotecanum Accord contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per dose, which means it is considered "sodium-free". If your doctor uses a saline solution to dilute Topotecanum Accord, the resulting sodium dose will be higher.

3. How to use Topotecanum Accord

The dose of Topotecanum Accord is determined by the doctor based on:
the patient's body size (body surface area measured in square meters) and
the results of blood tests performed before starting treatment and
the disease being treated.

Usual dose

Ovarian cancer and small cell lung cancer: 1.5 mg per square meter of body surface area per day. The medicine is administered once a day for 5 days. This treatment schedule is usually repeated every 3 weeks.
Cervical cancer: 0.75 mg per square meter of body surface area per day. The medicine is administered once a day for 3 days. This treatment schedule is usually repeated every 3 weeks.
During the treatment of cervical cancer, Topotecanum Accord is used in combination with another medicine called cisplatin. The doctor will recommend the appropriate dose of cisplatin.

How Topotecanum Accord is administered

The doctor or nurse will administer the appropriate dose of Topotecanum Accord as an intravenous infusion into a vein in the upper limb over a period of about 30 minutes.
The treatment regimen may be changed based on the results of regular blood tests.

4. Possible side effects

Like all medicines, Topotecanum Accord can cause side effects, although not everybody gets them.

Severe side effects: consult a doctor

Very common side effects: occur in more than 1 in 10 patients treated with Topotecanum Accord

• Infection symptoms:Topotecanum Accord may decrease the number of white blood cells and reduce resistance to infections. This can be life-threatening. Symptoms include:
• fever
• severe deterioration of general health
• local symptoms, such as throat inflammation or urinary tract problems (e.g., burning during urination, which may be a sign of a urinary tract infection)
• Sporadic severe abdominal pain, fever, and possibly diarrhea (rarely bloody), which may be symptoms of colitis (inflammation of the colon).

Rare side effects: occur in 1 in 1000 patients treated with Topotecanum Accord

Topotecanum Accord

• Severe allergic or anaphylactic reactions causing swelling of the lips, face, or neck, which can cause difficulty breathing, rash, or hives, anaphylactic shock (severe drop in blood pressure, paleness, agitation, weak pulse, decreased consciousness).
• Pneumonitis(interstitial lung disease): The greatest risk applies to patients with pre-existing lung disease, previously exposed to ionizing radiation, or treated with medicines that have caused lung damage. Symptoms include:
• difficulty breathing
• cough
• fever.

You should immediately inform your doctorif you experience any of the above symptoms, as hospital treatment may be necessary.

Very common side effects: occur in more than 1 in 10 patients treated with Topotecanum Accord

• General fatigue and weakness (transient anemia). In some cases, blood transfusion may be necessary.
• Low white blood cell count (neutropenia), which may be accompanied by fever and infection symptoms (febrile neutropenia)
• Unusual bruising or bleeding, caused by 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 (hemorrhage) may occur. You should consult your doctor on how to minimize the risk of bleeding.
• Weight loss and loss of appetite (anorexia), fatigue, weakness.
• Nausea (nausea), vomiting, diarrhea, abdominal pain, constipation.
• Inflammation and ulcers of the mouth, tongue, or gums.
• Increased body temperature (fever).
• Hair loss.

Common side effects: occur in less than 1 in 10 patients treated with Topotecanum Accord

Allergic reactions or hypersensitivity (including rash).
Yellowing of the skin.
Itching.
Malaise.

• Lack of blood cells (red blood cells, white blood cells, and platelets) (pancytopenia).

Rare side effects: occur in more than 1 in 10,000 patients treated with Topotecanum Accord

• Severe allergic or anaphylactic reactions.
• Edema caused by fluid accumulation (angioedema)
• Mild pain and inflammation at the injection site
• Itchy rash (or hives)

Very rare side effects: occur in less than 1 in 10,000 patients

• Blood leakage into tissues (extravasation)

Frequency not known

The frequency of some side effects is unknown (reactions from spontaneous reports and their frequency cannot be determined from available data).

• Severe abdominal pain, nausea, vomiting blood, black or bloody stools (possible symptoms of stomach or intestinal perforation)
• Mouth ulcers
• Difficulty swallowing
• Abdominal pain
• Nausea
• Vomiting
• Diarrhea, bloody stools (possible symptoms of inflammation of the mouth, stomach, and/or intestines)

During the treatment of cervical cancer, side effects may occur due to the other medicine (cisplatin) used in combination with Topotecanum Accord. These side effects are described in the patient leaflet for cisplatin.

Reporting side effects

If you experience any side effects, including those not mentioned in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of the medicine.

5. How to store Topotecanum Accord

Store in a place inaccessible and invisible to children.
Do not use this medicine after the expiry date stated on the carton or after the EXP date on the vial label. The expiry date refers to the last day of the month.
Store at a temperature below 25°C.
Store the vial in the outer packaging to protect it from light.
The product is intended for single use. After opening, it should be diluted immediately.
Chemical and physical stability has been demonstrated for a period of 30 days at 25°C in normal lighting conditions and at 2-8°C in protected from light conditions. From a microbiological point of view, the product should be used immediately. If the solution is not administered immediately, the person administering the medicine is responsible for the storage time and conditions before administration. The storage period should not exceed 24 hours at a temperature of 2°C to 8°C, unless the solution has been diluted in controlled and approved aseptic conditions.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Topotecanum Accord contains

• The active substance of the medicine is topotecan hydrochloride.
• The other ingredients are: tartaric acid, concentrated hydrochloric acid (for pH adjustment) or sodium hydroxide (for pH adjustment), and water for injections.

What Topotecanum Accord looks like and what the pack contains

Topotecanum Accord is a clear yellow solution.
Topotecanum Accord is packaged in type I orange glass vials, closed with a rubber stopper covered with a fluoropolymer and a flip-off seal.
Each 1 ml vial contains 1 mg of topotecan (as hydrochloride).
Each 4 ml vial contains 4 mg of topotecan (as hydrochloride).
The product is available in packs containing 1 or 5 vials.

Marketing authorization holder

Accord Healthcare Polska Sp. z o.o.
ul. Taśmowa 7
02-677 Warsaw

Manufacturer and importer:

Accord Healthcare Polska Sp. z o.o.
ul. Lutomierska 50
95-200 Pabianice
Poland
Accord Healthcare Single Member S.A.
64th Km National Road Athens
32009 Lamia
Greece

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet: February 2025

Information intended for healthcare professionals only:

Preparation of the solution

The concentrate is a yellow solution and contains 1 mg of topotecan per 1 ml.
To obtain the expected concentration between 25-50 µg/ml, the concentrate should be diluted with 0.9% sodium chloride solution (9 mg/ml) or 5% glucose solution (50 mg/ml) before administration to the patient.

Storage of the prepared solution

Chemical and physical stability has been demonstrated for a period of 30 days at 25°C in normal lighting conditions and at 2-8°C in protected from light conditions. From a microbiological point of view, the product should be used immediately. If the solution is not administered immediately, the person administering the medicine is responsible for the storage time and conditions before administration. The storage period should not exceed 24 hours at a temperature of 2°C to 8°C, unless the solution has been diluted in controlled and approved aseptic conditions.

Handling and disposal of the medicine

Appropriate procedures for handling and disposing of anticancer medicines should be followed:

• Personnel should be trained in the preparation of the medicinal product.
• Pregnant women should be excluded from working with this medicinal product.
• Personnel working with the medicinal product during its dilution should wear appropriate protective clothing, including a mask, protective glasses, and gloves.
• All materials used during administration or cleaning, including gloves, should be placed in high-risk waste bags for incineration at high temperatures.
• In case of accidental contact of the medicine with the skin or eyes, flushing with plenty of water should be performed immediately.