Topotecan accord

Package leaflet: Information for the patient

Topotecanum Accord, 1 mg/ml, concentrate for solution for infusion
Topotecan
Read the entire leaflet before using this medicine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• Contact your doctor, pharmacist, or nurse if you have any further questions.
• If any side effects worsen or if you experience any side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet contents:

1. What Topotecanum Accord is and what it is 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 package and other information

1. What Topotecanum Accord is and what it is used for
What Topotecanum Accord is:
Topotecanum Accord helps destroy cancer cells. The medicine is administered in a hospital setting by a doctor or nurse as an intravenous infusion.
What Topotecanum Accord is used for:
Topotecanum Accord is used to treat:

• ovarian cancer and small cell lung cancer that has recurred after chemotherapy,
• advanced cervical cancer when surgical or radiotherapeutic treatment is not possible. During cervical cancer treatment, Topotecanum Accord is used in combination with another medicine called cisplatin.

Your doctor will decide together with you whether treatment with Topotecanum Accord is preferable or whether to continue the initial chemotherapy regimen.

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 blood cell counts are too low. Your doctor will provide information on this based on the results of your most recent blood test.

Inform your doctor if any of these situations apply to you.
Warnings and precautions
Before starting Topotecanum Accord, inform your doctor if:

• the patient has kidney or liver disease. A dose adjustment of Topotecanum Accord may be necessary,
• if the patient is pregnant or planning to become pregnant. See section "Pregnancy, breastfeeding and fertility" below.
• if the patient is planning to father a child. See section "Pregnancy, breastfeeding and fertility" below.
  Inform your doctor if any of these situations apply to you.

Topotecanum Accord and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including herbal preparations and over-the-counter medicines, as well as any medicines the patient plans to take.
Inform your doctor if the patient plans to take other medicines during treatment with Topotecanum Accord.
Pregnancy, breastfeeding and fertility
Topotecanum Accord is not recommended for use in pregnant women, as it may harm the unborn child conceived before, during, or shortly after treatment. Effective contraception must be used during treatment with Topotecanum Accord and for 6 months after treatment ends. Consult your doctor. Do not attempt to become pregnant until your doctor confirms it is safe.
Men are advised to use effective contraception and to avoid attempting to father a child during treatment with Topotecanum Accord and for 3 months after treatment ends. If a man plans to father a child, he should consult his doctor regarding family planning or treatment options. If the patient's partner becomes pregnant during treatment, inform the doctor immediately.
Breastfeeding must not be performed during treatment with Topotecanum Accord. Do not restart breastfeeding until your doctor confirms it is safe.

Driving and operating machinery
Topotecanum Accord may cause fatigue.
Do not drive or operate machinery if you experience fatigue or weakness.

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

3. How to use Topotecanum Accord

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

Typical dosage
Ovarian cancer and small cell lung cancer: 1.5 mg per square meter of body surface area per day. The medicine is administered once daily for 5 consecutive days. This treatment regimen 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 daily for 3 consecutive days. This treatment regimen is usually repeated every 3 weeks.

During treatment of cervical cancer, Topotecanum Accord is used in combination with another medicine called cisplatin. Your doctor will recommend the appropriate dose of cisplatin.

How Topotecanum Accord is administered
Your doctor or nurse will administer the appropriate dose of Topotecanum Accord as an intravenous infusion into a vein in the arm over approximately 30 minutes.

The treatment schedule may be adjusted depending on the results of regular blood tests.

4. Possible adverse reactions

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

Serious adverse reactions: inform your doctor

Very common adverse reactions: occur in more than 1 in 10 patients treated with Topotecanum Accord

• Signs of infection: Topotecanum Accord may reduce the number of white blood cells and decrease resistance to infections. This may be life-threatening. Symptoms include:
  • fever
  • severe deterioration in general health
  • local symptoms such as sore throat or urinary tract symptoms (e.g. burning sensation during urination, which may indicate a urinary tract infection)
• Occasionally severe abdominal pain, fever and possibly diarrhoea (rarely bloody), which may be symptoms of intestinal inflammation (colitis).

Rare adverse reactions: occur in 1 in 1,000 patients treated with Topotecanum Accord

• Severe allergic or anaphylactic reactions causing swelling of the lips, face or neck, possibly leading to breathing difficulties, rash or urticaria, anaphylactic shock (severe drop in blood pressure, pallor, restlessness, weak pulse, reduced consciousness).
• Pneumonitis (interstitial lung disease): The greatest risk applies to patients with pre-existing lung disease, who have previously undergone thoracic radiotherapy or have been treated with medicines causing lung damage. Symptoms include:
  • difficulty breathing
  • cough
  • fever.

Contact your doctor immediately if any of the above symptoms occur, as hospital treatment may be necessary.

Very common adverse reactions: occur in more than 1 in 10 patients treated with Topotecanum Accord

• General fatigue and weakness (transient anaemia). In some cases, blood transfusion may be necessary.
• Low white blood cell count (neutropenia), which may be accompanied by fever and signs of infection (febrile neutropenia).
• Unusual bruising or bleeding due to reduced number of blood cells responsible for clotting. This may lead to increased bleeding after relatively minor injuries, such as small cuts. Rarely, more severe bleeding (haemorrhage) may occur. Consult your doctor on how to minimize the risk of bleeding.
• Decreased body weight and loss of appetite (anorexia), fatigue, weakness.
• Nausea, vomiting, diarrhoea, abdominal pain, constipation.
• Inflammation and ulceration of the mouth, tongue or gums.
• Elevated body temperature (fever).
• Hair loss.

Common adverse reactions: occur in less than 1 in 10 patients treated with Topotecanum Accord

• Allergic or hypersensitivity reactions (including rash).

• Yellowing of the skin.

• Itching.

• Malaise.

• Blood cell deficiency (red blood cells, white blood cells and platelets) (pancytopenia).

Uncommon adverse reactions: occur in more than 1 in 10,000 patients treated with Topotecanum Accord

• Severe allergic or anaphylactic reactions.
• Fluid accumulation causing swelling (angioedema).
• Mild pain and inflammation at the injection site.
• Itchy rash (or urticaria).

Very rare adverse reactions: occur in less than 1 in 10,000 patients

• Bleeding into tissues (haemorrhage).

Frequency not known

The frequency of certain adverse reactions is unknown (reactions derived from spontaneous reports and their frequency cannot be estimated from available data).

• Severe abdominal pain, nausea, vomiting blood, black or bloody stools (possible symptoms of gastric or intestinal perforation)
• Mouth ulcers
• Difficulty 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, adverse reactions may occur due to another medicine (cisplatin) used concomitantly with Topotecanum Accord. These adverse reactions are described in the patient leaflet for cisplatin.

Reporting of adverse reactions

If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl

Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Topotecanum Accord

Keep the medicine out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the cardboard box or
after the EXP date on the vial label. The expiry date refers to the last day of the stated month.
Store below 25°C.
Keep the vial in the outer packaging to protect from light.
The product is intended for single use only. After opening, it should be diluted immediately.
Chemical and physical in-use stability has been demonstrated for 30 days at 25°C under normal lighting conditions, and for 30 days at 2-8°C under light-protected conditions.
From a microbiological standpoint, the product should be used immediately. If the solution is not administered immediately, the person administering the medicine is responsible for the storage duration and conditions prior to administration. The storage period should not exceed 24 hours at 2ºC to 8ºC, unless the solution has been diluted under controlled and validated aseptic conditions.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Topotecanum Accord contains

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

What Topotecanum Accord looks like and contents of the pack
Topotecanum Accord is a concentrate for solution for infusion.
The concentrate is a clear yellow solution.
Topotecanum Accord is supplied in 1 ml or 4 ml amber glass type I vials, closed with a rubber stopper coated with fluoropolymer and sealed with a flip-off cap.
Each 1 ml vial of concentrate contains 1 mg of topotecan (as hydrochloride).
Each 4 ml vial of concentrate contains 4 mg of topotecan (as hydrochloride).
The product is available in packs containing 1 or 5 vials.
Marketing Authorisation Holder
Accord Healthcare Polska Sp. z o.o.
Taśmowa 7 Street
02-677 Warsaw
Poland
Manufacturer and Importer:
Accord Healthcare Polska Sp. z o.o.
Lutomierska 50
95-200 Pabianice
Poland
Accord Healthcare Single Member S.A.
64th Km National Road Athens
32009 Lamia
Greece
This medicinal product is authorised in the European Economic Area member states under the following names:

Information intended exclusively for healthcare professionals:

Preparation of the solution
The concentrate is a yellow solution containing 1 mg of topotecan per 1 ml.
To obtain the desired 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) prior to administration to the patient.
Storage of the prepared solution
Chemical and physical in-use stability has been demonstrated for 30 days at 25°C under normal lighting conditions and for 2–8°C under light-protected conditions. From a microbiological standpoint, the product should be used immediately. If the solution is not administered immediately, responsibility for storage conditions and duration prior to administration lies with the person administering the medicine. The storage period should not exceed 24 hours at a temperature of 2°C to 8°C, unless the solution has been diluted under controlled and validated aseptic conditions.
Handling and disposal of the medicine and its residues
Appropriate procedures for handling cytotoxic anticancer agents and disposal of their residues must be followed:

• Personnel should be trained in the preparation of the medicinal product.
• Pregnant women should not handle this medicinal product.
• Personnel involved in dilution of the medicinal product should wear appropriate protective clothing, including mask, protective goggles, 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 skin or eyes, immediately rinse thoroughly with plenty of water.