Topotecan hcl

Package leaflet: Information for the user

Topotecan AHCL 1 mg/ml concentrate for solution for infusion

Generic medicine
Please read all of this leaflet carefully before you are given this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. See section 4.

Contents of this leaflet:

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

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

Topotecan AHCL helps treat tumours. A doctor or nurse will administer the medicine to you in hospital
by intravenous infusion.
Topotecan AHCL is used to treat:

• ovarian cancer or small cell lung cancer that has relapsed after chemotherapy
• advanced cervical cancer when surgical or radiotherapeutic treatment is not possible. In the treatment of cervical cancer, Topotecan AHCL is given in combination with another medicine called cisplatin.

Your doctor will decide with you whether treatment c on with Topotecan AHCL is preferable to further treatment with
the initial chemotherapy.

2. What you need to know before you are given Topotecan AHCL

Do not be given Topotecan AHCL:

• 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 advise you if this applies, based on the results of your most recent blood tests.

Tell your doctor if any of these situations apply to you.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before you are given this medicine:

• if you have any problems with your kidneys or liver. It may be necessary to adjust the dose of Topotecan AHCL.
• if you are pregnant or think you may become pregnant. See section below “Pregnancy, breastfeeding and fertility”.
• if you intend to become a father. See section below “Pregnancy, breastfeeding and fertility”. Tell your doctor if any of these situations apply to you.

Other medicines and Topotecan AHCL
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines, including herbal products or over-the-counter medicines.
Remember to inform your doctor if you start taking any other medicines while being treated with
Topotecan AHCL.

Pregnancy, breastfeeding and fertility
Topotecan AHCL is not recommended for pregnant women. It may harm the unborn child if conception occurs
before, during, or immediately after treatment. You must use effective contraception during treatment with
Topotecan AHCL and for 6 months after treatment ends. Ask your doctor for advice.
Do not attempt to become pregnant until your doctor tells you it is safe to do so.
Men are advised to use effective contraception and not to father a child during treatment with
Topotecan AHCL and for 3 months after treatment ends. Male patients who may wish to become fathers should
seek advice or treatment for family planning from their doctor. If your partner becomes pregnant during your
treatment, inform your doctor immediately.
Do not breastfeed during treatment with Topotecan AHCL. Do not resume breastfeeding until your
doctor tells you it is safe to do so.

Driving and using machines
Topotecan AHCL may cause fatigue.
If you feel tired or weak, do not drive or operate machinery.

Topotecan AHCL contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially
“sodium-free”. If your doctor uses a saline solution to dilute Topotecan AHCL, the amount of
sodium received would be higher.

3. How to use Topotecan AHCL

The dose of Topotecan AHCL you will be given is calculated by your doctor based on:

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

Usual dose

• Ovarian cancer or 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 usually 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 usually repeated every 3 weeks. In the treatment of cervical cancer, Topotecan AHCL is given in combination with another medicine called cisplatin. Your doctor will determine the correct dose of cisplatin.

How Topotecan AHCL is administered
A doctor or nurse will administer Topotecan AHCL to you by intravenous infusion into your arm over approximately 30 minutes.
Treatment may be adjusted depending on the results of regular blood tests.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects: tell your doctor
The following very common side effects may occur in more than 1 in 10 people treated with
Topotecan AHCL:

• Signs of infection: Topotecan AHCL may reduce the number of white blood cells in the blood and reduce resistance to infections. This can be life-threatening. Such signs include:
  • fever
  • severe worsening of general condition
  • local symptoms such as sore throat or urinary problems (for example, a burning sensation when urinating, which may be caused by a urinary tract infection)
• occasionally severe stomach pain, fever and possibly diarrhoea (rarely with blood) may be signs of intestinal inflammation ( colitis ). This rare side effect may occur in up to 1 in 1,000 people treated with Topotecan AHCL:
• Severe anaphylactic or allergic reactions causing swelling of the lips, face or neck leading to severe breathing difficulties, skin rash or hives, anaphylactic shock (a severe drop in blood pressure), pallor, restlessness, weak pulse, decreased level of consciousness
• Lung inflammation ( interstitial lung disease ): your risk is higher if you already have lung disease, have previously received radiation therapy to the lungs, or have previously taken medicines that caused lung damage. Symptoms include:
  • difficulty breathing
  • cough
  • fever

If you experience any symptoms related to these conditions, speak to your doctor immediately , as hospitalisation may be necessary.
Very common side effects
These may occur in more than 1 in 10 people treated with Topotecan AHCL:

• General feeling of weakness and tiredness ( temporary anaemia ). In some cases, you may need a blood transfusion.
• Abnormally low white blood cell count (neutropenia), which may be accompanied by fever and signs of infection (febrile neutropenia)
• Unusual bruising and bleeding, caused by a decrease in the number of platelets, the cells responsible for blood clotting. This may lead to severe bleeding following relatively minor injuries, such as small cuts. Rarely, it may result in more serious bleeding ( haemorrhage ). Speak to your doctor for advice on how to minimise the risk of bleeding.
• Weight loss and loss of appetite ( anorexia ); tiredness; weakness
• Feeling unwell (nausea), malaise (vomiting); diarrhoea; stomach pain; constipation
• Inflammation and sores on the lining of the mouth, tongue or gums
• High body temperature (fever)
• Hair loss

Common side effects
These may occur in up to 1 in 10 people treated with Topotecan AHCL:

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

Rare side effects
These may occur in up to 1 in 1,000 people treated with Topotecan AHCL: - Severe allergic or anaphylactic reactions

• Swelling due to fluid accumulation ( angioedema )
• Mild pain and inflammation at the injection site
• Itchy rash ( urticaria ). Very rare: (may affect up to 1 in 10,000 people)
• Leakage of blood into tissues (extravasation)

Side effects with unknown frequency
The frequency of some side effects is not known (events reported spontaneously and frequency cannot be estimated from available data):

• Severe stomach pain, nausea, blood in vomit, dark or bloody stools (possible symptoms of gastrointestinal perforation)
• Mouth ulcers, difficulty swallowing, abdominal pain, nausea, vomiting, diarrhoea, bloody 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 side effects due to the other medicine (cisplatin) administered together with Topotecan AHCL. These side effects are described in the patient leaflet for cisplatin therapy.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the
Website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Topotecan AHCL

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 after "Exp". The expiry date refers to the last day of that month.
Store below 25°C.
Keep the container in the outer packaging to protect the medicine from light.
This medicine is for single use only. After opening, the product must be immediately used for dilution.
The physicochemical stability of the product after dilution has been demonstrated for 30 days at 25°C under normal light conditions and for 30 days at 2-8°C when protected from light.
From a microbiological standpoint, the product should be used immediately after dilution. If not used immediately, the user is responsible for the storage duration and conditions prior to administration, which must not exceed 24 hours at a temperature of 2-8°C, unless the dilution was carried out 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. This will help protect the environment.

6. Contents of the pack and other information

What Topotecan AHCL contains

• The active substance is topotecan hydrochloride.

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 other components are: tartaric acid (E334), water for injections, and hydrochloric acid (E507) or sodium hydroxide (for pH adjustment).

Description of the appearance of Topotecan AHCL and contents of the pack
This medicine is a concentrate for solution for intravenous infusion.
The concentrate is a clear yellow solution in an amber glass vial closed with Flurotec rubber stoppers and aluminium seals with a flip-off cap.
Each 1 ml vial of concentrate contains 1 mg of topotecan (hydrochloride).
Each 4 ml vial of concentrate contains 4 mg of topotecan (hydrochloride).
This medicinal product is available in cartons containing 1 or 5 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Accord Healthcare S.L.U.
World Trade Center,
Moll de Barcelona,
s/n, Edifici Est 6ª planta,
08039 Barcelona,
Spain

Manufacturer
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, Lamia, Schimatari, 32009,
Greece

This medicinal product is authorised in EEA Member States under the following names:

The following information is intended exclusively for physicians or healthcare professionals

Instructions for the preparation, storage, and disposal of Topotecan HCl
Dilution instructions
The concentrate is a clear yellow solution containing 1 mg per ml of Topotecan. Further dilution is required. To obtain a final Topotecan concentration between 25 and 50 micrograms/ml, the appropriate volume of solution should be diluted either with sodium chloride 9 mg/ml (0.9%) or with glucose 50 mg/ml (5%).
Storage of the diluted solution
The physico-chemical stability of the product after dilution has been demonstrated for 30 days at a temperature of 25°C under normal light conditions, and for 2-8°C when protected from light. From a microbiological standpoint, the product should be used immediately after dilution. If not used immediately, the user is responsible for the storage duration and conditions prior to administration, which must not exceed 24 hours at a temperature of 2-8°C, unless the dilution was carried out under controlled, aseptic, and validated conditions.
Handling and disposal
Standard procedures for the safe handling and disposal of antineoplastic medicinal products should be followed:

• Personnel must be trained in the proper reconstitution procedures of the medicinal product.
• Pregnant personnel must be excluded from activities involving the use of this medicinal product.
• Personnel handling the medicinal product during reconstitution must wear protective clothing, including mask, goggles, and gloves.
• All equipment and materials used for administration and cleaning, including gloves, must be placed in bags designated for the disposal of high-risk materials, to be incinerated at high temperature.
• In case of accidental contact with skin or eyes, immediately flush with large amounts of water.