Label: information for the user

Topotecan Hospira 4 mg/4 ml concentrate for solution for infusion

topotecan

Read this label carefully before starting to use this medicine, as it contains important information for you.

- Keep this label, as you may need to read it again.

- If you have any questions, consult your doctor or pharmacist.

- If you experience any adverse effects, consult your doctor, even if they are not listed in this label. See section 4.

1.What is Topotecan Hospira and how is it used

2.What you need to know before receiving Topotecan Hospira

3.How to use Topotecan Hospira

4.Possible adverse effects

5.Storage of Topotecan Hospira

6.Contents of the package and additional information

Topotecán Hospira helps eliminate tumors. A doctor or nurse will administer your medication as an infusion through a vein in the hospital.

Topotecán Hospira is used to treat:

• ovarian cancer or small cell lung cancerthat has recurred after receiving chemotherapy.
• advanced cervical cancer, if surgery or radiation therapy is not possible. When used to treat cervical cancer, Topotecán Hospira is combined with another medication called cisplatin.

Your doctor will decide with you whether treatment with Topotecán Hospira is better than your initial chemotherapy treatment.

You should not receive Topotecán Hospira

• if you are allergic to topotecan or any of the other ingredients in this medication (listed in section 6).
• if you are breastfeeding.
• if your blood cell count is very low. Your doctor will tell you if this is the case, based on the results of your last blood test.

Inform your doctorif you are in any of these situations.

Warnings and precautions

Your doctor needs to know:

• if you have liver or kidney problems. Your dose of Topotecán Hospira may need to be adjusted.

• if you are pregnant or think you may become pregnant. See the section “Pregnancy and breastfeeding” below.
• if you think you may become a father. See the section “Pregnancy and breastfeeding” below.

Inform your doctorif you are in any of these situations.

Other medications and Topotecán Hospira

Inform your doctor if you are using, have used recently, or may need to use any other medication, including those purchased without a prescription or any herbal medication. Remember to inform your doctor if you start taking any medication while you are being treated with Topotecán Hospira.

Pregnancy and breastfeeding

Topotecan should not be used in pregnant women. It may cause harm to the fetus, before, during, or after treatment. You should use an effective contraceptive method. Do not try to become pregnant or father a child until your doctor tells you it is safe to do so.

Men who wish to father a child should ask their doctor for advice on family planning. If your partner becomes pregnant during your treatment, inform your doctor immediately.

Avoidbreastfeeding if you are being treated with topotecan. Do not resume breastfeeding until your doctor tells you it is safe to do so.

Driving and operating machines

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

Topotecán Hospira contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per vial; it is essentially “sodium-free”.

The dose of topotecán you receive will be calculated by your doctor based on:

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

The usual dose is

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

When treating cervical cancer, Topotecán Hospira is combined with another medication calledcisplatin. Your doctor will indicate the appropriate dose of cisplatin.

Treatment may vary depending on the results obtained in your periodic blood tests.

How topotecán is administered

A doctor or nurse will administer topotecán as an infusion in your arm that lasts about 30 minutes.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Severe side effects: report to your doctor

These side effectsvery commonmay affectmore than 1 in 10 peopletreated with Topotecán Hospira

• Signs of infection:Topotecán may reduce the number of white blood cells and decrease their resistance to infections. This may pose a risk to life. Some signs of infection are:
• • fever
  • severe deterioration of your general condition
  • local symptoms such as sore throat or urinary problems (e.g. burning sensation while urinating, which may be due to a urinary tract infection)

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

This side effectraremay affectup to 1 in 1,000 peopletreated with Topotecán Hospira:

• Pulmonary inflammation(interstitial lung disease):has a higher risk if you already have a lung disease, have received radiation treatment in your lungs, or have previously taken medications that caused lung damage. The signs include:

• difficulty breathing
• cough
• fever

Report to your doctor immediatelyif you notice any of these symptoms, as it may require hospitalization.

Very common side effects

Mayaffectmore than 1 in 10 peopletreated with Topotecán Hospira

• General feeling of weakness and fatigue (temporary anemia). In some cases, a blood transfusion may be necessary.
• Unjustified bruises or bleeding, caused by a decrease in the number of cells that participate in blood coagulation. This may lead to severe bleeding from relatively small injuries such as small cuts. Rarely, this may lead to more severe bleeding (hemorrhage). Consult with your doctor to advise 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, and gums
• Elevation of body temperature (fever).
• Loss of hair.

Frequent side effects

May affectup to 1 in 10 peopletreated with Topotecán Hospira

• Allergies or hypersensitivity reactions (including skin rash).
• Yellowing of the skin.
• Discomfort.
• Itching sensation

Rare side effects

May affectup to 1 in 1,000 peopletreated with Topotecán Hospira

• Severe allergic reactions or anaphylactic reactions.
• Swelling caused by fluid retention (angioedema).
• Mild pain and inflammation at the injection site.
• Skin rash with itching (or hives).

Side effects of unknown frequency

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

• Severe stomach pain, nausea, vomiting with blood, black stools or with blood (possible symptoms of gastrointestinal perforation).
• Sores in the mouth, difficulty swallowing, abdominal pain, nausea, vomiting, diarrhea, stools with blood (possible signs and symptoms of inflammation of the inner lining of the mouth, stomach, and/or intestine [mucosal inflammation]).

If you are being treated for cervical cancer, you may experience side effects related to another medication (cisplatino) that will be administered with Topotecán Hospira. These side effects are described in the cisplatino prospectus.

Reporting side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is apossibleside effect that does not appear in this prospectus.You can also report them directly through thenational notification system included in theAppendix V.By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use Topotecán Hospira after the expiration date that appears on the vial and on the packaging after CAD.

Store in refrigerator (2°C - 8°C). Do not freeze.

Store the vial in the outer packaging to protect it from light.

This medication is for single use only. After opening the vial, the product must be used immediately. If not used immediately, Topotecán Hospira may be used up to 24 hours later when stored in the refrigerator (protected from light) or at room temperature (in normal daylight conditions).

Do not use this medication if you observe visible particles in it.

Medicines should not be disposed of through drains. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of Topotecan Hospira

The active ingredient of Topotecan Hospira is topotecan (as hydrochloride). 1 ml of concentrate for solution for infusion contains 1 mg of topotecan (as hydrochloride). Each vial of 4 ml of concentrate contains 4 mg of topotecan (as hydrochloride).

The other components are: tartaric acid (E334), water for injection, hydrochloric acid (E507) and sodium hydroxide (to adjust the pH of the solution).

Appearance of the product and contents of the pack

Topotecan Hospira is a transparent, yellow to yellow-green concentrate for solution for infusion, presented in transparent glass vials, each containing 4 ml of concentrate. Topotecan Hospira is available in two pack sizes: 1 vial or 5 vials. Not all presentations may be marketed.

Marketing Authorisation Holder

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Bruxelles

Belgium

Responsible Person

Pfizer Service Company BVBA

Hoge Wei 10

1930 Zaventem

Belgium

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Last update of the summary of product characteristics:

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu/

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This information is intended for healthcare professionals only:

Instructions for the storage, use, handling and disposal of Topotecan Hospira

Storage

Unopened vial: Store in refrigerator (2-8°C). Do not freeze. Store the vial in the outer packaging to protect from light.

Instructions for use

Consult the Topotecan Hospira Technical Dossier for more detailed information.

Topotecan Hospira 4 mg/4 ml concentrate for solution for infusion must be diluted to a final concentration of between 25 and 50 micrograms/ml before administration to the patient. The approved diluents for the concentrate are a sodium chloride solution for injection 9 mg/ml (0.9%) or a glucose solution 50 mg/ml (5%) for infusion. Use aseptic technique during any new dilution of the infusion solution.

Parenteral medicines must be visually inspected to observe if there are any particles or discoloration in the solution. Topotecan Hospira is a yellow/yellow-green solution.

Before the first cycle of topotecan, patients should have a baseline neutrophil count ≥ 1.5 x 10^9/l, a platelet count ≥ 100 x 10^9/l, and a hemoglobin level > 9 g/dl (after transfusion, if necessary). Neutropenia and thrombocytopenia must be controlled. For more details, consult the Technical Dossier.

Dose: Ovarian and small cell lung cancer

Initial dose: 1.5 mg/m^2 of body surface area/day administered by intravenous infusion over 30 minutes, for 5 consecutive days, with a 3-week interval between the start of each cycle.

Subsequent doses: Topotecan should not be administered again unless the neutrophil count is ≥ 1 x 10^9/l, the platelet count ≥ 100 x 10^9/l, and the hemoglobin level ≥ 9 g/dl (after transfusion, if necessary).

Dose: Cervical cancer

Initial dose: 0.75 mg/m^2/day, administered as an intravenous infusion over 30 minutes, on days 1, 2, and 3. Cisplatin is administered as an intravenous infusion on day 1 at a dose of 50 mg/m^2/day, and after the topotecan dose. This treatment regimen is repeated every 21 days, for 6 cycles or until disease progression.

Subsequent doses: Topotecan should not be administered again unless the neutrophil count is ≥ 1.5 x 10^9/l, the platelet count ≥ 100 x 10^9/l, and the hemoglobin level ≥ 9 g/dl (after transfusion, if necessary).

Dose: Patients with renal insufficiency

Limited data indicate that the dose should be reduced in patients with moderate renal insufficiency. Consult the Technical Dossier for more details.

Dose: Pediatric population

Experience in children is limited. It is not recommended for use.

The physical and chemical stability of the concentrate has been demonstrated for 24 hours at 25°C under normal lighting conditions, and between 2°C and 8°C, protected from light. From a microbiological point of view, the product should be used immediately. If not used immediately, the storage times and conditions during use are the responsibility of the user, and are usually not greater than 24 hours between 2°C and 8°C, unless the reconstitution/dilution has been performed in controlled and validated aseptic conditions.

Handling and disposal

Standard procedures for the correct handling and disposal of cytotoxic medicines should be adopted:

• Healthcare personnel should be trained for the preparation and administration of the medicine.
• Healthcare personnel should not handle cytotoxic preparations during pregnancy.
• Healthcare personnel should use appropriate protective clothing, including a mask, glasses, and gloves.
• All items used for the preparation, administration, and cleaning of the medicine, including gloves, should be placed in high-risk waste bags for incineration at high temperature. Liquid waste can be disposed of with large amounts of water
• Accidental contact with the skin or eyes should be treated immediately with large amounts of water. If irritation persists, consult a doctor.
• The disposal of unused medicine and all materials that have come into contact with it will be carried out in accordance with the hospital's standard procedure for cytotoxic medicines.