TOPOTECAN HOSPIRA 4 mg/4 mL Concentrate for Infusion Solution

Introduction

Package Leaflet: Information for the User

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

topotecan

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

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

Contents of the pack

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

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

Topotecan Hospira helps to eliminate tumors. A doctor or nurse will give you your medicine as an infusion into a vein in the hospital.

Topotecan Hospira is used to treat:

• ovarian cancer or small cell lung cancerthat has come back after you have received chemotherapy.
• advanced cancer of the cervix, if surgery or radiotherapy is not possible. When used for the treatment of cancer of the cervix, Topotecan Hospira is given with another medicine called cisplatin.

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

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

You must not be given Topotecan Hospira

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

Tell your doctorif you are in any of these situations.

Warnings and precautions

Before you are given this medicine, your doctor needs to know:

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

• if you are pregnant or think you may be pregnant. See the section “Pregnancy and breast-feeding” below.
• if you are planning to become a father. See the section “Pregnancy and breast-feeding” below.

Tell your doctorif you are in any of these situations.

Other medicines and Topotecan Hospira

Tell your doctor if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription or any herbal medicines. Remember to tell your doctor if you start taking any new medicines while being treated with Topotecan Hospira.

Pregnancy and breast-feeding

Topotecan must not be used in pregnant women. It may harm the fetus before, during or after treatment. You must use an effective method of contraception. 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 become fathers should ask their doctor for advice on family planning. If your partner becomes pregnant during your treatment, tell your doctor immediately.

Avoidbreast-feeding if you are being treated with topotecan. Do not restart breast-feeding until your doctor tells you it is safe to do so.

Driving and using machines

Topotecan may cause tiredness. If you feel tired or weak, do not drive or use machines.

Topotecan Hospira contains sodium

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

3. How Topotecan Hospira is given

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

• your body size (body surface area measured in square meters)
• the results of your blood tests before treatment
• the type of disease 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 a day for 5 days. This treatment schedule will normally be repeated every 3 weeks.
• Cancer of the cervix:0.75 mg per square meter of body surface area per day. You will receive treatment once a day for 3 days. This treatment schedule will normally be repeated every 3 weeks.

When treating cancer of the cervix, Topotecan Hospira is given with another medicine called cisplatin. Your doctor will tell you what dose of cisplatin is right for you.

This treatment may vary depending on the results of your regular blood tests.

How topotecan is given

A doctor or nurse will give you topotecan as an infusion into your arm that lasts about 30 minutes.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects: tell your doctor

These very commonside effects may affect more than 1 in 10 peopletreated with Topotecan Hospira

• Signs of infection:Topotecan can reduce the number of white blood cells and decrease your resistance to infections. This can be life-threatening. 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 when urinating, which may be due to a urinary tract infection)

• Ocasional inflammation of the intestine (colitis) may cause severe stomach pain, fever, and possibly diarrhea (rarely with blood).

This rareside effect may affect up to 1 in 1,000 peopletreated with Topotecan Hospira:

• Lung inflammation (interstitial lung disease):you are more at risk if you already have lung disease, have received radiation treatment to your lungs, or have taken medicines that have caused lung damage in the past. Signs include:

• difficulty breathing
• cough
• fever

Tell your doctor immediatelyif you notice any of these symptoms, as you may need to be hospitalized.

Very common side effects

May affect more than 1 in 10 peopletreated with Topotecan Hospira

• Feeling of general weakness and tiredness (temporary anemia). In some cases, you may need to have a blood transfusion.
• Bruising or unexplained bleeding, caused by a decrease in the number of cells that help the blood to clot. This can lead to serious bleeding from relatively small wounds, such as minor cuts. Rarely, this can lead to more serious bleeding (hemorrhage). Talk to your doctor for advice on how to minimize the risk of bleeding.
• Weight loss and loss of appetite (anorexia); tiredness; weakness.
• Nausea; vomiting; diarrhea; stomach pain; constipation.
• Inflammation and ulcers in the mouth, tongue, and gums
• Increased body temperature (fever).
• Hair loss.

Common side effects

May affect up to 1 in 10 peopletreated with Topotecan Hospira

• Allergic reactions or hypersensitivity reactions (including skin rash).
• Yellowing of the skin.
• Discomfort.
• Feeling of itching

Rare side effects

May affect up to 1 in 1,000 peopletreated with Topotecan Hospira

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

Side effects of unknown frequency

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

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

If you are being treated for cancer of the cervix, you may experience side effects related to the other medicine (cisplatin) that will be given to you with Topotecan Hospira. These side effects are described in the package leaflet for cisplatin.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Topotecan Hospira

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

Do not use Topotecan Hospira after the expiry date which is stated on the vial and on the outer packaging after EXP.

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

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

This medicine is for single use only. After opening the vial, the product should be used immediately. If not used immediately, Topotecan Hospira can be used for up to 24 hours when stored in a refrigerator (protected from light) or at room temperature (in normal daylight conditions).

Do not use this medicine if you notice visible particles in it.

Medicines should 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. Container Content and Additional Information

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

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

Appearance of the Product and Container Content

Topotecan Hospira is a clear, yellow to yellow-green 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 pack sizes may be marketed.

Marketing Authorisation Holder

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Brussels

Belgium

Manufacturer

Pfizer Service Company BVBA

Hoge Wei 10

1930 Zaventem

Belgium

You can request more information about this medicinal product by contacting the local representative of the marketing authorisation holder:

Date of Last Revision of this Leaflet:

Other Sources of Information

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

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This information is intended for healthcare professionals only:

Instructions for Storage, Use, Handling, and Disposal of Topotecan Hospira

Storage

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

Instructions for Use

Consult the Summary of Product Characteristics of Topotecan Hospira 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 sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution for infusion. Use aseptic technique during any further dilution of the infusion solution.

Parenteral medicinal products must be inspected visually for particulate matter or discoloration prior to administration. Topotecan Hospira is a yellow to yellow-green solution.

Prior to the administration of 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 should be controlled. For more details, consult the Summary of Product Characteristics.

Dose: Ovarian Cancer and Small Cell Lung Cancer

Initial dose: 1.5 mg/m^2 body surface area/day administered as a 30-minute intravenous infusion daily 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 is ≥100 x 10^9/l, and the hemoglobin level is ≥9 g/dl (after transfusion, if necessary).

Dose: Cervical Cancer

Initial dose: 0.75 mg/m^2/day, administered as a 30-minute intravenous infusion 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, following 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 is ≥100 x 10^9/l, and the hemoglobin level is ≥9 g/dl (after transfusion, if necessary).

Dose: Patients with Renal Impairment

Limited data indicate that the dose should be reduced in patients with moderate renal impairment. Consult the Summary of Product Characteristics for more details.

Dose: Paediatric Population

Experience in children is limited. Its use is not recommended.

The physical and chemical stability of the concentrate has been demonstrated for 24 hours at 25°C in 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 in-use storage times and conditions are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless the reconstitution/dilution has been carried out in controlled and validated aseptic conditions.

Handling and Disposal

Normal procedures for the handling and disposal of antineoplastic medicinal products should be adopted:

• Healthcare personnel should be trained in the preparation and administration of the medicinal product.
• Healthcare personnel should not handle cytotoxic preparations during pregnancy.
• Healthcare personnel should wear appropriate protective clothing, including a mask, glasses, and gloves.
• All items used for the preparation, administration, and cleaning of the medicinal product, including gloves, should be placed in cytotoxic waste disposal bags for incineration at a high temperature. Liquid waste may 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.
• Disposal of the unused medicinal product and all materials that have come into contact with it should be carried out in accordance with the standard procedures of the hospital for cytotoxic medicinal products.