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PACKAGE LEAFLET: INFORMATION FOR THE USER

Topotecan Ebewe 1 mg/ml concentrate for solution for infusion

Topotecan

Read all of this leaflet carefully before you start using this medicine.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

In this leaflet:

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

2.    Before you use Topotecan Ebewe

3.    How to use Topotecan Ebewe

4.    Possible side effects

5 How to store Topotecan Ebewe 6. Further information

1.    WHAT TOPOTECAN EBEWE IS AND WHAT IT IS USED FOR

Topotecan Ebewe helps to kill tumour cells. A doctor or a nurse will give you the medicine as an infusion into a vein (a drip) in hospital.

Topotecan Ebewe is used to treat

•    ovarian cancer or small cell lung cancer that has come back after chemotherapy

•    advanced cervical cancer if surgery or radiotherapy treatment is not possible. When treating cervical cancer, Topotecan Ebewe is combined with another drug called cisplatin.

2.    BEFORE YOU USE TOPOTECAN EBEWE Do not use Topotecan Ebewe

•    if you are allergic (hypersensitive) to topotecan or any of the other ingredients of Topotecan Ebewe listed in section 6 under ‘What Topotecan Ebewe contains’.

•    if you are breast-feeding. You should stop breast-feeding before starting treatment with Topotecan Ebewe.

•    if your blood cell count is too low.Your doctor will tell you, based on the results of your last blood test.

Tell your doctor if any of these could apply to you.

Take special care with Topotecan Ebewe

Your doctor needs to know before you are given this medicine:

•    if you have any kidney problems. Your dose of Topotecan Ebewe may need to be adjusted. Topotecan Ebewe is not recommended in case of severe renal impairment.

•    if you have liver problems. Topotecan Ebewe is not recommended in case of severe liver impairment.

Topotecan Ebewe may harm your lung. The risk of damage to your lung increases if you had a lung disease, lung cancer, received radiation treatment of the lungs or drugs which can cause lung damage or have a so-called smoker’s lung.

Your treating doctor will examine your lung function in regular intervals and might decide to stop treatment if you develop symptoms like cough, fever and/or breathing problems. Topotecan Ebewe may cause a decrease in the number of blood clotting cells (platelets). This can lead to severe bleeding from relatively small injuries such as a small cut. Rarely, it can lead to more severe bleeding (hemorrhage).

If your general health status is not very good, it is more likely that you experience side effects during the treatment with Topotecan Ebewe. The treatment might also be less effective.

The doctor will evaluate your general health during the treatment and you should tell him/her in case you have fever, infection or are in some ways feeling unwell.

Using other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Topotecan Ebewe should not be used in pregnant women, unless clearly necessary. It may harm the baby if conceived before, during or soon after treatment. You should use an effective method of contraception. Ask your doctor for advice. Do not try to become pregnant/father a child until your doctor advises you it is safe to do so.

Male patients, who may wish to father a child, should ask their doctor for family planning advice or treatment.

If pregnancy occurs during treatment, tell your doctor immediately.

You must not breast-feed while on treatment with Topotecan Ebewe.

Driving and using machines

Topotecan Ebewe can make you feel tired or weak. If you experience this, do not drive or use machines.

3.    HOW TO USE TOPOTECAN EBEWE

Your dose of Topotecan Ebewe will depend on:

•    your body surface area (m²)

•    the results of blood tests carried out before and during treatment

•    the disease being treated

•    how well you tolerate treatment

Adults

Ovarian and Small cell lung cancer:

The usual dose is 1.5 mg per m² of body surface area once daily for 5 days. This treatment cycle will normally be repeated every three weeks.

Cervical cancer:

The usual dose is 0.75 mg per m2 of body surface area once daily for 3 days. This treatment cycle will normally be repeated every three weeks.

For cervical cancer, it will be used together with another anticancer medicine containing cisplatin. For more information about cisplatin, please refer to the corresponding Package Leaflet.

Children

The experience in children is limited and treatment is therefore not recommended.

How Topotecan Ebewe is prepared

Topotecan Ebewe is supplied as a concentrate for solution for infusion. The concentrate must be further diluted before administration, either with 0.9 % sodium chloride or 5 % glucose.

How Topotecan Ebewe is given

A doctor or a nurse will give you the diluted Topotecan Ebewe solution as an infusion (a drip). It is usually dripped into your arm over about 30 minutes.

4.    POSSIBLE SIDE EFFECTS

Like all medicines, Topotecan Ebewe can cause side effects, although not everybody gets them.

These side effects may occur with certain frequencies, which are defined as follows: very common: affects more than 1 user in 10 common: affects 1 to 10 users in 100 uncommon: affects 1 to 10 users in 1,000 rare: affects 1 to 10 users in 10,000 very rare: affects less than 1 user in 10,000

not known: frequency cannot be estimated from the available data.

Serious side effects:

You must tell your doctor immediately if you experience any of the following serious side effects. They may require hospitalisation and could even be life threatening.

•    Infections (very common), with signs such as:

-    fever

-    serious decline of your general condition

-    local symptoms such as sore throat or burning sensation when urinating

-    severe stomach pain, fever and possibly diarrhoea (rarely with blood) can be a signs of bowel inflammation (neutropenic colitis)

Topotecan Ebewe may reduce your ability to fight infections.

•    Lung inflammation (rare), with signs such as:

-    difficulty in breathing

-    cough

-    fever

The risk of developing this severe condition (interstitial lung disease) is higher if you currently have lung problems, or if you have received previous radiation treatment or medicines that affected your lungs, see also section 2 “Take special care with Topotecan Ebewe“.

Other side effects with Topotecan Ebewe include:

Very common side effects

•    Feeling generally weak and tired, which can be symptoms of a decrease in the number of red blood cells (anaemia). In some cases you may need a blood transfusion.

•    Unusual bruising or bleeding, sometimes severe, caused by the decrease in the number of blood clotting cells (platelets).

•    Decrease in number of circulating white blood cells (leucocytes) in the blood. Abnormal low number of neutrophil granulocytes (a type of white blood cells) in the blood, with or without fever.

•    weight loss and loss of appetite (anorexia), tiredness, weakness

•    feeling sick (nausea), vomiting, diarrhoea, stomach pain, constipation

•    inflammation and ulcers of the mouth, throat, tongue or gums (mucositis)

•    fever

•    infections

•    hair loss

Common side effects

•    allergic or hypersensitivity reactions (including rash)

•    yellow skin (jaundice) caused by abnormal liver function

•    itching (pruritus)

•    severe infection (sepsis)

•    feeling unwell (malaise)

Rare side effects

•    severe allergic anaphylactic reactions

•    swelling caused by fluid build up (angioedema) e.g. around the eyes and lips as well as hands, feet and throat. If severe it may cause breathing difficulties.

•    itchy rash (or hives)

Very rare side effects

•    Mild pain and inflammation at the site of injection due to accidental administration of the medicinal product into the surrounding tissue (extravasation) e.g. by leakage.

If you are being treated for cervical cancer, you may get side effects from the other medicine (cisplatin) that you will be given along with Topotecan Ebewe.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.

5.    HOW TO STORE TOPOTECAN EBEWE Keep out of the sight and reach of children.

Do not use Topotecan Ebewe after the expiry date which is stated on the carton and the vial after EXP The expiry date refers to the last day of that month.

Store in a refrigerator (2°C - 8°C).

Keep the vial in the outer carton, in order to protect from light.

Do not freeze.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.    FURTHER INFORMATION What Topotecan Ebewe contains The active substance is topotecan.

One milliliter concentrate for solution for infusion contains 1 mg topotecan (as hydrochloride).

Each vial of 1 ml contains 1 mg topotecan.

Each vial of 3 ml contains 3 mg topotecan.

Each vial of 4 ml contains 4 mg topotecan.

The other ingredients are: tartaric acid, hydrochloric acid dilute and water for injections What Topotecan Ebewe looks like and contents of the pack

This medicinal product is presented as a concentrate for solution for infusion.

The concentrate is a clear, yellow solution contained in a colourless glass vial with or without a protective plastic overwrap (Onco-Safe). The Onco-Safe has no contact with the drug product and increases safety during transport for medical and pharmaceutical personnel.

Pack sizes:

1 x 1 ml, 5 x 1 ml, 10 x 1 ml,

1 x 3 ml, 5 x 3 ml, 10 x 3 ml,

1 x 4 ml, 5 x 4 ml, 10 x 4 ml.

XXX-5016-Reg

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Ebewe Pharma Ges.m.b.H. Nfg. KG

A-4866 Unterach, Austria

This leaflet was last revised in 03/2015.

The following information is intended for medical or healthcare professionals only: Special precautions for disposal and other handling

Inspection prior to use

As with all parenteral drug products, Topotecan Ebewe concentrate for solution for infusion should be inspected visually for particulate matter and discolouration prior to use. Do not use Topotecan Ebewe if you notice certain signs of deteriorations. Instruction for dilution Must be diluted before use.

Further dilution of the appropriate volume of the concentrate for solution for infusion with either 0.9 % sodium chloride intravenous infusion or 5 % glucose intravenous infusion is required to a final concentration of between 10 and 50 microgram/ml (0.01 mg/ml, 0.025 mg/ml and 0.05 mg/ml).

The required volume can be directly withdrawn from the vial.

More than one vial might be necessary to obtain the required dose for the patient. Based on the required dose for the patient expressed in mg, aseptically withdraw the corresponding volume containing 1 mg/ml topotecan from the appropriate number of vials using graduated syringes. For example, a dose of 2.7 mg topotecan would require 2.7 ml topotecan concentrate for solution for infusion.

Inject the required volume into a 100 ml infusion bag or bottle containing either 5% glucose solution or 0.9% sodium chloride solution.

If a dose greater than 5mg of topotecan is required, use a larger volume of the infusion vehicle so that a concentration of 0.05 mg/ml topotecan is not exceeded.

Mix the infusion bag or bottle manually using a rocking motion.

General precaution

The normal procedures for proper handling and disposal of anticancer medicinal products should be adopted, namely:

-    Staff should be trained to dilute the medicinal product.

-    Pregnant staff should be excluded from working with this medicinal product.

-    Personnel handling this medicinal product during dilution should wear protective clothing, including mask, goggles and gloves.

-    All items for administration or cleaning, including gloves, should be placed in high-risk, waste disposal bags for high-temperature incineration. Liquid waste may be flushed with large amounts of water.

-    Accidental contact with the skin or eyes should be treated immediately with copious amounts of water.

Any unused product or waste material should be disposed of in accordance with local requirements.

The medicinal product is for single use only.

Incompatibilities

This medicinal product must not be mixed with other medicinal products except with glucose 5 % or sodium chloride 0.9 %.

Posology and method of administration

The use of topotecan should be confined to units specialised in the administration of cytotoxic chemotherapy and should only be administered under the supervision of a physician experienced in the use of chemotherapy (see section 6.6).

When used in combination with cisplatin, the full prescribing information for cisplatin should be consulted.

Prior to administration of the first course of topotecan, patients must have a baseline neutrophil count of ^ 1.5 x 10⁹/l, a platelet count of ^ 100 x 10⁹/l and a haemoglobin level of ^ 9 g/dl (after transfusion if necessary).

Topotecan Ebewe must be further diluted before use (see section 6.6).

Ovarian and Small Cell Lung Carcinoma Initial dose

The recommended dose of topotecan is 1.5 mg/m² body surface area/day administered by intravenous infusion over 30 minutes daily for 5 consecutive days with a 3 week interval between the start of each course. If well tolerated, treatment may continue until disease progression (see sections 4.8 and 5.1).

Subsequent doses

Topotecan should not be re-administered unless the neutrophil count is ^ 1 x 10⁹/l, the platelet count is ^ 100 x 10⁹/l, and the haemoglobin level is ^ 9 g/dl (after transfusion if necessary).

Standard oncology practice for the management of neutropenia is either to administer topotecan with other medications (e.g. G-CSF) or to dose reduce to maintain neutrophil counts.

If dose reduction is chosen for patients who experience severe neutropenia (neutrophil count < 0.5 x 10⁹/l) for 7 days or more, or severe neutropenia associated with fever or infection, or who have had treatment delayed due to neutropenia, the dose should be reduced by 0.25 mg/m2/day to 1.25 mg/m2/day (or subsequently down to 1.0 mg/m2/day if necessary).

Doses should be similarly reduced if the platelet count falls below 25 x 10⁹/l. In clinical trials, topotecan was discontinued if the dose had been reduced to 1.0 mg/m2 and a further dose reduction was required to manage adverse effects.

Cervical Carcinoma Initial dose

The recommended dose of topotecan is 0.75 mg/m2/day administered as 30 minute intravenous infusion daily on days 1, 2 and 3. Cisplatin is administered as an intravenous infusion on day 1 at a dose of 50 mg/m2/day and following the topotecan dose. This treatment schedule is repeated every 21 days for 6 courses or until progressive disease.

Subsequent doses

Topotecan should not be re-administered unless the neutrophil count is more than or equal to 1.5 x 10⁹/l, the platelet count is more than or equal to 100 x 10⁹/l, and the haemoglobin level is more than or equal to 9g/dl (after transfusion if necessary). Standard oncology practice for the management of neutropenia is either to administer topotecan with other medications (e.g. G-CSF) or to dose reduce to maintain neutrophil counts.

If dose reduction is chosen for patients who experience severe neutropenia (neutrophil count less than 0.5 x 10⁹/l) for 7 days or more, or severe neutropenia associated with fever or infection or who have had treatment delayed due to neutropenia, the dose should be reduced by 20% to 0.60 mg/m2/day for subsequent courses (or subsequently down to 0.45 mg/m2/day if necessary).

Doses should be similarly reduced if the platelet count falls below 25 x 10⁹/l.

Dosage in renally impaired patients

Monotherapy (Ovarian and Small cell lung carcinoma)

Insufficient data are available to make a recommendation for patients with a creatinine clearance < 20 ml/min. Limited data indicate that the dose should be reduced in patients with moderate renal impairment. The recommended monotherapy dose of topotecan in patients with ovarian or small cell lung carcinoma and a creatinine clearance between 20 and 39 ml/min is 0.75 mg/m2 /day for 5 consecutive days.

Combination therapy (Cervical carcinoma)

In clinical studies with topotecan in combination with cisplatin for the treatment of cervical cancer, therapy was only initiated in patients with serum creatinine less than or equal to 1.5 mg/dL. If, during topotecan/cisplatin combination therapy serum creatinine exceeds 1.5 mg/dL, it is recommended that the full prescribing information be consulted for any advice on cisplatin dose reduction/continuation.

If cisplatin is discontinued, there are insufficient data regarding continuing monotherapy with topotecan in patients with cervical cancer.

Paediatrics

The experience in children is limited; therefore no recommendation for treatment of paediatric patients with topotecan can be given.

Storage and Shelf life

Keep the vial in the outer carton in order to protect from light.

Store in a refrigerator (2°C - 8°C).

Do not freeze.

Unopened Vials 30 months

After dilution

Chemical and physical in-use stability after dilution has been demonstrated for 7 days when the product is diluted to a concentration of 0.01 - 0.05 mg/ml with glucose 5% or sodium chloride 0.9% and stored between 2°C to 8°C and room temperature (20°C to 25°C).

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 °C to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.

ui8d6797.indd 3 # 17.03.2015 13:24:07