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TOPOTECAN 1 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): TOPOTECAN HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Topotecan 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 is and what it is used for
2. Before you use Topotecan
3. How to use Topotecan
4. Possible side effects
5 How to store Topotecan
6. Further information
1. WHAT TOPOTECAN IS AND WHAT IT IS USED FOR
Topotecan 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 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 is combined with another drug called cisplatin.
2. BEFORE YOU USE TOPOTECAN






Do not use Topotecan
• if you are allergic (hypersensitive) to topotecan or any of the other ingredients of
Topotecan listed in section 6 under ‘What Topotecan contains’.
• if you are breast-feeding. You should stop breast-feeding before starting treatment
with Topotecan.
• 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
Your doctor needs to know before you are given this medicine:
• if you have any kidney problems. Your dose of Topotecan may need to be adjusted.
Topotecan is not recommended in case of severe renal impairment.
• if you have liver problems. Topotecan is not recommended in case of severe liver
impairment.
Topotecan 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 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. 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.

Pregnancy and breast-feeding
Topotecan 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.
Driving and using machines
Topotecan can make you feel tired or weak. If you experience this, do not drive or use
machines.

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

3. HOW TO USE TOPOTECAN
Your dose of Topotecan 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 is prepared
Topotecan 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 is given
A doctor or a nurse will give you the diluted Topotecan 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 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.

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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 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.
Other side effects with Topotecan 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.
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


Keep out of the sight and reach of children.

Do not use Topotecan 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 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 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:
Not all pack sizes may be marketed.
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Marketing Authorisation Holder and Manufacturer
Ebewe Pharma Ges.m.b.H. Nfg. KG
A-4866 Unterach, Austria

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

Topoliquid 1 mg/ml Konzentrat zur Herstellung einer Infusionslösung

United Kingdom

Topotecan 1 mg/ml concentrate for solution for infusion






This leaflet was last approved 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 concentrate for solution for infusion
should be inspected visually for particulate matter and discolouration prior to use. Do
not use Topotecan 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 highrisk, 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 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.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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