Topotecan Eagle
topotecan
topotecan
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or nurse.
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 or nurse.
The name of your medicine is Topotecan Eagle 3 mg/1 ml concentrate for solution for infusion (called Topotecan Eagle in this leaflet).
Medicinal Product no longer authorised
Topotecan Eagle helps to kill tumour cells. It is a type of chemotherapy. Topotecan Eagle is used to treat:
small cell lung cancer that has come back after chemotherapy
advanced cervical cancer when surgery or radiotherapy are not possible. In this case, it is used with another medicine called cisplatin.
if you are allergic (hypersensitive) to topotecan or to any of the other ingredients of this medicine listed in Section 6
if you are breast-feeding. You should stop breast-feeding before starting treatment with Topotecan Eagle
if your blood cell count is too low. Your doctor will check this.
Do not use Topotecan Eagle if any of the above apply to you. If you are not sure, talk to your doctor or nurse before using this medicine.
Check with your doctor or nurse before using your medicine:
if you have any kidney problems. Your dose of Topotecan Eagle may need to be adjusted.
This medicine is not recommended if you have severe kidney problems;
if you have liver problems. Your dose of Topotecan Eagle may need to be adjusted.
This medicine is not recommended if you have severe liver problems;
if you have lung problems, or if you have had lung problems before from using other medicines or radiation. This is because you are more likely to get severe lung problems (interstitial lung disease) when using Topotecan Eagle;
if you have unusual bruising or bleeding;
if you are feeling very ill.
If any of the above apply to you (or you are not sure), talk to your doctor or nurse before using Topotecan Eagle.
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal medicines. This is because Topotecan Eagle can affect the way some other medicines work. Also some other medicines can affect the way Topotecan Eagle works.
Topotecan Eagle should not be used during pregnancy, unless clearly necessary. If you are pregnant or think you might be pregnant, tell your doctor immediately.
Women who could get pregnant should use contraception to stop them getting pregnant during treatment.
Men having Topotecan Eagle who wish to father a child should ask their doctor for family planning advice.
Do not breast-feed while using Topotecan Eagle.
Topotecan Eagle can make you feel tired or weak. If this happens, do not drive or use any tools or machines.
Medicinal Product no longer authorised
Your dose of Topotecan Eagle will depend on:
the disease being treated
the size of your body (measured in ‘square meters’ or ‘m2’)
the results of blood tests before and during treatment
how well your body responds to the medicine.
The usual dose is 1.5 mg of the medicine for each square meter of your body.
It is given once each day for 5 days.
This treatment cycle will normally be repeated every 3 weeks.
The usual dose is 0.75 mg of the medicine for each square meter of your body.
It is given once each day for 3 days.
This treatment cycle will normally be repeated every 3 weeks.
For cervical cancer Topotecan Eagle will be used with another medicine called cisplatin. For more information about cisplatin, please read its Package Leaflet.
The experience of using Topotecan Eagle in children is limited. This means that treatment is not recommended.
If you have any further questions on the use of this medicine, ask your doctor or nurse.
Topotecan Eagle is supplied as a concentrate for solution for infusion. The concentration of topotecan is higher (3 mg/ml) than with other topotecan products. The concentrate must be diluted before administration.
Topotecan Eagle is normally given by a doctor or nurse:
as a drip (infusion) for about 30 minutes
usually into your arm.
Like all medicines, Topotecan Eagle can cause side effects, although not everybody gets them. How likely these side effects may happen, is 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.
Tell your doctor immediately if you notice any of the following serious side effects. You may need urgent medical treatment:
The signs include:
fever
sudden decline of your general health
Medicinal Product no longer authorised
sore throat or burning sensation when passing water
severe stomach pain, fever and possibly diarrhoea (rarely with blood in it) - these can be signs of bowel inflammation (neutropenic colitis).
difficulty in breathing
cough
fever.
You are more likely to get severe lung problems (interstitial lung disease) if you already have lung problems or have had lung problems before from using other medicines or radiation.
Very common
feeling generally weak and tired. These may be signs of a drop in the number of your red blood cells (anaemia). In some cases you may need a blood transfusion.
unusual bruising or bleeding, sometimes severe. This is caused by a drop in the number of blood clotting cells (platelets).
abnormally low white blood cell count (neutropenia) which may be accompanied with fever and signs of infection (febrile neutropenia)
weight loss and loss of appetite, feeling tired or weak
feeling or being sick, diarrhoea, stomach pain, constipation
inflammation and ulcers of the mouth, throat, tongue or gums (mucositis)
high body temperature (fever)
infections
hair loss.
Common
mild allergic reactions (including rash)
yellow skin (jaundice) caused by liver problems
itching (pruritus)
severe infection (sepsis)
feeling unwell (malaise).
Rare
severe allergic (anaphylactic) reactions causing swelling of the lips, face or neck leading to severe difficulty in breathing, skin rash or hives, anaphylactic shock (a severe reduction in blood pressure, paleness, agitation, weak pulse, decreased consciousness)
sudden swelling of the skin and mucosa (e.g. throat or tongue) caused by fluid build up (angioedema)
itchy rash (or hives).
Very rare
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 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.
Keep out of the sight and reach of children.
Medicinal Product no longer authorised
Do not use Topotecan Eagle after the expiry date which is stated on the carton and vial after EXP. The expiry date refers to the last day of that month.
Do not store above 25°C.
Keep the vial in the outer carton in order to protect from light. Diluted solution
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 20°C - 25°C and ambient lighting conditions.
Do not use Topotecan Eagle if you notice any visible particles or if the solution is unclear. Medicines should not be disposed of via wastewater or household waste. Your doctor should dispose
of medicines that are no longer required. These measures will help to protect the environment.
The active substance is topotecan.
One ml of concentrate for solution for infusion contains 3 mg topotecan (as hydrochloride).
Each 1 ml single dose vial contains 3 mg of topotecan.
The other ingredients are: hydrochloric acid (E507) (for pH adjustment) and water for injections.
Topotecan Eagle is a clear yellow to orange liquid in a colourless glass vial with a butyl rubber stopper, aluminium seal and blue snap-cap and with yellow vial ring collar.
Topotecan Eagle is supplied in cartons containing 1 vial.
Eagle Laboratories Limited The Clock House
Station Approach Marlow, Bucks, SL7 1NT United Kingdom
MAWDSLEY-BROOKS & COMPANY LIMITED
Unit 22, Quest Park Wheatley Hall Road Doncaster, DN2 4LT United Kingdom
Medicinal Product no longer authorised
The concentration of topotecan in Topotecan Eagle differs from other topotecan products and care should be taken to ensure appropriate dilution occurs to achieve the intended dose, which should be checked prior to administration to the patient.
The normal procedures for proper handling and disposal of anticancer medicinal products should be adopted:
Staff should be trained to dilute the medicinal product.
Pregnant staff should be excluded from working with this medicinal product.
Staff 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.
Medicinal Product no longer authorised
Topotecan Eagle concentrate is clear yellow to orange in colour and contains 3 mg/ml of topotecan, which is a higher concentration than found in other topotecan products for intravenous infusion.
The user is requested to report any medication errors. The following dosing tables should be used as reference:
Medicinal Product no longer authorised
Body surface area (m2) | For recommended dose '1.5 mg/m2' | For reduced dose '1.25 mg/m2' | For reduced dose '1.0 mg/m2' | |||
Volume of solution required (ml) | Total dose (mg) | Volume of solution required (ml) | Total dose (mg) | Volume of solution required (ml) | Total dose (mg) | |
1 | 0.50 | 1.50 | 0.42 | 1.26 | 0.33 | 0.99 |
1.1 | 0.55 | 1.65 | 0.46 | 1.38 | 0.37 | 1.11 |
1.2 | 0.60 | 1.80 | 0.50 | 1.50 | 0.40 | 1.20 |
1.3 | 0.65 | 1.95 | 0.54 | 1.62 | 0.43 | 1.29 |
1.4 | 0.70 | 2.10 | 0.58 | 1.74 | 0.47 | 1.41 |
1.5 | 0.75 | 2.25 | 0.63 | 1.89 | 0.50 | 1.50 |
1.6 | 0.80 | 2.40 | 0.67 | 2.01 | 0.53 | 1.59 |
1.7 | 0.85 | 2.55 | 0.71 | 2.13 | 0.57 | 1.71 |
1.8 | 0.90 | 2.70 | 0.75 | 2.25 | 0.60 | 1.80 |
1.9 | 0.95 | 2.85 | 0.79 | 2.37 | 0.63 | 1.89 |
2 | 1.00 | 3.00 | 0.83 | 2.49 | 0.67 | 2.01 |
2.1 | 1.05 | 3.15 | 0.88 | 2.64 | 0.70 | 2.10 |
2.2 | 1.10 | 3.30 | 0.92 | 2.76 | 0.73 | 2.19 |
2.3 | 1.15 | 3.45 | 0.96 | 2.88 | 0.77 | 2.31 |
2.4 | 1.20 | 3.60 | 1.00 | 3.00 | 0.80 | 2.40 |
2.5 | 1.25 | 3.75 | 1.04 | 3.12 | 0.83 | 2.49 |
Body surface area (m2) | For recommended dose '0.75 mg/m2' | For reduced dose '0.60 mg/m2' | For reduced dose '0.45 mg/m2' | |||
Volume of solution required (ml) | Total dose (mg) | Volume of solution required (ml) | Total dose (mg) | Volume of solution required (ml) | Total dose (mg) | |
1 | 0.25 | 0.75 | 0.20 | 0.60 | 0.15 | 0.45 |
1.1 | 0.28 | 0.84 | 0.22 | 0.66 | 0.17 | 0.51 |
1.2 | 0.30 | 0.90 | 0.24 | 0.72 | 0.18 | 0.54 |
1.3 | 0.33 | 0.99 | 0.26 | 0.78 | 0.20 | 0.60 |
1.4 | 0.35 | 1.05 | 0.28 | 0.84 | 0.21 | 0.63 |
1.5 | 0.38 | 1.14 | 0.30 | 0.90 | 0.23 | 0.69 |
1.6 | 0.40 | 1.20 | 0.32 | 0.96 | 0.24 | 0.72 |
1.7 | 0.43 | 1.29 | 0.34 | 1.02 | 0.26 | 0.78 |
1.8 | 0.45 | 1.35 | 0.36 | 1.08 | 0.27 | 0.81 |
1.9 | 0.48 | 1.44 | 0.38 | 1.14 | 0.29 | 0.87 |
2 | 0.50 | 1.50 | 0.40 | 1.20 | 0.30 | 0.90 |
2.1 | 0.53 | 1.59 | 0.42 | 1.26 | 0.32 | 0.96 |
2.2 | 0.55 | 1.65 | 0.44 | 1.32 | 0.33 | 0.99 |
2.3 | 0.58 | 1.74 | 0.46 | 1.38 | 0.35 | 1.05 |
2.4 | 0.60 | 1.80 | 0.48 | 1.44 | 0.36 | 1.08 |
2.5 | 0.63 | 1.89 | 0.50 | 1.50 | 0.38 | 1.14 |
Medicinal Product no longer authorised
Further dilution of Topotecan Eagle is required with either sodium chloride 9 mg/ml (0.9 % w/v) solution for injection or glucose 50 mg/ml (5 % w/v) solution for injection in order to reach a final topotecan concentration of between 25 µg/ml and 50 µg/ml in the solution for infusion to the patient. Dilution should be performed under strict aseptic conditions (e.g. an LAF bench).
From a microbiological point of view, the solution 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 20°C - 25°C and ambient lighting conditions.
Topotecan Eagle 3 mg/1 ml is for single use only. Any unused product or waste material should be disposed of in accordance with local requirements.