Topotecan Teva
topotecan
topotecan
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or nurse.
If you get any side effects talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What Topotecan Teva is and what it is used for
What you need to know before you use Toptecan Teva
How to use Topotecan Teva
Possible side effects
How to store Topotecan Teva
Contents of the pack and other information
Topotecan Teva helps to kill tumour cells. Topotecan Teva is used to treat:
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 cells count is too low. Your doctor will tell you whether this is the case, based on the results of your last blood test;
→Tell your doctor if you think any of these could apply to you.
Talk to your doctor or nurse before using Topotecan Teva:
if you have any kidney problems. Your dose of Topotecan Teva may need to be adjusted. The use of Topotecan Teva is not recommended in patients with severe renal impairment;
if you have liver problems. Your dose of Topotecan Teva may need to be adjusted. The use of Topotecan Teva is not recommended in patients with severe liver impairment;
if you currently have lung problems, or if you have received previous radiation treatment or medicines that affected your lungs (also see section 4 ‘Possible side effects’);
if you suffer from unusual bruising or bleeding (also see section 4 ‘Possible side effects’);
if you are feeling very ill.
Topotecan Teva should not be used in pregnant women, unless clearly necessary. If you are or think you might be pregnant, tell your doctor immediately.
Women of child-bearing potential should use effective contraception to avoid becoming pregnant while on treatment.
Male patients who may wish to father a child should ask their doctor for family planning advice or treatment.
You must not breast-feed while on treatment with Topotecan Teva.
Topotecan Teva can make you feel tired or weak.
If you experience this, do not drive or use machines.
This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-
free’.
Your dose of Topotecan Teva will depend on:
the disease being treated
your body surface area (m2)
the results of blood tests carried out before and during treatment
how well you tolerate treatment.
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.
The experience in children is limited and treatment is therefore not recommended.
Topotecan Teva is supplied as a concentrate for solution for infusion. The concentrate must be diluted
before administration.
A doctor or nurse will give you the diluted Topotecan Teva solution as an infusion (a drip) usually into
your arm over about 30 minutes.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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 signs of bowel inflammation (neutropenic colitis).
Topotecan Teva may reduce your ability to fight infections.
difficulty 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 (also see section 2 ‘What you need to know before you use Topotecan Teva’).
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 a decrease in the number of blood clotting cells (platelets).
Abnormally low white blood cell count (leucopenia, neutropenia) which may be accompanied
with fever and signs of infections (febrile neutropenia).
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.
Hair loss.
Decrease in the number of all blood cells (pancytopenia)
Allergic or hypersensitivity reactions (including rash).
Yellow skin (jaundice) caused by abnormal liver function.
Itching (pruritus).
Severe infection (sepsis).
Feeling unwell (malaise).
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).
Discharge of blood into tissues (extravasation).
Severe stomach pain, nausea, vomiting of blood, black or bloody stools (possible symptoms of gastrointestinal perforation).
Mouth sores, difficulty swallowing, abdominal pain, nausea, vomiting, diarrhoea, bloody stools (possible signs and symptoms of inflammation of the inner lining of the mouth, stomach and/or
gut [mucosal inflammation]).
Tell a doctor if any of these becomes troublesome.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
effects 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.
Keep this medicine out of the sight and reach of children.
Do not use this medicine 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.
Store in a refrigerator (2°C - 8°C). Do not freeze.
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 12 hours if stored below 25°C or 24 hours at 2-8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Do not use Topotecan Teva if you notice any visible particles or if the solution is unclear.
Any unused product or waste material should be disposed of in accordance with local requirements for cytotoxic material.
The active substance is topotecan hydrochloride. One vial of 1 ml of concentrate contains 1 mg topotecan (as hydrochloride).
The other ingredients are: tartaric acid (E334), hydrochloric acid (E507), sodium hydroxide
(E524) and water for injections.
Topotecan Teva is a clear pale yellow liquid in a colourless glass vial with bromobutyl rubber stopper, aluminium seal and snap-cap.
Each vial contains 1 ml of the concentrate for solution for infusion. Topotecan Teva is supplied in cartons containing 1 vial or 5 vials. Not all pack sizes may be marketed.
Teva B.V. Swensweg 5 2031GA Haarlem The Netherlands
Pharmachemie B.V. Swensweg 5
2031 GA Haarlem
The Netherlands
TEVA Pharmaceutical Works Private Limited Company Táncsics Mihály út 82
H-2100 Gödöllő
Hungary
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Teva Pharma Belgium N.V./S.A./A.G. Tel/Tél: +32 3 820 73 73
UAB “Sicor Biotech” Tel: +370 5 266 02 03
Тева Фармасютикълс България ЕООД
Teл: +359 2 489 95 82
Teva Pharma Belgium N.V./S.A./A.G. Tél: +32 3 820 73 73
Teva Pharmaceuticals CR, s.r.o. Tel: +420 251 007 111
Teva Gyógyszergyár Zrt Tel.: +36 1 288 64 00
Teva Denmark A/S
Tlf: +45 44 98 55 11
Teva Pharmaceuticals Ireland L-Irlanda
Tel: +353 51 321740
Teva GmbH
Tel: +49 731 402 08
Teva Nederland B.V.
Tel: +31 800 0228 400
Teva Eesti esindus UAB Sicor Biotech Eesti filiaal
Tel: +372 661 0801
Teva Norway AS Tlf: +47 6677 55 90
Teva Ελλάς Α.Ε.
Τηλ: +30 210 72 79 099
ratiopharm Arzneimittel Vertriebs GmbH
Tel: +43 1 97007 0
Teva Pharma S.L.U. Tél: +34 91 387 32 80
Teva Pharmaceuticals Polska Sp. z o.o. Tel.: +48 22 345 93 00
Teva Santé
Tél: +33 1 55 91 7800
Teva Pharma - Produtos Farmacêuticos Lda
Tel: +351 21 476 75 50
Pliva Hrvatska d.o.o
Tel: + 385 1 37 20 000
Teva Pharmaceuticals S.R.L Tel: +4021 230 6524
Teva Pharmaceuticals Ireland Tel: +353 51 321 740
Pliva Ljubljana d.o.o. Tel: +386 1 58 90 390
ratiopharm Oy
Puh/Tel: +358 20 180 5900
Teva Pharmaceuticals Slovakia s.r.o. Tel: +421 2 5726 7911
Teva Italia S.r.l.
Tel: +39 028 917 981
ratiopharm Oy
Puh/Tel: +358 20 180 5900
Teva Ελλάς Α.Ε.
Τηλ: +30 210 72 79 099
Teva Sweden AB Tel: +46 42 12 11 00
UAB Sicor Biotech filiāle Latvijā
Tel: +371 67 323 666
Teva UK Limited
Tel: +44 1977 628 500
The concentrate is pale yellow in colour and contains 1 mg per ml of topotecan. Futher dilution of the appropriate volume of the concentrate with either sodium chloride 9 mg/ml (0.9%) solution for
injection or glucose 50 mg/ml (5%) solution for injection to reach a final topotecan concentration of between 25 and 50 microgram/ml in the solution for infusion.
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 12 hours if stored below 25°C or 24 hours at 2-8°C, unless dilution has taken place in controlled and validated aseptic conditions.
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.
Accidental contact with the skin or eyes should be treated immediately with copious amounts of water.
All items for administration or cleaning, including gloves, should be placed in high-risk, waste disposal bags for high-temperature incineration.