Topotecan Actavis
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 Actavis is and what it is used for
What you need to know before you use Topotecan Actavis
How to use Topotecan Actavis
Possible side effects
How to store Topotecan Actavis
Contents of the pack and other information
Medicinal product no longer authorised
Topotecan Actavis contains the active substance topotecan which helps to kill tumour cells. Topotecan Actavis is used to treat:
small cell lung cancer that has come back after chemotherapy, or
advanced cervical cancer if surgery or radiotherapy is not possible. In this case Topotecan Actavis treatment is combined with medicines containing cisplatin.
if you are allergic to topotecan or 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 Actavis;
if your blood cell counts are too low.
Talk to your doctor before using Topotecan Actavis:
if you have any kidney problems. Your dose of Topotecan Actavis may need to be adjusted.
Topotecan Actavis is not recommended in case of severe kidney impairment;
if you have liver problems. Topotecan Actavis is not recommended in case of severe liver impairment;
if you suffer from lung inflammation with signs such as cough, fever and difficulties in breathing, see also section 4 “Possible side effects”.
Topotecan Actavis 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 (haemorrhage). Talk to your doctor for advice on how to minimize the risk of bleeding.
The incidence of side effects is more frequent in patients who are in poor general health. 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.
The experience in children and adolescents is limited and treatment is therefore not recommended.
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Topotecan Actavis should not be used in pregnant women, unless clearly necessary. If you are or think you might be pregnant, tell your doctor immediately.
Effective contraception methods should be used to avoid becoming pregnant/fathering a child while on treatment. Ask your doctor for advice.
Patients who are concerned about their fertility should ask their doctor for counselling on fertility and family planning options prior to starting treatment.
You must not breast-feed while on treatment with Topotecan Actavis.
Topotecan Actavis can make you feel tired or weak. If you experience this, do not drive or use machines.
Medicinal product no longer authorised
This medicine contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodium-free’.
Your dose of Topotecan Actavis 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.
Adults
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 medicines containing cisplatin. For more information about cisplatin, please refer to the corresponding package leaflet.
Patients with impaired kidney function
Your doctor might need to reduce your dose based on your kidney function.
Topotecan is supplied as a powder for concentrate for solution for infusion. The powder must be dissolved, and the resulting concentrate further diluted before administration.
A doctor or nurse will give you the reconstituted and diluted Topotecan Actavis solution as an infusion (drip), usually into your arm, over about 30 minutes.
As this medicine is being given by your doctor or nurse, it is unlikely that you will be given too much. In the unlikely event of an overdose, your doctor will monitor you for side effects. Tell your doctor or nurse if you have any concerns about the amount of medicine that you receive.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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.
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 Actavis may reduce your ability to fight infections.
Medicinal product no longer authorised
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 “Warnings and precautions”.This condition can be fatal.
swelling of the face, lips, tongue or throat, difficulty breathing, low blood pressure, dizziness and itchy rash.
Other side effects with Topotecan Actavis include:
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.
Decrese in number of circulating white blood cells (leucotyes) in the blood. Abnormal low number of neutrophil granulocytes (a type of white blood cell) in the blood, with or without fever.
Unusual bruising or bleeding, sometimes severe, caused by a decrease in the number of blood clotting cells (platelets).
Weight loss and loss of appetite (anorexia); tiredness; weakness.
Feeling sick (nausea), vomiting; diarrhoea; stomach pain; constipation.
Inflammation of the lining of the mouth and digestive tract.
Fever.
Infections.
Hair loss.
Allergic (hypersensitivity) reactions (including rash).
Abnormal high level of bilirubin, a waste product produced by the liver during breakdown of red blood cells. Symptoms may include yellow skin (jaundice).
Decrease in the number of all blood cells (pancytopenia)
Feeling unwell.
Serious blood infection, which can be fatal.
Itching (pruritus).
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).
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 Actavis.
Medicinal product no longer authorised
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via thenationalreportingsystemlistedin 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 vial and carton. Keep the vial in the outer carton in order to protect from light. Storageafterreconstitutionanddilution
Chemical and physical stability of the concentrate has been demonstrated for 24 hours at 25 ± 2°C, in normal light conditions and 24 hours at 2°C to 8°C, protected from light.
The physico-chemical stability of the drug product solution obtained after dilution in solutions for infusion (NaCl 0.9 % and Glucose 5 %) has been demonstrated for 4 hours at room temperature, in normal lighting conditions, on samples reconstituted and stored for 12 hours and respectively
24 hours at 25oC ± 2oC and then diluted.
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 reconstitution/dilution has taken place in controlled and validated aseptic conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
The active substance is topotecan. Each vial contains 1 mg or 4 mg topotecan (as hydrochloride). After reconstitution 1 ml concentrate contains 1 mg topotecan.
The other ingredients are: mannitol (E421), tartaric acid (E334), hydrochloric acid (E507) and sodium hydroxide.
Topotecan Actavis is supplied in type I colourless glass vials with grey bromobutylic stopper and aluminium seals with plastic flip-off caps. Each vial is sheathed in a protective sleeve.
Packs:
1 x 1 mg vial; 5 x 1 mg vial
1 x 4 mg vial; 5 x 4 mg vial
Iceland
S.C. Sindan-Pharma S.R.L. 11 Ion Mihalache Blvd Bucharest
Romania
Medicinal product no longer authorised
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
ALL-in-1 bvba
Tél/Tel: +32 3 451 26 88
UAB “Actavis Baltics” Tel: +370 5 260 9615
Актавис ЕАД
Teл.: +359 2 9321 680
Tél/Tel: +32 3 451 26 88
Actavis CZ a.s.
Tel: +420 251 113 002
Actavis A/S
Tlf: +45 72 22 30 00
Actavis Ltd.
Tel: +35621693533
Actavis Deutschland GmbH & Co. KG Telefon: +49 (0)89 558909 0
Actavis B.V.
Tel: +31 35 54 299 33
UAB “Actavis Baltics” Eesti Filiaal Tel: +372 6100 565
Actavis Norway AS Tlf: +47 815 22 099
Τηλ: +30 210 5401500 Tel: +43 (0)662 435 235 00
Actavis Spain, S.A. Tfno.: +34 91 630 86 45
Actavis Export Int. Ltd., Malta. Kontakt w Polsce:
Tel.: (+48 22) 512 29 00
Actavis France
Tél: +33 4 72 72 60 72
Aurovitas, Unipessoal, Lda Tel: +351 214 185 104
Agmar d.o.o.
Tel: +385(1)6610-333
Actavis SRL
Tel: +40 21 318 17 77
Actavis Ireland Limited Tel: +353 (0)21 4619040
Apta Medica Internacional d.o.o. Tel: +386 51 615 015
Actavis Group PTC ehf. Sími: +354 550 3300
Actavis s.r.o.
Tel: +421 2 3255 3800
Aurobindo Pharma (Italia) s.r.l. Tel: +39 0296392601
Actavis Oy
Puh/Tel: +358 (0)9 348 233
Medicinal product no longer authorised
A. Potamitis Medicare Ltd Τηλ: +357 22583333
Actavis AB
Tel: +46 8 13 63 70
Actavis Baltics pārstāvniecība Latvijā Tel: +371 67067873
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The following information is intended for healthcare professionals only:
Reconstitution and dilution of the medicinal product must be performed by trained personnel.
The preparation should be performed in a designated area under aseptic conditions.
Adequate protective disposable gloves, goggles, gown and mask should be worn.
Precautions should be taken to avoid the medicinal product accidentally coming into contact with the eyes. In the event of contact with the eyes, irrigate with large amounts of water. Then seek medical evaluation by a physician.
In case of skin contact, thoroughly wash the affected area with large amount of water. Always wash hands after removing gloves.
Pregnant staff should not handle the cytotoxic preparation.
Adequate care and precautions should be taken in the disposal of items (syringes, needles etc) used to reconstitute and/or dilute cytotoxic medicinal products. Any unused product or waste material should be disposed of in accordance with local requirements.
Before infusion, Topotecan Actavis powder for concentrate for solution for infusion must be reconstituted with an appropriate volume of water for injections, as follows:
Topotecan Actavis 1 mg with 1.1 ml water for injections (as it contains 10 % overage of fill)
Topotecan Actavis 4 mg with 4 ml water for injections
Reconstitution will result in a concentrate containing 1 mg topotecan per ml. This concentrate (1 mg/ml) must be diluted prior to administration.
Medicinal product no longer authorised
The volume of reconstituted concentrate corresponding to the calculated individual dose, should be further diluted with either sodium chloride 9 mg/ml (0.9 %) solution for injection or 50 mg/ml (5 %) glucose solution for infusion, to a final concentration of between 25 and 50 microgram per ml in the solution for infusion, for example:
Volume for 25 microgram/ml solution | Volume for 50 microgram/ml solution | |
1 ml of 1 mg/ml topotecan solution | Add 39 ml to give 40 ml | Add 19 ml to give 20 ml |
4 ml of 1 mg/ml topotecan solution | Add 156 ml to give 160 ml | Add 76 ml to give 80 ml |
Chemical and physical stability of the concentrate has been demonstrated for 24 hours at 25 ± 2°C, in normal light conditions and 24 hours at 2°C to 8°C, protected from light.
Chemical and physical stability of the solution obtained after dilution of the concentrate in sodium chloride 9 mg/ml (0.9 %) solution for injection or 50 mg/ml (5 %) glucose solution for infusion has been demonstrated for 4 hours at 25 ± 2°C, in normal lighting conditions .The concentrates tested were reconstituted and stored at 25 ± 2°C for 12 hours and 24 hours respectively after reconstitution, and then diluted.
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 reconstitution/dilution has taken place in controlled and validated aseptic conditions.
Any unused product or waste material should be disposed of in accordance with local requirements. 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.
46
Medicinal product no longer authorised