Topotecan Actavis

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

topotecan

Available from:

Actavis Group PTC ehf

ATC code:

L01CE01

INN (International Name):

topotecan

Therapeutic group:

Antineoplastic agents

Therapeutic area:

Uterine Cervical Neoplasms; Small Cell Lung Carcinoma

Therapeutic indications:

Topotecan monotherapy is indicated for the treatment of patients with relapsed small cell lung cancer [SCLC] for whom re-treatment with the first-line regimen is not considered appropriate. Topotecan in combination with cisplatin is indicated for patients with carcinoma of the cervix recurrent after radiotherapy and for patients with Stage IVB disease. Patients with prior exposure to cisplatin require a sustained treatment free interval to justify treatment with the combination.,

Product summary:

Revision: 6

Authorization status:

Withdrawn

Authorization date:

2009-07-24

Patient Information leaflet

38
B. PACKAGE LEAFLET
39
PACKAGE LEAFLET: INFORMATION FOR THE USER
TOPOTECAN ACTAVIS 1 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR
INFUSION
TOPOTECAN ACTAVIS 4 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR
INFUSION
topotecan
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
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 IS IN THIS LEAFLET:
1.
What Topotecan Actavis is and what it is used for
2.
What you need to know before you use Topotecan Actavis
3.
How to use Topotecan Actavis
4.
Possible side effects
5.
How to store Topotecan Actavis
6.
Contents of the pack and other information
1.
WHAT TOPOTECAN ACTAVIS IS AND WHAT IT IS USED FOR
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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE TOPOTECAN ACTAVIS
DO NOT USE TOPOTECAN ACTAVIS
-
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.
TELL YOU DOCTOR if you think any of these could apply to you.
WARNINGS AND PRECAUTIONS
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 su

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Topotecan Actavis 1 mg powder for concentrate for solution for
infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 1 mg topotecan (as hydrochloride).
After reconstitution, 1 ml concentrate contains 1 mg topotecan.
Excipient with known effect:
Each vial contains 0.52 mg (0.0225 mmol) sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
Yellow lyophilisate.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Topotecan monotherapy is indicated for the treatment of patients with
relapsed small cell lung cancer
(SCLC) for whom re-treatment with the first-line regimen is not
considered appropriate (see
section 5.1).
Topotecan in combination with cisplatin is indicated for patients with
carcinoma of the cervix
recurrent after radiotherapy and for patients with Stage IVB disease.
Patients with prior exposure to
cisplatin require a sustained treatment free interval to justify
treatment with the combination (see
section 5.1).
4.2
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).
Posology
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 10
9
/l, a platelet count of ≥ 100 x 10
9
/l and a haemoglobin level of ≥ 9 g/dl (after transfusion
if necessary).
_Small Cell Lung Carcinoma _
_Initial dose _
The recommended dose of topotecan is 1.5 mg/m
2
body surface area/day administered by intravenous
infusion over 30 minutes daily for five consecutive days with a three
week interval between the start
3
of each course. If well tolerated, treatment may continue un