Vargatef

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

nintedanib

Available from:

Boehringer Ingelheim International GmbH

ATC code:

L01XE3

INN (International Name):

nintedanib

Therapeutic group:

Antineoplastic agents

Therapeutic area:

Carcinoma, Non-Small-Cell Lung

Therapeutic indications:

Vargatef is indicated in combination with docetaxel for the treatment of adult patients with locally advanced, metastatic or locally recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumour histology after first line chemotherapy.

Product summary:

Revision: 18

Authorization status:

Authorised

Authorization date:

2014-11-21

Patient Information leaflet

35
B. PACKAGE LEAFLET
36
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VARGATEF 100 MG SOFT CAPSULES
nintedanib
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Vargatef is and what it is used for
2.
What you need to know before you take Vargatef
3.
How to take Vargatef
4.
Possible side effects
5.
How to store Vargatef
6.
Contents of the pack and other information
1.
WHAT VARGATEF IS AND WHAT IT IS USED FOR
Vargatef capsules contain the active substance nintedanib. Nintedanib
blocks the activity of a group of
proteins which are involved in the development of new blood vessels
that cancer cells need to supply
them with food and oxygen. By blocking the activity of these proteins,
nintedanib can help stop the
growth and spread of the cancer.
This medicine is used in combination with another cancer medicine
(docetaxel) to treat a cancer of the
lung called non-small cell lung cancer (NSCLC). It is for adult
patients whose NSCLC is of a certain
type (“_adenocarcinoma_”) and who had already received one
treatment with another medicine to treat
this cancer but whose tumour started to grow again.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE VARGATEF
DO NOT TAKE VARGATEF
-
if you are allergic to nintedanib, to peanut or soya, or to any of the
other ingredients of this
medicine (listed in section 6)
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking this medicine
-
if you have or had liver problems, if you have or had bleeding
problems, particularly recent
bleeding in the lung
-
if you

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Vargatef 100 mg soft capsules
Vargatef 150 mg soft capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Vargatef 100 mg soft capsules
Each soft capsule contains 100 mg nintedanib (as esilate).
_Excipients with known effect_
Each capsule contains 1.2 mg of soya lecithin.
Vargatef 150 mg soft capsules
Each soft capsule contains 150 mg nintedanib (as esilate).
_Excipients with known effect_
Each capsule contains 1.8 mg of soya lecithin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Soft capsule (capsule).
Vargatef 100 mg soft capsules
Peach-coloured, opaque, oblong soft-gelatin capsules imprinted on one
side in black with the
Boehringer Ingelheim company symbol and “100”.
Vargatef 150 mg soft capsules
Brown-coloured, opaque, oblong soft-gelatin capsule imprinted on one
side in black with the
Boehringer Ingelheim company symbol and “150”.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Vargatef is indicated in combination with docetaxel for the treatment
of adult patients with locally
advanced, metastatic or locally recurrent non-small cell lung cancer
(NSCLC) of adenocarcinoma
tumour histology after first-line chemotherapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Vargatef should be initiated and supervised by a
physician experienced in the use of
anticancer therapies.
Posology
The recommended dose of nintedanib is 200 mg twice daily administered
approximately 12 hours
apart, on days 2 to 21 of a standard 21 day docetaxel treatment cycle.
Vargatef must not be taken on the same day of docetaxel chemotherapy
administration (= day 1).
If a dose of nintedanib is missed, administration should resume at the
next scheduled time at the
recommended dose. The individual daily doses of nintedanib should not
be increased beyond the
recommended dose to make up for missed doses. The recommended maximum
daily dose of 400 mg
should not be exceeded.
3
Patients may continue therapy with nintedanib aft