Tarceva

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

erlotinib

Available from:

Roche Registration GmbH

ATC code:

L01EB02

INN (International Name):

erlotinib

Therapeutic group:

Antineoplastic agents

Therapeutic area:

Carcinoma, Non-Small-Cell Lung; Pancreatic Neoplasms

Therapeutic indications:

Non-small cell lung cancer (NSCLC)Tarceva is also indicated for switch maintenance treatment in patients with locally advanced or metastatic non-small cell lung cancer with EGFR activating mutations and stable disease after first-line chemotherapy.Tarceva is also indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen.In patients with tumours without EGFR activating mutations, Tarceva is indicated when other treatment options are not considered suitable.When prescribing Tarceva, factors associated with prolonged survival should be taken into account.No survival benefit or other clinically relevant effects of the treatment have been demonstrated in patients with Epidermal Growth Factor Receptor (EGFR)-IHC - negative tumours.Pancreatic cancerTarceva in combination with gemcitabine is indicated for the treatment of patients with metastatic pancreatic cancer.When prescribing Tarceva, factors associated with prolonged survival should be taken into account.

Product summary:

Revision: 32

Authorization status:

Authorised

Authorization date:

2005-09-19

Patient Information leaflet

34
B. PACKAGE LEAFLET
35
PACKAGE LEAFLET: INFORMATION FOR THE USER
TARCEVA 25 MG FILM-COATED TABLETS
TARCEVA 100 MG FILM-COATED TABLETS
TARCEVA 150 MG FILM-COATED TABLETS
erlotinib
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 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 Tarceva is and what it is used for
2.
What you need to know before you take Tarceva
3.
How to take Tarceva
4.
Possible side effects
5.
How to store Tarceva
6.
Contents of the pack and other information
1.
WHAT TARCEVA IS AND WHAT IT IS USED FOR
Tarceva contains the active substance erlotinib. Tarceva is a medicine
used to treat cancer by
preventing the activity of a protein called epidermal growth factor
receptor (EGFR). This protein is
known to be involved in the growth and spread of cancer cells.
Tarceva is indicated for adults. This medicine can be prescribed to
you if you have non-small cell lung
cancer at an advanced stage. It can be prescribed as initial therapy
or as therapy if your disease
remains largely unchanged after initial chemotherapy, provided your
cancer cells have specific EGFR
mutations. It can also be prescribed if previous chemotherapy has not
helped to stop your disease.
This medicine can also be prescribed to you in combination with
another treatment called gemcitabine
if you have cancer of the pancreas at a metastatic stage.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TARCEVA
DO NOT TAKE TARCEVA
•
if you are allergic to erlotinib or any of the ingredients of this
medicine (listed in section 6).
WARNINGS AND PRECAUTIONS:
•
if you are taking ot

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
_ _
2
1.
NAME OF THE MEDICINAL PRODUCT
Tarceva 25 mg film-coated tablets
Tarceva 100 mg film-coated tablets
Tarceva 150 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tarceva 25 mg film coated tablets
Each film-coated tablet contains 25 mg erlotinib (as erlotinib
hydrochloride).
Tarceva 100 mg film-coated tablets
Each film-coated tablet contains 100 mg erlotinib (as erlotinib
hydrochloride).
Tarceva 150 mg film-coated tablets
Each film-coated tablet contains 150 mg erlotinib (as erlotinib
hydrochloride).
Excipients with known effect
_Tarceva 25 mg film coated tablets _
Each 25 mg film-coated tablet contains 27.43 mg Lactose monohydrate.
_Tarceva 100 mg film-coated tablets _
Each 100 mg film-coated tablet contains 69.21 mg Lactose monohydrate.
_Tarceva 150 mg film-coated tablets _
Each 150 mg film-coated tablet contains 103.82 mg Lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Tarceva 25 mg film coated tablets
White to yellowish, round, biconvex tablets with ‘T 25’ engraved
on one side.
Tarceva 100 mg film-coated tablets
White to yellowish, round, biconvex tablets with ‘T 100’ engraved
on one side.
Tarceva 150 mg film-coated tablets
White to yellowish, round, biconvex tablets with ‘T 150’ engraved
on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Non-Small Cell Lung Cancer (NSCLC)
Tarceva is indicated for the first-line treatment of patients with
locally advanced or metastatic non-
small cell lung cancer (NSCLC) with EGFR activating mutations.
Tarceva is also indicated for switch maintenance treatment in patients
with locally advanced or
metastatic NSCLC with EGFR activating mutations and stable disease
after first-line chemotherapy.
3
Tarceva is also indicated for the treatment of patients with locally
advanced or metastatic NSCLC
after failure of at least one prior chemotherapy regimen. In patients
with tumours without EGFR
activating mutations, Tarceva is