GIOTRIF afatinib 50 mg (as dimaleate) film coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

afatinib dimaleate, Quantity: 73.9 mg

Available from:

Boehringer Ingelheim Pty Ltd

INN (International Name):

Afatinib dimaleate

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: purified talc; polysorbate 80; indigo carmine aluminium lake; colloidal anhydrous silica; magnesium stearate; lactose monohydrate; macrogol 400; hypromellose; microcrystalline cellulose; titanium dioxide; crospovidone

Administration route:

Oral

Units in package:

14 film coated tablets, 7 film coated tablets, 28 film coated tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

GIOTRIF is indicated as monotherapy for the treatment of adult patients with:,? Locally advanced or metastatic non-squamous non-small cell carcinoma of the lung, either as first line therapy or after failure of cytotoxic chemotherapy. Tumours must have activating Epidermal Growth Factor Receptor (EGFR) mutations.,? Locally advanced or metastatic squamous non-small cell carcinoma of the lung progressing on or after platinum-based chemotherapy.

Product summary:

Visual Identification: Dark blue, oval, biconvex film coated tablet. One side debossed with T50, other side debossed with BI company symbol.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2013-11-07

Patient Information leaflet

GIOTRIF
®
_FILM-COATED TABLETS_
_afatinib (as dimaleate)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Giotrif.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking this medicine
against the expected benefits.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
This leaflet was last updated on the
date at the end of this leaflet. More
recent information may be available.
The latest Consumer Medicine
Information is available from your
pharmacist, doctor or from
www.medicines.org.au and may
contain important information about
the medicine and its use of which
you should be aware.
KEEP THIS INFORMATION WITH THE
MEDICINE.
You may need to read it again.
WHAT GIOTRIF IS USED
FOR
Giotrif contains the active substance
afatinib (as afatinib dimaleate).
Giotrif belongs to a group of
medicines called antineoplastic (or
anti-cancer) agents.
It works by blocking the activity of a
group of proteins from the ErbB
family, which includes a protein
called Epidermal Growth Factor
Receptor (EGFR). These proteins are
known to be involved in the growth
and spread of cancer cells. By
blocking the activity of these proteins
Giotrif stops the cancer cells from
growing and multiplying.
Giotrif is used to treat adult patients
with a type of lung cancer called
non-small cell lung cancer (NSCLC):
•
of non-squamous type identified
with a change (mutation) in the
gene for EGFR. Giotrif can be
prescribed to you as your first
treatment or if your cancer has
progressed after receiving
chemotherapy
•
of squamous type if your cancer
has progressed after receiving
chemotherapy.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY GIOTRIF HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
Giotrif for another reason.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE GIOTR

Summary of Product characteristics

GIOTRIF PI0143-08
1
AUSTRALIAN PRODUCT INFORMATION – GIOTRIF
® AFATINIB DIMALEATE FILM COATED TABLET
1 NAME OF THE MEDICINE
afatinib (as afatinib dimaleate)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
GIOTRIF 20 mg film-coated tablets
One film-coated tablet contains 20 mg afatinib (as dimaleate).
Excipient with known effect: One film-coated tablet contains 118 mg
lactose (as monohydrate).
GIOTRIF 30 mg film-coated tablets
One film-coated tablet contains 30 mg afatinib (as dimaleate).
Excipient with known effect: One film-coated tablet contains 176 mg
lactose (as monohydrate).
GIOTRIF 40 mg film-coated tablets
One film-coated tablet contains 40 mg afatinib (as dimaleate).
Excipient with known effect: One film-coated tablet contains 235 mg
lactose (as monohydrate).
GIOTRIF 50 mg film-coated tablets
One film-coated tablet contains 50 mg afatinib (as dimaleate).
Excipient with known effect: One film-coated tablet contains 294 mg
lactose (as monohydrate).
For the full list of excipients, see Section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
GIOTRIF 20 mg tablets are film-coated white to slightly yellowish,
round, biconvex and bevel-
edged. One side is debossed with the code “T20”, the other side is
debossed with the Boehringer
Ingelheim company symbol.
GIOTRIF 30 mg tablets are film-coated dark blue, round, biconvex and
bevel-edged. One side
is debossed with the code “T30”, the other side is debossed with
the Boehringer Ingelheim
company symbol.
GIOTRIF
40 mg tablets are film-coated light blue, round, biconvex and
bevel-edged. One side is
debossed with the code “T40”, the other side is debossed with the
Boehringer Ingelheim
company symbol.
GIOTRIF 50 mg tablets are film-coated dark blue, oval and biconvex.
One side is debossed with
the code “T50”, the other side is debossed with the Boehringer
Ingelheim company symbol.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
GIOTRIF is indicated as monotherapy for the treatment of patients
with:
•
Locally advanced or metastatic non-squamous non-small