TARCEVA erlotinib 25 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

erlotinib hydrochloride, Quantity: 27.32 mg

Available from:

Roche Products Pty Ltd

INN (International Name):

Erlotinib hydrochloride

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: magnesium stearate; microcrystalline cellulose; lactose monohydrate; sodium lauryl sulfate; sodium starch glycollate; titanium dioxide; hypromellose; hyprolose; macrogol 400

Administration route:

Oral

Units in package:

30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Non-small cell lung cancer: TARCEVA is indicated for the first-line treatment of patients with advanced (Stage IIIB) or metastatic (Stage IV) non-small cell lung cancer (NSCLC) with activating EGFR mutations. TARCEVA is indicated for maintenance therapy in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutations who have not progressed on 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 prior chemotherapy. Pancreatic cancer: TARCEVA in combination with gemcitabine is indicated for the treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.

Product summary:

Visual Identification: Round, biconvex, white to yellowish film-coated tablet with "T25" engraved on one side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 4 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2006-01-30

Patient Information leaflet

TARCEVA
®
_FILM-COATED TABLETS_
pronounced "tar-see-va"
_contains the active ingredient erlotinib_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Tarceva tablets. 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 Tarceva
tablets against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT TARCEVA IS USED
FOR
Tarceva contains the active
ingredient erlotinib.
Tarceva is used for the treatment of
non-small cell lung cancer (NSCLC).
It can be given before or after initial
chemotherapy if your cancer has
specific mutations in a protein called
epidermal growth factor receptor
(EGFR). It can also be given later on
when initial chemotherapy has not
worked.
Tarceva is also used in combination
with gemcitabine for the treatment of
pancreatic cancer.
Tarceva belongs to a group of
medicines called anti-neoplastic (or
anti-cancer) agents which are used to
treat cancer.
Tarceva prevents the activity of the
EGFR protein. This protein is known
to be involved in the growth and
spread of cancer cells.
Your doctor may have prescribed
Tarceva for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY TARCEVA HAS
BEEN PRESCRIBED FOR YOU.
Tarceva is not addictive.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
TARCEVA
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE TARCEVA IF:
1.
YOU HAVE HAD AN ALLERGIC
REACTION TO ERLOTINIB OR ANY
INGREDIENTS LISTED AT THE END OF
THIS LEAFLET
Some symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin
2.
THE PACKAGE IS TORN OR SHOWS
SIGNS OF TAMPERING

Summary of Product characteristics

Tarceva 190131
1
AUSTRALIAN PRODUCT INFORMATION
TARCEVA
® (ERLOTINIB HYDROCHLORIDE)
1.
NAME OF THE MEDICINE
Erlotinib hydrochloride
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tarceva film coated tablets are available in 3 dosage strengths
containing erlotinib
hydrochloride equivalent to 25 mg, 100 mg or 150 mg of erlotinib.
Excipients with known effect
Each 25 mg film-coated tablet contains 27.43 mg Lactose monohydrate.
Each 100 mg film-coated tablet contains 69.21 mg Lactose monohydrate.
Each 150 mg film-coated tablet contains 103.82 mg Lactose monohydrate.
For the full list of excipients, see section 6.1 List of Excipients.
3.
PHARMACEUTICAL FORM
Tarceva 25 mg film-coated tablets are white to yellowish, round,
biconvex tablets engraved
with ‘T 25’ on one side.
Tarceva 100 mg film-coated tablets are white to yellowish, round,
biconvex tablets engraved
with ‘T 100’ on one side.
Tarceva 150 mg film-coated tablets are white to yellowish, round,
biconvex tablets engraved
with ‘T 150’ on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
NON-SMALL CELL LUNG CANCER
Tarceva is indicated for the first-line treatment of patients with
advanced (Stage IIIB) or
metastatic (Stage IV) non-small cell lung cancer (NSCLC) with
activating EGFR mutations.
Tarceva is indicated for maintenance therapy in patients with locally
advanced or metastatic
non-small cell lung cancer (NSCLC) with activating EGFR mutations who
have not progressed
on 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 prior chemotherapy.
PANCREATIC CANCER
Tarceva in combination with gemcitabine is indicated for the treatment
of patients with locally
advanced, unresectable or metastatic pancreatic cancer.
4.2
DOSE AND METHOD OF ADMINISTRATION
NON-SMALL CELL LUNG CANCER
The recommended daily dose of Tarceva is 150 mg taken at least one
hour before or two hours
after the ingestion of food. Treatment should be continued until
disea