ERBITUX cetuximab (rmc) 100mg/20mL solution for intravenous infusion

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Cetuximab, Quantity: 5 mg/mL

Available from:

Merck Healthcare Pty Ltd

INN (International Name):

Cetuximab

Pharmaceutical form:

Injection, intravenous infusion

Composition:

Excipient Ingredients: water for injections; citric acid monohydrate; polysorbate 80; sodium chloride; sodium hydroxide; glycine

Administration route:

Intravenous

Units in package:

1 x 20mL vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Erbitux is indicated for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, RAS wild-type metastatic colorectal cancer. In combination with infusional 5-fluorouracil/folinic acid plus irinotecan. In combination with irinotecan in patients who are refractory to first-line chemotherapy. In first-line in combination with FOLFOX. As a single agent in patients who have failed or are intolerant to oxaliplatin-based therapy and irinotecan-based therapy. (See CLINICAL TRIALS) Erbitux is indicated for the treatment of patients with squamous cell cancer of the head and neck. In combination with radiation therapy for locally advanced disease. In combination with platinum-based chemotherapy for recurrent and/or metastatic disease.

Product summary:

Visual Identification: Clear to slightly opalescent, colourless to yellowish solution.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 4 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2007-09-25

Patient Information leaflet

ERBITUX
®
_cetuximab (rmc)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ERBITUX.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of treating you with ERBITUX
against the benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT
RECEIVING THIS MEDICINE, TALK TO
YOUR DOCTOR, NURSE OR THE HOSPITAL
PHARMACIST.
KEEP THIS LEAFLET WHILE YOU ARE
BEING TREATED WITH ERBITUX.
You may need to read it again.
WHAT ERBITUX IS
USED FOR
ERBITUX is used to treat certain
cancers that have a protein on their
cell surface called epidermal growth
factor receptor (EGFR). When a
growth factor called EGF attaches to
EGFR it turns on signals within the
cell causing it to grow and divide to
form more cells. In many human
tumours, there is an over-activation
of these receptors, which leads to
increased uncontrolled growth of
cancer cells and development into a
tumour.
_HOW ERBITUX WORKS_
The active substance in ERBITUX is
cetuximab. It belongs to a group of
medicines called monoclonal
antibodies. Monoclonal antibodies
are proteins that specifically
recognise and attach to other unique
proteins. ERBITUX attaches to the
EGFR more tightly than EGF and
thereby interferes with the growth of
cancer cells.
_WHAT ERBITUX DOES_
ERBITUX is used to treat metastatic
colorectal cancer (cancer of the colon
or large intestine and rectum that has
spread to other parts of the body). It
may be used alone or in combination
with certain types of medicines
called chemotherapy to treat
metastatic colorectal cancer.
Before you are prescribed
ERBITUX, your doctor will test your
cancer cells to see if they contain
either the normal (wild-type) or
mutant forms of genes called RAS.
ERBITUX is used to treat patients
who express normal RAS genes.
ERBITUX is used to treat locally
advanced head and neck cancer, in
combination with radiation therapy.
It is also used to tr

Summary of Product characteristics

ERBITUX Product Information
Version: A016-1019
Page 1 of 21
Supersedes: A015-1018
AUSTRALIAN PRODUCT INFORMATION – ERBITUX
® (CETUXIMAB (RMC)) SOLUTION FOR
INJECTION (INTRAVENOUS INFUSION)
1.
NAME OF THE MEDICINE
cetuximab (rmc)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 20 mL vial contains 100 mg cetuximab.
Each 100 mL vial contains 500 mg cetuximab.
Each mL solution contains 5 mg cetuximab.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
Erbitux is a sterile, preservative-free, colourless solution that is
intended for intravenous
infusion.
4.
CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Erbitux is indicated for the treatment of patients with epidermal
growth factor receptor
(EGFR)-expressing, _RAS_ wild-type metastatic colorectal cancer
•
in combination with infusional 5-fluorouracil/folinic acid plus
irinotecan
•
in combination with irinotecan in patients who are refractory to
first-line chemotherapy
•
in first-line in combination with FOLFOX
•
as a single agent in patients who have failed or are intolerant to
oxaliplatin-based
therapy and irinotecan-based therapy.
(see Clinical trials)
Erbitux is indicated for the treatment of patients with squamous cell
cancer of the head and
neck
•
in combination with radiation therapy for locally advanced disease
•
in combination with platinum-based chemotherapy for recurrent and/or
metastatic
disease.
4.2. DOSE AND METHOD OF ADMINISTRATION
Erbitux must be administered under the supervision of a physician
experienced in the use of
antineoplastic agents. Close monitoring is required during the
infusion and for at least 1 hour
after the end of the infusion. Availability of resuscitation equipment
must be ensured.
ERBITUX Product Information
Version: A016-1019
Page 2 of 21
Supersedes: A015-1018
Prior to the first infusion, patients must receive a premedication
with an antihistamine and a
corticosteroid at least 1 hour prior to administration of cetuximab.
Similar premedication is
recommended prior to all su