Erbitux

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

cetuximab

Saatavilla:

Merck Europe B.V. 

ATC-koodi:

L01FE01

INN (Kansainvälinen yleisnimi):

cetuximab

Terapeuttinen ryhmä:

Antineoplastic agents

Terapeuttinen alue:

Head and Neck Neoplasms; Colorectal Neoplasms

Käyttöaiheet:

Erbitux is indicated for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, RAS wild-type metastatic colorectal cancer:in combination with irinotecan-based chemotherapy;in first-line in combination with FOLFOX;as a single agent in patients who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecan.For details, see section 5.1.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.

Tuoteyhteenveto:

Revision: 29

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2004-06-29

Pakkausseloste

28
B. PACKAGE LEAFLET
29
PACKAGE LEAFLET: INFORMATION FOR THE USER
ERBITUX 5 MG/ML SOLUTION FOR INFUSION
Cetuximab
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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.
−
If you get any side effects, talk to your doctor. This includes any
possible side effects not listed
in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Erbitux is and what it is used for
2.
What you need to know before you use Erbitux
3.
How to use Erbitux
4.
Possible side effects
5.
How to store Erbitux
6.
Contents of the pack and other information
1.
WHAT ERBITUX IS AND WHAT IT IS USED FOR
WHAT ERBITUX IS
Erbitux contains cetuximab, a monoclonal antibody. Monoclonal
antibodies are proteins that
specifically recognise and bind to other unique proteins called
antigens. Cetuximab binds to the
epidermal growth factor receptor (EGFR), an antigen on the surface of
certain cancer cells. EGFR
activates proteins called RAS. RAS proteins play an important role in
the EGFR pathway – a complex
signalling cascade which is involved in the development and
progression of cancer. As a result of this
binding, the cancer cell can no longer receive the messages it needs
for growth, progression and
metastasis.
WHAT ERBITUX IS USED FOR
Erbitux is used to treat two different types of cancer:
•
metastatic cancer of the large intestine. In these patients, Erbitux
is used alone or in combination
with other anticancer medicines.
•
a certain type of cancer of the head and neck (squamous cell cancer).
In these patients, Erbitux
is used in combination with radiation therapy or with other anticancer
medicines.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ERBITUX
DO NOT USE ERBITUX
Do not use Erbitux if you have ever had a severe hypersensitivity
(allergic) reaction to cetuximab.
Before starting treatment for metastatic cancer of the large intestine
your doctor will test your cancer

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Erbitux 5 mg/mL solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of solution for infusion contains 5 mg cetuximab.
Each vial of 20 mL contains 100 mg cetuximab.
Each vial of 100 mL contains 500 mg cetuximab.
Cetuximab is a chimeric monoclonal IgG
1
antibody produced in a mammalian cell line (Sp2/0) by
recombinant DNA technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion.
Colourless solution.
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 irinotecan-based chemotherapy,
•
in first-line in combination with FOLFOX,
•
as a single agent in patients who have failed oxaliplatin- and
irinotecan-based therapy and who
are intolerant to irinotecan.
_For details, see section 5.1. _
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
POSOLOGY AND METHOD OF ADMINISTRATION
Erbitux must be administered under the supervision of a physician
experienced in the use of
antineoplastic medicinal products. 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.
_ _
Posology
Prior to the first infusion, patients must receive premedication with
an antihistamine and a
corticosteroid at least 1 hour prior to administration of cetuximab.
This premedication is recommended
prior to all subsequent infusions.
In all indications, Erbitux is administered once a week. The initial
dose is 400 mg cetuximab per m
2
body surface area. All subsequent weekly doses are 250 mg cetuximab
per m
2
each.
3
_Col