Erbitux 100mg20ml solution for infusion vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Cetuximab

Available from:

Merck Serono Ltd

ATC code:

L01XC06

INN (International Name):

Cetuximab

Dosage:

5mg/1ml

Pharmaceutical form:

Solution for infusion

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: ; GTIN: 5013837321564

Patient Information leaflet

page 1
7872185210
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 cells if
they contain the normal (wild-type) or mutant form of
RaS. You must not receive erbitux i

Summary of Product characteristics

OBJECT 1
ERBITUX 5MG/ML SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 15-Dec-2016 | Merck
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 subseque