Vectibix

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

panitumumab

Saatavilla:

Amgen Europe B.V.

ATC-koodi:

L01XC08

INN (Kansainvälinen yleisnimi):

panitumumab

Terapeuttinen ryhmä:

Antineoplastic agents

Terapeuttinen alue:

Colorectal Neoplasms

Käyttöaiheet:

Vectibix is indicated for the treatment of adult patients with wild-type RAS metastatic colorectal cancer (mCRC): , in first-line in combination with Folfox or Folfiri., in second-line in combination with Folfiri for patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan)., as monotherapy after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.

Tuoteyhteenveto:

Revision: 34

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2007-12-03

Pakkausseloste

27
B. PACKAGE LEAFLET
28
PACKAGE LEAFLET: INFORMATION FOR THE USER
VECTIBIX 20 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
panitumumab
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 Vectibix is and what it is used for
2.
What you need to know before you use Vectibix
3.
How to use Vectibix
4.
Possible side effects
5.
How to store Vectibix
6.
Contents of the pack and other information
1.
WHAT VECTIBIX IS AND WHAT IT IS USED FOR
Vectibix is used in the treatment of metastatic colorectal cancer
(cancer of the bowel) for adult patients
with a certain type of tumour known as a “Wild-type
_RAS _
tumour”. Vectibix is used alone or in
combination with other anti-cancer medicines.
Vectibix contains the active substance panitumumab, which belongs to a
group of medicines called
monoclonal antibodies. Monoclonal antibodies are proteins, which
specifically recognise and attach
(bind) to other unique proteins in the body.
Panitumumab recognises and binds specifically to a protein known as
epidermal growth factor
receptor (EGFR), which is found on the surface of some cancer cells.
When growth factors (other
body proteins) attach to the EGFR, the cancer cell is stimulated to
grow and divide. Panitumumab
binds onto the EGFR and prevents the cancer cell from receiving the
messages it needs for growth and
division.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE VECTIBIX
DO NOT USE VECTIBIX
•
if you are allergic to panitumumab or any of the other ingredients of
this medicine (listed in
section 6).
•
if you have previously had or have evidence of interstitial
pneumonitis (swelling of the lungs
causing coughing and difficulty breathing) or pulmonary fibrosis
(scarring and thickening in t

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Vectibix 20 mg/mL concentrate for solution for infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of concentrate contains 20 mg panitumumab.
Each vial contains either 100 mg of panitumumab in 5 mL, or 400 mg of
panitumumab in 20 mL.
When prepared according to the instructions given in section 6.6, the
final panitumumab concentration
should not exceed 10 mg/mL.
Panitumumab is a fully human monoclonal IgG2 antibody produced in a
mammalian cell line (CHO)
by recombinant DNA technology.
Excipient with known effect
Each mL of concentrate contains 0.150 mmol sodium, which is 3.45 mg
sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate).
Colourless, pH 5.6 to 6.0 solution that may contain translucent to
white, visible amorphous,
proteinaceous panitumumab particles.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Vectibix is indicated for the treatment of adult patients with
wild-type
_RAS_
metastatic colorectal
cancer (mCRC):
•
in first-line in combination with FOLFOX or FOLFIRI.
•
in second-line in combination with FOLFIRI for patients who have
received first-line
fluoropyrimidine-based chemotherapy (excluding irinotecan).
•
as monotherapy after failure of fluoropyrimidine-, oxaliplatin-, and
irinotecan-containing
chemotherapy regimens.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Vectibix treatment should be supervised by a physician experienced in
the use of anti-cancer therapy.
Evidence of wild-type
_RAS_
(
_KRAS_
and
_NRAS_
) status is required before initiating treatment with
Vectibix. Mutational status should be determined by an experienced
laboratory using validated test
methods for detection of
_KRAS_
(exons 2, 3, and 4) and
_NRAS_
(exons 2, 3, and 4) mutations.
Posology
The recommended dose of Vectibix is 6 mg/kg of bodyweight given once
every two weeks.
3
Modification of the dose of Vectibix may be necessary in cases of
severe