Rybrevant

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

amivantamab

Available from:

Janssen-Cilag International N.V.   

ATC code:

L01FX

INN (International Name):

amivantamab

Therapeutic group:

Antineoplastic agents

Therapeutic area:

Carcinoma, Non-Small-Cell Lung

Therapeutic indications:

Rybrevant as monotherapy is indicated for treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) Exon 20 insertion mutations, after failure of platinum-based chemotherapy.

Product summary:

Revision: 3

Authorization status:

Authorised

Authorization date:

2021-12-09

Patient Information leaflet

23
B. PACKAGE LEAFLET
24
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RYBREVANT 350 MG CONCENTRATE FOR SOLUTION FOR INFUSION
amivantamab
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 or nurse.

If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Rybrevant is and what it is used for
2.
What you need to know before you are given Rybrevant
3.
How Rybrevant is given
4.
Possible side effects
5.
How to store Rybrevant
6.
Contents of the pack and other information
1.
WHAT RYBREVANT IS AND WHAT IT IS USED FOR
WHAT RYBREVANT IS
Rybrevant is a cancer medicine. It contains the active substance
‘amivantamab’, which is an antibody
(type of protein) designed to recognise and attach to specific targets
in the body.
WHAT RYBREVANT IS USED FOR
Rybrevant is used in adults with a type of lung cancer called
‘non-small cell lung cancer’. It is used
when the cancer has spread to other parts of your body and has gone
through certain changes (Exon 20
insertion mutations) in a gene called ‘EGFR’.
HOW RYBREVANT WORKS
The active substance in Rybrevant, amivantamab, targets two proteins
found on cancer cells:

epidermal growth factor receptor (EGFR), and

mesenchymal-epithelial transition factor (MET).
This medicine works by attaching to these proteins. This may help to
slow or stop your lung cancer
from growing. It may also help to reduce the size of the tumour.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN RYBREVANT
DO NOT USE RYBREVANT IF

you are allergic to amivantamab or any of the other

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Rybrevant 350 mg concentrate for solution for infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One mL of concentrate for solution for infusion contains 50 mg
amivantamab.
One 7 mL vial contains 350 mg of amivantamab.
Amivantamab is a fully-human Immunoglobulin G1 (IgG1)-based bispecific
antibody directed against
the epidermal growth factor (EGF) and mesenchymal-epidermal transition
(MET) receptors, produced
by a mammalian cell line (Chinese Hamster Ovary [CHO]) using
recombinant DNA technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
The solution is colourless to pale yellow, with a pH of 5.7 and an
osmolality of approximately
310 mOsm/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rybrevant as monotherapy is indicated for treatment of adult patients
with advanced non-small cell
lung cancer (NSCLC) with activating epidermal growth factor receptor
(EGFR) Exon 20 insertion
mutations, after failure of platinum-based therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Rybrevant should be initiated and supervised by a
physician experienced in the use of
anticancer medicinal products.
Rybrevant should be administered by a healthcare professional with
access to appropriate medical
support to manage infusion-related reactions (IRRs) if they occur.
Before initiation of Rybrevant therapy, EGFR Exon 20 insertion
mutation-positive status must be
established using a validated test method (see section 5.1).
Posology
Premedications should be administered to reduce the risk of IRRs with
Rybrevant (see below “Dose
modifications” and “Recommended concomitant medicinal
products”).
The recommended