Opdualag

Pajjiż: Unjoni Ewropea

Lingwa: Ingliż

Sors: EMA (European Medicines Agency)

Ingredjent attiv:

nivolumab, Relatlimab

Disponibbli minn:

Bristol-Myers Squibb Pharma EEIG

Kodiċi ATC:

L01XY03

INN (Isem Internazzjonali):

relatlimab / nivolumab

Grupp terapewtiku:

Antineoplastic agents, Monoclonal antibodies

Żona terapewtika:

Melanoma

Indikazzjonijiet terapewtiċi:

Opdualag is indicated for the first line treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older with tumour cell PD L1 expression < 1%.

L-istatus ta 'awtorizzazzjoni:

Authorised

Data ta 'l-awtorizzazzjoni:

2022-09-15

Fuljett ta 'informazzjoni

31
B. PACKAGE LEAFLET
32
PACKAGE LEAFLET: INFORMATION FOR THE USER
OPDUALAG 240 MG/80 MG CONCENTRATE FOR SOLUTION FOR INFUSION
nivolumab/relatlimab
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 START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
It is important that you keep the patient card with you at all times.
-
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 Opdualag is and what it is used for
2.
What you need to know before you are given Opdualag
3.
How to use Opdualag
4.
Possible side effects
5.
How to store Opdualag
6.
Contents of the pack and other information
1.
WHAT OPDUALAG IS AND WHAT IT IS USED FOR
Opdualag is a cancer medicine used to treat advanced melanoma (a type
of skin cancer that can spread
elsewhere in the body). It can be used in adults and in adolescents 12
years of age and older.
Opdualag contains two active substances: nivolumab and relatlimab.
Both active substances are
monoclonal antibodies, proteins designed to recognise and attach to a
specific target substance in the
body. Nivolumab attaches to a target protein called PD 1. Relatlimab
attaches to a target protein called
LAG-3.
PD 1 and LAG-3 can switch off the activity of T cells (a type of white
blood cell that forms part of the
immune system, the body’s natural defences). By attaching to the two
proteins, nivolumab and
relatlimab block their actions and prevent them from switching off
your T cells. This helps increase
the T cell activity against the melanoma cancer cells.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN OPDUALAG
YOU SHOULD NOT BE GIVEN OPDUALAG
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Karatteristiċi tal-prodott

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
Opdualag 240 mg/80 mg concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of concentrate for solution for infusion contains 12 mg of
nivolumab and 4 mg of relatlimab.
One vial of 20 mL contains 240 mg of nivolumab and 80 mg of
relatlimab.
Nivolumab and relatlimab are human immunoglobulin G4 (IgG4) monoclonal
antibodies produced in
Chinese Hamster Ovary cells by recombinant DNA technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate).
Clear to opalescent, colourless to slightly yellow liquid that is
essentially free of particles.
The solution has a pH of approximately 5.8 and an osmolality of
approximately 310 mOsm/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Opdualag is indicated for the first-line treatment of advanced
(unresectable or metastatic) melanoma in
adults and adolescents 12 years of age and older with tumour cell
PD-L1 expression < 1%.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment must be initiated and supervised by physicians experienced
in the treatment of cancer.
Patients treated with Opdualag must be given the patient card and be
informed about the risks of
Opdualag (see also package leaflet).
PD-L1 testing
Patients should be selected for treatment with Opdualag based on the
tumour expression of PD-L1
confirmed by a validated test (see sections 4.4 and 5.1).
Posology
The recommended dose for adults and adolescents 12 years of age and
older is 480 mg nivolumab and
160 mg relatlimab every 4 weeks administered as an intravenous
infusion over 30 minutes. This dose
is established for adolescent patients weighing at least 30 kg (see
s