OPDUALAG CONCENTRATE FOR SOLUTION FOR INFUSION 240MG80MG

Χώρα: Σιγκαπούρη

Γλώσσα: Αγγλικά

Πηγή: HSA (Health Sciences Authority)

Δραστική ουσία:

Nivolumab; Relatlimab

Διαθέσιμο από:

BRISTOL-MYERS SQUIBB (SINGAPORE) PTE. LTD.

Φαρμακολογική κατηγορία (ATC):

L01XY03

Φαρμακοτεχνική μορφή:

INFUSION, SOLUTION CONCENTRATE

Σύνθεση:

Nivolumab 240mg per vial; Relatlimab 80mg per vial

Οδός χορήγησης:

INTRAVENOUS

Τρόπος διάθεσης:

Prescription Only

Κατασκευάζεται από:

Catalent Indiana LLC

Καθεστώς αδειοδότησης:

ACTIVE

Ημερομηνία της άδειας:

2023-08-31

Αρχείο Π.Χ.Π.

OPDUALAG
® (NIVOLUMAB/RELATLIMAB)
CONCENTRATE FOR SOLUTION FOR INFUSION 240 MG/80 MG
1.
NAME OF THE MEDICINAL PRODUCT
Opdualag concentrate for solution for infusion 240 mg/80 mg.
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 unresectable or
metastatic melanoma in adults 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.
Posology

The recommended dose of Opdualag is 480 mg nivolumab and 160 mg
relatlimab every 4 weeks
administered as an intravenous infusion over 30-60 minutes.
Treatment with Opdualag should be continued as long as clinical
benefit is observed or until treatment
is no longer tolerated by the patient. Dose escalation or reduction is
not recommended. Dosing delay
or discontinuation may be required based on individual safety and
tolerability. Guidelines for
permanent discontinuation or withholding of doses are described in
Table 1. Detailed guidelines for
the management of immune-related adverse reactions are described in
section 4.4.
TABLE
1:
RECOMMENDED TREATMENT MODIFICATIONS FOR OPDUALAG
IMMUNE-RELATED ADVERSE
REACTION
SEVERITY
TREATMENT MODIFICATION
Immune-related pneumonitis
Grade 2 pneumonitis
Withhold dose(s) until symptom