IMFINZI

Nchi: Indonesia

Lugha: Kiindonesia

Chanzo: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Viambatanisho vya kazi:

DURVALUMAB

Inapatikana kutoka:

ASTRAZENECA INDONESIA - Indonesia

INN (Jina la Kimataifa):

DURVALUMAB

Kipimo:

120 Mg

Dawa fomu:

LARUTAN KONSENTRAT UNTUK INFUS

Vitengo katika mfuko:

DUS, 1 VIAL @ 2.4 ML

Viwandani na:

CATALENT INDIANA LLC - United States of America

Idhini ya tarehe:

2019-11-17

Tabia za bidhaa

IMFINZI™
DURVALUMAB CONCENTRATED SOLUTION FOR INFUSION
1
NAME OF THE MEDICINAL PRODUCT
IMFINZI 120 mg Infusion
IMFINZI 500 mg Infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of IMFINZI concentrated solution for infusion contains
either 120 mg or 500 mg of
durvalumab.
For the full list of excipients, see Section 6.1.
3
PHARMACEUTICAL FORM
Sterile, preservative free, clear to opalescent and free from visible
particles, colourless to slightly
yellow, concentrated solution for infusion.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
LOCALLY ADVANCED NON-SMALL CELL LUNG CANCER (NSCLC)
IMFINZI (durvalumab) is indicated for the treatment of patients with
locally advanced,
unresectable NSCLC whose disease has not progressed following
platinum-based chemoradiation
therapy.
4.2
DOSE AND METHOD OF ADMINISTRATION
IMFINZI is for single use in one patient only. Discard any residue.
LOCALLY ADVANCED NSCLC
The recommended dose of IMFINZI is 10 mg/kg administered as an
intravenous infusion over 60
minutes every 2 weeks, for one year or until disease progression or
unacceptable toxicity.
It is recommended to continue treatment for clinically stable patients
with initial evidence of disease
progression until disease progression is confirmed.
Dose escalation or reduction is not recommended. Dose withholding, or
discontinuation may be
required based on individual safety and tolerability.
Guidelines for management of adverse reactions are described in Table
1.
Refer to Section 4.4 Special warnings and precautions for use for
further monitoring and evaluation
information.
1 of 19
TABLE 1. RECOMMENDED TREATMENT MODIFICATIONS AND MANAGEMENT FOR
ADVERSE REACTIONS
ADVERSE REACTIONS
SEVERITY
a
IMFINZI TREATMENT
MODIFICATION
ADDITIONAL MANAGEMENT
ADVICE
Pneumonitis
Grade 2
Withhold dose
b
Initiate 1 to 2 mg/kg/day
prednisone or equivalent
followed by a taper
Grade 3 or 4
Permanently discontinue
1 to 4 mg/kg/day prednisone or
equivalent followed by a taper
Hepatitis
Grade 2 with ALT
or AST >3-5xULN
and/or total
bilirubin >