IMFINZI CONCENTRATE FOR SOLUTION FOR INFUSION 50 MGML

Riik: Singapur

keel: inglise

Allikas: HSA (Health Sciences Authority)

Toimeaine:

Durvalumab

Saadav alates:

ASTRAZENECA SINGAPORE PTE LTD

ATC kood:

L01XC28

Ravimvorm:

INFUSION, SOLUTION CONCENTRATE

Koostis:

Durvalumab 50 mg/ml

Manustamisviis:

INTRAVENOUS

Retsepti tüüp:

Prescription Only

Valmistatud:

Catalent Indiana, LLC

Volitamisolek:

ACTIVE

Loa andmise kuupäev:

2018-10-29

Toote omadused

IMFINZI
®
(DURVALUMAB)
1.
NAME OF THE MEDICINAL PRODUCT
•
IMFINZI, 500 mg (500 mg/10 mL) for intravenous infusion.
•
IMFINZI, 120 mg (120 mg/2.4 mL) for intravenous infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL contains 50 mg of IMFINZI.
Each vial of 2.4 mL contains 120 mg of durvalumab.
Each vial of 10 mL contains 500 mg of durvalumab.
IMFINZI is a human immunoglobulin (IgG1κ) monoclonal antibody.
For a full list of excipient(s), see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate
for
solution
for
infusion;
50
mg/mL
in
single-dose
vial
for
intravenous
administration.
Sterile, preservative-free, clear to opalescent, colourless to
slightly yellow solution, free from
visible particles.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
LOCALLY ADVANCED NON-SMALL CELL LUNG CANCER (NSCLC)
IMFINZI is indicated for the treatment of patients with locally
advanced, unresectable NSCLC
whose disease has not progressed following platinum-based
chemoradiation therapy.
SMALL CELL LUNG CANCER (SCLC)
IMFINZI in combination with etoposide and either carboplatin or
cisplatin is indicated for the
first-line treatment of patients with extensive-stage small cell lung
cancer (ES-SCLC).
BILIARY TRACT CANCER (BTC)
IMFINZI in combination with cisplatin and gemcitabine, is indicated
for the treatment of
patients with locally advanced or metastatic biliary tract cancer
(BTC).
HEPATOCELLULAR CARCINOMA (HCC)
IMFINZI in combination with tremelimumab is indicated for the
treatment of patients with
unresectable hepatocellular carcinoma (uHCC) who have not received
prior systemic therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The recommended dose of IMFINZI depends on the indication as presented
in Table 1.
IMFINZI is administered as an intravenous infusion over 1 hour.
TABLE 1
RECOMMENDED DOSAGE OF IMFINZI
INDICATION
RECOMMENDED IMFINZI
DOSAGE
DURATION OF THERAPY
MONOTHERAPY
Locally Advanced NSCLC
10 mg/kg every 2 weeks or
1500 mg every 4 weeks
a
Until disease progression or
unacceptable toxicity
COMBINATION THERAPY