Country: Indoneżja
Lingwa: Indoneżjan
Sors: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
DURVALUMAB
ASTRAZENECA INDONESIA - Indonesia
DURVALUMAB
500 Mg
LARUTAN KONSENTRAT UNTUK INFUS
DUS, 1 VIAL @ 10 ML
CATALENT INDIANA LLC - United States of America
2019-11-17
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 > Aqra d-dokument sħiħ