Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
REGORAFENIB MONOHYDRATE
BAYER CO. (MALAYSIA) SDN. BHD.
REGORAFENIB MONOHYDRATE
1X28tablet Tablets; 3X28tablet Tablets
BAYER AG
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Reference: NDA 203085 Stivarga USPI CCDS 9 SN0155 Safety Updates. Date of revision: 12 Jul 2022 RESTRICTED 1 INDICATIONS AND USAGE 1.1 COLORECTAL CANCER STIVARGA ® is indicated for the treatment of patients with metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild- type, an anti-EGFR therapy. 1.2 GASTROINTESTINAL STROMAL TUMORS STIVARGA ® is indicated for the treatment of patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate. 1.3 HEPATOCELLULAR CARCINOMA STIVARGA ® is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. 2 DOSAGE AND ADMINISTRATION 2.1 RECOMMENDED DOSE The recommended dose is 160 mg STIVARGA (four 40 mg tablets) taken orally once daily for the first 21 days of each 28-day cycle. Continue treatment until disease progression or unacceptable toxicity. Take STIVARGA at the same time each day. Swallow tablet whole with water after a low-fat meal that contains less than 600 calories and less than 30% fat _[see Clinical Pharmacology (11.3)]_ . Do not take two doses of STIVARGA on the same day to make up for a missed dose from the previous day. 2.2 DOSE MODIFICATIONS If dose modifications are required, reduce the dose in 40 mg (one tablet) increments; the lowest recommended daily dose of STIVARGA is 80 mg daily. Interrupt STIVARGA for the following: • Grade 2 hand-foot skin reaction (HFSR) [palmar-plantar erythrodysesthesia syndrome (PPES)] that is recurrent or does not improve within 7 days despite dose reduction; interrupt therapy for a minimum of 7 days for Grade 3 HFSR • Symptomatic Grade 2 hypertension • Any Grade 3 or 4 adverse reaction • Worsening infection of any grade Reduce the dose of STIVARGA to 120 mg: STIVARGA ® 40MG FILM-COATED TABLETS Reference: NDA 203085 Stivarga Baca dokumen lengkap