STIVARGA 40MG FILM-COATED TABLETS

Nchi: Malesia

Lugha: Kiingereza

Chanzo: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Viambatanisho vya kazi:

REGORAFENIB MONOHYDRATE

Inapatikana kutoka:

BAYER CO. (MALAYSIA) SDN. BHD.

INN (Jina la Kimataifa):

REGORAFENIB MONOHYDRATE

Vitengo katika mfuko:

1X28tablet Tablets; 3X28tablet Tablets

Viwandani na:

BAYER AG

Taarifa za kipeperushi

NOT APPLICABLE

Tabia za bidhaa

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