Your Health, We Care
Another NameSotan、舒尼替尼、纾癌特、Votrient
IndicationsSunitinib is a Broad-spectrum antitumor agents.
Reg No.08 L 1166/24
Inspection NO.1895-24
Sunitinib, developed by the globally renowned pharmaceutical company Pfizer, is a novel multi-target oral drug.
There are three drug specifications produced by Lucius: 12.5mg/pill, 28 pills/box, 25mg/pill, 28 pills/box, and 50mg/pill, 28 pills/box.
Sunitinib is a multi-target tyrosine kinase inhibitor that selectively targets receptors of certain proteins that play a critical role in tumor growth.
Sunitinib
Sunitinib is a Broad-spectrum antitumor agents.
Based on animal reproduction studies and its mechanism of action, Sunitinib can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential of the potential risk to a fetus.
There is no information regarding the presence of sunitinib and its metabolites in human milk. Because of the potential for serious adverse reactions in breastfed infants, advise women not to breastfeed during treatment with Sunitinib and for at least 4 weeks after the last dose.
Sunitinib can cause fetal harm when administered to a pregnant woman.
Females
Advise females of reproductive potential to use effective contraception during treatment with Sunitinib and for at least 4 weeks after the last dose.
Males
Based on findings in animal reproduction studies, advise males with female partners of reproductive potential to use effective contraception during treatment with Sunitinib and for 7 weeks after the last dose.
The safety and effectiveness of Sunitinib in pediatric patients have not been established.
Clinical studies of Sunitinib did not include sufficient numbers of patients with pNET to determine if patients 65 years of age and older respond differently than younger patients.
No dose adjustment is required in patients with mild or moderate (Child-Pugh Class A or B) hepatic impairment. Sunitinib was not studied in patients with severe (Child-Pugh Class C) hepatic impairment.
No dose adjustment is recommended in patients with mild (CLcr 50 to 80 mL/min), moderate (CLcr 30 to <50 mL/min), or severe (CLcr <30 mL/min) renal impairment who are not on dialysis.
No dose adjustment is recommended for patients with end-stage renal disease (ESRD) on hemodialysis.
Treatment of overdose with Sunitinib should consist of general supportive measures. There is no specific antidote for overdosage with Sunitinib. If indicated, elimination of unabsorbed drug should be achieved by emesis or gastric lavage. Cases of accidental overdose have been reported; these cases were associated with adverse reactions consistent with the known safety profile of Sunitinib, or without adverse reactions. In nonclinical studies, mortality was observed following as few as 5 daily doses of 500 mg/kg (3000 mg/m2 ) in rats. At this dose, signs of toxicity included impaired muscle coordination, head shakes, hypoactivity, ocular discharge, piloerection, and gastrointestinal distress. Mortality and similar signs of toxicity were observed at lower doses when administered for longer durations.
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).
Following oral administration of sunitinib, the time to maximum plasma concentration (Tmax) ranged from 6 to 12 hours
from FDA，2021.08
