Sunitinib

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.

1.Main components

Sunitinib

2.Adapt to the population

Sunitinib is a Broad-spectrum antitumor agents.

3.Medication for special populations

3.1Pregnancy

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.  

3.2Lactation

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.

3.3Females and Males of Reproductive Potential

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.

3.4Pediatric Use

The safety and effectiveness of Sunitinib in pediatric patients have not been established.

3.5Geriatric Use

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.

3.6Hepatic Impairment  

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.

3.7Renal 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.

4.Drug overdose

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.

5.Drug storage

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).

6.Pharmacokinetics

Following oral administration of sunitinib, the time to maximum plasma concentration (Tmax) ranged from 6 to 12 hours

from FDA，2021.08