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Another Namemobocertinib、TAK-788、琥珀酸莫博赛替尼胶囊、莫博替尼、莫博赛替尼、安卫力
IndicationsExkivity is suitable for specific non-small cell lung cancer(NSCLC).
Reg No.07 L 0993/23
Inspection NO.
Exkivity was originally developed and produced by Takeda Corporation in Japan as an oral small molecule tyrosine kinase inhibitor, with a drug specification of 40mg * 120pills。
On September 16, 2021, the FDA officially approved the launch of Exkivity, becoming the second globally approved targeted therapy for EGFR exon 20 insertion mutation lung cancer patients.
Exkivity inhibits the phosphorylation of EGFR, particularly targeting the insertion mutation of EGFR exon 20, blocking the signaling pathway of tumor cells and inhibiting their growth and proliferation.
Exkivity
Adult patients with locally advanced or metastatic non-small cell lung cancer.
There are no available data on Exkivity use in pregnant women. Oral administration of mobocertinib to pregnant rats during the period of organogenesis resulted in embryolethality (embryo-fetal death) and maternal toxicity at plasma exposures approximately 1.7 times the human exposure based on AUC at the 160 mg once daily clinical dose (see Data). Advise pregnant women of the potential risk to a fetus.
There are no data on the presence of mobocertinib or its metabolites in human milk or their effects on the breastfed child or on milk production. Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with Exkivity and for 1 week after the last dose.
Advise females of reproductive potential to use effective non-hormonal contraception during treatment with Exkivity and for 1 month after the last dose. Exkivity may render hormonal contraceptives ineffective .Advise males with female partners of reproductive potential to use effective contraception during treatment with Exkivity and for 1 week after the last dose.
No overall difference in effectiveness was observed between patients aged 65 and older and younger patients. Exploratory analysis suggests a higher incidence of Grade 3 and 4 adverse reactions (69% vs 47%) and serious adverse reactions (64% vs 35%) in patients 65 years and older as compared to those younger than 65 years.
The safety and effectiveness of Exkivity in pediatric patients have not been established.
Mobocertinib plasma concentrations are higher in patients with severe renal impairment which may increase the risk of adverse reactions. Reduce the recommended dosage of Exkivity for patients with severe renal impairment .No dosage adjustment of Exkivity is recommended for patients with mild-to-moderate renal impairment .
No dosage adjustment of Exkivity is recommended for patients with mild -to-severehepatic impairment .
Drug overdose is not yet clear.
Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F).
The median (min, max) time to peak concentration (Tmax) of mobocertinib is 4 hours (1, 8 hours). The mean (%CV) absolute bioavailability is 37% (50%).
from FDA，2023.09
