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Another Name达克替尼、达可替尼、多泽润、DacoMitinib、Dacoplice、 PF299804
IndicationsThe first-line treatment for metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21L858R substitution mutation.
Reg No.06 L 1115/24
Inspection NO.
Dacomitinib is a pan HER inhibitor that irreversibly inhibits three different members of the ERBB family, EGFR (HER1), HER2, and HER4, demonstrating good therapeutic efficacy.
Multiple clinical trials have shown that Dacomitinib has the potential to extend progression free survival (PFS) and overall survival (OS) compared to other EGFR-TKI. For example, in the ARCHER-1050 clinical study, the median PFS and OS of the Dacomitinib group were significantly better than those of the gefitinib group.
Dacomitinib
Metastatic non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21L858R substitution mutation.
Pregnant women taking Dacomitinib can cause harm to the fetus. There is currently no data available on pregnant women taking Dacomitinib.
At present, there is no information available on the presence of Dacomitinib or its metabolites in human milk, or their effects on breastfed infants or milk production. Due to the possibility of serious adverse reactions caused by Dacomitinib in breastfed infants, women should be advised not to breastfeed during and at least 17 days after treatment with Dacomitinib.
Before using Dacomitinib, first determine the pregnancy status of women with fertility. Pregnant women using Dacomitinib may cause harm to the fetus. Women with fertility should be informed to use effective contraceptive measures for at least 17 days during treatment with Dakatinib and after the last dose.
Exploratory analysis of this group showed that patients aged ≥ 65 had a higher incidence of grade 3 and 4 adverse reactions (67% vs. 56%) compared to patients under 65 years old, and had a higher frequency of medication interruption (53% vs. 45%) and discontinuation (24% vs. 10%).
The safety and efficacy of using Dacomitinib in children have not been determined yet.
Drug overdose is not yet clear.
Store below 30℃.
Within the dosage range of 2mg to 60mg (0.04 to 1.3 times the recommended dose) of oral Dacomitinib once daily, the steady-state maximum plasma concentration (Cmax) and steady-state AUC of dacotinib increase proportionally. In a dose exploration clinical study conducted in solid tumor patients, the geometric mean [coefficient of variation (CV%)] Cmax at steady state was 108ng/mL (35%) and the AUC0-24h was 2213ng • h/mL (35%) when taking orally 45mg of Dacomitinib once daily. Reached steady state within 14 days after repeated administration, with a geometric mean (CV%) accumulation ratio estimated based on AUC of 5.7 (28%).
from FDA，2020.12
