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Another Namepemigatinib、佩米替尼、达伯坦
IndicationsUsed for the treatment of advanced, unresectable cholangiocarcinoma with FGFR2 gene fusion or rearrangement.
Reg No.07 L 0997/23
Inspection NO.
Pemigatinib is a small molecule kinase inhibitor targeting FGFR1, FGFR2, and FGFR3, with an IC50 value less than 2nM. This drug reduces cell viability, inhibits tumor cell proliferation and survival by inhibiting the phosphorylation and signaling of these receptors.
Pemigatinib, as the world's first targeted therapy for cholangiocarcinoma, provides new treatment options for cholangiocarcinoma patients, especially with significant therapeutic effects in the treatment of FGFR2 gene fusion or rearrangement in cholangiocarcinoma patients.
Pemigatinib
Adult patients with cholangiocarcinoma and myeloid/lymphocytic tumors with FGFR1 gene rearrangement.
Pregnant women taking Pemigatinib can cause fetal injury or miscarriage. It is recommended that pregnant women pay attention to the potential risks to the fetus and use it under the guidance of a doctor.
Due to the serious adverse reactions that may occur when breastfeeding children with pemitinib, it is recommended that women do not breastfeed during treatment and for one week after the last dose.
The safety and efficacy of Pemigatinib in pediatric patients have not been confirmed yet.
There was no overall difference observed in safety or efficacy between elderly and young patients, but elderly patients have special circumstances and it is recommended to use it under the guidance of a doctor.
Reduce the recommended dose of Pemigatinib in patients with severe renal dysfunction (eGFR15 to 29mL/min/1.73m2, estimated based on the MDRD equation).It is not recommended to adjust the dosage for patients with mild or moderate renal dysfunction (eGFR30 to 89mL/min/1.73m2).It is not recommended to adjust the dosage for end-stage renal disease patients receiving intermittent hemodialysis (eGFR<15mL/min/1.73m2).
Reduce the recommended dose of Pemigatinib for patients with severe liver function impairment.For patients with mild or moderate liver function impairment, dose adjustment is not recommended.
Drug overdose is not yet clear.
Tablets are stored at room temperature between 20 ℃ and 25 ℃, and are allowed to be transported at temperatures between 15 ℃ and 30 ℃.
When taken orally once a day at 13.5mg, the geometric mean (CV%) of steady state Pemigatinib AUC0-24h is 2620 nM · h (54%), and the Cmax is 236 nM (56%). Within the dose range of 1 to 20mg (0.07 to 1.5 times the recommended dose), the steady-state concentration of Pemigatinib increases proportionally. Within 4 days of reaching a stable state, after repeated daily administration, the median accumulation ratio of Pemigatinib was 1.63 (range 0.63 to 3.28).
from FDA，2022.08
