Your Health, We Care
Another NameAbrocitinib、阿布昔替尼、希必可
IndicationsCibinqo can treat atopic dermatitis.
Reg No.02 L 1061/24
Inspection NO.0190-24
Cibinqo was first developed by Pfizer and approved for market by the FDA on January 14, 2022.
Cibinqo is used to treat refractory, moderate to severe atopic dermatitis in adult patients who have poor response to other systemic treatments (such as hormones or biologics) or are not suitable for the above treatments.
Cibinqo reversibly and selectively inhibits JAK1 by blocking the adenosine triphosphate (ATP) binding site. This inhibitory effect helps alleviate clinical symptoms in patients with atopic dermatitis and also has a certain inhibitory effect on tumor cells.
Abrocitinib
Adult patients with atopic dermatitis.
Available data from pregnancies reported in clinical trials with Cibinqo are not sufficient to establish a drugassociated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In animal reproduction studies, oral administration of abrocitinib to pregnant rats and rabbits during organogenesis at exposure 11 or 4 times the maximum recommended human dose (MRHD) based on AUC comparison, respectively, resulted in maternal dystocia and skeletal variations in rats and no adverse effects in rabbits.
There are no data on the presence of abrocitinib in human milk, the effects on the breast-fed infant, or the effects on milk production. Abrocitinib was secreted in milk of lactating rats. When a drug is present in animal milk, it is likely that the drug will be present in human milk. Because of the serious adverse findings in adults, including risks of serious infections, malignancy, and thrombosis, advise women not to breastfeed during treatment with Cibinqo and for one day after the last dose (approximately 5-6 elimination half-lives).
Based on the findings in rats, oral administration of Cibinqo may impair female fertility. Impaired fertility in female rats was reversible 1 month after cessation of abrocitinib oral administration.
The safety and effectiveness of Cibinqo in pediatric patients 12 years of age and older with atopic dermatitis have been established.
The safety and effectiveness of Cibinqo have not been established in pediatric patients below 12 years of age.
A higher proportion of subjects 65 years of age and older discontinued from clinical trials compared to younger subjects.
Cibinqo is not recommended for use in patients with severe renal impairment and ESRD including those on renal replacement therapy.
A dosage reduction in patients with moderate renal impairment is recommended. No dosage adjustment is required in patients with mild renal impairment (eGFR 60-89 mL/min).
Avoid use of Cibinqo in patients with severe (Child Pugh C) hepatic impairment. In clinical trials, Cibinqo was not evaluated in subjects with severe (Child Pugh C) hepatic impairment. Dosage adjustment is not required in patients with mild (Child Pugh A) or moderate (Child Pugh B) hepatic impairment based on similar combined exposure (AUCinf,u) of abrocitinib and its two active metabolites, M1 and M2 compared to patients with normal hepatic function .
In patients who are CYP2C19 poor metabolizers, the AUC of abrocitinib is increased compared to CYP2C19 normal metabolizers due to reduced metabolic clearance. Dosage reduction of Cibinqo is recommended in patients who are known or suspected to be CYP2C19 poor metabolizers based on genotype or previous history/experience with other CYP2C19 substrates.
Store Cibinqo at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F). Keep in original package. The container closure system is child resistant.
Abrocitinib is absorbed with over 91% extent of oral absorption and absolute oral bioavailability of approximately 60%. The peak plasma concentrations of abrocitinib are reached within 1 hour.
from FDA，2023.12
