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Is there a pregnancy exposure registry for CIBINQO?Yes, there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to CIBINQO during pregnancy. Pregnant women exposed to CIBINQO and health care providers are encouraged to call 1-877-311-3770.
Is CIBINQO safe to use during pregnancy?Available data from pregnancies reported in clinical trials with CIBINQO are not sufficient to establish a drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. However, all pregnancies carry some risk of birth defects, loss, or other adverse outcomes. Pregnant women should consult with their healthcare provider before using CIBINQO.
Is it safe to breastfeed while using CIBINQO?No data is available on the presence of abrocitinib in human milk, the effects on the breast-fed infant, or the effects on milk production. 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.
Can CIBINQO impair female fertility?Based on 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. Women who are trying to conceive should consult with their healthcare provider before using CIBINQO.
Is CIBINQO safe for pediatric patients?The safety and effectiveness of CIBINQO in pediatric patients 12 years of age and older weighing 25 kg or more with atopic dermatitis has been established. The safety and effectiveness of CIBINQO have not been established in pediatric patients below 12 years of age. In addition, irreversible bone findings have been observed in juvenile animal toxicity studies in rats. Parents or guardians of pediatric patients should consult with their healthcare provider before using CIBINQO.
Is CIBINQO safe for geriatric patients?Clinical trials of CIBINQO did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients. However, a higher proportion of patients 65 years of age and older discontinued from clinical trials compared to younger patients, and they may be at increased risk of certain adverse reactions. Geriatric patients should consult with their healthcare provider before using CIBINQO.
What should I know about using CIBINQO if I have renal impairment?In patients with severe (eGFR <30 mL/min) and moderate (eGFR 30–59 mL/min) renal impairment, the combined exposure of abrocitinib and its active metabolites is increased compared to patients with normal renal function. This may increase the risk of adverse reactions such as infections. CIBINQO is not recommended for use in patients with severe renal impairment and ESRD including those on renal replacement therapy. A dosage reduction is recommended in patients with moderate renal impairment, and no dosage adjustment is required in patients with mild renal impairment.
Can I use CIBINQO if I have hepatic impairment?CIBINQO is not recommended for use in patients 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 of abrocitinib and its active metabolites compared to patients with normal hepatic function. In clinical trials, CIBINQO was not evaluated in patients with severe hepatic impairment.
What should I know about using CIBINQO if I am a CYP2C19 poor metabolizer?In patients who are CYP2C19 poor metabolizers, the exposure of abrocitinib is increased 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.
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