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|Dosage & Administration|
Initial dose of 600 mg (four 150 mg injections), followed by 300 mg (two 150 mg injections) administered every other week. A dosage of 300 mg every 4 weeks may be considered for patients below 100 kg who achieve clear or almost clear skin after 16 weeks.. Learn more.
100 mg once daily, 200 mg once daily for those not responding to 100 mg. Moderate renal impairment and CYP2C19 Poor Metabolizers: 50 mg once daily or 100 mg once daily for those not responding to 50 mg once daily. . Learn more.
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Most common adverse reactions (≥1%) in subjects receiving 100 mg and 200 mg include: nasopharyngitis, nausea, headache, herpes simplex, increased blood creatine phosphokinase, dizziness, urinary tract infection, fatigue, acne, vomiting, oropharyngeal pain, influenza, gastroenteritis. Most common adverse reactions (≥1%) in subjects receiving either 100 mg or 200 mg also include: impetigo, hypertension, contact dermatitis, upper abdominal pain, abdominal discomfort, herpes zoster, and thrombocytopenia. . Learn more.
Mechanism of Actions (MoA)
Is ADBRY safe to use during pregnancy?
There is limited data on the use of ADBRY in pregnant women to determine if there is a drug-associated risk of adverse developmental outcomes. Healthcare providers are encouraged to register pregnant patients, or pregnant women may enroll themselves in a pregnancy exposure registry by calling 1-877-311-8972 or visiting https://mothertobaby.org/ongoing-study/adbry-tralokinumab/. Human IgG antibodies, such as those in ADBRY, are known to cross the placental barrier; therefore, ADBRY may be transmitted from the mother to the developing fetus. The background risk of major birth defects and miscarriage for the indicated population is unknown, and all pregnancies have a background risk of adverse outcomes.
Has ADBRY been tested in animals for pregnancy and developmental effects?
In animal studies, intravenous doses of up to 100 mg/kg tralokinumab-ldrm were administered to pregnant cynomolgus monkeys without observing any maternal or developmental toxicity at doses up to 100 mg/kg/week. No treatment-related adverse effects on embryofetal toxicity or malformations, or on morphological, functional, or immunological development were observed in the infants from birth through 6 months of age in another enhanced pre- and post-natal development study.
Is it safe to use ADBRY while breastfeeding?
There is no data on the presence of tralokinumab-ldrm in human milk or its effects on breastfed infants or milk production. Maternal IgG is present in breast milk, and the effects of local gastrointestinal exposure and limited systemic exposure to ADBRY on the breastfed infant are unknown. Healthcare providers should consider the development and health benefits of breastfeeding along with the mother's clinical need for ADBRY and any potential adverse effects on the breastfed child from ADBRY or from the underlying maternal condition.
Is ADBRY safe for use in pediatric patients?
The safety and effectiveness of ADBRY have not been established in pediatric patients.
Is ADBRY safe for use in geriatric patients?
Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Healthcare providers should exercise caution in dose selection for elderly patients, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
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.