Cibinqo Dosage/Direction for Use

Posology: The recommended dose of CIBINQO is either 100 mg or 200 mg once daily. For most patients, 200 mg is the recommended starting dose. A dose of 100 mg once daily is the recommended starting dose for patients aged ≥65 years, and for those who have risk factors for developing an adverse reaction to abrocitinib or those who are less likely to tolerate the adverse reactions (see Precautions and Adverse Reactions). During treatment, the dose may be decreased or increased based on tolerability and efficacy. The lowest effective dose for maintenance should be considered. The maximum daily dose is 200 mg.
CIBINQO can be used with or without medicated topical therapies for atopic dermatitis.
Treatment initiation: Treatment with CIBINQO should not be initiated in patients with a platelet count <150 × 10³/mm³, an absolute lymphocyte count (ALC) <0.5 × 10³/mm³, an absolute neutrophil count (ANC) <1 × 10³/mm³ or who have a hemoglobin value <8 g/dL (see Precautions).
Dose interruption: If a patient develops a serious infection, sepsis or opportunistic infection, consider interruption of CIBINQO until the infection is controlled should be considered (see Precautions).
Interruption of dosing may be needed for management of laboratory abnormalities as described in Table 7 (see Precautions).
Missed doses: If a dose is missed, patients should be advised to take the dose as soon as possible unless it is less than 12 hours before the next dose, in which case the patient should not take the missed dose. Thereafter, resume dosing at the regular scheduled time.
Drug-drug interactions: When recommended dose is 100 mg or 200 mg CIBINQO once daily, dose should be reduced by 50% to 50 mg or 100 mg once daily, respectively, in patients taking strong inhibitors of cytochrome P450 (CYP) 2C19 (e.g., fluvoxamine, fluconazole). The use of CIBINQO is not recommended concomitantly with strong inducers of CYP enzymes (e.g., rifampin) (see Interactions).
Special populations: Renal impairment: No dose adjustment is required in patients with mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60 to <90 mL/min.
In patients with moderate (eGFR 30 to <60 mL/min) renal impairment, the recommended dose of CIBINQO should be reduced by half to 100 mg or 50 mg once daily (see Pharmacology: Pharmacokinetics under Actions).
In patients with severe (eGFR <30 mL/min) renal impairment, 50 mg once daily is the recommended starting dose. The maximum daily dose is 100 mg (see Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: No dose adjustment is required in patients with mild (Child Pugh A) or moderate (Child Pugh B) hepatic impairment. CIBINQO has not been studied in patients with severe (Child Pugh C) hepatic impairment (see Pharmacology: Pharmacokinetics under Actions).
Elderly population: The recommended starting dose for patients ≥65 years of age is 100 mg once daily (see Precautions).
Pediatric population: The safety and efficacy of CIBINQO in pediatric patients under 12 years of age have not yet been established. No data are available.
Method of administration: CIBINQO is to be taken orally once daily with or without food at approximately the same time each day.
In patients who experience nausea while taking CIBINQO, taking with food may improve nausea.
Swallow CIBINQO tablets whole and intact with water. Do not crush, split, or chew CIBINQO tablets.