Cibinqo Dosage/Direction for Use

Posology: The recommended starting dose of CIBINQO is 100 mg or 200 mg once daily based on individual patient characteristics: A starting dose of 100 mg once daily is recommended for patients at higher risk of venous thromboembolism (VTE), major adverse cardiovascular event (MACE), and malignancy (see Precautions). If the patient does not respond adequately to 100 mg once daily, the dose can be increased to 200 mg once daily (see as follows).
A dose of 200 mg once daily may be appropriate for patients who are not at higher risk of VTE, MACE, and malignancy or for patients with an inadequate response to 100 mg once daily. Upon disease control, dose should be decreased to 100 mg once daily. If disease control is not maintained after dose reduction, re-treatment with 200 mg once daily can be considered.
The lowest effective dose for maintenance should be considered. Discontinuation of treatment should be considered in patients who show no evidence of therapeutic benefit after 24 weeks.
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 x 10³/mm³, an absolute lymphocyte count (ALC) <0.5 x 10³/mm³, an absolute neutrophil count (ANC) <1 x 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 moderate or strong inhibitors of cytochrome P450 (CYP) 2C19 (e.g., fluvoxamine, fluconazole). The use of CIBINQO is not recommended concomitantly with strong inducers of CYP2C19/CYP2C9 enzymes (e.g., rifampin, apalutamide, efavirenz, enzalutamide, phenytoin) (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, taking CIBINQO with food may improve nausea.
Swallow CIBINQO tablets whole and intact with water. Do not crush, split, or chew CIBINQO tablets.