Xeljanz Dosage/Direction for Use

Posology: XELJANZ may be used as monotherapy or in combination with methotrexate (MTX) or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs). The recommended dose is 5 mg administered twice daily.
XELJANZ has not been studied and its use should be avoided in combination with biological DMARDs, such as tumor necrosis factor (TNF) antagonists, IL-1R antagonists, IL-6R antagonists, anti-CD20 monoclonal antibodies and selective co-stimulation modulators and potent immunosuppressants, such as azathioprine, cyclosporine, and tacrolimus because of the possibility of increased immunosuppression and increased risk of infection.
XELJANZ treatment should be interrupted if a patient develops a serious infection until the infection is controlled.
Dose Adjustments due to Laboratory Abnormalities (see Precautions): Dose adjustment or interruption of dosing may be needed for management of dose-related laboratory abnormalities including lymphopenia, neutropenia and anemia as described in Tables 6, 7 and 8 as follows.
It is recommended that XELJANZ not be initiated in patients with a lymphocyte count less than 500 cells/mm³. (See Table 6.)

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It is recommended that XELJANZ not be initiated in patients with an absolute neutrophil count (ANC) <1000 cells/mm³. (See Table 7.)

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It is recommended that XELJANZ not be initiated in patients with hemoglobin <9 g/dL. (See Table 8.)

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Special Populations: Renal Impairment: No dose adjustment is required in patients with mild renal impairment. XELJANZ dosage should be reduced to 5 mg once daily in patients with moderate or severe renal impairment (including but not limited to those undergoing hemodialysis) (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Hepatic Impairment: No dose adjustment is required in patients with mild hepatic impairment. XELJANZ should not be used in patients with severe hepatic impairment. XELJANZ dosage should be reduced to 5 mg once daily in patients with moderate hepatic impairment (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Patients Receiving Inhibitors of Cytochrome P450 (CYP3A4) and Cytochrome 2C19 (CYP2C19): XELJANZ dosage should be reduced to 5 mg once daily in patients receiving potent inhibitors of CYP3A4 (e.g., ketoconazole). XELJANZ dosage should be reduced to 5 mg once daily in patients receiving one or more concomitant medications that result in both moderate inhibition of CYP3A4 and potent inhibition of CYP2C19 (e.g., fluconazole). Co-administration of XELJANZ with potent CYP inducers (e.g., rifampin) may result in loss of or reduced clinical response (see Interactions).
Elderly Patients (≥65 years): No dosage adjustment is required in patients aged 65 years and older.
Pediatric: The safety and efficacy of XELJANZ in children aged from neonates to <18 years of age has not yet been established.
Method of Administration: XELJANZ is given orally with or without food.