Xeljanz Dosage/Direction for Use

Posology: 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, IL-17 antagonists, IL-12/IL-23 antagonists, anti-integrins, 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.
Method of Administration: XELJANZ is given orally with or without food.
Rheumatoid Arthritis 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.
Psoriatic Arthritis Posology: The recommended dose of XELJANZ is 5 mg administered twice daily used in combination with conventional synthetic DMARDs (csDMARDs).
Ankylosing Spondylitis Posology: The recommended dose of XELJANZ is 5 mg administered twice daily.
Ulcerative Colitis Posology: The recommended dose of XELJANZ for adult patients with moderately to severely active ulcerative colitis is 10 mg given orally twice daily for induction for at least 8 weeks, followed by 5 mg or 10 mg given twice daily for maintenance depending on therapeutic response.
Discontinue induction therapy for XELJANZ in patients who show no evidence of therapeutic benefit by Week 16.
For refractory patients, such as patients who failed prior TNF antagonist therapy, consideration should be given to continuation of the maintenance dose with XELJANZ 10 mg twice daily dose.
Patients who fail to maintain therapeutic benefit on XELJANZ 5 mg twice daily may benefit from an increase to XELJANZ 10 mg administered twice daily.
In general, use the lowest effective dose to maintain therapeutic benefit.
Polyarticular Course Juvenile Idiopathic Arthritis Posology: XELJANZ may be used as monotherapy or in combination with methotrexate (MTX).
The recommended dose of tofacitinib is 5 mg film-coated tablets twice daily for pcJIA patients with body weight ≥40 kg.
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 17, 18 and 19 as follows.
It is recommended that XELJANZ not be initiated in patients with a lymphocyte count less than 500 cells/mm³. (See Table 17.)

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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 18.)

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It is recommended that XELJANZ not be initiated in patients with hemoglobin <9 g/dL. (See Table 19.)

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Special Populations: Renal Impairment: If XELJANZ dose is 5 mg twice daily, the recommended dose in patients with severe renal impairment is XELJANZ 5 mg once daily (see Precautions and Pharmacology: Pharmacokinetics under Actions). Specific recommendations for each indication are provided as follows.
If XELJANZ dose is 10 mg twice daily, the recommended dose in patients with severe renal impairment is XELJANZ 5 mg twice daily (see Precautions and Pharmacology: Pharmacokinetics under Actions). Specific recommendations for each indication are provided as follows.
Rheumatoid Arthritis: 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).
Psoriatic Arthritis: No dose adjustment is required in patients with mild or moderate renal impairment. The recommended XELJANZ dose is 5 mg once daily in patients with severe renal impairment (including but not limited to those undergoing hemodialysis) (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Ankylosing Spondylitis: No dose adjustment is required in patients with mild or moderate renal impairment. The recommended XELJANZ dose is 5 mg once daily in patients with severe renal impairment (including but not limited to those undergoing hemodialysis) (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Ulcerative Colitis: No dose adjustment is required in patients with mild or moderate renal impairment. In patients with severe renal impairment (including but not limited to those undergoing hemodialysis), the recommended XELJANZ dose is 5 mg once daily if the dose in the presence of normal renal function is 5 mg twice daily (see Precautions and Pharmacology: Pharmacokinetics under Actions).
In patients with severe renal impairment (including but not limited to those undergoing hemodialysis), the recommended XELJANZ dose is 5 mg twice daily if the dose in the presence of normal renal function is 10 mg twice daily (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Polyarticular Course Juvenile Idiopathic Arthritis: No dose adjustment is required in patients with mild or moderate renal impairment. In patients with severe renal impairment (including but not limited to those undergoing hemodialysis), the recommended XELJANZ dose is 5 mg once daily if the dose in the presence of normal renal function is 5 mg twice daily (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. If XELJANZ dose is 5 mg twice daily, the recommended dose in patients with moderate hepatic impairment, is XELJANZ 5 mg once daily.
If XELJANZ dose is 10 mg twice daily, the recommended dose in patients with moderate hepatic impairment is XELJANZ 5 mg twice daily.
Specific recommendations for each indication are provided as follows.
Rheumatoid Arthritis: 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 not exceed 5 mg twice daily in patients with moderate hepatic impairment (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Psoriatic Arthritis: No dose adjustment is required in patients with mild hepatic impairment. XELJANZ should not be used in patients with severe hepatic impairment. The recommended XELJANZ dose is 5 mg once daily in patients with moderate hepatic impairment (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Ankylosing Spondylitis: No dose adjustment is required in patients with mild hepatic impairment. XELJANZ should not be used in patients with severe hepatic impairment. The recommended XELJANZ dose is 5 mg once daily in patients with moderate hepatic impairment (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Ulcerative Colitis: No dose adjustment is required in patients with mild hepatic impairment. XELJANZ should not be used in patients with severe hepatic impairment. In patients with moderate hepatic impairment, the recommended XELJANZ dose is 5 mg twice daily when the indicated dose in the presence of normal hepatic function is 10 mg twice daily, and the recommended dose is 5 mg once daily when the indicated dose in the presence of normal hepatic function is 5 mg twice daily.
Polyarticular Course Juvenile Idiopathic Arthritis: No dose adjustment is required in patients with mild hepatic impairment. XELJANZ should not be used in patients with severe hepatic impairment. In patients with moderate hepatic impairment, the recommended XELJANZ dose is 5 mg once daily if the dose in the presence of normal renal function is 5 mg twice daily (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Ulcerative Colitis and Polyarticular Course Juvenile Idiopathic Arthritis Patients Receiving Inhibitors of Cytochrome P450 (CYP3A4) and Cytochrome 2C19 (CYP2C19): For indications with a maximum recommended dose of XELJANZ 5 mg twice daily, in patients receiving potent inhibitors of CYP3A4 (e.g., ketoconazole) or one or more concomitant medications that result in both moderate inhibition of CYP3A4 and potent inhibition of CYP2C19 (e.g., fluconazole), the recommended dose is XELJANZ 5 mg once daily. Specific recommendations for each indication are provided as follows.
Rheumatoid Arthritis: XELJANZ dosage should not exceed 5 mg twice daily in patients receiving potent inhibitors of CYP3A4 (e.g., ketoconazole). XELJANZ dosage should not exceed 5 mg twice 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).
Psoriatic Arthritis: The recommended XELJANZ dose is 5 mg once daily in patients receiving potent inhibitors of CYP3A4 (e.g., ketoconazole). The recommended XELJANZ dose is 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).
Ankylosing Spondylitis: The recommended XELJANZ dose is 5 mg once daily in patients receiving potent inhibitors of CYP3A4 (e.g., ketoconazole) The recommended XELJANZ dose is 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).
Ulcerative Colitis: In patients receiving potent inhibitors of CYP3A4 (e.g., ketoconazole) or one or more concomitant medications that result in both moderate inhibition of CYP3A4 and potent inhibition of CYP2C19 (e.g., fluconazole), the XELJANZ dose should be reduced to 5 mg twice daily if the patient is taking 10 mg twice daily, and the XELJANZ dose should be reduced to 5 mg once daily if the patient is taking 5 mg twice daily.
Polyarticular Course Juvenile Idiopathic Arthritis: In patients receiving potent inhibitors of CYP3A4 (e.g., ketoconazole) or one or more concomitant medications that result in both moderate inhibition of CYP3A4 and potent inhibition of CYP2C19 (e.g., fluconazole), the recommended XELJANZ dose is 5 mg once daily if the dose in the presence of normal renal function is 5 mg twice daily (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Ulcerative Colitis, and Polyarticular Course Juvenile Idiopathic Arthritis Patients Receiving Inducers of Cytochrome P450 (CYP3A4): Coadministration of XELJANZ with potent CYP inducers (e.g., rifampin) may result in loss of or reduced clinical response (see Interactions). Coadministration of potent inducers of CYP3A4 with XELJANZ is not recommended.
Elderly Patients (≥65 years): No dosage adjustment is required in patients aged 65 years and older.
Pediatric: The safety and efficacy of XELJANZ 5 mg twice daily have been evaluated in pcJIA patients from 2 years to <18 years of age.