Applies to the following strength(s): 11 mg ; 5 mg
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Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Rheumatoid Arthritis
-Immediate release: 5 mg orally 2 times a day
-Extended release: 11 mg orally once a day
-Patients treated with the 5 mg immediate release 2 times a day may be switched to the 11 mg extended release once a day the day following the last dose of 5 mg.
-Do not start this drug in patients with a lymphocyte count less than 500 cells/mm3, an absolute neutrophil count (ANC) less than 1000 cells/mm3 or a hemoglobin level less than 9 g/dL.
-Dose interruption is recommended for management of lymphopenia, neutropenia and anemia.
-Avoid use of this drug if a patient develops a serious infection until the infection is controlled.
-Use of this drug in combination with biologic DMARDs or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.
Use: Moderately to severely active rheumatoid arthritis in adult patients who have had an inadequate response or intolerance to methotrexate. It may be used as monotherapy or in combination with methotrexate or other nonbiologic disease-modifying antirheumatic drugs.
Renal Dose Adjustments
Mild renal impairment: No adjustment recommended
Moderate or severe renal impairment: 5 mg orally once a day
Liver Dose Adjustments
Mild hepatic impairment: No adjustment recommended
Moderate hepatic impairment: 5 mg orally once a day
Severe hepatic impairment: Avoid use
DOSE MODIFICATIONS DUE TO DRUG INTERACTIONS:
Dosage should be reduced to 5 mg once a day in patients:
-Receiving potent CYP450 3A4 inhibitors (e.g., ketoconazole).
-Receiving one or more concomitant medications that result in both moderate inhibition of CYP450 3A4 and potent inhibition of CYP450 2C19 (e.g., fluconazole).
DOSE MODIFICATIONS FOR LYMPHOPENIA:
-Lymphocyte count greater than or equal to 500 cells/mm3: Maintain dose
-Lymphocyte count less than 500 cells/mm3: Discontinue therapy
DOSE MODIFICATIONS FOR NEUTROPENIA:
-Absolute neutrophil count (ANC) greater than 1000 cells/mm3: Maintain dose
-ANC between 500 and 1000 cells/mm3: Interrupt dosing until ANC is greater than 1000, then resume therapy
-ANC below 500 cells/mm3: Discontinue therapy
DOSE MODIFICATIONS FOR ANEMIA:
-Hemoglobin less than or equal to 2 g/dL decrease and greater than or equal to 9 g/dL: Maintain dose
-If there is a greater than 2 g/dL decrease in hemoglobin or a decrease to below 8 g/dL: Interrupt therapy until hemoglobin values have normalized
US BOXED WARNINGS:
-There is an increased risk for developing serious infections that may lead to hospitalization or death
-Serious infections including tuberculosis (TB), bacterial, viral, invasive fungal and other opportunistic infections have occurred.
-Interrupt therapy if a serious infection develops.
-The risks and benefits of treatment should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.
-Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment.
-Test for latent TB prior to starting treatment with this drug. If positive, start treatment for TB prior to initiating tofacitinib therapy.
-Monitor for active TB during treatment, even if the initial TB test is negative.
-Lymphoma and other malignancies have been reported.
-Epstein Barr Virus associated posttransplant lymphoproliferative disorder has been observed.
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Supplemental doses are not necessary after dialysis.
-May be given with or without food.
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