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Tofacitinib Dosage

Medically reviewed by Drugs.com. Last updated on Apr 15, 2020.

Applies to the following strengths: 11 mg; 22 mg; 5 mg; 10 mg

Usual Adult Dose for Rheumatoid Arthritis

As monotherapy or in combination with nonbiologic disease-modifying antirheumatic drugs:
-Immediate-release: 5 mg orally 2 times a day
-Extended-release: 11 mg orally once a day

Comments:
-Do not initiate this drug if absolute lymphocyte count is less than 500 cells/mm3, absolute neutrophil count (ANC) is less than 1000 cells/mm3, or hemoglobin is less than 9 g/dL.
-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.

Use: For moderately to severely active rheumatoid arthritis (RA) 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 (DMARDs)

Usual Adult Dose for Psoriatic Arthritis

In combination with nonbiologic disease-modifying antirheumatic drugs:
-Immediate-release: 5 mg orally 2 times a day
-Extended-release: 11 mg orally once a day

Comments:
-Do not initiate this drug if absolute lymphocyte count is less than 500 cells/mm3, absolute neutrophil count (ANC) is less than 1000 cells/mm3, or hemoglobin is less than 9 g/dL.
-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.

Use: For active psoriatic arthritis in adult patients who have had an inadequate response or intolerance to methotrexate or other DMARDs

Usual Adult Dose for Ulcerative Colitis

-Induction: 10 mg orally 2 times a day for 8 weeks; evaluate patients and transition to maintenance therapy depending on therapeutic response; if needed, continue 10 mg 2 times a day for a maximum of 16 weeks; discontinue 10 mg 2 times a day after 16 weeks if adequate therapeutic response is not achieved
-Maintenance: 5 mg orally 2 times a day; limit use of 10 mg 2 times a day beyond induction for those with loss of response

Comments:
-Do not initiate this drug if absolute lymphocyte count is less than 500 cells/mm3, absolute neutrophil count (ANC) is less than 1000 cells/mm3, or hemoglobin is less than 9 g/dL.
-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.

Use: For the treatment of adult patients with moderately to severely active
ulcerative colitis (UC) who have had an inadequate response or who are intolerant to TNF blockers

Renal Dose Adjustments

Dose adjustments for rheumatoid arthritis and psoriatic arthritis:
MILD RENAL IMPAIRMENT:
-No adjustment recommended.
MODERATE OR SEVERE RENAL IMPAIRMENT (for patients undergoing hemodialysis, the dose should be administered after the dialysis session on dialysis days; if a dose was taken before the dialysis procedure, supplemental doses are not recommended in patients after dialysis):
-If taking 5 mg 2 times a day, reduce dose to 5 mg once a day
-If taking 11 mg once a day, reduce dose to 5 mg once a day

Dose adjustments for ulcerative colitis:
MILD RENAL IMPAIRMENT:
-No adjustment recommended.
MODERATE OR SEVERE RENAL IMPAIRMENT (for patients undergoing hemodialysis, the dose should be administered after the dialysis session on dialysis days; if a dose was taken before the dialysis procedure, supplemental doses are not recommended in patients after dialysis):
-If taking 10 mg orally 2 times a day, reduce to 5 mg orally 2 times a day
-If taking 5 mg orally 2 times a day, reduce to 5 mg orally once a day

Liver Dose Adjustments

Dose adjustments for rheumatoid arthritis and psoriatic arthritis:
MILD HEPATIC IMPAIRMENT:
-No adjustment recommended.
MODERATE HEPATIC IMPAIRMENT:
-If taking 5 mg 2 times a day, reduce dose to 5 mg once a day
-If taking 11 mg once a day, reduce dose to 5 mg once a day
SEVERE HEPATIC IMPAIRMENT:
-Use is not recommended.

Dose adjustments for ulcerative colitis:
MILD HEPATIC IMPAIRMENT:
-No adjustment recommended.
MODERATE HEPATIC IMPAIRMENT:
-If taking 10 mg orally 2 times a day, reduce to 5 mg orally 2 times a day
-If taking 5 mg orally 2 times a day, reduce to 5 mg orally once a day
SEVERE HEPATIC IMPAIRMENT:
-Use is not recommended.

Dose Adjustments

SWITCHING FROM IMMEDIATE RELEASE TABLETS TO XR TABLETS:
-Patients treated with 5 mg 2 times a day may be switched to 11 mg once a day the day following the last dose of 5 mg.

DOSE MODIFICATIONS IN RHEUMATOID ARTHRITIS AND PSORIATIC ARTHRITIS:
DRUG INTERACTIONS:
Patients receiving strong CYP450 3A4 inhibitors (e.g., ketoconazole), or
a moderate CYP450 3A4 inhibitor(s) with a strong CYP450 2C19 inhibitor(s) (e.g., fluconazole):
-If taking 5 mg 2 times a day, reduce dose to 5 mg once a day.
-If taking 11 mg once a day, reduce dose to 5 mg once a day.
MODERATE OR SEVERE RENAL IMPAIRMENT:
-If taking 5 mg 2 times a day, reduce dose to 5 mg once a day.
-If taking 11 mg once a day, reduce dose to 5 mg once a day.
NOTE: For patients undergoing hemodialysis, dose should be administered after the dialysis session on dialysis days. If a dose was taken before dialysis, supplemental doses are not recommended in patients after dialysis.
MODERATE HEPATIC IMPAIRMENT:
-If taking 5 mg 2 times a day, reduce dose to 5 mg once a day.
-If taking 11 mg once a day, reduce dose to 5 mg once a day.
SEVERE HEPATIC IMPAIRMENT:
-Do not administer this drug.
PATIENTS WITH LYMPHOCYTE COUNT LESS THAN 500 CELLS/MM3 CONFIRMED BY REPEAT TESTING:
-Discontinue dosing.
PATIENTS WITH ANC 500 TO 1000 CELLS/MM3:
-If taking 5 mg 2 times a day, interrupt dosing; when ANC is greater than 1000 resume 5 mg 2 times a day
-If taking 11 mg once a day, interrupt dosing; when ANC is greater than 1000, resume 11 mg once a day
PATIENTS WITH ANC LESS THAN 500 CELLS/MM3:
-Discontinue dosing.
PATIENTS WITH HEMOGLOBIN LESS THAN 8 G/DL OR A DECREASE OF MORE THAN 2 G/DL:
-Interrupt dosing until hemoglobin values have normalized.

DOSE MODIFICATIONS IN ULCERATIVE COLITIS:
DRUG INTERACTIONS:
Patients receiving strong CYP450 3A4 inhibitors (e.g., ketoconazole) or
a moderate CYP450 3A4 inhibitor(s) with a strong CYP450 2C19 inhibitor(s) (e.g., fluconazole):
-If taking 10 mg 2 times a day reduce to 5 mg 2 times a day.
-If taking 5 mg 2 times a day reduce to 5 mg once a day.
PATIENTS WITH MODERATE OR SEVERE RENAL IMPAIRMENT:
-If taking 10 mg 2 times a day reduce to 5 mg 2 times a day.
-If taking 5 mg 2 times a day reduce to 5 mg once a day.
NOTE: For patients undergoing hemodialysis, dose should be administered after the dialysis session on dialysis days. If a dose was taken before dialysis, supplemental doses are not recommended in patients after dialysis.
PATIENTS WITH MODERATE HEPATIC IMPAIRMENT:
-If taking 10 mg 2 times a day reduce to 5 mg 2 times a day.
-If taking 5 mg 2 times a day reduce to 5 mg once a day.
SEVERE HEPATIC IMPAIRMENT:
-Do not administer this drug.
PATIENTS WITH LYMPHOCYTE COUNT LESS THAN 500 CELLS/MM3, CONFIRMED BY REPEAT TESTING:
-Discontinue dosing.
PATIENTS WITH ANC 500 TO 1000 CELLS/MM3:
-If taking 10 mg 2 times a day reduce to 5 mg 2 times a day; when ANC is greater than 1000, increase to 10 mg 2 times a day based on response; if taking 5 mg 2 times a day interrupt dosing; when ABC is greater than 1000 resume 5 mg 2 times a day.
PATIENTS WITH ANC LESS THAN 500 CELLS/MM3:
-Discontinue dosing.
PATIENTS WITH HEMOGLOBIN LESS THAN 8 G/DL OR A DECREASE OF MORE THAN 2 G/DL:
-Interrupt dosing until hemoglobin values have normalized.

Precautions

US BOXED WARNINGS:
SERIOUS INFECTIONS:
-Patients treated with this drug are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants (e.g., methotrexate, corticosteroids).
Recommendation:
-If a serious infection develops, interrupt therapy until the infection is controlled.
Reported infections include:
-Active tuberculosis (TB), which may present with pulmonary or extrapulmonary disease. Patients should be tested for latent TB before initiating this drug and during therapy. Treatment for latent TB infection should be initiated prior to initiating this drug.
-Invasive fungal infections (e.g., cryptococcosis, pneumocystosis). Patients with invasive fungal infections may present with disseminated, rather than localized, disease.
-Bacterial, viral (including herpes zoster) and other infections due to opportunistic pathogens.
Recommendations:
-The risks and benefits of this drug should be considered prior to initiating therapy in patients with chronic or recurrent infection.
-Monitor patients for infection during and after therapy with this drug, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.
MORTALITY:
-Rheumatoid arthritis patients 50 years and older with at least one cardiovascular (CV) risk factor treated with 10 mg twice a day had a higher rate of all-cause mortality, including sudden CV death, compared to those treated with 5 mg twice a day or TNF blockers in a study.
MALIGNANCIES:
-Lymphoma and other malignancies have been reported. Epstein Barr Virus-associated post-transplant lymphoproliferative disorder has been observed at an increased rate in renal transplant patients treated with this drug and concomitant immunosuppressive medications.
THROMBOSIS:
-Thrombosis (including pulmonary embolism), deep venous thrombosis, and arterial thrombosis has been observed at an increased incidence in rheumatoid arthritis patients who were 50 years and older with at least one CV risk factor treated with 10 mg twice a day compared to 5 mg twice a day or TNF blockers in a study. Many of these events were serious and fatal. Avoid this drug in patients at risk. Discontinue this drug and evaluate patients with symptoms of thrombosis.

For patients with ulcerative colitis, use XELJANZ at the lowest effective dose and for the shortest duration needed to achieve/maintain therapeutic response

CONTRAINDICATIONS:
-None

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Supplemental doses are not necessary after dialysis.

Other Comments

Administration Advice:
-This drug may be taken with or without food.
-For patients who have difficulties swallowing, the 5 mg tablets may be crushed and taken with water.
-Swallow the extended-release tablets whole and intact; do not crush, split, or chew.
-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.
-When transitioning from immediate release to extended release, begin extended release the day following the last dose of 5 mg immediate release.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Frequently Asked Questions