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Tofacitinib Dosage

Medically reviewed on September 14, 2018.

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

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.

Comments:
-This drug may be given with or without food.
-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.

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

Usual Adult Dose for Psoriatic 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.

Comments:
-This drug may be given with or without food.
-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.

Uses:
-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).
-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

Immediate-release: 10 mg orally 2 times a day for at least 8 weeks; then 5 or 10 mg orally 2 times a day; discontinue after 16 weeks of 10 mg twice daily, if adequate therapeutic benefit is not achieved; use the lowest effective dose to maintain response

Comments:
-This drug may be given with or without food.
-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: For the treatment of adult patients with moderately to severely active
ulcerative colitis (UC)

Renal Dose Adjustments

Dose adjustments for rheumatoid arthritis and psoriatic arthritis:
-Mild renal impairment: No adjustment recommended.
-Moderate or severe renal impairment:
---If taking 5 mg orally 2 times a day, reduce to 5 mg orally once a day
---If taking 11 mg orally once a day, reduce to 5 mg orally once a day.

Dose adjustments for ulcerative colitis:
-Mild renal impairment: No adjustment recommended.
-Moderate or severe renal impairment:
---If taking 10 mg orally 2 times a day, reduce to 5 mg orally once 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 orally 2 times a day, reduce to 5 mg orally once a day
---If taking 11 mg orally once a day, reduce to 5 mg orally 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

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 5 mg 2 times a day or 11 mg once a day
-ANC below 500 cells/mm3: Discontinue therapy


DOSE MODIFICATIONS FOR ANEMIA:
-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.

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 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.
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.

CONTRAINDICATIONS:
-None

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

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

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.

Further information

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

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