Medically reviewed by Drugs.com. Last updated on Sep 21, 2021.
Applies to the following strengths: 15 mg
Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Rheumatoid Arthritis
15 mg orally once a day
-This drug may be used as monotherapy or in combination with methotrexate or other nonbiologic DMARDs.
-This drug is not recommended in patients with an absolute lymphocyte count (ALC) less than 500 cells/mm3, absolute neutrophil count (ANC) less than 1000 cells/mm3, or hemoglobin level less than 8 g/dL.
Use: Treatment of patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate.
Renal Dose Adjustments
No adjustment recommended.
Liver Dose Adjustments
Mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment: No adjustment recommended.
Severe (Child-Pugh C) hepatic impairment: Not recommended.
Recommended Dose Interruptions for Laboratory Abnormalities:
-Absolute Neutrophil Count (ANC): Interrupt therapy if ANC is less than 1000
cells/mm3; restart when ANC is above 1000 cells/mm3.
-Absolute Lymphocyte Count (ALC): Interrupt therapy if ALC is less than 500
cells/mm3; restart when ANC is above 500 cells/mm3.
-Hemoglobin (Hb): Interrupt therapy if Hb is less than 8 g/dL.
-Hepatic transaminases: Interrupt therapy if drug-induced liver injury is suspected.
US BOXED WARNINGS:
-Patients treated with this drug are at increased risk of serious infections that may lead to hospitalization or death.
-Most patients that developed infections were taking concomitant
immunosuppressants such as methotrexate or corticosteroids.
-If a serious infection develops, interrupt therapy until the infection is controlled.
---Active tuberculosis (TB) which may present with pulmonary or extrapulmonary disease. Test for latent TB before initiating and during therapy. Treatment for latent infection should be considered prior to initiating therapy.
---Invasive fungal infections (e.g., cryptococcosis, pneumocystosis)
---Bacterial, viral (e.g., herpes zoster), and other infections due to opportunistic
---The risks and benefits of therapy should be considered prior to initiating therapy in patients with chronic or recurrent infection.
-Patients should be closely monitored for infection during and after completing therapy, including TB in patients who tested negative for latent TB prior to
-Lymphoma and other malignancies have been reported.
-Thrombosis (e.g., deep venous thrombosis), pulmonary embolism, and arterial
thrombosis have occurred in patients treated with Janus kinase inhibitors used to treat inflammatory conditions.
-Many adverse events were serious and fatal.
-Consider risk versus benefit prior to treating patients who may be at increased
-Evaluate and treat patients with symptoms of thrombosis.
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Data not available
-This drug may be taken with or without food.
-Tablets should be swallowed whole, not split, crushed, or chewed.
-Therapy should be interrupted if a patient develops a serious infection until the infection is controlled.
-Store at 2C to 25C (36F to 77F).
-Store in the original bottle to protect from moisture.
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