Medically reviewed by Drugs.com. Last updated on Jul 13, 2020.
Applies to the following strengths: 2 mg; 1 mg
Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Rheumatoid Arthritis
2 mg orally once a day
-This drug may be used as monotherapy or in combination with methotrexate or other DMARDs.
Use: For the treatment of adult patients with moderately to severely active
rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies
Renal Dose Adjustments
Mild renal impairment (CrCl 60 to less than 90 mL/min): No adjustment recommended.
Moderate renal impairment (CrCl 30 to 60 mL/min): Reduce dose to 1 mg orally once a day.
Severe renal impairment (CrCl less than 30 mL/min): Not recommended.
Liver Dose Adjustments
Mild to moderate hepatic impairment: No adjustment recommended.
Severe hepatic impairment: Not recommended.
General Considerations for Administration:
-Therapy should not be initiated 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.
-If a patient develops a serious infection, hold therapy until the infection is controlled.
DOSE ADJUSTMENTS FOR LYMPHOPENIA:
-ALC 500 cells/m3 or greater: Maintain dose
-ALC less than 500 cells/me: Interrupt therapy until ALC is greater than or equal to 500 cells/m3
DOSE ADJUSTMENTS FOR NEUTROPENIA:
-ANC 1000 cells/m3 or greater: Maintain dose
-ANC less than 1000 cells/m3: Interrupt therapy until ANC is greater than or equal to 1000 cells/m3
DOSE ADJUSTMENTS FOR ANEMIA:
-Hemoglobin 8 g/dL or greater: Maintain dose
-Hemoglobin less than 8 g/dL: Interrupt therapy until hemoglobin is 8 mg/dL or greater
Dose Modifications Due to Drug Interactions:
-Patients taking Organic Anion Transporter 3 (OAT3) inhibitors with a strong inhibition potential (e.g., probenecid): 1 mg orally once a day
US BOXED WARNINGS:
SERIOUS INFECTIONS: Patients treated with this drug are at risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. 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 considered prior to initiating therapy.
-Invasive fungal infections (e.g., candidiasis, pneumocystosis). Patients with invasive fungal infections may present with disseminated, rather than localized, disease.
-Bacterial, viral, and other infections due to opportunistic pathogens.
-Consider risks and benefits prior to initiating therapy in patients with chronic or recurrent infection.
-Monitor patients for infection during and after therapy including the possible development of TB in patients who tested negative for latent TB prior to initiating therapy.
MALIGNANCIES: Lymphoma and other malignancies have been reported.
THROMBOSIS: Thrombosis, including deep venous thrombosis and pulmonary embolism, has been reported at an increased incidence in patients treated with this drug compared to placebo. There were also cases of arterial thrombosis. Many of these adverse events were serious and some resulted in death.
-Evaluate 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 at any time of the day.
-This drug may be taken with or without food.
-Prior to initiating therapy, test patients for latent TB. If positive, consider treating for TB prior to initiating therapy.
-Treatment should be initiated by physicians experienced in the diagnosis and treatment of rheumatoid arthritis.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.