CV: MI, ARTERIAL THROMBOSIS, CARDIOVASCULAR DEATH, DEEP VEIN THROMBOSIS.
GI: ↑ liver enzymes, GI PERFORATION, nausea.
Hemat: anemia, lymphopenia, NEUTROPENIA.
Metab: dyslipidemia.
MS: ↑ creatine kinase.
Neuro: STROKE.
Resp: cough, PULMONARY EMBOLISM.
Misc: DEATH, fever, HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS AND ANGIOEDEMA), INFECTION (INCLUDING TB, BACTERIAL, INVASIVE FUNGAL, VIRAL, OR OPPORTUNISTIC INFECTIONS), MALIGNANCY.
Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, or Non-Radiographic Axial Spondyloarthritis
- PO (Adults): 15 mg once daily.
Atopic Dermatitis
- PO (Geriatric Patients ≥65 yr): 15 mg once daily.
- PO (Adults and Children 1264 and ≥40 kg): 15 mg once daily. If adequate response not achieved, may ↑ to 30 mg once daily. If adequate response not achieved with 30 mg once daily, discontinue therapy. Concurrent use of strong CYP3A4 inhibitors: 15 mg once daily.
Renal Impairment
- (Adults and Children ≥12 yr and ≥40 kg): CCr 15<30 mL/min: 15 mg once daily. CCr <15 mL/min: Not recommended.
Ulcerative Colitis
- PO (Adults): Induction therapy: 45 mg once daily for 8 wk. Maintenance therapy: 15 mg once daily; may ↑ to 30 mg once daily if patients have refractory, severe, or extensive disease. If adequate response not achieved with 30 mg once daily, discontinue therapy. Concurrent use of strong CYP3A4 inhibitors: ↓ induction therapy dose to 30 mg once daily for 8 wk. For maintenance therapy, do not exceed 15 mg once daily.
Renal Impairment
- PO (Adults): CCr 15<30 mL/min: Induction therapy: 30 mg once daily for 8 wk. Maintenance therapy: 15 mg once daily. CCr <15 mL/min: Not recommended.
Crohn's Disease
- PO (Adults): Induction therapy: 45 mg once daily for 12 wk. Maintenance therapy: 15 mg once daily; may ↑ to 30 mg once daily if patients have refractory, severe, or extensive disease. If adequate response not achieved with 30 mg once daily, discontinue therapy. Concurrent use of strong CYP3A4 inhibitors: ↓ induction therapy dose to 30 mg once daily for 12 wk. For maintenance therapy, do not exceed 15 mg once daily.
Renal Impairment
- PO (Adults): CCr 15<30 mL/min: Induction therapy: 30 mg once daily for 12 wk. Maintenance therapy: 15 mg once daily. CCr <15 mL/min: Not recommended.
Therapeutic Classification: antirheumatics
Pharmacologic Classification: kinase inhibitors
Absorption: Well absorbed following oral administration.
Distribution: Unknown.
Metabolism/Excretion: Primarily metabolized by the liver via the CYP3A4 isoenzyme and to a lesser extent by the CYP2D6 isoenzyme; 38% excreted in feces and 24% excreted in urine as unchanged drug.
Half-life: 814 hr.