Immunologic Agents : Immunomodulators
OXELJ1 “Xeljanz FC tablet” 5mg/Tab.
適應症：本品適用於治療患有中至重度活動性類風濕性關節炎且對methotrexate無法產生適當治療反應或無法耐受methotrexate之成人患者。本品可用於單一療法或與methotrexate或其他非生物性的疾病緩解型抗風濕藥物(DMARDs)合併使用。本品不可與生物性DMARDs合併使用。
Usual dose:
PO, 5 mg bid as monotherapy or in combination with methotrexate or other nonbiologic disease-modifying antirheumatic drugs.
Dose adjustment:
Renal impairment(moderate or severe), hepatic impairment(moderate), concomitant use of potent CYP3A inhibitors, concomitant use of a medication or medications resulting in simultaneous moderate CYP3A4 inhibition and potent CYP2C19 inhibition: reduce dose to immediate-release tablets 5 mg qd.
Contraindication:
Hypersensitivity to tofacitinib.
Precaution:
Do not initiate tofacitinib in patients with an absolute neutrophil count (ANC) less than 1000 cells/mm(3), a lymphocyte count less than 500 cells/mm(3), or an Hb level less than 9 g/dL.
Adverse effect:
Common: increased HDL level, raised low density lipoprotein cholesterol, headache, nasopharyngitis, upper respiratory infection, urinary tract infectious disease.
Serious: skin cancer, non-melanoma, infectious disease, decreased lymphocyte count, neutropenia, anamia.
健保使用規範：健保藥品給付規定第八章免疫製劑。