藥品新增

<20F045>Filgotinib maleate (Jyseleca®) (200mg).錠

新藥介紹

<20F045>Filgotinib maleate (Jyseleca®) (200mg).錠

藥理作用/作用機轉

Janus Kinase Inhibitor

適應症/

劑量

PO

【Adult】

　●Rheumatoid arthritis: 200 mg QD.

　●Ulcerative colitis: 200 mg QD. Discontinue if no benefit after 22 weeks.

【Pediatric】Safety and efficacy not established.

【Geriatric】Refer to adult dosing.

『Renal Impairment: Adult』

CrCl 15 to 59 mL/minute: 100 mg QD.

CrCl <15 mL/minute: Use is not recommended.

『Hepatic Impairment: Adult』

Severe hepatic impairment (Child-Pugh Class C): Use is not recommended.

使用禁忌

Hypersensitivity to filgotinib or any component of the formulation; active tuberculosis or serious infection; pregnancy.

警告/預防

Hematologic toxicity, infections, lipid abnormalities, malignancy, venous thromboembolism

不良反應

【>10%】Infection (including upper respiratory tract infection , UTI, and pneumonia)

【1% to 10%】 Nausea, dizziness

【<1%】Hypercholesterolemia, neutropenia, increased creatinine phosphokinase in blood specimen.

【Frequency not defined】Increased serum creatinine

懷孕用藥分級(FDA)

X / 致畸胎性

健保規範

  • 藥品說明：限內科專科醫師且具有風濕病專科醫師證書者使用。經事前審查核准後使用。每日限用1錠

  • 藥品理由：(需專審)類風濕關節炎

其他

Contraception during treatment and for at least 1 week following the last dose.

Breastfeeding is not recommended.

May enhance the immunosuppressive effect of Immunosuppressants.