Filgotin 200

• Rheumatoid Arthritis: Used for moderate to severe active RA in patients who have responded inadequately to, or are intolerant to DMARDs.
• Ulcerative Colitis: Used for moderately to severely active UC in patients who had inadequate response to conventional therapy or a biologic agent.

Adult Dose (Oral):

• Rheumatoid Arthritis: 200 mg tablet once a day.
• Ulcerative Colitis: 200 mg once daily; discontinue if no therapeutic benefit after 22 weeks.
• High-risk patients (VTE, MACE, malignancy): Maintenance: 100 mg once daily; may escalate to 200 mg in case of flare.

Elderly (>=65 years, RA): 100 mg once daily; may escalate to 200 mg if insufficient control.

Elderly (UC, >=65 years): Induction: 200 mg/day; Maintenance: 100 mg/day; not recommended in patients >=75 years.

Common Side Effects:

• Nausea
• Upper respiratory tract infection (URTI)
• Urinary tract infection (UTI)
• Dizziness

Precautions:

• Immunosuppressive medicinal products: Combination with azathioprine, ciclosporin, tacrolimus, bDMARDs or other JAK inhibitors not recommended.
• Infections: Serious infections (pneumonia, TB, esophageal candidiasis, cryptococcosis) reported; herpes zoster requires temporary interruption.
• Malignancy: RA patients have increased risk; immunomodulatory medicinal products may increase risk.
• Fertility: Animal studies showed histopathological effects on male reproductive organs.
• Vaccinations: Live vaccines not recommended.
• Lipids: Dose-dependent increase in total cholesterol, HDL, and LDL.
• Venous thromboembolism: Consider risks and benefits in patients at increased risk of thrombosis.