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At a glance

Filgotinib Maleate is a JAK inhibitor used for the treatment of moderate to severe active rheumatoid arthritis and ulcerative colitis.

Indications
  • 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.
Pharmacology

Filgotinib is an adenosine triphosphate (ATP)-competitive and reversible inhibitor of the JAK family. JAKs are intracellular enzymes which transmit signals arising from cytokine or growth factor-receptor interactions on the cellular membrane. JAK1 is important in mediating inflammatory cytokine signals. Filgotinib preferentially inhibited the activity of JAK1.

Dosage

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.

Side effects

Common Side Effects:

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

Use in Pregnancy: Category D; animal studies showed reproductive toxicity; contraindicated during pregnancy; women of childbearing potential must use effective contraception during and for at least 1 week after cessation.

Pregnancy Category: D — always consult a doctor before taking during pregnancy.

Precautions & warnings

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.
Overdose effects

Overdose: Doses up to 450 mg without dose-limiting toxicity in clinical studies; in case of overdose, general supportive measures should be given.

Storage conditions

Storage: Do not store above 25 degree C. Protect from light. Keep out of reach of children.

Filgotinib Maleate — see the full informationPharmacology, precautions, pregnancy, overdose and the rest on the generic page
⚠️ This information is for educational purposes only — not a substitute for medical advice. Consult a registered physician before taking any medicine.