Adult: For moderately to severely active cases in patients who have had inadequate response or are intolerant to ≥1 DMARDs: Monotherapy or in combination with methotrexate: 200 mg once daily. In patients at increased risk of VTE, major adverse CV events and malignancy: 100 mg once daily, may be increased to 200 mg once daily if disease control is insufficient. Use the lowest effective dose for long-term treatment. Do not initiate or continue treatment in patients with absolute lymphocyte count (ALC) <0.5 x 109 cells/L, absolute neutrophil count (ANC) <1 x 109 cells/L or Hb level <8 g/dL. Dosing interruption or discontinuation may be required according to patient's haematologic parameters or if serious infection develops (refer to detailed product guidelines). Elderly: ≥65 years 100 mg once daily, may be increased to 200 mg once daily if disease control is insufficient. Use the lowest effective dose for long-term treatment.
Oral Ulcerative colitis
Adult: For moderately to severely active cases in patients who have had inadequate response, lost response, or are intolerant to either conventional treatment or biologic agent: Induction: 200 mg once daily for 10 weeks; if adequate therapeutic response is not achieved after the initial 10 weeks, extend the initial dose for additional 12 weeks. Discontinue treatment if there is no therapeutic benefit after 22 weeks. Maintenance: 200 mg once daily. In patients at increased risk of VTE, major adverse CV events and malignancy: 100 mg once daily, may be increased to 200 mg once daily in case of disease flare. Use the lowest effective dose for long-term treatment. Do not initiate or continue treatment in patients with absolute lymphocyte count (ALC) <0.5 x 109 cells/L, absolute neutrophil count (ANC) <1 x 109 cells/L or Hb level <8 g/dL. Dosing interruption or discontinuation may be required according to patient's haematologic parameters or if serious infection develops (refer to detailed product guidelines). Elderly: 65-74 years Induction: 200 mg once daily. Maintenance: 100 mg once daily; in case of disease flare, increase dose to 200 mg once daily. Use the lowest effective dose for long-term treatment. ≥75 years Not recommended.
Renal Impairment
CrCl (mL/min)
Dosage
<15
Not recommended.
15-<60
100 mg once daily.
Hepatic Impairment
Severe (Child-Pugh class C): Not recommended.
Administration
Filgotinib May be taken with or without food.
Contraindications
Active TB or active serious infections. Pregnancy.
Special Precautions
Patient with chronic or recurrent infection; history of serious or opportunistic infection; underlying conditions that may predispose to infection; CV risk factors; risk factors for DVT or pulmonary embolism (e.g. obesity, medical history of DVT or pulmonary embolism, prolonged immobilisation); known malignancy (other than successfully treated non-melanoma skin cancer) or history of malignancy. Patient who has been exposed to TB or has resided or travelled in areas of endemic TB or mycoses. Patient undergoing surgery. Vaccination with live vaccines immediately before or during treatment is not recommended. Moderate to severe renal and severe hepatic impairment. Elderly. Lactation. Concomitant use with other potent immunosuppressants (e.g. ciclosporin, tacrolimus, other Janus kinase [JAK] inhibitors) is not recommended.
Adverse Reactions
Significant: Haematologic toxicity (e.g. lymphopenia, anaemia, neutropenia); serious infections (e.g. pneumonia), opportunistic infections (e.g. TB, oesophageal candidiasis, cryptococcosis); viral reactivation (e.g. herpes zoster); malignancies (e.g. non-melanoma skin cancer); dose-dependent increases in lipid parameters (e.g. increased total cholesterol, HDL and LDL levels); DVT, pulmonary embolism. Ear and labyrinth disorders: Vertigo. Gastrointestinal disorders: Nausea. Investigations: Decreased blood phosphorus; increased blood creatine phosphokinase and serum creatinine. Nervous system disorders: Dizziness. Renal and urinary disorders: UTI. Respiratory, thoracic and mediastinal disorders: URTI.
PO: Z (Embryo-foetal mortality and teratogenicity were observed in animal studies at exposures comparable to recommended dosing in human. Use in pregnancy is contraindicated.)
Patient Counseling Information
Women of childbearing potential must use effective birth control method during and for at least 1 week after stopping the treatment. This drug may cause dizziness or vertigo, if affected, do not drive or operate machinery.
Monitoring Parameters
Verify pregnancy status before use in women of childbearing potential. Screen for TB before starting treatment and for viral hepatitis prior to and during treatment. Monitor lymphocyte count, neutrophil count, Hb, and LFTs (at baseline and periodically thereafter); lipids (12 weeks before start of treatment and periodically thereafter). Assess for signs and symptoms of infection (during and after treatment) and thrombosis. Perform periodic skin examination, particularly in patients at increased risk of skin cancer.
Drug Interactions
Increased risk of additive immunosuppression with other potent immunosuppressants (e.g. ciclosporin, tacrolimus, biologics or other JAK inhibitors).
Action
Description: Mechanism of Action: Filgotinib is a Janus kinase (JAK) inhibitor that is selective for JAK1, which is important in mediating inflammatory cytokine signals. In the signalling pathway, JAKs phosphorylate and activate signal transducers and activators of transcription (STATs), which regulate intracellular activity, including gene expression. Filgotinib modulates these pathways by inhibiting the phosphorylation and activation of STATs. Onset: Rheumatoid arthritis: 2 weeks. Ulcerative colitis: 10 weeks. Pharmacokinetics: Absorption: Absorbed quickly. Time to peak plasma concentration: 2-3 hours (filgotinib); 5 hours (active metabolite). Distribution: Plasma protein binding: 55-59% (filgotinib); 39-44% (active metabolite). Metabolism: Extensively metabolised mainly by carboxylesterase 2 (CES2) and, to a lesser extent, carboxylesterase 1 (CES1) to form a less potent active metabolite (GS-829845). Excretion: Via urine (approx 87%); faeces (approx 15%). Elimination half-life: Approx 7 hours (filgotinib); 19 hours (active metabolite).
Chemical Structure
Filgotinib Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 49831257, Filgotinib. https://pubchem.ncbi.nlm.nih.gov/compound/Filgotinib. Accessed Sept. 25, 2025.
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