JYSELECA 100MG /200MG TAB (FILGOTINIB)

🧬 Introduction & Composition

• Generic Name: Filgotinib

• Brand Name: Jyseleca

• Drug Class: Selective JAK1 inhibitor (a type of Janus kinase inhibitor)

• Formulation: Film‑coated tablets, available in 100 mg and 200 mg strengths

📋 Indications

• Moderate to severe active rheumatoid arthritis (RA) in adults who:

  • Have had an inadequate response or intolerance to one or more conventional DMARDs

  • Can be used as monotherapy or with methotrexate

• Moderate to severe ulcerative colitis (UC) in adults with inadequate response or intolerance to conventional therapy or biologics

💊 Dosage & Administration

        Rheumatoid Arthritis (RA):

• Standard: 200 mg once daily

• For patients at increased risk (VTE, MACE, malignancy): Start with 100 mg once daily, may increase to 200 mg based on response

         Ulcerative Colitis (UC):

• Induction: 200 mg once daily; may continue up to 22 weeks if response is insufficient

• Maintenance: 200 mg once daily; reduce to 100 mg if risk factors present; escalate to 200 mg if flare occurs

🔁 Monitoring & Interruption

• Avoid dosing if blood counts are too low:

  • ANC < 1×10⁹/L

  • ALC < 0.5×10⁹/L

  • Hb < 8 g/dL

• Restart possible once counts normalize; monitor lipids at 12 weeks and beyond

⚠️ Side Effects

        Common :

• Nausea, upper respiratory and urinary tract infections, dizziness

        Lab & Monitoring:

• Risk of cytopenias (low blood counts)

• Lipid elevations requiring management

⚠️ Warnings & Precautions

• Infections: Watch for serious infections; treatment should be paused until infections resolve

• Thromboembolic events/MACE/Malignancies: Start with 100 mg in high-risk patients; require vigilant assessment

• Laboratory monitoring: Regular CBCs, hepatic panels, and lipid profiles per standard guidelines

• Pregnancy & Breastfeeding: Use contraception during treatment; contraindicated in pregnancy/lactation

✅ Conclusion

• Targeted oral therapy: Offers a selective JAK1 blockade, reducing inflammatory activity in RA and UC

• Efficacy: Clinically effective, well-tolerated, with simpler oral administration

• Safety: Requires regular monitoring—especially for infections, blood counts, lipids, and thromboembolic risks

• Personalization: Dose adjustments based on comorbidities and lab parameters enhance safe use