Europe — EMA
Jyseleca (Filgotinib)
GNH USA supplies Jyseleca (Filgotinib), a Janus kinase inhibitor for rheumatoid arthritis and ulcerative colitis. Request a quote for global supply.
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What is Filgotinib?
Filgotinib, the active ingredient in Jyseleca, is a Janus kinase inhibitor (JAK inhibitor) presented as an oral dosage form for oral use. It is indicated for the treatment of rheumatoid arthritis and ulcerative colitis in adult patients. GNH USA supplies Jyseleca as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.
What is Filgotinib used for?
Jyseleca, a selective JAK1 inhibitor, is used in inflammatory autoimmune conditions where cytokine signaling drives disease activity. - Rheumatoid arthritis: reduces joint inflammation, pain, and structural damage, improving functional ability. - Ulcerative colitis: induces clinical remission and promotes mucosal healing in patients with moderate to severe disease.
What are the side effects of Filgotinib?
Adverse reactions may vary in frequency and severity.
Common Side Effects: - Nausea: mild to moderate gastrointestinal upset. - Headache: transient cranial discomfort. - Upper respiratory tract infection: symptoms of cold or sinusitis. - Diarrhea: loose stools, usually self‑limited. - Elevated liver enzymes: mild transaminase increase. - Hypertension: rise in blood pressure readings.
Serious or Rare Side Effects: - Serious infections: including tuberculosis and opportunistic pathogens. - Thromboembolic events: deep vein thrombosis or pulmonary embolism. - Malignancies: potential increased risk of certain cancers. - Hepatic failure: severe liver injury. - Severe allergic reactions: anaphylaxis or angioedema. - Cytopenias: marked reduction in blood cell counts.
What precautions apply to Filgotinib?
Before initiating therapy, clinicians should evaluate patient history and monitor specific parameters. - Liver function monitoring: assess transaminases and bilirubin regularly. - Blood count surveillance: check for neutropenia, anemia, or thrombocytopenia. - Infection risk assessment: screen for active infections and consider vaccination status. - Pregnancy and lactation: avoid use unless potential benefit justifies potential risk, as safety data are limited. - Drug interactions: review concomitant medications that may affect JAK1 inhibition. - Store at room temperature: keep in original packaging, protect from moisture and direct sunlight.
What does Filgotinib interact with?
Filgotinib may interact with several drug classes, requiring careful management.
Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., ketoconazole): may increase filgotinib exposure. - Strong CYP3A4 inducers (e.g., rifampin): may reduce therapeutic levels. - Live vaccines: heightened risk of infection due to immunosuppression.
Moderate Interactions (Monitor Closely): - NSAIDs: increased risk of gastrointestinal bleeding. - Anticoagulants (e.g., warfarin): potential for enhanced anticoagulant effect. - Statins metabolized by CYP3A4: monitor for muscle toxicity.


