- Indications and Usage Juvenile Idiopathic Arthritis: Indicated for active Juvenile Idiopathic Arthritis in patients who are 2 years and older. Rheumatoid Arthritis: Indicated for the treatment of adult patients with moderate-to-severe active rheumatoid arthritis that has not responded adequately to one or more tumor necrosis factor (TNF) inhibitors. Atopic Dermatitis: Indicated for the treatment of adult patients with moderate-to-severe atopic dermatitis whose disease has not responded adequately to other systemic therapies. Ulcerative Colitis: Indicated for the treatment of adult patients with moderately to severely active ulcerative colitis.
- Dosage and Administration Standard Dosage: In clinical trials, the dosage strength has varied. For adult Rheumatoid Arthritis, it is typically 45 mg once daily. To maintain response, the lowest effective dose should be used. Administration: Oral administration. Can be taken with or without food. The tablet should be taken as soon as possible after a missed dose on the same day, but skipped if taken on the next day to avoid double dosing. Dose Modifications: Dose interruptions or reductions are required for severe infections or specific adverse reactions (e.g., fasting glucose elevation).
- Mechanism of Action JAK1 Inhibition: Ivarmacitinib is a potent, highly selective, small-molecule inhibitor of janus kinase 1 (JAK1), which is involved in transmitting immune and inflammatory signals. Pathway Blocking: By inhibiting JAK1, it interrupts the signaling pathways of cytokines such as interferons, interleukins, and interferon gamma.
- Safety and Warnings Serious Infections: Causes immune suppression; patients should be evaluated for tuberculosis and hepatitis B before initiation, and safe use during active serious infections is unknown. Malignancy and Lymphoproliferation: An increased risk of malignancy, including lymphoma and non-melanoma skin cancer, may occur due to immunosuppression. Major Adverse Cardiovascular Events: There is an increased risk of major adverse cardiovascular events such as myocardial infarction, stroke, and death. Thrombosis: Increased risk of thrombosis, including deep vein thrombosis and pulmonary embolism. Laboratory Abnormalities: Risk of elevations in LDH, aminotransferases, triglycerides, and fasting glucose.
- Adverse Reactions and Clinical Research Common Adverse Reactions: The most common adverse reactions observed in rheumatoid arthritis trials include upper respiratory tract infection, headache, acne, and nasopharyngitis.
- Drug Interactions Strong CYP3A Inhibitors: May increase plasma concentrations; dose adjustments or restrictions on concomitant use are necessary. Strong CYP3A Inducers: May decrease plasma concentrations; concomitant use should be avoided. Moderate CYP3A Inhibitors: May require dose adjustments depending on concomitant medication.
- Pharmaceutical Information Active Ingredient: Ivarmacitinib (as maleate). Dosage Forms: Tablets available in strengths of 5 mg, 15 mg, and 45 mg. Storage: Store at room temperature; protect from moisture.
Aisuda Ivarmacitinib Sulfate Tablets
Brand Name: 艾速达 ®（Aisuda®）
Generic Name: Ivarmacitinib Sulfate
Strength: 4 mg per tablet; 7 tablets per blister, 4 blisters per box (28 tablets total)
Manufacturer: Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Marketing Authorization Holder: Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Approval Date in China: January 10, 2025
Registration Number: 国药准字H20250008
Storage: Seal tightly, store below 30°C, protect from light and moisture. Refer to the full package insert for detailed storage specifications.
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