Description
Indication & Scope
AiSuDa® Ivarmacitinib Sulfate Tablets treats active ankylosing spondylitis in adult patients who have poor response or intolerance to at least one TNF inhibitor.
- Mechanism: Highly selective JAK1 inhibitor, which blocks the intracellular JAK/STAT signaling pathway of pro-inflammatory cytokines such as IL-6 and IL-17, reduces spinal inflammation and joint damage.
- Drug class: Selective Janus Kinase 1 inhibitor, oral disease-modifying anti-rheumatic prescription medicine.
- Clinical use: Second-line systemic treatment for active ankylosing spondylitis that is resistant to TNF-α inhibitors.
| Generic Name | Ivarmacitinib Sulfate Tablets |
| Brand Name | AiSuDa |
| Ingredient | Ivarmacitinib Sulfate Tablets |
| Dosage Form | Tablets |
| Package | 4mg*7 tablets*4 blisters/box |
| Conditions Treated | Active ankylosing spondylitis |
| Taboos | Patients with active severe bacterial, viral or fungal infection; patients with active tuberculosis; patients with hypersensitivity to ivarmacitinib; patients with severe liver function impairment |
| Place of origin | China |
| Prescription type | Prescription-only |
| Storage Conditions | Store at a temperature not higher than 25°C, sealed to avoid light and moisture |
| Manufacturer | HengRui Pharmaceutical Co., Ltd. |
| Registration Authority | National Medical Products Administration (NMPA), China |
| Approval number | H20250008 |
| Approval Date | Mar 18, 2025 |
| Shelf Life | 36 months |
How to use ?
Recommended Dose: 4mg taken orally once a day.
Time: Fixed daily dosing time, long-term continuous medication for chronic inflammatory disease management.
Instructions for use: It can be taken orally with or without food. For moderate adverse reactions, the dose can be reduced to 2mg per day.
Interaction: Strong CYP3A4 inhibitors will increase the blood concentration of ivarmacitinib. Live vaccines cannot be used during medication.
Side effects: Upper respiratory tract infection, headache, elevated creatine kinase, nausea, elevated cholesterol and mild neutropenia.
Important Notice
This product should be administered only by qualified healthcare professionals in accordance with the approved prescribing information and local clinical guidelines. Dosage and administration may vary depending on patient condition, indicatiaon, and regional regulatory requirements.
Packaging & Shipping
Packaging
Original manufacturer’s packaging with secure export carton. Customized export packaging is available upon request.
Shipping Methods
Express Courier (EMS, DHL, FedEx, UPS), Air Freight, and Sea Freight. Cold-chain transportation is available for products requiring temperature-controlled logistics.
Export Support
Certificate of Analysis
GMP Certificate
Commercial Invoice
Packing List & CPP
Cold Chain Logistics
Customs Documentation
Scientific and regulatory sources
FAQ
What disease does Ivarmacitinib Sulfate Tablets treat?
It treats active ankylosing spondylitis unresponsive or intolerant to TNF inhibitor therapy.
What is Ivarmacitinib Sulfate Tablets' pharmacological classification?
It is a highly selective oral JAK1 inhibitor for inflammatory rheumatic diseases.
How does Ivarmacitinib Sulfate Tablets relieve inflammation?
It blocks JAK/STAT inflammatory signaling and reduces pro-inflammatory cytokine activity in axial joints.
What infections are absolute contraindications when using Ivarmacitinib Sulfate Tablets?
Active tuberculosis and severe active bacterial, viral, or fungal infections prohibit drug use.
AiSuDa® | Ivarmacitinib Sulfate Tablets | Ankylosing Spondylitis | DengYueRX
INN: Ivarmacitinib Sulfate Tablets
Indications: Ankylosing spondylitis
Dosage Form: Tablets
Strength: 4mg/tablet
