Description
Indication & Scope
AnXu® Rovadicitinib Tablets dedicates to chronic oral targeted therapy for adult patients diagnosed with primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF) or post-essential thrombocythemia myelofibrosis (PET-MF), to treat disease-related splenomegaly and constitutional systemic symptoms.
- Mechanism: Selective oral Janus kinase 2 (JAK2) small-molecule inhibitor with high selectivity against mutant JAK2 V617F driver kinase. It blocks constitutively activated JAK2-mediated downstream STAT signaling pathways in myeloproliferative neoplasm stem cells, reduces aberrant cytokine release, shrinks splenic extramedullary hematopoiesis and alleviates MF constitutional symptoms (fatigue, night sweats, weight loss, bone pain).
- Drug class: Oral selective JAK2 tyrosine kinase inhibitor / Myeloproliferative neoplasm targeted therapeutic tablet.
- Clinical use: First-line continuous oral monotherapy for intermediate and high-risk adult myelofibrosis patients of all three MF subtypes; reduces symptomatic splenomegaly and eliminates disease-related systemic constitutional symptoms to improve patient quality of life.
| Generic Name | Rovadicitinib Tablets |
| Brand Name | AnXu |
| Ingredient | Rovadicitinib |
| Dosage Form | Tablets |
| Package | 5mg*30 tablets/box |
| Conditions Treated | Primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF), post-essential thrombocythemia myelofibrosis (PET-MF) in adult patients |
| Taboos | Severe hypersensitivity to rovadicitinib or tablet excipients; baseline absolute neutrophil count <0.5×10⁹/L or platelet count <50×10⁹/L; active uncontrolled severe systemic infection; pregnant and breastfeeding women |
| Place of origin | China |
| Prescription type | Prescription-only |
| Storage Conditions | Sealed blister tablet packs stored at controlled room temperature 15°C–30°C, moisture-proof sealed packaging |
| Manufacturer | CHIATAI TIANQING Pharmaceutical Group Co., Ltd. |
| Registration Authority | National Medical Products Administration (NMPA), China |
| Approval number | H20260008 |
| Approval Date | Feb 25, 2026 |
| Shelf Life | 24 months |
How to use ?
Recommended Dose: Standard starting maintenance dose 20 mg oral once daily; reduce to 10 mg daily for grade ≥3 thrombocytopenia or neutropenia toxicity; escalate back to 20 mg daily after hematologic count recovery.
Time: Single daily oral tablet taken at fixed consistent time, may be administered with or without food intake.
Instructions for use: Swallow whole tablet with clean water without crushing or splitting; conduct baseline complete blood count before treatment initiation; monitor peripheral blood cell counts every two weeks for the first three treatment months; hold dosing temporarily for severe myelosuppression until neutrophil/platelet recovery.
Interaction: Strong CYP3A4 inhibitors elevate rovadicitinib plasma concentrations and myelosuppression risk; strong CYP3A4 enzyme inducers drastically reduce therapeutic anti-JAK2 efficacy. Concurrent myelosuppressive chemotherapeutic agents amplify hematologic toxicity risk significantly.
Side effects:
1. Common dose-manageable adverse reactions: mild thrombocytopenia, neutropenia, fatigue, diarrhea, dizziness, bone pain.
2. Severe grade ≥3 risks: severe prolonged myelosuppression, secondary invasive bacterial/fungal infection, elevated liver transaminases.
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 mutated driver kinase protein is selectively inhibited by Rovadicitinib Tablets to treat myeloproliferative neoplasm-associated myelofibrosis?
The drug targets constitutively activated mutant Janus kinase 2 (JAK2), most commonly the JAK2 V617F oncogenic variant.
What three distinct clinical subtypes of myelofibrosis receive therapeutic approval for oral Rovadicitinib Tablets treatment?
Primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF), and post-essential thrombocythemia myelofibrosis (PET-MF).
What two core clinical disease manifestations represent the primary therapeutic endpoints of Rovadicitinib Tablets in myelofibrosis patients?
Reduction of disease-caused splenomegaly and alleviation of debilitating MF constitutional symptoms (fatigue, night sweats, weight loss, bone pain).
What routine laboratory monitoring schedule is mandated during the initial three months of continuous Rovadicitinib Tablets therapy?
Peripheral complete blood count testing every two weeks to track dose-limiting thrombocytopenia and neutropenia toxicities.
AnXu® | Rovadicitinib Tablets | PMF/PPV-MF/PET-MF | DengYueRX
INN: Rovadicitinib Tablets
Indications: PMF/PPV-MF/PET-MF
Dosage Form: Tablets
Strength: 5mg/tablet
