bangruishun bezacitinib tablets pmf ppv mf pet mf 16mg

Description

Indication & Scope

BangRuiShun® Bezacitinib Tablets treats adult patients with intermediate-2 or high-risk primary myelofibrosis (PMF), to reduce splenomegaly, alleviate systemic myeloproliferative symptoms and improve peripheral blood cytopenias.

Mechanism: Bezacitinib is a highly selective Janus kinase 2 (JAK2) tyrosine kinase inhibitor. It selectively suppresses overactivated JAK2 signaling pathways driving abnormal bone marrow hematopoietic proliferation in myelofibrosis patients. It reduces pathological bone marrow fibrosis, shrinks enlarged spleen volume, relieves inflammatory systemic symptoms and improves abnormal blood cell counts without strong inhibitory effects on other JAK family kinases, leading to fewer off-target side effects.
Drug class: Oral high-selective JAK2 inhibitor; targeted therapeutic agent for myeloproliferative neoplasms.
Clinical use: Long-term oral monotherapy for intermediate-2 and high-risk primary myelofibrosis adults. It effectively reduces spleen enlargement-related abdominal distension and early satiety, relieves persistent fatigue, night sweats and bone pain, stabilizes hemoglobin and platelet levels to reduce blood transfusion reliance, and features a low severe adverse event discontinuation rate in clinical trials.

Specification

Generic Name	Bezacitinib Tablets
Brand Name	BangRuiShun
Ingredient	Bezacitinib
Dosage Form	Tablets
Package	4mg(quantity to be determined); 16mg(quantity to be determined)
Conditions Treated	Adult patients diagnosed with intermediate-2 or high-risk primary myelofibrosis confirmed via bone marrow biopsy and risk stratification assessment
Taboos	Patients with severe hypersensitivity to bezacitinib or tablet excipients; patients with active uncontrolled severe bacterial/fungal/viral systemic infections; pregnant and breastfeeding women; patients with severe persistent thrombocytopenia below critical baseline levels before treatment initiation
Place of origin	China
Prescription type	Prescription-only
Storage Conditions	Sealed medicine bottles stored at controlled room temperature 20°C–25°C, protected from high humidity and direct sunlight, retain original packaging with desiccant inside
Manufacturer	Pharmablock Pharmaceuticals (Shandong) Co., Ltd.
Registration Authority	National Medical Products Administration (NMPA), China
Approval number	H20260021; H20260022
Approval Date	Apr 29, 2026
Shelf Life	24 months

How to use ?

Recommended Dose: Standard initial oral dose 16mg once daily.

Time: Take one tablet orally at a fixed time every day, can be taken with or without daily meals. If a dose is missed, skip the forgotten tablet and resume normal dosing the next calendar day; avoid double-dose supplementation.

Instructions for use: Swallow whole film-coated tablets with plain water, do not split, crush or chew tablets. Conduct complete blood count testing every two weeks for the first three treatment months, and screen for active infections before each dosing cycle. Delay treatment if severe fever or systemic infection occurs until infection fully resolves. Avoid live attenuated vaccines throughout the full treatment period.

Interaction: Strong CYP3A4 inhibitors increase bezacitinib blood concentration and raise blood cytopenia risk, requiring mandatory dose reduction. Strong CYP3A4 inducers lower therapeutic efficacy and should be avoided. Combined immunosuppressants significantly elevate severe systemic infection risk and need close hematologist monitoring.

Side effects:

1. Common mild to moderate adverse reactions: mild thrombocytopenia, anemia, mild diarrhea, fatigue, upper respiratory tract infection, slight elevated serum creatinine.

2. Severe rare adverse reactions: grade 3/4 severe pancytopenia, severe recurrent bacterial pneumonia, progressive renal function decline, severe hemorrhagic complications.

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

1.WHO References

2.NMPA

3.FDA

4.EMA

FAQ

Which blood disease patients can take Bezacitinib Tablets oral tablets for long-term control?

Adult patients diagnosed with intermediate-2 or high-risk primary myelofibrosis after bone marrow biopsy and risk stratification evaluation by hematologists.

What routine blood tests does patients need to complete regularly during long-term treatment of Bezacitinib Tablets?

Patients need full blood count examinations every two weeks for the first three months to monitor platelet and hemoglobin levels and adjust your dose timely.

What situation is required to temporarily stop taking Bezacitinib Tablets and contact my hematologist?

Severe persistent fever, uncontrolled bacterial infections or extremely low platelet counts require immediate medical consultation and possible treatment suspension.

How should Bezacitinib Tablets be stored safely at home?

Keep the original sealed bottle with desiccant at normal room temperature, avoid damp environments, and never split or crush the film-coated tablet shell.