Description

Indication & Scope

Rezvilutamide Tablets are indicated for adult patients with metastatic hormone-sensitive prostate cancer (mHSPC) with high tumor burden, to be used in combination with androgen deprivation therapy.

Mechanism
It is a selective androgen receptor inhibitor that blocks androgen binding to receptors, inhibits nuclear translocation and receptor-mediated gene transcription, thereby suppressing prostate cancer cell proliferation.
Drug class
Oral small-molecule anti-androgen, prostate cancer targeted therapeutic agent, film-coated tablet.
Clinical use
Phase III trials confirm its robust anti-tumor efficacy and controllable safety profile. Oral administration at 240 mg once daily; dose reduction is allowed for intolerable adverse reactions. It is a domestic novel second-generation androgen receptor inhibitor for mHSPC.

Specification

Generic Name	Rezvilutamide Tablets
Brand Name	Airuien®
Ingredient	Rezvilutamide
Dosage Form	Film-coated tablet
Package	80 mg rezvilutamide per tablet, 21 tablets per blister
Conditions Treated	Treat adult patients with high-tumor-burden metastatic hormone-sensitive prostate cancer (mHSPC), combined with androgen deprivation therapy
Taboos	Contraindicated in patients hypersensitive to rezvilutamide or any excipients
Place of origin	Jiangsu, China
Priscription Type	Prescription drug (Rx)
Storage Conditions	Seal and store below 30℃, keep away from moisture
Manufacturer	Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Registration Authority	National Medical Products Administration (NMPA)
Approval number	H20220016
Date of Revision	June 28, 2022
Shelf Life	18 months

How to use ?

Recommended Dose: 240mg orally once daily, three 80mg tablets taken together; reduce to 160mg or 80mg daily for intolerable adverse reactions.

Time: Continuous long-term oral administration, regular liver function monitoring within the first four months of treatment.

Interaction: Avoid strong CYP3A4 inhibitors and warfarin; check all concurrent medications before administration.

Side effects: Common mild reactions include fatigue, hot flushes, joint pain, hypertension and elevated liver enzymes; severe liver injury and QT prolongation occur rarely.

Important Notice

This product shall only be used for post-exposure rabies prophylaxis by professional medical staff. It must be applied combined with rabies vaccine and injected via wound infiltration plus intramuscular routes as specified. Do not administer intravenously or alter the dosage at will. Hypersensitivity monitoring is required throughout the whole injection process.

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