tofidence tocilizumab injection 200mg10ml per vial

anweitai tocilizumab injection 80mg40ml per vial

Description

Indication & Scope

Tocilizumab Injection treats adults with moderate-severe active RA unresponsive to DMARDs and patients ≥2 years old with active sJIA or CAR-T-related severe CRS, alone or with methotrexate for inflammation control.

Mechanism
As a recombinant humanized anti-human IL-6 receptor IgG1 monoclonal antibody, it specifically binds soluble and membrane-bound IL-6 receptors, blocks IL-6-mediated inflammatory signaling cascades, suppresses overactive systemic inflammation, and reduces joint swelling, pain and tissue damage.
Drug class
Class 1 therapeutic biological product, recombinant humanized monoclonal antibody, interleukin-6 receptor inhibitor for autoimmune inflammatory disorders.
Clinical use
Global Phase III clinical trials verified its consistent safety and efficacy compared with reference tocilizumab; clinically administered via intravenous infusion. For RA, single dose of 8mg/kg every 4 weeks; for sJIA and CRS, weight-based dosing every 2 weeks. It is the first domestic biosimilar of tocilizumab approved for RA, sJIA and CRS in China.

Specification

Generic Name	Tocilizumab Injection
Brand Name	Tofidence®, AnWeiTai®
Ingredient	Tocilizumab
Dosage Form	Solution for injection
Package	200mg/10ml/vial, 400mg/20ml/vial, 80mg/4ml/vial
Conditions Treated	Treats adults with moderate-severe active RA unresponsive to DMARDs and patients ≥2 years old with active sJIA or CAR-T-related severe CRS, alone or with methotrexate for inflammation control
Taboos	Contraindicated for patients with hypersensitivity to tocilizumab or any excipients, or those with severe allergic history
Place of origin	Guangzhou, China
Priscription Type	Prescription drug (Rx)
Storage Conditions	Store at 2–8℃, avoid freezing and light
Manufacturer	Bio-Thera Solutions, Inc.
Registration Authority	National Medical Products Administration (NMPA)
Approval number	S20230001
Date of Revision	January 16, 2023
Shelf Life	24 months

How to use ?

Recommended Dose: 8 mg/kg intravenous infusion once every 4 weeks for adult RA; weight-based dosage every 2 weeks for patients ≥2 years old with sJIA or CRS. Administer via slow IV drip only.
Time: Complete infusion within 60 minutes; pause or stop infusion immediately once hypersensitivity signs appear. Adjust dosage or interval if liver enzymes, neutrophils or platelets drop abnormally.
Interaction: Live vaccines are contraindicated during treatment. Combined immunosuppressants raise infection risk; monitor liver function and blood routine regularly.
Side effects: Common: upper respiratory tract infection, headache, hypertension, elevated transaminases. Rare risks: severe infection, neutropenia, gastrointestinal perforation, hypersensitivity.

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