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columvi glofitamab injection 10mg

Description

 Indication & Scope

Glofitamab injection is a CD20/CD3 bispecific antibody conditionally approved in China as monotherapy for adult patients with relapsed or refractory diffuse large B-cell lymphoma who have received at least two prior lines of systemic therapy.

  • Mechanism: Glofitamab is a CD20/CD3 bispecific antibody that engages T cells to kill CD20-positive B-cell lymphoma cells.
  • Drug class: Bispecific antibody.
  • Clinical use: Applied for adult patients with relapsed or refractory diffuse large B-cell lymphoma failing prior systemic treatments.
Specification
Generic Name Glofitamab
Brand Name Columvi
Ingredient Glofitamab
Dosage Form Injection
Package 10mg/vial
Conditions Treated Applied for adult patients with relapsed or refractory diffuse large B-cell lymphoma failing prior systemic treatments.
Taboos Contraindicated in patients with known hypersensitivity to glofitamab or any of its excipients.
Place of origin  1 DNA Way, South San Francisco, California (CA) 94080, United States (USA)
Prescription type Prescription-only
Storage Conditions Store refrigerated at 2–8°C in original carton to protect from light. Do not freeze or shake.
Manufacturer Roche Diagnostics GmbH, Ltd
Registration Authority National Medical Products Administration (NMPA), China
Approval number SJ20230017
Date of Revision 2023
Shelf Life 24 months

How to use ?

Recommended Dose: Escalating dosing schedule with a 21-day cycle for up to 12 cycles: 2.5mg on Cycle 1 Day 8, 10mg on Cycle 1 Day 15, then 30mg fixed dose on Day 1 of Cycle 2-12. Pre-treatment with obinutuzumab is required 7 days before the first dose.

 

Time: 21 days per treatment cycle. Infuse on Day 8 & Day 15 of Cycle 1, then Day 1 of each subsequent cycle. Each infusion lasts about 4 hours.

 

Instructions for use: For intravenous infusion only with a 0.2μm sterile in-line filter. Administer under supervision in qualified oncology centers. Pre-medication and adverse reaction monitoring are required. Do not administer as bolus injection, rapid infusion, or vigorously shake the vial.

 

Interaction: It may suppress CYP enzyme activity via cytokine release, raising exposure of CYP-metabolized drugs. Monitor toxicity or drug levels of CYP substrates during co-administration. Avoid unregulated combination with immunosuppressive agents that raise infection risks.

 

Side effects: Common adverse reactions include cytokine release syndrome, tumor flare reaction, diarrhea, nausea, constipation, fatigue and neutropenia. Most adverse events are manageable with dose adjustment and symptomatic treatment.

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

What is Columvi used for?

COLUMVI (glofitamab-gxbm) is a prescription medicine for adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or large B-cell lymphoma (LBCL) who have received at least two prior systemic therapies.

How long is the treatment for Columvi ?

A 12-cycle treatment that can be completed in ~8.5 months.

What is the structure of Columvi?

Columvi is a CD20xCD3 T-cell engaging bispecific antibody specifically engineered with a unique 2:1 binding structure.

Is Columvi a bispecific?

COLUMVI is a bispecific antibody that is designed to bind to 1 part of a T cell (immune cell) and 2 parts of a B cell to bring them closer together.

Columvi® | Glofitamab Injection | Relapsed or Refractory Diffuse Large B-cell Lymphoma | DengYueRX

INN: Glofitamab-gxbm
Indications: Relapsed/refractory large B-cell lymphoma.
Dosage Form: Injection
Strength: 10mg/vial

Low MOQ

WHO-GMP

Worldwide Delivery

Compliance and Regulatory Documents

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