Home - Prescription Medicines - Columvi® | Glofitamab Injection | Relapsed or Refractory Diffuse Large B-cell Lymphoma | DengYueRX
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.
| 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
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