Brand Name
Columvi
Generic Name
Glofitamab
View Brand Information FDA approval date: June 15, 2023
Classification: Bispecific CD20-directed CD3 T Cell Engager
Form: Concentrate, Solution
What is Columvi (Glofitamab)?
COLUMVI is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified or large B-cell lymphoma arising from follicular lymphoma, after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate and durability of response [see Clinical Studies (1.
Approved To Treat
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Summary: The main goal of this trial is to study the frequency and severity of cytokine release syndrome (CRS) in participants with diffuse large B-cell lymphoma (DLBCL) who are using a combination of glofitamab + gemcitabine + oxaliplatin (Glofit-GemOx) followed by glofitamab-only treatment.
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Brand Information
Columvi (Glofitamab)
WARNING: CYTOKINE RELEASE SYNDROME
Cytokine Release Syndrome (CRS), including serious or fatal reactions, can occur in patients receiving COLUMVI. Premedicate before each dose, and initiate treatment with the COLUMVI step-up dosing schedule to reduce the risk of CRS. Withhold COLUMVI until CRS resolves or permanently discontinue based on severity [see .
1INDICATIONS AND USAGE
COLUMVI is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS) or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy.
This indication is approved under accelerated approval based on response rate and durability of response
2DOSAGE FORMS AND STRENGTHS
Injection:
- 2.5 mg/2.5 mL (1 mg/mL) clear, colorless solution in a single-dose vial.
- 10 mg/10 mL (1 mg/mL) clear, colorless solution in a single-dose vial.
3CONTRAINDICATIONS
None.
4ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Cytokine Release Syndrome
- Neurologic Toxicity
- Serious Infections
- Tumor Flare
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
5DRUG INTERACTIONS
For certain CYP substrates where minimal concentration changes may lead to serious adverse reactions, monitor for toxicities or drug concentrations of such CYP substrates when coadministered with COLUMVI.
Glofitamab-gxbm causes the release of cytokines
6DESCRIPTION
Glofitamab-gxbm is a bispecific CD20-directed CD3 T-cell engager. It is a recombinant humanized anti-CD20 anti-CD3ɛ bispecific immunoglobulin G1 (IgG1) monoclonal antibody produced in Chinese hamster ovary (CHO) cells. Glofitamab-gxbm has an approximate molecular weight of 197 kDa.
COLUMVI (glofitamab-gxbm) injection is a sterile, preservative-free, colorless, clear solution supplied in single-dose vials for intravenous infusion.
COLUMVI is supplied in 2.5 mg/2.5 mL and 10 mg/10 mL single-dose vials at a concentration of 1 mg/mL. Each mL of solution contains 1 mg glofitamab-gxbm, histidine (0.63 mg), histidine hydrochloride monohydrate (3.34 mg), methionine (1.49 mg), polysorbate 20 (0.5 mg), sucrose (82.15 mg), and Water for Injection, USP, at pH 5.5.
7HOW SUPPLIED/STORAGE AND HANDLING
COLUMVI (glofitamab-gxbm) injection is a sterile, preservative-free, colorless, clear solution for intravenous infusion.
COLUMVI is supplied as:
8PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (
9PRINCIPAL DISPLAY PANEL - 10 mg/10 mL Vial Carton
NDC 50242-127-01
Columvi
(glofitamab-gxbm)
10 mg/10 mL
For Intravenous Infusion
Single-Dose Vial.
ATTENTION: Dispense the enclosed
1 vial
Rx only
11038205
10PRINCIPAL DISPLAY PANEL - 2.5 mg/2.5 mL Vial Carton
NDC 50242-125-01
Columvi
(glofitamab-gxbm)
2.5 mg/2.5 mL
For Intravenous Infusion
Single-Dose Vial.
ATTENTION: Dispense the enclosed
1 vial
Rx only
11038250
