Columvi (Glofitamab)

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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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

PRINCIPAL DISPLAY PANEL - 10 mg/10 mL Vial Carton

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

PRINCIPAL DISPLAY PANEL - 2.5 mg/2.5 mL Vial Carton