COLUMVI

Generic Name/API: glofitamab-gxbm

Manufacturer: Genentech, Inc., A Member of the Roche Group

Packaging & Strength:
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.

Storage:
• Gently invert infusion bag to mix the solution, in order to avoid excessive foaming. Do not shake.
• Immediately use diluted COLUMVI solution. If not used immediately, the diluted solution can be
stored:
o Refrigerated at 2°C to 8°C (36°F to 46°F) for up to 64 hours, or
o At room temperature up to 25°C (77°F) for up to 4 hours.
o Do not freeze the diluted infusion solution.
o Discard diluted infusion solution if storage time exceeds these limits.

  • INDICATION
  • IMPORTANT SAFETY INFORMATION

INDICATIONS What is COLUMVI?
COLUMVI (glofitamab-gxbm) is a prescription medicine to treat adults with certain types of diffuse large B-cell lymphoma (DLBCL) or large B-cell lymphoma (LBCL) that has come back (relapsed) or that did not respond to previous treatment (refractory), and who have received 2 or more prior treatments for their cancer.

It is not known if COLUMVI is safe and effective in children.

The conditional approval of COLUMVI is based on response rate and durability of response. There are ongoing studies to establish how well the drug works.

What is the most important
information I should know about COLUMVI?
COLUMVI can cause Cytokine Release Syndrome (CRS), a serious side effect that is common during treatment with COLUMVI, and can also be serious and lead to death.

Important Safety Information
What is the most important
information I should know about COLUMVI?
COLUMVI can cause Cytokine Release Syndrome (CRS), a serious side effect that is common during treatment with COLUMVI, and can also be serious and lead to death.
Call your healthcare provider or get emergency medical help right away if you
develop any signs or symptoms of CRS, including:
– fever of 100.4°F (38°C) or higher
– chills or shaking
– fast or irregular heartbeat
– dizziness or light-headedness
– trouble breathing
– shortness of breath
If your DLBCL has come back
or has not responded to at least
2 prior treatments, there is hope
This brochure has been created to help you and your loved ones gain a better
understanding of the COLUMVI™ treatment journey and how this therapy may help
with your current condition.
In this brochure, you will learn more about:
• Diffuse large B-cell lymphoma (DLBCL)
• What COLUMVI is and how it is thought to work
• What you may expect during treatment with COLUMVI
• Resources that may be helpful during your treatment journey
Contact your healthcare team if you have any questions.
Important Safety Information (cont’d)
Call your healthcare provider or get emergency medical help right away if you
develop any signs or symptoms of CRS, including:
– fever of 100.4°F (38°C) or higher
– chills or shaking
– fast or irregular heartbeat
– dizziness or light-headedness
– trouble breathing
– shortness of breath
What is DLBCL?
DLBCL develops when a type of white blood cell, called a B cell, grows and divides
or multiplies abnormally.
• B cells are a type of white blood cell that helps defend your body against bacteria,
viruses, and abnormal cells
• Your immune system also includes T cells, which can detect and destroy both
infected and cancerous cells
Large B-cell Lymphoma (LBCL) is a broad category that includes DLBCL.
Relapsed or refractory DLBCL (R/R DLBCL) is cancer that has come back after
treatment (relapsed) or has not responded to certain treatments (refractory).
Important Safety Information (cont’d)
Due to the risk of CRS, you will receive COLUMVI on a “step-up dosing schedule”.
• A single dose of a medicine called obinutuzumab will be given to you on the first day
of your first treatment cycle (Day 1 of Cycle 1).
• You will start the COLUMVI step-up dosing schedule a week after the obinutuzumab
dose. The step-up dosing schedule is when you receive smaller “step-up” doses of
COLUMVI on Day 8 and Day 15 of Cycle 1. This is to help reduce your risk of CRS.
You should be hospitalized during your infusion and for 24 hours after receiving the
first step-up dose on Day 8. You should be hospitalized during your infusion and for
24 hours after receiving the second step-up dose on Day 15 if you experienced CRS
during the first step-up dose.
• You will receive your first full dose of COLUMVI a week after the second step-up dose
(this will be Day 1 of Cycle 2).
• If your dose of COLUMVI is delayed for any reason, you may need to repeat the
“step-up dosing schedule”.
• If you had more than mild CRS with your previous dose of COLUMVI, you should be
hospitalized during and for 24 hours after receiving your next dose of COLUVMI.
• Before each dose of COLUMVI, you will receive medicines to help reduce your risk of
CRS and infusion-related reactions.

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