On June 15, 2023, the FDA approved Columvi™ (glofitamab-gxbm) for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) not otherwise specified or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy.
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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:
Due to the risk of CRS, you will receive COLUMVI on a “step-up dosing schedule”.
Your healthcare provider will monitor you for CRS during treatment with COLUMVI and may treat you in a hospital if you develop signs and symptoms of CRS. Your healthcare provider may temporarily stop or completely stop your treatment with COLUMVI if you have severe side effects.
Carry the COLUMVI Patient Wallet Card with you at all times and show it to all of your healthcare providers. The COLUMVI Patient Wallet Card lists the signs and symptoms of CRS you should get emergency medical help for right away.
What are the possible side effects of COLUMVI?
COLUMVI may cause serious side effects, including:
The most common side effects of COLUMVI include: CRS, muscle and bone pain, rash, and tiredness.
The most common severe abnormal lab test results with COLUMVI include: decreased white blood cells, decreased phosphate (an electrolyte), increased uric acid levels, and decreased fibrinogen (a protein that helps with blood clotting).
Your healthcare provider may temporarily stop or completely stop treatment with COLUMVI if you develop certain side effects.
Before receiving COLUMVI, tell your healthcare provider about all of your medical conditions, including if you:
Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
What should I avoid while receiving COLUMVI?
Do not drive, operate heavy machinery, or do other dangerous activities if you develop dizziness, confusion, shaking (tremors), sleepiness, or any other symptoms that impair consciousness until your signs and symptoms go away. These may be signs and symptoms of neurologic problems.
These are not all the possible side effects of COLUMVI. Talk to your health care provider for more information about the benefits and risks of COLUMVI.
“People with diffuse large B-cell lymphoma who have gone through multiple lines of therapy have a poor prognosis and desperately need additional treatment options. As an off-the-shelf, fixed-duration treatment providing durable response rates, we believe Columvi could change the way this aggressive lymphoma is treated, reinforcing our dedication to bringing innovative treatment options to people with critical unmet needs.”