(gloe fit′ a mab)

Brand Name(s): Columvi^®

IMPORTANT WARNING:

Glofitamab-gxbm injection may cause a serious or life-threatening reaction called cytokine release syndrome (CRS). Tell your doctor if you have an inflammatory disorder or if you have or think you may have any type of infection now. Your doctor may tell you to take certain medications before receiving glofitamab-gxbm injection to prevent this reaction. If you experience any of the following symptoms during and after your injection, tell your doctor immediately: fever, chills, fast or irregular heartbeat, difficulty breathing, shortness of breath, cough, confusion, anxiety, restlessness, headache, dizziness, lightheadedness, muscle pain, shaking, diarrhea, nausea, vomiting, tiredness, or weakness.

You may experience CRS or central nervous system reactions while you receive a dose of glofitamab-gxbm injection but these reactions may occur afterwards. A doctor or nurse will monitor you carefully in a hospital or medical facility during your injections and for at least 24 hours after at least your first 3 doses of glofitamab-gxbm injection to be sure you are not having a serious reaction to the medication.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests to check your body's response to glofitamab-gxbm injection.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with glofitamab-gxbm injection and each time you receive an infusion. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

Talk to your doctor about the risk(s) of receiving glofitamab-gxbm injection.

WHY is this medicine prescribed?

Glofitamab-gxbm is used for treatment of certain types of diffuse large B-cell lymphoma (DLBCL; a type of cancer that impacts the lymphatic [infection-fighting] system in the body) or large B-cell lymphoma (LBCL; a type of cancer that impacts the lymphatic [infection-fighting] system in the body) in adults that has either returned after completing treatment or failed to respond to other treatments. Glofitamab-gxbm is in a class of medications called bispecific T-cell engager antibodies. It works by killing cancer cells.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Glofitamab-gxbm comes as a solution (liquid) to be given intravenously (into the vein) by a doctor or a nurse at a healthcare facility. During cycle 1 (21 day cycles), you will be given another medicine called obinutuzumab and then glofitamab-gxbm on days 8 and 15 and you will then receive it once every 21 days thereafter.

Your doctor will probably start you on a low dose of glofitamab-gxbm and gradually increase your dose.

Your doctor may delay or stop your treatment with glofitamab-gxbm injection, or treat you with additional medications, depending on your response to the medication and any side effects that you experience. Talk to your doctor about how you are feeling during your treatment.

What SPECIAL PRECAUTIONS should I follow?

Before receiving glofitamab-gxbm,

• tell your doctor and pharmacist if you are allergic to glofitamab-gxbm, any other medications, or any of the ingredients in glofitamab-gxbm injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

• tell your doctor if you have an infection or if you have or have ever had low blood cell counts (leukopenia, neutropenia, anemia) or kidney disease.

• tell your doctor if you are pregnant or plan to become pregnant. You must have a pregnancy test before you start treatment with glofitamab-gxbm injection. You should use birth control to prevent pregnancy during your treatment with glofitamab-gxbm injection and for 1 months after your final dose. Talk to your doctor about birth control methods that you can use. If you become pregnant while receiving glofitamab-gxbm injection, call your doctor. Glofitamab-gxbm injection may harm the fetus.

• tell your doctor if you are breastfeeding. Do not breastfeed during your treatment and for 1 month after your final dose.

• you should know that glofitamab-gxbm may make you dizzy or cause confusion. Do not drive a car or operate machinery until you know how this medication affects you.

• you should know that glofitamab-gxbm can cause serious neurologic problems that sometimes can lead to death. Call your doctor right away if you have any of the following symptoms: headache, confusion or feeling disoriented, difficulty with focus or attention, memory problems, trouble speaking, sleepiness, numbness, tingling, or weakness of the hands or feet, dizziness, and shakiness (tremors).

• you should know that glofitamab-gxbm can cause tumor flares (growth in tumor or worsening of tumor-related problems). Call your doctor right away if you have any of the following symptoms: tender or swollen lymph nodes, pain or swelling at tumor site, chest pain, cough, trouble breathing.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What SIDE EFFECTS can this medicine cause?

Glofitamab-gxbm may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• pain in muscle, bone or joints
• tiredness
• swelling
• rash
• constipation or diarrhea
• abdominal pain

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

• fever, chills, weakness, cough, shortness of breath, or sore throat

Glofitamab-gxbm may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to glofitamab-gxbm. If you miss a scheduled infusion for glofitamab-gxbm, you may have to start over with the first cycle dose.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™. © Copyright, 2024. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: October 15, 2023.