Columvi 1 mg/mL intravenous solution

Generic name:
Glofitamab - injection

Pronunciation
(gloe-FIT-a-mab)

Brand name(s)
Columvi

Glofitamab may cause a serious (even fatal) reaction called cytokine release syndrome-CRS. You will be given this medication in a hospital or clinic so your doctor can watch for serious side effects and quickly provide treatment if needed. Tell your doctor right away if you have any symptoms of CRS such as high fever, trouble breathing, chills, dizziness/lightheadedness, or fast heartbeat.

This medication is used to treat certain types of cancer (large B-cell lymphoma- LBCL, diffuse large B-cell lymphoma- DLBCL). Glofitamab works by slowing or stopping the growth of cancer cells.

Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start using glofitamab and each time you get a treatment. If you have any questions, ask your doctor or pharmacist. Carry the Patient Wallet Card with you at all times. Show the card to all of your health care providers to let them know that you are being treated with glofitamab.

This medication is given by injection into a vein as directed by your doctor. The injection is given by a health care professional, usually over 2 to 4 hours. To reduce your risk of side effects, your doctor will start this medication at a low dose and gradually increase your dose. These starting doses are part of a "step-up dosing schedule." You will also be given a single dose of another medication (obinutuzumab) a week before your first "step-up dose" of glofitamab. You must stay in the hospital/clinic during and for some time after the first "step-up dose" so your doctor can monitor you closely and help you manage any side effects. Your doctor will decide if you need to be monitored after any of the following doses, based on any side effects you may have (such as CRS). The treatment schedule is based on your medical condition and response to treatment.

Before you receive this medication, your doctor will prescribe other medications (such as acetaminophen, dexamethasone, diphenhydramine) to help prevent side effects. Your doctor may also prescribe other medications (such as antibiotics, antivirals) to help prevent infection. Carefully follow your doctor's directions for all your medications.

Use this medication regularly to get the most benefit from it. To help you remember, mark your calendar with a reminder.

See also Warning section.

Tiredness or muscle/joint pain may occur. If either of these effects lasts or gets worse, tell your doctor or pharmacist promptly.

People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including:

• easy bruising/bleeding
• signs of anemia (such as unusual tiredness, pale skin)

This medication can also cause serious (sometimes fatal) nervous system problems. Careful monitoring and prompt treatment may decrease your risk. Tell your doctor right away if you have any symptoms such as headache, numbness/tingling/weakness of hands or feet, feeling of spinning/dizziness, mental/mood changes (such as confusion/delirium, memory problems), trouble speaking, shaking, or drowsiness.

This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as sore throat that doesn't go away, fever, chills, cough).

Glofitamab sometimes causes side effects due to the rapid destruction of cancer cells (tumor lysis syndrome). To lower your risk, your doctor may add a medication and tell you to drink plenty of fluids. Tell your doctor right away if you have symptoms such as:

• low back/side pain (flank pain)
• signs of kidney problems (such as painful urination, pink/bloody urine, change in the amount of urine)
• muscle spasms/weakness

People using this medication may have worsening of their symptoms (tumor flare). Tell your doctor right away if you have symptoms of tumor flare such as: tender or swollen lymph nodes, chest pain, cough, trouble breathing, or pain or swelling at the site of the tumor.

Glofitamab can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Get medical help right away if you develop any rash.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using glofitamab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• current/recent infections
• kidney problems

This drug may make you dizzy or drowsy or affect your thinking and coordination. Alcohol or marijuana (cannabis) can worsen these effects. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

This medication can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

Tell your health care professional that you are using glofitamab before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using glofitamab. Glofitamab may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Ask about reliable forms of birth control while using this medication and for some time after the last dose. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this drug and for some time after the last dose. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Lab and/or medical tests (such as complete blood count, kidney function) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Not applicable. This medication is given in a hospital or clinic and will not be stored at home.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.