Glofitamab-gxbm (gloe-fi-TAM-ab - gxbm)

Treats lymphoma, including diffuse large B-cell lymphoma and large B-cell lymphoma.

Brand Name(s):

Columvi

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through an IV placed in a vein. This medicine must be given slowly, so the needle will have to stay in place for at least 2 to 4 hours. Your treatment schedule is divided into cycles that are usually 21 days long.
• You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine.
• You doctor may also give you other medicines (including allergy medicine, gout medicine, steroid, fever medicine, antiviral medicine) 30 to 60 minutes before starting treatment with this medicine.
• Your doctor will also give you another cancer medicine (including obinutuzumab) 7 days before starting treatment with this medicine.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control to keep from getting pregnant during treatment and for 1 month after the last dose.
• Do not breastfeed during treatment and for 1 month after the last dose.
• Tell your doctor if you have kidney disease or an infection.
• This medicine may cause the following problems:
  • Cytokine release syndrome, which may be life-threatening
  • Nervous system problems, including immune effector cell-associated neurotoxicity syndrome (ICANS)
  • Serious infections
  • Serious tumor flare
• This medicine may cause dizziness, confusion, tremors, or sleepiness. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain, trouble breathing, fast, slow, or uneven heartbeat
• Fever, chills, cough, sore throat, body aches
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet
• Seizures, confusion, problems with balance, walking, or speech
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Muscle or bone pain
• Skin rash

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088