Glofitamab-gxbm (Intravenous)

Glofitamab-gxbm injection is used to treat specific types of large B-cell lymphoma (including diffuse large B-cell lymphoma [DLBCL] and large B-cell lymphoma [LBCL]) that has returned or did not respond to earlier treatments in patients who have already tried 2 or more other medicines that did not work well. Lymphoma is a type of cancer where the body produces abnormal white blood cells.

This medicine is to be given only by your doctor or under their direct supervision.

It is very important that your doctor checks your progress at regular visits to ensure that this medicine is working properly. Blood tests are needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to ensure you are not pregnant before starting treatment. Use an effective form of birth control to prevent getting pregnant during treatment and for 1 month after the last dose. If you think you may have become pregnant while using this medicine, tell your doctor right away.

This medicine may cause cytokine release syndrome (CRS) and nervous system problems, including immune effector cell-associated neurotoxicity syndrome (ICANS). These can be life-threatening and require immediate attention. Tell your doctor right away if you experience agitation, back pain, blurred vision, burning, throbbing, or stabbing pain, coma, confusion, double vision, drowsiness, feeling restless, fever, chills, hallucinations, headache, hearing loss, irritability, jerking movements, mood or mental changes, muscle spasms, nausea, lightheadedness, dizziness, fainting, rigid muscles, seizures, skin rash, stiff neck, tremor, trouble breathing, trouble speaking, unusual tiredness or weakness, or vomiting.

This medicine may cause serious infections. Check with your doctor right away if you have fever or chills, confusion, cough or hoarseness, lower back or side pain, or painful or difficult urination.

Check with your doctor right away if you have chest pain, cough, pain or swelling at the site of the tumor, tender or swollen lymph nodes, or trouble breathing. These may be symptoms of a serious or worsening tumor.

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.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor will weigh the risks of taking the medicine against the benefits it may provide. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also let your health care professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies have not been done to determine how age affects the effects of glofitamab-gxbm injection in children. Safety and effectiveness have not been established.

Geriatric

Studies conducted so far have not shown any specific problems in older adults that would limit the usefulness of glofitamab-gxbm injection in the elderly.

Breast Feeding

There are not enough studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction is possible. In these situations, your doctor may want to adjust the dose, or other precautions may be necessary. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• Burning, numbness, tingling, or painful sensations
• Chest pain
• Cough
• Difficulty in moving
• Dizziness or lightheadedness
• Feeling of constant movement of self or surroundings
• Headache
• Joint or bone pain
• Muscle cramps, pains, or stiffness
• Pain or swelling at the site of the tumor
• Rapid or irregular heartbeat
• Rapid weight gain
• Sensation of spinning
• Swollen joints
• Tender or swollen lymph nodes
• Tingling of the hands or feet
• Trembling and shaking of hands
• Trouble breathing
• Unsteadiness or awkwardness
• Unusual weight gain or loss
• Weakness
• Weakness in arms, hands, legs, or feet

Less common

• Black, tarry stools
• Chest tightness
• Confusion as to time, place, or person
• Fever or chills
• Hallucinations
• Holding false beliefs that cannot be changed by fact
• Lower back or side pain
• Mental depression or anxiety
• Nightmares or unusually vivid dreams
• Painful or difficult urination
• Pale skin
• Sleepiness or unusual drowsiness
• Sneezing
• Sore throat
• Ulcers, sores, or white spots in the mouth
• Unusual bleeding or bruising
• Unusual excitement, nervousness, or restlessness
• Unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Back pain
• Blistering, crusting, irritation, itching, or reddening of the skin
• Constipation
• Cracked, dry, or scaly skin
• Diarrhea
• Neck pain
• Pain in the arms or legs
• Stomach pain
• Swelling

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

In the U.S.

• Columvi

Available Dosage Forms:

• Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Glofitamab

Find detailed information on biosimilars for this medication.

Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins. It 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 on a "step-up dosing schedule" on Day 8 and 15 of your first cycle. You will receive your full dose 1 week after the second step-up dose (Day 1 of cycle 2). Your doctor will ask you to stay for 24 hours after receiving this medicine.

This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Your may also receive extra fluids and other medicines (eg, allergy medicine, gout medicine, steroid, fever medicine, viral medicine) 30 to 60 minutes before starting treatment with this medicine.

Your doctor may also give you other cancer medicine (eg, obinutuzumab) on Day 1 of cycle 1 before starting treatment with this medicine.