Pronunciation:

gloe-fi-TAM-ab - gxbm

Brand Names:

• Columvi

Dosage Forms:

• Solution

Warnings:

Warning: Cytokine Release SyndromeCytokine Release Syndrome (CRS), including serious or fatal reactions, can occur in patients receiving glofitamab-gxbm. Premedicate before each dose, and initiate treatment with the glofitamab-gxbm step-up dosing schedule to reduce the risk of CRS. Withhold glofitamab-gxbm until CRS resolves or permanently discontinue based on severity .

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Glofitamab

Uses of This Medicine:

Glofitamab-gxbm injection is used to treat certain types of large B-cell lymphoma (including diffuse large B-cell lymphoma [DLBCL] and large B-cell lymphoma [LBCL]) that has come back or did not respond to previous treatment in patients who have received 2 or more other medicines that did not work well. Lymphoma is a type of cancer where the body makes abnormal white blood cells.

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

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

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

Children—

Appropriate studies have not been performed on the relationship of age to the effects of glofitamab-gxbm injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of glofitamab-gxbm injection in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

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

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure 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 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. If you think you 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 may be life-threatening and require immediate attention. Tell your doctor right away if you have 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 serious or worsening of 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.

Side Effects of This Medicine:

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.