Pronunciation:

ep-koe-RIT-a-mab - bysp

Brand Names:

• Epkinly

Dosage Forms:

• Solution

Warnings:

Warning: Cytokine Release Syndrome and Immune Effector Cell-Associated Neurotoxicity SyndromeCytokine release syndrome (CRS), including serious or life-threatening reactions, can occur in patients receiving epcoritamab-bysp. Initiate treatment with the epcoritamab-bysp step-up dosing schedule to reduce the incidence and severity of CRS. Withhold epcoritamab-bysp until CRS resolves or permanently discontinue based on severity.Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), including life threatening and fatal reactions, can occur with epcoritamab-bysp. Monitor patients for neurological signs or symptoms of ICANS during treatment. Withhold epcoritamab-bysp until ICANS resolves or permanently discontinue based on severity .

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Epcoritamab

Uses of This Medicine:

Epcoritamab-bysp injection is used to treat certain types of large B-cell lymphoma (including diffuse large B-cell lymphoma [DLBCL] and high grade B-cell lymphoma) 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 epcoritamab-bysp 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 epcoritamab-bysp 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.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Serious infections—Use with caution. May make this condition worse.

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 as a shot under the skin of your thighs or stomach. Your treatment schedule is divided into cycles that are usually 28 days long.

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

You doctor may also give you other medicines (eg, allergy medicine, steroid, fever medicine) 30 to 120 minutes 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 4 months 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.

This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

This medicine may cause dizziness, confusion, or tremors. Do not drive or do anything else that could be dangerous after receiving this medicine until you know how this medicine affects you.

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

Back pain

bloating or swelling of the face, arms, hands, lower legs, or feet

chest pain or discomfort

decreased appetite

difficulty in moving

dizziness

fainting

fast, slow, or irregular heartbeat

headache

joint pain

lightheadedness

muscle aches, cramps, or stiffness

muscle or bone pain

nausea

neck pain

pain in the arms or legs

palpitations

pounding or rapid pulse

rapid weight gain

rash with flat lesions or small raised lesions on the skin

stomach pain

swollen joints

tingling of the hands or feet

trembling and shaking of hands

trouble breathing

unusual tiredness or weakness

unusual weight gain or loss

vomiting

Less common

Black, tarry stools

bleeding gums

blood in the urine or stools

body aches or pain

chest tightness

chills

confusion

cough

ear congestion

fever

loss of voice

lower back or side pain

painful or difficult urination

pale skin

pinpoint red spots on the skin

problems with speech or speaking

sneezing

sore throat

stuffy or runny nose

ulcers, sores, or white spots in the mouth

unusual bleeding or bruising

unusual drowsiness, dullness, tiredness, weakness or feeling of sluggishness

Rare

Anxiety

dark urine

pain or discomfort in the arms, jaw, back, or neck

sweating

yellow eyes or skin

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

Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

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.