Epcoritamab-bysp (Subcutaneous)

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 returned or did not respond to previous treatment in patients who have already received 2 or more other medicines that were not effective. Lymphoma is a type of cancer where the body produces abnormal white blood cells.

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

It is very important for your doctor to check your progress at regular visits to ensure that this medicine is working properly. Blood tests are needed to look 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 confirm that you are not pregnant before starting treatment. Use an effective form of birth control to prevent pregnancy during treatment and for 4 months after the last dose. If you think you might be 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, restlessness, 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 lead to serious infections. Contact your doctor immediately 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. As a result, you may bleed or get infections more easily. To help with these issues, avoid close contact with people who are sick or have infections. Wash your hands frequently. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be cautious 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 it affects you.

In deciding to use a medicine, you and your doctor need to consider the risks and benefits. For this medicine, keep the following in mind:

Allergies

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

Pediatric

Studies have not been conducted to determine how age affects the effects of epcoritamab-bysp injection in children. Safety and effectiveness have not been confirmed.

Geriatric

Studies so far have not shown any specific problems in elderly patients that would limit the usefulness of epcoritamab-bysp injection.

Breast Feeding

There are not enough studies in women to determine the risk to infants when using this medicine while breastfeeding. Consider the potential benefits and risks before taking 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 despite possible interactions. In such cases, your doctor may need to adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken 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 about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may influence the use of this medicine. Make sure to inform your doctor if you have any other medical issues, particularly:

• Serious infections—Use with caution. May worsen this condition.

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

Check with your doctor or nurse right away 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.

In the U.S.

• Epkinly

Available Dosage Forms:

• Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Epcoritamab

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 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.

• What is the success rate of Epkinly?