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Overview: Epkinly is a medicine used to treat certain types of cancer. Tiredness, stomach pain, diarrhea, muscle pain, bone pain, or itching, swelling, or redness near where you get this medicine are common side effects. A serious side effect called cytokine release syndrome (CRS) is also common. Get emergency help if you get a fever, chills, dizziness, trouble breathing, fast heartbeat, headache, confusion, tremors, or trouble walking. Keep all appointments to have your blood checked.

Uses

What is Epkinly used for?

Epkinly (epcoritamab-bysp) is commonly used to treat certain types of B-cell lymphomas.

Epkinly may also be used for other conditions as determined by your health care provider.

How does Epkinly work (mechanism of action)?

Epkinly is a medicine that helps your immune system fight cancer cells. Epkinly is a man-made protein (antibody) that binds to specific immune cells, called T cells. Epkinly also binds to a protein called CD20 that is found on other immune cells called B-cells. As a result, Epkinly causes T-cells to kill CD20+ B-cells. Both healthy and cancerous B-cells are killed.

How is Epkinly supplied (dosage forms)?

Epkinly is available in an injectable form that is given by a healthcare provider.

How should I store Epkinly?

Epkinly is usually given by a health care provider in a hospital or clinic. You will not store it at home.

Side Effects

What are the most common side effects of Epkinly?

The most common side effects of Epkinly are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Pain, itching, swelling, or redness near the injection site
  • Cytokine release syndrome (see below)
  • Tiredness
  • Stomach pain, nausea, or diarrhea
  • Fever
  • Muscle or bone pain
  • Infection in the nose or throat, sore throat, cough, or common cold symptoms
  • Headache
  • Low neutrophil levels (see below)
  • Severely low platelet levels (see below)
  • Anemia (see below)

There may be other side effects of Epkinly that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Epkinly?

While less common, the most serious side effects of Epkinly are described below, along with what to do if they happen.

Severe Allergic Reactions. Epkinly may cause allergic reactions, which can be serious. Get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching or skin rash
  • Bumps on the skin called hives that can be red, pink, white, or brown depending on your skin tone
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Cytokine Release Syndrome (CRS). Epkinley can cause a dangerous and sometimes life-threatening problem called cytokine release syndrome. CRS occurs when your immune system responds too much to medicines or infection. CRS may happen right away or several days after you get Epkinley. Get emergency help if you have any of the following symptoms of CRS. 

  • Fever or chills
  • Fast or racing heart
  • Dizziness 
  • Feeling lightheaded or off-balance
  • Trouble breathing
  • Severe nausea, vomiting, or diarrhea
  • Severe headache
  • Confusion

Neurologic Problems. Epkinley can cause a condition called immune effector cell-associated neurotoxicity syndrome (ICANS) that can be life-threatening. This side effect can happen days or weeks after you get Epkinly. Get emergency help if you have any of the following symptoms.

  • Confusion or memory problems
  • Seizures
  • Balance problems
  • Trouble talking, walking, or writing
  • Tremor or muscle weakness
  • Lack of energy or drowsiness

Infections. Epkinly can increase your risk of infections, including serious infections that can be life-threatening. Take any medicines that you are given to help prevent infections. Call your health care provider right away if you have an infection or any of the following symptoms.

  • Burning or stinging when you pee 
  • Coughing, or coughing up blood
  • Fever, sweats, chills, or muscle aches
  • Shortness of breath
  • Diarrhea or stomach pain
  • Weight loss
  • Tiredness or feeling weak or unwell
  • Sore throat
  • Painful rash

Severely Low Platelet Levels. Epkinly can cause you to have a severely low number of platelets in your blood, also called thrombocytopenia. Platelets help to form blood clots. Having a low level of platelets may increase your risk of bleeding. Keep all appointments to have your blood checked. Tell your health care provider if you have any of the following symptoms of low platelet levels.

  • Easy bruising or bleeding
  • Bleeding that does not stop
  • Nosebleeds

Low Neutrophil Levels (Neutropenia). Epkinly may cause low levels of a type of white blood cell (called neutrophils), which is known as neutropenia. Neutrophils help prevent infection. Having a low level of neutrophils may increase your risk of infection. Keep all appointments to have your blood checked. Tell your health care provider right away if you have any of the following symptoms of low neutrophil levels.

  • Fever, chills, or sweats
  • Tiredness
  • Sore throat, cough, or shortness of breath
  • Mouth or throat sores
  • Swollen lymph nodes

Anemia. Epkinly may cause anemia, which is when you have low levels of red blood cells. Keep all appointments to have your blood checked. Tell your health care provider if you have any of the following symptoms of anemia.

  • Unusual weakness or tiredness
  • Cold hands and feet
  • Fast or abnormal heartbeat
  • Pale or yellowish skin 
  • Dizziness, lightheadedness, or feeling like you are about to pass out
  • Shortness of breath

Warnings & Precautions

Who should not use Epkinly?

Allergies to Ingredients. People who are allergic to any of the following should not use Epkinly.

  • Epcoritamab-bysp
  • Epkinly 
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Epkinly.

What should I know about Epkinly before using it?

Epkinly is usually given by a health care provider in a hospital or clinic. 

Do not drive or do other activities that require alertness or coordination if you get serious side effects called cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS). See the Side Effects section for symptoms of these problems. Both of these side effects need to go away completely before you can drive or operate heavy machinery. Talk with your health care provider if you get either CRS or ICANS. Your health care provider can tell you when it is safe to do  activities that require alertness or coordination.

What should I tell my health care provider before using Epkinly?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Epkinly is right for you.

In particular, make sure that you discuss any of the following.

Current Infection. Tell your health care provider if you have an infection or think you may have an infection before getting a dose of Epkinly. This medicine can make it hard for you to fight infections.

Pregnancy. Epkinly may cause harm to an unborn baby. A negative pregnancy test is necessary before starting treatment. If you can become pregnant, use effective birth control during your treatment and for at least 4 months after your last dose. Tell your health care provider right away if you are pregnant, think you may be pregnant, or plan to become pregnant.

Breastfeeding. It is not known if Epkinly passes into breast milk. Do not breastfeed during Epkinly treatment and for 4 months after your last dose. Tell your health care provider if you are breastfeeding or plan to breastfeed.

How can I get more information about Epkinly?

For more information about Epkinly, you can visit the drugmaker’s website at www.epkinly.com or call them at 855-443-6622.

Interactions

Does Epkinly interact with foods or drinks?

There are no known interactions between Epkinly and foods or drinks.

There are no known interactions between Epkinly and alcohol, but heavy drinking can slow your immune response and make it harder for your body to fight cancer.

Does Epkinly interact with other medicines (drug interactions)?

Epkinly may interact with certain medicines. Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Epkinly?

If you or someone else has used too much Epkinly, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Epkinly?

Epkinly is usually given by a healthcare provider in a hospital or clinic. Your healthcare provider will make sure you are receiving Epkinly as scheduled. 

If you miss an appointment to get your Epkinly dose, call to make another appointment as soon as possible.

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