EPKINLY is a treatment for people with certain types of diffuse large B-cell lymphoma (DLBCL) whose cancer has returned or didn't respond after 2 or more prior treatments. It's the first-and-only FDA-approved bispecific antibody given as a subcutaneous injection, which means it’s given under the skin.
EPKINLY is given by your healthcare provider as a subcutaneous injection (an injection given under the skin). You will be able to receive EPKINLY as soon as you and your healthcare provider are ready to begin treatment.
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You will continue to receive EPKINLY as long as your doctor finds it is working for you and your side effects are manageable.
You may have side effects during or after your injection. EPKINLY can cause serious side effects including CRS, neurologic problems, infections, and low blood counts. Your healthcare provider will monitor you for symptoms of CRS and neurologic problems during treatment with EPKINLY, as well as other side effects, and treat you if needed. Your healthcare provider may temporarily or completely stop your treatment with EPKINLY if you develop CRS, neurologic problems, or any other side effects that are severe.
Before each dose of EPKINLY in your first 4 weeks of treatment, you will receive medicines to help reduce the risk of CRS. Your healthcare provider will decide if you need to receive medicine to help reduce the risk of CRS in later doses of EPKINLY.
Do not drive, operate heavy machinery, or do other dangerous activities if you develop dizziness, confusion, tremors, sleepiness, or any other symptoms that impair consciousness until your symptoms go away. These may be symptoms of CRS or neurologic problems.
You will continue to receive EPKINLY as long as your doctor finds it is working for you and your side effects are manageable. Your healthcare provider may temporarily or completely stop your treatment with EPKINLY if you develop CRS, neurologic problems, or any other side effects that are severe.
You should contact your healthcare provider if you can't attend your regularly scheduled dosing appointment. They can walk you through what you may need to do if you miss a dose.
Keep this card with you in the event a healthcare provider needs to quickly reference your important information.
Keep track of how you are feeling and questions you have for your healthcare team in your EPKINLY Treatment Tracker.
EPKINLY is a prescription medicine used to treat adults with certain types of diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma that has come back (relapsed) or that did not respond to previous treatment (refractory), and who have received 2 or more treatments for their cancer.
EPKINLY is approved based on patient response data. A study is ongoing to confirm the clinical benefit of EPKINLY. It is not known if EPKINLY is safe and effective in children.
Due to the risk of CRS, you will receive EPKINLY on a “step-up” dosing schedule. The step-up dosing schedule is when you receive smaller “step-up” doses of EPKINLY on day 1 and day 8 of your first cycle of treatment (cycle 1). You will receive your first full dose of EPKINLY on day 15 of cycle 1. If your dose of EPKINLY is delayed for any reason, you may need to repeat the step-up dosing schedule. Before each dose in cycle 1, you will receive medicines to help reduce your risk of CRS. Your healthcare provider will decide if you need to receive medicine to help reduce your risk of CRS with future cycles.
Due to the risk of CRS and neurologic problems, you should be hospitalized for 24 hours after receiving your first full dose of EPKINLY on day 15 of cycle 1. Your healthcare provider will monitor you for symptoms of CRS and neurologic problems during treatment with EPKINLY, as well as other side effects, and treat you if needed. Your healthcare provider may temporarily stop or completely stop your treatment with EPKINLY if you develop CRS, neurologic problems, or any other side effects that are severe.
Do not drive or use heavy or potentially dangerous machinery if you develop dizziness, confusion, tremors, drowsiness, or any other symptoms that impair consciousness until your symptoms go away. These may be symptoms of CRS or neurologic problems.
EPKINLY can also cause other serious side effects, including:
Your healthcare provider may temporarily stop or completely stop treatment with EPKINLY if you develop certain side effects.
Before you receive EPKINLY, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
The most common side effects of EPKINLY include CRS, tiredness, muscle and bone pain, injection site reactions, fever, stomach-area (abdominal) pain, nausea, and diarrhea.
These are not all the possible side effects of EPKINLY. Call your doctor for medical advice about side effects.
You are encouraged to report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch or to Genmab US, Inc. at 1-855-4GENMAB (1-855-443-6622).
Please see Medication Guide, including Important Warnings.
