The goal of EPKINLY is to help you achieve long-term remission. Learn about the results that were seen in the clinical study with EPKINLY.
EPKINLY is approved based on patient response data. A study is ongoing to confirm the clinical benefit of EPKINLY.
Complete or partial remission
EPKINLY helped 61% of patients (90 of 148) achieve complete or partial remission (signs of cancer either disappeared or decreased)
Complete remission
EPKINLY helped 38% of patients (56 of 148) achieve complete remission (signs of cancer disappeared completely)
Partial remission
EPKINLY helped 23% of patients (34 of 148) achieve partial remission (signs of cancer decreased)
Of the 90 patients who achieved complete or partial remission, half were still responding to EPKINLY for at least 15.6 months
~6
WEEKS
*Median† of 1.4 months. Range 1 to 8.4 months.
EPKINLY was studied in 148 patients with DLBCL who had 2 or more treatments and whose cancer returned or did not respond.
Patients had been through a median† of 3 different types of treatments (range of prior treatments was 2 to 11), such as chemotherapy, immunotherapy (uses your body's immune system to help fight cancer), stem cell transplant, and CAR T therapy (chimeric antigen receptor T cell).
†The median is the number that is exactly in the middle of range seen in the study.
Talk to your healthcare provider and discuss what these results could mean for you.
Before deciding on any medication, it's important to understand its benefits and risks. Here are some important things to keep in mind before taking EPKINLY. If you have any concerns or questions, be sure to talk to your healthcare provider to learn more.
EPKINLY can cause serious side effects, including:
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.
Before you receive EPKINLY, tell your healthcare provider about all of your medical conditions, including if you:
have an infection, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. If you receive EPKINLY while pregnant, it may harm your unborn baby. If you are a female who can become pregnant, your healthcare provider should do a pregnancy test before you start treatment with EPKINLY and you should use effective birth control (contraception) during treatment and for 4 months after your last dose of EPKINLY. Tell your healthcare provider if you become pregnant or think that you may be pregnant during treatment with EPKINLY. Do not breastfeed during treatment with EPKINLY and for 4 months after your last dose of EPKINLY.
These are not all the possible side effects of EPKINLY. Review the Important Safety Information below and the Medication Guide for EPKINLY. Talk to your healthcare provider about any concerns or for more information on possible side effects. Call your healthcare provider right away if you experience any side effects. You may report side effects to the FDA at 1-800-FDA-1088.
After starting on EPKINLY, keep this card with you in the event a healthcare provider needs to quickly reference your important treatment information.
When starting on EPKINLY, use the EPKINLY treatment tracker to track how you're feeling and questions you have for your healthcare team.
See how EPKINLY is given.
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 or that did not respond to previous treatment after receiving 2 or more treatments. 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.
Tell your healthcare provider or get medical help right away if you develop a fever of 100.4°F (38°C) or higher; dizziness or lightheadedness; trouble breathing; chills; fast heartbeat; feeling anxious; headache; confusion; shaking (tremors); problems with balance and movement, such as trouble walking; trouble speaking or writing; confusion and disorientation; drowsiness, tiredness or lack of energy; muscle weakness; seizures; or memory loss. These may be symptoms of CRS or neurologic problems. Do not drive or use heavy machinery or do other dangerous activities if you have any symptoms that impair consciousness until your symptoms go away.
EPKINLY can cause other serious side effects, including:
Your healthcare provider will monitor you for symptoms of CRS, neurologic problems, infections, and low blood cell counts during treatment with EPKINLY. 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 your medical conditions, including if you have an infection, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. If you receive EPKINLY while pregnant, it may harm your unborn baby. If you are a female who can become pregnant, your healthcare provider should do a pregnancy test before you start treatment with EPKINLY and you should use effective birth control (contraception) during treatment and for 4 months after your last dose of EPKINLY. Tell your healthcare provider if you become pregnant or think that you may be pregnant during treatment with EPKINLY. Do not breastfeed during treatment with EPKINLY and for 4 months after your last dose of EPKINLY.
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.
