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So, you are getting ready to start EPKINLY®. Your healthcare provider will direct you throughout your EPKINLY® treatment and is the primary contact for healthcare-related issues and questions. As you approach the start of your EPKINLY® treatment, this video will provide you an overview of what you might expect.
First, what is EPKINLY®?
EPKINLY® is a prescription medicine used to treat adults with certain types of diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL) that have 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.
EPKINLY can cause serious side effects, including:
- Cytokine release syndrome (CRS), which is common during treatment with EPKINLY and can be serious or life threatening.
- Neurologic problems that can be serious, and can be life-threatening and lead to death. Neurologic problems may happen days or weeks after you receive EPKINLY.
- Infections and low blood cell counts.
Please see additional Important Safety Information, including Important Warnings for CRS and neurologic problems, at the end of this video.
EPKINLY® is not an infusion, chemotherapy, or stem cell therapy.
It is a bispecific antibody treatment that harnesses the power of your own immune system to help fight cancer. In DLBCL and FL, some B cells can become cancerous and grow uncontrollably. EPKINLY® works by attaching to both your T cells and B cells, binding them together so that the T cells can attack and destroy B cells.
Now, let’s dive into how EPKINLY is given and the dosing schedule. EPKINLY is given as a subcutaneous injection, which may be different from other treatments you have received. EPKINLY is administered on a step-up dosing schedule, meaning you’ll be given 2 or 3 smaller “step-up” doses of EPKINLY® during your first cycle of treatment prior to your first full dose. Step-up dosing is designed to help you safely adjust to treatment due to the risk of CRS.
You will receive treatment once a week for the first 3 months, then once every two weeks for 6 months, and then once every month after that. You will receive EPKINLY® for as long as your healthcare provider finds it is working for you and any side effects you may experience are manageable.
If you are being treated for DLBCL, your healthcare provider will discuss the need to be hospitalized for 24 hours after your first full dose of EPKINLY® (week 3/3rd dose) due to your risk of CRS and neurologic problems.
Before your appointment, it’s important that you are well hydrated. Your healthcare team will instruct you to drink plenty of water the day before and continue to do so the day of treatment. Consider bringing a large water bottle to your visit.
At your appointment, your healthcare provider will ask a few questions about your general health status, and check your vital signs (e.g. temperature, blood pressure, heart rate) before your injection. Additionally, in the first four weeks, before each dose of EPKINLY®, you’ll receive medications 30 to 120 minutes before your injection to help reduce your risk of CRS. In addition, your healthcare team will instruct you to take certain medications for three days after each dose.
For future doses, your healthcare provider will decide if you need to receive medicine to help reduce your risk of CRS.
After the administration of any dose, you may be asked by your healthcare team to stay longer after the injection so that they can monitor for any reactions.
You may have side effects during treatment. 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 or completely stop treatment with EPKINLY® if you develop certain side effects.
It’s a good idea to notify care partners of this possibility so they can plan transportation arrangements and other logistics accordingly.
Care partners and patients: be sure to ask for and keep a copy of the EPKINLY® patient wallet card, which outlines important information for healthcare providers. Also, check with your provider to see if there is anything you should be monitoring for at home. Tell your healthcare provider or get medical help right away if you develop symptoms of CRS.
No matter where you are with your EPKINLY treatment, MyNavCare patient support can help – whether you need information about access to treatment, financial assistance, or helpful resources while you’re undergoing treatment with EPKINLY. A dedicated team member will reach out to you within 24 hours to help with onboarding. Also, care partners, you are not alone. MyNavCare is here to support you with personalized guidance and resources, ensuring you feel empowered throughout the patient’s treatment journey.
Your health care provider’s office can sign you up or you can self-enroll in MyNavCare and your patient engagement liaison can provide ongoing support throughout treatment.
What is EPKINLY?
EPKINLY is a prescription medicine used to treat adults with certain types of diffuse large B-cell lymphoma DLBCL), high-grade a-cell lymphoma, or follicular lymphoma (FL) 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. Studies are ongoing to confirm the clinical benefit of EPKINLY. It is not known if EPKINLY is safe and effective in children.
IMPORTANT SAFETY INFORMATION
Important Warnings-EPKINLY can cause serious side effects, including:
- cytokine release syndrome (CRS), which is common during treatment with EPKINLY and can be serious or life-threatening. To help reduce your risk of CRS, you will receive EPKINLY on a step-up dosing schedule (when you receive 2 or 3 smaller step- up doses of EPKINLY before your first full dose during your first cycle of treatment), and you may also receive other medicines before and for 3 days after receiving EPKINLY. If your dose of EPKINLY is delayed for any reason, you may need to repeat the step-up dosing schedule.
- Neurologic problems that can be serious, and can be life-threatening and lead to death. Neurologic problems may happen days or weeks after you receive EPKINLY.
People with DLBCL or high-grade B-cell lymphoma should be hospitalized for 24 hours after receiving their first full dose of EPKINLY on day 15 of cycle 1 due to the risk of CRS and neurologic problems. 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 light-headedness; 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. If you have any symptoms that impair consciousness, do not drive or use heavy machinery or do other dangerous activities until your symptoms go away.
EPKINLY can cause other serious side effects, including:
- Infections that may lead to death. Your healthcare provider will check you for signs and symptoms of infection before and during treatment and treat you as needed if you develop an infection. You should receive medicines from your healthcare provider before you start treatment to help prevent infection. Tell your healthcare provider right away if you develop any symptoms of infection during treatment, including fever of 100.4°F (38°C) or higher, cough, chest pain, tiredness, shortness of breath, painful rash, sore throat, pain during urination, or feeling weak or generally unwell.
- Low blood cell counts, which can be serious or severe. Your healthcare provider will check your blood cell counts during treatment. EPKINLY may cause low blood cell counts, including low white blood cells (neutropenia), which can increase your risk for infection; low red blood cells (anemia), which can cause tiredness and shortness of breath; and low platelets (thrombocytopenia), which can cause bruising or bleeding problems.
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.
In DLBCL or high-grade B-cell lymphoma, 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. The most common severe abnormal laboratory test results include decreased white blood cells, decreased red blood cells, and decreased platelets.
In follicular lymphoma the most common side effects of EPKINLY include injection site reactions, CRS, COVID-19, tiredness, upper respiratory tract infections, muscle and bone pain, rash, diarrhea, fever, cough, and headache. The most common severe abnormal laboratory test results include decreased white blood cells and decreased red blood cells. These are not all of 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 the EPKINLY® Medication Guide, including Important Warnings here or by visiting EPKINLYMedGuide.com.
For more information, visit EPKINLY.com by scanning the code here.