What is the most important information I should know about ELREXFIO?

What is the most important information I should know about ELREXFIO?

ELREXFIO may cause serious side effects, including:

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Cytokine Release Syndrome (CRS). CRS is common during treatment with ELREXFIO and can also be serious, life-threatening, or can lead to death. Tell your healthcare provider or get medical help right away if you develop any signs or symptoms of CRS, including:

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fever of 100.4 °F (38 °C) or higher

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trouble breathing

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chills

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dizziness or light-headedness

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fast heartbeat

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headache

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increased liver enzymes in your blood. See “What are the possible side effects of ELREXFIO?” for more information about the signs and symptoms of liver problems.

 

Due to the risk of CRS, you will receive ELREXFIO on a “step-up dosing schedule” and should be hospitalized for 48 hours after the first “step-up” dose and for 24 hours after the second “step-up” dose of ELREXFIO.

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During the step-up dosing schedule:

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for your first dose, you will receive a smaller “step-up” dose of ELREXFIO on Day 1 of your treatment

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for your second dose, you will receive a larger “step-up” dose of ELREXFIO, which is usually given on Day 4 of your treatment

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for your third dose, you will receive the first full “treatment” dose of ELREXFIO, which is usually given on Day 8 of your treatment

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If your dose of ELREXFIO is delayed for any reason, you may need to repeat the step-up dosing schedule.

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Before each step-up dose and the first full treatment dose of ELREXFIO, you will receive medicines to help reduce your risk of CRS. Your healthcare provider will decide if you need to receive medicines to help reduce your risk of CRS with future doses.

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See “How will I receive ELREXFIO?” for more information about how you will receive ELREXFIO.

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Neurologic problems. ELREXFIO can cause neurologic problems that can be serious or life-threatening. Tell your healthcare provider or get medical help right away if you develop any signs or symptoms of neurologic problems, including:

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headache

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agitation, trouble staying awake, confusion or disorientation, seeing or hearing things that are not real (hallucinations)

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trouble speaking, thinking, remembering things, paying attention, or understanding things

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problems walking, muscle weakness, shaking (tremors), loss of balance, or muscle spasms

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numbness and tingling (feeling like “pins and needles”)

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burning, throbbing, or stabbing pain

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changes in your handwriting

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ELREXFIO is available only through the ELREXFIO Risk Evaluation and Mitigation Strategy (REMS) due to the risk of CRS and neurologic problems. You will receive an ELREXFIO Patient Wallet Card from your healthcare provider. Carry the ELREXFIO Patient Wallet Card with you at all times and show it to all of your healthcare providers. The ELREXFIO Patient Wallet Card lists symptoms of CRS and neurologic problems. Get medical help right away if you develop any of the symptoms listed on the ELREXFIO Patient Wallet Card. You may need to be treated in a hospital.

Your healthcare provider will monitor you for signs and symptoms of CRS and neurologic problems during treatment with ELREXFIO, as well as other side effects, and will treat you if needed. Your healthcare provider may temporarily stop or completely stop your treatment with ELREXFIO if you develop CRS, neurologic problems, or any other side effects that are severe.

If you have any questions about ELREXFIO, ask your healthcare provider.

See “What are possible side effects of ELREXFIO?” for more information about side effects.