ELREXFIO Side Effects
It’s important to be aware of potential side effects while on ELREXFIO. Most who had side effects during treatment with ELREXFIO were able to manage them and continue on treatment.
ELREXFIO may cause side effects that are serious, life-threatening, or lead to death, including cytokine release syndrome (CRS) and neurologic problems.
Possible side effects with ELREXFIO treatment
Cytokine release syndrome (CRS)
CRS is a result of the immune system becoming overactive. In a clinical trial, 58% of people taking ELREXFIO had CRS. The majority of CRS events were low grade. Most happened early and were resolved with proper treatment.
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:
- Fever of 100.4°F (38°C) or higher
- Trouble breathing
- Chills
- Dizziness or light-headedness
- Fast heartbeat
- Headache
- Increased liver enzymes in your blood
Learn more about how the step-up dosing schedule with ELREXFIO may help reduce the chance and severity of CRS.
Neurologic problems
Neurologic problems are potential serious side effects of ELREXFIO. In a clinical trial, 59% of people taking ELREXFIO experienced neurologic problems. 7% of people experienced severe neurologic problems (occurrences that were Grade 3 or 4).
Tell your healthcare provider or get medical help right away if you develop any signs or symptoms of neurologic problems, including:
- Headache
- Agitation, trouble staying awake, confusion or disorientation, or seeing or hearing things that are not real (hallucinations)
- Trouble speaking, thinking, remembering things, paying attention, or understanding things
- Problems walking, muscle weakness, shaking (tremors), loss of balance, or muscle spasms
- Numbness and tingling (feeling like “pins and needles”)
- Burning, throbbing, or stabbing pain
- Changes in your handwriting
ELREXFIO Risk Evaluation and Mitigation Strategy (REMS) Program
The Food and Drug Administration (FDA) requires a drug safety program for ELREXFIO due to the risk of CRS and neurologic problems. This drug safety program, called a Risk Evaluation and Mitigation Strategy (REMS) Program, requires healthcare professionals to be aware of and monitor the serious side effects that can happen when taking ELREXFIO.
As part of the ELREXFIO REMS Program, your healthcare provider will give you an ELREXFIO Patient Wallet Card before or at your first ELREXFIO treatment. It will let your other healthcare providers know that you have been prescribed ELREXFIO and includes symptoms of CRS or neurologic problems to look out for in case you experience them.
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. Be sure to carry your ELREXFIO Patient Wallet Card with you at all times and show it to all of your healthcare providers.
Other potential side effects of ELREXFIO
Infections: Upper respiratory tract infection and pneumonia are common during treatment with ELREXFIO. ELREXFIO can cause bacterial and viral infections that are severe, life-threatening, or that may lead to death.
In people who received ELREXFIO according to the recommended dosing schedule, serious infections, including opportunistic infections, occurred in 42% of people, Grade 3 or 4 infections were seen in 31% of people, and fatal infections in 7% of people. People with active infections should not start ELREXFIO.
Most infections responded to treatment. In a clinical trial, 6.5% of people with an infection had to permanently stop treatment with ELREXFIO. Your healthcare provider may prescribe treatments to help prevent some infections while on ELREXFIO.
Decreased white blood cell counts: Decreased white blood cell counts are common with ELREXFIO and can also be severe. A fever can occur with low white blood cell counts and may be a sign that you have an infection. Your healthcare provider will treat you as needed.
Liver problems: ELREXFIO can cause increased liver enzymes and bilirubin in your blood. These increases can happen with or without you also having CRS. Tell your healthcare provider if you develop any of the following signs or symptoms of liver problems:
- Tiredness
- Loss of appetite
- Pain in your right upper stomach-area (abdomen)
- Dark urine
- Yellowing of your skin or the white part of your eyes
Your healthcare provider will check your blood and monitor you for signs and symptoms of these serious side effects before you start and during treatment with ELREXFIO and may temporarily or completely stop treatment with ELREXFIO if you develop certain side effects.
Most common side effects
In addition to the serious side effects, ELREXFIO can cause other side effects. The most common side effects of ELREXFIO include:
- Tiredness
- Injection site reaction, such as redness, itching, pain, bruising, rash, swelling, and tenderness
- Diarrhea
- Muscle and bone pain
- Decreased appetite
- Rash
- Cough
- Nausea
- Fever
The most common severe abnormal lab test results with ELREXFIO include decreased white blood cells, red blood cells, and platelets.
In a clinical trial, most who had side effects during treatment with ELREXFIO were able to manage them and stay on treatment.
Free support resources
ELREXFIO offers resources, tools, and personalized support to help manage some of the challenges that may arise during treatment.
