Elrexfio
Elrexfio (elranatamab or elranatamab-bcmm) is a type of monoclonal antibody known as BiTE therapy, which stands for bispecific T-cell engager. It's used to treat relapsed or advanced multiple myeloma. Elrexfio (elranatamab) is given as an injection under the skin. When you first start this medication, you'll stay in the hospital to receive the “step-up” doses so your oncologist can monitor you for serious side effects, like cytokine release syndrome. After that, you'll receive it once a week or once every two weeks. Some common side effects of Elrexfio (elranatamab) include injection site reactions, tiredness, and diarrhea.
What is Elrexfio (elranatamab)?
What is Elrexfio (elranatamab) used for?
- Advanced multiple myeloma in adults who've already tried at least four other therapies
How Elrexfio (elranatamab) works
Elrexfio (elranatamab) is a bispecific T-cell engager, or BiTE therapy. This means it’s a monoclonal antibody that works by grabbing onto 2 different targets. One side of the antibody binds to a protein on the multiple myeloma cancer cells. The other side targets a type of cells in your own immune system called T-cells. By bringing these cells together, Elrexfio (elranatamab) makes it easier for the T cells to attack the cancer cells. In addition, when Elrexfio (elranatamab) binds to both cells, the multiple myeloma cancer cells can’t grow or spread as well.
Drug facts
Side effects of Elrexfio (elranatamab)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Lower blood cell counts (up to 91%)
- Cytokine release syndrome (58%)
- Tiredness (43%)
- Higher liver enzymes (up to 40%)
- Higher serum creatinine (38%)
- Reaction around injection site (37%)
- Diarrhea (36%)
- Lower potassium in blood (36%)
- Muscle pain (34%)
- Upper respiratory tract infection (34%)
- Lower appetite (26%)
- Rash (25%)
- Cough (24%)
- Nausea (22%)
- Fever (21%)
Less Common Side Effects
- Headache
- Swelling
- Constipation
- Sepsis
- Confusion, memory problems, sleepiness (encephalopathy)
Elrexfio (elranatamab) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Cytokine release syndrome: Fever, trouble breathing, chills, low blood pressure, changes in heart rhythm, headache
- Serious nervous system problems: headache, confusion, difficulty speaking, difficulty writing, seizures
- Serious liver problems: yellow skin, yellow eyes, swelling in the belly
- Serious infection: fever, cough, weakness, tiredness, body aches, chills, painful rash, blisters, stomach pain
The following Elrexfio (elranatamab) side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Fever, chills, unusual weakness or fatigue, loss of appetite, nausea, headache, dizziness, feeling faint or lightheaded, shortness of breath, fast or irregular heartbeat, which may be signs of cytokine release syndrome
- Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
- Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
- Low red blood cell level—unusual weakness or fatigue, dizziness, headache, trouble breathing
- Pain, tingling, or numbness in the hands or feet, muscle weakness, change in vision, confusion or trouble speaking, loss of balance or coordination, trouble walking, seizures
- Unusual bruising or bleeding
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
- Diarrhea
- Loss of appetite
- Muscle pain
- Nausea
- Pain, redness, or irritation at injection site
- Skin rash
Pros and cons of Elrexfio (elranatamab)
Pros
- Option for treating multiple myeloma that no longer responds to other treatments
- Works in a targeted, more specific way than traditional chemotherapy
- Given as a brief injection under the skin, so more convenient once the step-up dose process is complete
Cons
- Step-up doses require several hospital visits
- Given as an injection, so requires a needle
- Can cause side effects such as serious infections and cytokine release syndrome
Pharmacist tips for Elrexfio (elranatamab)
- If you develop a temperature of 100.4 Fahrenheit or higher, get medical help right away. This means you have a fever. A fever with Elrexfio (elranatamab) can be serious, because it can mean you have an infection or it can be an early sign of cytokine release syndrome (CRS).
- Elrexfio (elranatamab) is given as a shot underneath your skin. Sometimes, you might have a skin reaction such as redness or swelling around the area where you received the shot. This usually isn’t dangerous, but let your oncologist know if it happens. They might recommend using an ice pack to manage it.
- You might experience diarrhea while taking Elrexfio (elranatamab). If you have this side effect, your oncologist might recommend you take over-the-counter medications like loperamide (Imodium A-D) to help treat it. Make sure you drink enough fluids to stay hydrated. But avoid sugary sports drinks because they can make diarrhea worse.
- Elrexfio (elranatamab) can cause tiredness, especially during the step-up dosing period. This is also the most common time for nervous system side effects to happen, such as confusion and possible seizures. Because of these risks, you’re recommended to avoid driving or doing any activity that needs a lot of attention during step up dosing and for two days after you complete those doses.
- Sometimes, taking Elrexfio (elranatamab) can cause irritation to your liver. Your oncologist will order regular blood tests during treatment to check your liver health. If you have stomach pain, yellowish skin, or yellow around the whites of your eyes, call your care team right away because these are symptoms of serious liver problems.
- Females who are taking Elrexfio (elranatamab) should avoid breastfeeding during treatment and for 4 months after the last dose. We don’t know whether Elrexfio (elranatamab) is found in breast milk and whether it affects breastfed babies, but there’s a possible risk of harm to a baby.
Common questions about Elrexfio (elranatamab)
No, Elrexfio (elranatamab) isn't considered a chemotherapy medication. Chemotherapy typically works by attacking cells that are growing quickly, including cancer cells. But Elrexfio (elranatamab) works differently. It’s considered an immunotherapy that specifically targets multiple myeloma cancer cells and T-cells (a type of immune cells). In doing so, Elrexfio (elranatamab) helps activate the immune system to attack the cancer cells.
A Risk Evaluation and Mitigation Strategy (REMS) program is a special program created by the FDA. It’s used for medications that need special monitoring because they might cause serious side effects. These requirements help keep people taking the medication as safe as possible. Elrexfio (elranatamab) has a REMS program because it can cause serious problems with your nervous system and a reaction called cytokine release syndrome. For Elrexfio (elranatamab) specifically, healthcare professionals (HCPs) involved in your care must complete training about these possible side effects to make sure they can safely monitor you.
Typically, you'll need to stay in the hospital when you first start Elrexfio (elranatamab), during and after the first couple of “step-up” doses. This is because you're most likely to experience serious side effects during this time. Staying in the hospital allows your care team to catch symptoms of these side effects early and treat them quickly. If you don’t have any serious side effects during your "step-up" treatment, you can probably receive future injections in an outpatient setting because the risk of these side effects is much lower after this.
The most common side effect of Elrexfio (elranatamab) is having a lower number of white blood cells (WBCs) in your body. Your WBCs help your body fight infection. So when they’re low, your body might not be able to get rid of an infection as well if you get sick. Your oncologist will order blood tests to monitor your blood cell counts very closely while you’re taking Elrexfio (elranatamab). If your WBC level drops too low, they might ask you to pause taking Elrexfio (elranatamab) until the level returns to a safe range. Because having low WBCs means you could get sick easier, it’s important to check your temperature regularly and call your oncology team if you have a temperature of 100.4 degrees Fahrenheit or higher. Sometimes, a fever is the only sign you might have that you’re sick.
Cytokine release syndrome (CRS) is a common side effect of Elrexfio (elranatamab). In mild cases of CRS, symptoms include tiredness, body aches, and low-grade fever. But this reaction can also be severe and cause high fever, dangerously low blood pressure, a serious blood clotting disorder, and organ damage. Most commonly, CRS develops with the first few doses of Elrexfio (elranatamab). You'll stay in the hospital during this time so your care team can monitor you for CRS. To lower your risk of CRS, your care team will give you pre-medications, including dexamethasone and diphenhydramine (Benadryl), before the first few doses of Elrexfio (elranatamab).
Yes, Elrexfio (elranatamab) can cause problems in the nervous system. These problems can be mild, such as numbness in the fingers or headache, or they can be serious, such as a condition called immune effector-cell associated neurotoxicity syndrome (ICANS). ICANS might cause symptoms such as headache, tremor, and confusion. If you experience any of these symptoms, seek medical attention right away. Typically, you’ll need to pause taking Elrexfio (elranatamab) while your oncologist looks into it. Depending on how serious the side effect is, you might be able to restart Elrexfio (elranatamab). But sometimes, your oncologist might have you stop taking it altogether.
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Risks and warnings for Elrexfio (elranatamab)
Elrexfio (elranatamab) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Cytokine release syndrome (CRS)
Cytokine release syndrome (CRS) is a common and potentially life-threatening side effect of Elrexfio (elranatamab). CRS happens when small immune proteins called cytokines overreact to Elrexfio (elranatamab) treatment. Most people experience CRS within the first three injections, when their oncologist is raising the dose. Symptoms of CRS can appear up to 9 days after an injection and can include headache, fever, chills. In more serious cases, CRS can lead to organ damage.
To prevent CRS, your oncologist will give you pre-treatment medications, like corticosteroids and antihistamines, before your first three doses of Elrexfio (elranatamab). To be safe, they’ll also ask you to stay in the hospital for up to two days after each of your first two doses to monitor you for symptoms and provide treatment if needed. If you develop CRS, your oncologist will pause Elrexfio (elranatamab). Depending on how severe your symptoms are, sometimes you can restart Elrexfio (elranatamab) when you get better. But, other times, your oncologist will ask you to stop Elrexfio (elranatamab) altogether.
Serious nervous system problems
Some people taking Elrexfio (elranatamab) developed nervous system problems. These problems can be mild, such as headache or numbness in the fingers. In rare, but more serious cases, people have developed a condition called immune effector-cell associated neurotoxicity syndrome (ICANS) with symptoms such as trouble waking up, confusion, agitation, or hallucination. Typically, symptoms of ICANS show up during the first few doses of Elrexfio (elranatamab), up to 4 days after the dose. Because of the risk of serious harm, don’t drive or do anything that needs a lot of attention in the days right after your step-up doses.
If you experience any of these symptoms, seek medical attention right away. Typically, you’ll need to pause taking Elrexfio (elranatamab) while your oncologist looks into it. Depending on how serious the side effect is, you might be able to restart Elrexfio (elranatamab). Or, you might have to stop taking it altogether.
Because these side effects can affect your thinking and movement, you’re recommend to avoid driving or doing activities that need a lot of focus and attention for at least 2 days after your step-up doses of Elrexfio (elranatamab), or anytime you start to experience symptoms.
REMS program
Because Elrexfio (elranatamab) can cause serious side effects such as cytokine release syndrome (CRS) and nervous system problems including immune effector-cell associated neurotoxicity syndrome (ICANS), it is only available through a special program called a Risk Evaluation and Mitigation Strategy (REMS). This program requires your oncologist and pharmacy to complete special training to prescribe and dispense Elrexfio (elranatamab). Your oncologist must know how to diagnose and treat these serious side effects, and must discuss these side effects with you before you start taking Elrexfio (elranatamab).
Serious infection and lower white blood cell count
People who take Elrexfio (elranatamab) commonly develop infections. Sometimes, the infections can be serious, such as pneumonia and sepsis. You’re at risk for infections because your immune system might not work as well when you have multiple myeloma. Additionally, the treatment you take for multiple myeloma, such as Elrexfio (elranatamab), can weaken your immune system even more because they lower your white blood cell (WBC) count. As a result, your body can’t fight infections as well.
Your oncology team might recommend you take certain medications, such as antivirals or antibiotics, to help prevent infections. They will also order blood tests to check your WBC level before you start Elrexfio (elranatamab) and regularly throughout treatment to make sure it’s within a safe range. You can lower your risk of getting sick by washing your hands often and avoiding crowds. Check your temperature regularly, and call your provider right away if your temperature is 100.4 degrees Fahrenheit or higher. Contact your care team right away if you have any signs or symptoms of infection such as fever, body aches, chills, or cough.
Serious liver problems
Sometimes, people taking Elrexfio (elranatamab) had high liver enzymes, which is a sign of liver irritation. Your oncologist will monitor your liver health using blood tests, because usually you won’t notice any symptoms or feel differently. But, if you do have yellowish skin, yellow eyes, or sudden stomach pain, contact your oncology team right away. If your lab tests are abnormal, you might need to pause taking Elrexfio (elranatamab) while your oncologist looks into it.
Harm to unborn baby
Based on the way Elrexfio (elranatamab) works, it might harm an unborn baby or raise the risk for miscarriage (pregnancy loss) when taken during pregnancy. Because of these risks, if you’re a female who can get pregnant, you should use birth control while taking Elrexfio (elranatamab) and for 4 months after the last dose. Your oncologist ask you to take a pregnancy test before you start Elrexfio (elranatamab) to make sure you’re not pregnant. Let your oncology team know right away if you become pregnant while taking Elrexfio (elranatamab).
Elrexfio (elranatamab) dosage
Typical dosage for Elrexfio (elranatamab)
Elrexfio (elranatamab) is injected under the skin by a trained healthcare professional on your oncology team, typically in a hospital or clinic setting.
- Starting dose (“step-up” dosing): During your first week of treatment, your oncologist will raise your dose over the course of a week.
- Day 1 dose: 12 mg injected once.
- Day 4 dose: 32 mg injected once.
- Day 8 dose: 76 mg injected once.
- Maintenance dose: Starting a week after the last dose, your oncologist will inject 76 mg under the skin once a week.
- If the medication works well for you for at least 6 months, your oncologist might lower your dose to 76 mg once every two weeks.
Your oncologist will also prescribe several medications before the first three doses to help prevent a serious side effect called cytokine release syndrome. These include dexamethasone and diphenhydramine (Benadryl).
