Ryzneuta (efbemalenograstim alfa) is an injectable medication used to lower the risk of infection in adults with certain cancers who are getting chemotherapy that can cause low white blood cells. It's a long-acting growth factor that helps the body make more neutrophils, a type of white blood cell important for fighting infections. A healthcare professional will give it as a shot under the skin once during each chemotherapy cycle. Side effects include nausea, low red blood cells, and low platelet count.
Ryzneuta (efbemalenograstim alfa) is a man-made leukocyte growth factor called a recombinant granulocyte colony-stimulating factor (G-CSF). G-CSF is a protein your body uses to tell your bone marrow to make more neutrophils, which are white blood cells that help fight infections.
By acting like G-CSF, Ryzneuta (efbemalenograstim alfa) helps raise your neutrophil levels. This is especially important during chemotherapy, when white blood cells can drop and make it harder for your immune system to protect you.
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.
Contact your healthcare provider immediately if you experience any of the following.
Side effects that you should report to your care team as soon as possible:
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
Yes. Ryzneuta (efbemalenograstim alfa) was approved by the FDA in November 2023 to reduce the risk of infection in adults with certain cancers.
No. Ryzneuta (efbemalenograstim alfa) isn't a biosimilar, but it is a biologic medication. Biologics are complex medications made from living cells rather than chemicals. A biosimilar is a "copy" that's made to work exactly like an existing biologic. So Ryzneuta (efbemalenograstim alfa) is its own original biologic, not a version of something else.
To get Ryzneuta (efbemalenograstim alfa), you need a prescription from your oncologist. They will decide if it’s right for you based on your cancer treatment plan and your risk of infection from low white blood cell counts. You usually receive the medication as an injection under the skin in a clinic or hospital after each chemotherapy cycle.
The best time to receive Ryzneuta (efbemalenograstim alfa) is at least 24 hours after chemotherapy and at least 14 days before your next dose of chemotherapy. Chemotherapy kills cancer cells, but it can also kill fast-growing healthy cells, including new white blood cells. If you get Ryzneuta (efbemalenograstim alfa) too close to chemotherapy, the treatment can destroy the new white blood cells your body makes. Your oncologist will choose the best timing for you.
In a clinical study, Ryzneuta (efbemalenograstim alfa) worked better than placebo at shortening the number of days people had very low white blood cell counts. People who received Ryzneuta (efbemalenograstim alfa) had about 1 day with very low white blood cell counts, compared with about 4 days for those who received placebo. In another study, Ryzneuta (efbemalenograstim alfa) worked about as well as another long-acting treatment, pegfilgrastim, at reducing severe low white blood cell counts during chemotherapy. Speak to your oncologist if you have questions about how these two medications compare.
Ryzneuta (efbemalenograstim alfa) 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.
Ryzneuta (efbemalenograstim alfa) can sometimes cause the spleen to swell or tear, which can be life-threatening in rare cases. Contact your care team right away if you have pain in the upper left side of your stomach or pain in your left shoulder.
Ryzneuta (efbemalenograstim alfa) can cause a serious breathing condition called acute respiratory distress syndrome (ARDS). ARDS happens when fluid builds up in the lungs, making it hard for oxygen to get into your blood and reach your organs. This prevents enough oxygen from getting into your blood and to your organs. Get medical help right away if you have shortness of breath, fast breathing, or fever.
Ryzneuta (efbemalenograstim alfa) can cause serious allergic reactions, including a life-threatening reaction called anaphylaxis. You shouldn't receive Ryzneuta (efbemalenograstim alfa) if you've ever had an allergic reaction to it or similar medications, such as Neulasta (pegfilgrastim) or Neupogen (filgrastim). Contact your care team right away if you have symptoms like trouble breathing, swelling of your face or throat, hives, or a severe rash after receiving the medication.
Ryzneuta (efbemalenograstim alfa) can cause severe and sometimes life-threatening sickle cell crises if you have sickle cell disease. Contact your care team right away if you develop severe pain, trouble breathing, or other symptoms of a sickle cell crisis after receiving the medication. If a sickle cell crisis happens, your care team will stop the medication.
Kidney injury can happen in people receiving Ryzneuta (efbemalenograstim alfa). If your care team thinks you might have kidney problems, they might order blood tests to check how your kidneys are working. Let your care team know if you have blood in your urine, swelling in your legs, trouble urinating, or unusual tiredness.
Ryzneuta (efbemalenograstim alfa) can sometimes cause your white blood cell count to become too high. You'll need regular blood tests during treatment to watch for this. If your white blood cell count gets too high, you'll likely stop the medication.
Ryzneuta (efbemalenograstim alfa) can also lower your platelet count, which can affect how well your blood clots. Your care team will monitor your platelet count and watch for signs like easy bruising or bleeding so they can manage this safely.
Ryzneuta (efbemalenograstim alfa) can cause a serious condition called capillary leak syndrome (CLS). CLS happens when fluid leaks out of your blood vessels, which can lead to low blood pressure and swelling. Contact your care team right away if you have sudden swelling, trouble breathing, dizziness, weakness, or tiredness.
Ryzneuta (efbemalenograstim alfa) is a growth factor that helps the body make more white blood cells. In some cases, it can also help tumors grow, which can make cancer worse. There is a risk of developing certain blood conditions or blood cancers when this medication is used during breast or lung cancer treatment, along with chemotherapy or radiation. Keep regular follow-up visits with your oncologist so they can make sure this medication is safe for you.
Some people who received Ryzneuta (efbemalenograstim alfa) developed a condition called aortitis, which is inflammation of the aorta, a major blood vessel. This can happen as early as the first week after starting treatment. Let your care team know if you have a fever, stomach pain, back pain, or start feeling unwell. Your care team might need to stop the medication to help protect your blood vessels.
Ryzneuta (efbemalenograstim alfa) is usually given in a clinic or hospital by a healthcare professional.
The typical dose is 20 mg injected under the skin once each chemotherapy cycle, at least 24 hours after chemotherapy.
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Ryzneuta (efbemalenograstim alfa) will not be safe for you to take.