Ryzneuta

Pronunciation: rīz-new-ta
Generic name: Efbemalenograstim alfa
Dosage form: subcutaneous injection (20 mg/mL)
Drug class: Colony stimulating factors

Medically reviewed by Melisa Puckey, BPharm. Last updated on Nov 27, 2023.

What is Ryzneuta?

Ryzneuta (Efbemalenograstim alfa) is a granulocyte colony-stimulating factor (G-CSF) used to lower the risk of infection when you have neutropenia, low levels of a type of white blood cells caused by cancer chemotherapy. Ryzneuta works by increasing the number of white blood cells (neutrophils) to improve the immune system’s ability to fight infection and lower the risk of infections. Ryzneuta's mechanism of action is by binding to the granulocyte colony-stimulating factor (G-CSF) receptor, which results in an increase in the number and survival of neutrophils.

Ryzneuta received FDA approval on November 16, 2023, to be used to decrease infection, seen as febrile neutropenia, in adult patients with non-myeloid malignancies who are being treated with myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia.

Ryzneuta is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

What is the Chemotherapy-Induced Neutropenia?

Chemotherapy-Induced Neutropenia (CIN) is low levels of neutrophils, a type of white blood cell that fights infection, which is caused by chemotherapy for cancer treatment. Low levels of neutrophils increase the risk of infections and fevers that may result in chemotherapy dose reductions or delays, which may affect chemotherapy outcomes. Ryzneuta increases levels of neutrophils to decrease the risk of chemotherapy side effects of infection and fever.

Ryzneuta Side Effects

The most common Ryzneuta side effects are nausea, low blood iron levels (anemia), and low blood platelet levels (thrombocytopenia). These affected at least 10% of patients.

Serious Ryzneuta side effects

Serious Ryzneuta side effects include:

Spleen rupture. Your spleen may become enlarged and can rupture. A ruptured spleen can cause death. Call your healthcare provider right away if you have pain in the left upper stomach area or your left shoulder.

Acute Respiratory Distress Syndrome (ARDS). This is a serious lung problem. Call your healthcare provider or get emergency care right away if you have symptoms of shortness of breath with or without a fever, trouble breathing, or a fast rate of breathing.

Serious allergic reactions. Ryzneuta can cause severe allergic reactions. These reactions can cause a rash over your whole body, swelling around your mouth or eyes, wheezing, shortness of breath, dizziness, and fast heart rate. If you have any of these symptoms, stop using Ryzneuta and call your healthcare provider or get emergency medical help right away.

Risk of sickle cell crises. You may have a serious sickle cell crisis, which could lead to death if you have a sickle cell disorder and receive Ryzneuta. Call your healthcare provider right away if you have symptoms of sickle cell crisis, such as pain or difficulty breathing.

Kidney injury (glomerulonephritis). Products like Ryzneuta can cause kidney injury. Call your healthcare provider right away if you develop any of these symptoms, swelling of your face or ankles, dark colored urine or blood in your urine, or you urinate less than usual.

Increased white blood cell count (leukocytosis) or Decreased platelet count (thrombocytopenia). Your healthcare provider will check your white blood cell count during treatment with this medicine.

Capillary Leak Syndrome. Ryzneuta can cause fluid to leak from blood vessels into your body’s tissues. This condition is called “Capillary Leak Syndrome” (CLS). CLS can quickly cause you to have symptoms that may become life-threatening. Get emergency medical help right away if you develop any of these symptoms: swelling or puffiness and urinating less than usual, trouble breathing, swelling of your stomach area (abdomen) and feeling of fullness, dizziness or feeling faint, or a general feeling of tiredness.

Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML). If you have breast cancer or lung cancer, when Ryzneuta is used with chemotherapy and radiation therapy, or with radiation therapy alone, you may have an increased risk of developing a precancerous blood condition called myelodysplastic syndrome (MDS) or a blood cancer called acute myeloid leukemia (AML). Symptoms of MDS and AML may include tiredness, fever, and easy bruising or bleeding. Call your healthcare provider if you develop these symptoms during treatment with Ryzneuta.

Inflammation of the aorta (aortitis). Inflammation of the aorta (the large blood vessel that transports blood from the heart to the body) has been reported in patients who received products like Ryzneuta. Symptoms may include fever, abdominal pain, feeling tired, and back pain. Call your healthcare provider if you experience these symptoms

These are not all the possible side effects of RYZNEUTA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before taking this medicine

Do not take Ryzenuta if you have had a serious allergic reaction to granulocyte-stimulating factors such as pegfilgrastim products, filgrastim products, or efbemalenograstim alfa-vuxw.

Before you receive Ryzneuta, tell your healthcare provider about all of your medical conditions, including if you:

have a sickle cell disorder.
have kidney problems.
are allergic to latex, the needle cap on the prefilled syringe contains dry natural rubber (derived from latex).

Pregnancy

Tell your healthcare provider if you are pregnant or plan to become pregnant, as it is not known if Ryzneuta will harm your unborn baby.

Breastfeeding

Tell your healthcare provider if you are breastfeeding or plan to breastfeed, as it is not known if Ryzneuta passes into your breast milk.

How will I receive Ryzneuta?

Ryzneuta is given as an injection under your skin (subcutaneous injection) by a healthcare provider. Ryzneuta is injected at least 24 hours after your dose of chemotherapy and at least 14 days before your next dose of chemotherapy.

Dosing information

Recommended Dose: 20 mg administered subcutaneously once per chemotherapy cycle.

Ryzneuta is available as a 20 mg/mL solution in a single-dose prefilled syringe.

The Ryzneuta prefilled syringe does not bear graduation marks and is intended only to deliver the entire contents of the syringe (20 mg/mL) for direct administration to adult patients.

What happens if I miss a dose?

If you miss a dose of Ryzneuta, talk to your healthcare provider about when you should receive your next dose.

Interactions

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Storage

Store refrigerated at 2° to 8°C (36° to 46°F) in the carton to protect from light.
Do not shake.
Discard syringes stored at room temperature for more than 48 hours.
Do not freeze. Discard the syringe if frozen.

Ingredient

Active ingredient: efbemalenograstim alfa-vuxw.

Inactive ingredients: acetate, EDTA, polysorbate 20, sodium, and sorbitol in water for injection.

Caution: This product contains natural rubber latex, which may cause allergic reactions. The needle cap of the prefilled syringe contains natural rubber; persons with latex allergies should not administer this product.