Ryzneuta

Ryzneuta

Ryzneuta

What is Ryzneuta?

Ryzneuta received FDA approval on November 16, 2023 for use in reducing infections called febrile neutropenia in adult patients with non-myeloid malignancies treated with myelosuppressive cancer drugs that are associated with a clinically significant incidence of febrile neutropenia.

Ryzneuta isnotIndicated for mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

What is Chemotherapy-Induced Neutropenia?

Chemotherapy-induced neutropenia (CIN) is a lack of neutrophils, a type of white blood cell that fights infections caused by chemotherapy used to treat cancer. Low levels of neutrophils increase the risk of infection and fever, which may lead to a reduction or delay in the chemotherapy dose, which may affect chemotherapy results. Ryzneuta increases neutrophil levels to reduce the risk of chemotherapy side effects such as infections and fever.

Ryzneuta side effects

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

Serious side effects of Ryzneuta

Serious side effects of Ryzneuta include:

Splenic rupture. Your spleen may enlarge and rupture. A ruptured spleen can lead to death. Call your doctor immediately if you have pain in your left upper abdomen or left shoulder.

Acute respiratory distress syndrome (ARDS). This is a serious lung problem. Call your doctor or seek emergency medical attention immediately if you have symptoms of shortness of breath with or without fever, difficulty breathing, or rapid breathing.

Serious allergic reactions.Ryzneuta can cause serious allergic reactions. These reactions can cause a rash all over the body, swelling around the mouth or eyes, wheezing, shortness of breath, dizziness, and rapid heartbeat. If you experience any of these symptoms, stop using Ryzneuta and call your doctor or get emergency medical help immediately.

Danger of sickle cell crises.If you have sickle cell anemia and are given Ryzneuta, you may have a severe sickle cell crisis, which can result in death. Call your doctor immediately if you have symptoms of sickle cell anemia, such as pain or difficulty breathing.

Kidney injury (glomerulonephritis).Products like Ryzneuta can cause kidney damage. Call your doctor immediately if you experience any of these symptoms, such as: B. Swelling of the face or ankles, dark colored urine or blood in the urine, or if you urinate less than usual.

Increased number of white blood cells (leukocytosis).) orDecreased platelet count (thrombocytopenia). Your doctor will check your white blood cell count during treatment with this medicine.

Capillary leak syndrome.Ryzneuta can cause fluid to leak from your blood vessels into the tissues of your body. This condition is called “capillary leak syndrome” (CLS). CLS can quickly cause symptoms that can become life-threatening. Get medical help right away if you experience any of these symptoms: swelling or swelling and urinating less than usual, difficulty breathing, swelling of the stomach area (abdomen) and a 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 and Ryzneuta is used together with chemotherapy and radiation therapy or with radiation therapy alone, you may be at increased risk of developing a precancerous blood disorder called myelodysplastic syndrome (MDS) or a blood cancer called acute myeloid leukemia (AML). Symptoms of MDS and AML can include fatigue, fever, and easy bruising or bleeding. Call your doctor if you experience these symptoms while taking Ryzneuta.

Inflammation of the aorta (aortitis). Inflammation of the aorta (the large blood vessel that carries blood from the heart to the body) has been reported in patients receiving products like Ryzneuta. Symptoms may include fever, stomach pain, fatigue and back pain. Call your doctor if you notice these symptoms

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

Before you take this medicine

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

Before you receive Ryzneuta, tell your doctor about all your medical conditions, including if you:

• eine Sichelzellanämie haben.
• Nierenprobleme haben.
• Wenn Sie allergisch gegen Latex sind, enthält die Nadelkappe der Fertigspritze trockenen Naturkautschuk (aus Latex gewonnen).

pregnancy

Tell your doctor if you are pregnant or planning to become pregnant, as it is not known whether Ryzneuta will harm your unborn baby.

Breastfeeding

Tell your doctor if you are breast-feeding or planning to breast-feed, as it is not known whether Ryzneuta passes into breast milk.

How do I get Ryzneuta?

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

Dosage information

Recommended dose:20 mg will be administered subcutaneously once per chemotherapy cycle.

Ryzneuta is available as a 20 mg/ml solution in a single-dose pre-filled syringe.

The Ryzneuta pre-filled syringe is not graduated 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 doctor about when you should get your next dose.

Interactions

Tell your doctor about all medications you take, including prescription and over-the-counter medications, vitamins, and herbal supplements.

storage

• Im Karton gekühlt bei 2 bis 8 °C (36 bis 46 °F) lagern, um den Inhalt vor Licht zu schützen.
• Nicht schütteln.
• Entsorgen Sie Spritzen, die länger als 48 Stunden bei Raumtemperatur gelagert wurden.
• Nicht einfrieren. Entsorgen Sie die Spritze, wenn sie gefroren ist.

ingredient

Active ingredient:Efbemalenograstim alfa-vuxw.

Inactive ingredients:Acetate, EDTA, polysorbate 20, sodium and sorbitol in water for injections.

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

Pursue

Manufactured by:EVIVE BIOTECHNOLOGY PTE. LTD., Singapore, 189720.

References

1. Ryzneuta-Produktetikett der Food and Drug Administration (FDA).

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