Brand Name
Ryzneuta
Generic Name
Efbemalenograstim Alfa-Vuxw
View Brand Information FDA approval date: November 23, 2023
Classification: Leukocyte Growth Factor
Form: Injection
What is Ryzneuta (Efbemalenograstim Alfa-Vuxw)?
RYZNEUTA is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. Limitations of Use RYZNEUTA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. RYZNEUTA is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. Limitations of Use RYZNEUTA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
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Related Clinical Trials
A Multicenter, Exploratory Clinical Study of Efbemalenograstim Alfa-vuxw Injection for Primary/Secondary Prevention in Patients With Solid Tumors at High Risk for Febrile Neutropenia (FN) or Intermediate Risk of Chemotherapy Regimens Associated With Other Risk Factors in FN
Summary: Efbemalenograstim alfa for primary/secondary prevention in patients with solid tumors at high risk for febrile neutropenia (FN) or Intermediate risk of chemotherapy regimens associated with other risk factors in FN
Brand Information
RYZNEUTA (efbemalenograstim alfa-vuxw)
1INDICATIONS AND USAGE
RYZNEUTA is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
Limitations of Use
RYZNEUTA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
2DOSAGE FORMS AND STRENGTHS
Injection: 20 mg/mL clear, colorless, preservative-free solution in a single-dose prefilled syringe.
3CONTRAINDICATIONS
RYZNEUTA is contraindicated in patients with a history of serious allergic reactions to granulocyte stimulating factors such as efbemalenograstim alfa-vuxw, pegfilgrastim, or filgrastim products
4ADVERSE REACTIONS
The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling:
- Splenic Rupture
- Acute Respiratory Distress Syndrome
- Serious Allergic Reactions
- Sickle Cell Crisis in Patients with Sickle Cell Disorders
- Glomerulonephritis
- Leukocytosis
- Thrombocytopenia
- Capillary Leak Syndrome
- Potential for Tumor Growth Stimulatory Effects on Malignant Cells
- Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) in Patients with Breast and Lung Cancer
- Aortitis
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The following adverse reaction data are based on two studies [see Clinical Studies (
In Study GC-627-04, the most common adverse reactions (≥10%) in the RYZNEUTA arm through cycle 1 were nausea, anemia, and thrombocytopenia (see Table 1). Other adverse reactions reported by ≥ 20% of RYZNEUTA-treated Patients with Breast Cancer Receiving Myelosuppressive Chemotherapy in Study GC-627-05 were fatigue and bone pain.
5OVERDOSAGE
Overdosage of RYZNEUTA may result in leukocytosis and bone pain. In the event of overdose, general supportive measures should be instituted, as necessary. Monitor the patient for adverse reactions
6DESCRIPTION
Efbemalenograstim alfa-vuxw, a leukocyte growth factor, is a 413 amino acid recombinant fusion protein consisting of human G-CSF, a 16 amino-acid linker, and the Fc portion of human IgG2. In solution, efbemalenograstim alfa-vuxw forms covalently-linked dimers (disulfide bonds between Fc moieties), resulting in an immunoglobulin-like structure. The dimer is a water-soluble, glycosylated protein with a molecular weight of approximately 93.4 kilodaltons (kDa), of which 89.5 kDa is attributed to amino acids (protein sequence) and the remainder is from glycosylation. Efbemalenograstim alfa-vuxw is obtained from genetically-engineered strain of Chinese hamster ovary (CHO) cells grown in a serum-free medium.
RYZNEUTA (efbemalenograstim alfa-vuxw) injection is supplied in 1 mL prefilled single-dose syringes for manual subcutaneous injection. The prefilled syringe does not bear graduation marks and is designed to deliver the entire contents of the syringe (20 mg/mL). Each syringe contains 20 mg efbemalenograstim alfa-vuxw in a sterile, clear, colorless, preservative-free solution (pH 5.2) containing acetate (0.6 mg), EDTA (0.29 mg), polysorbate 20 (0.1 mg), sodium (0.23 mg), and sorbitol (50 mg) in Water for Injection, USP.
7CLINICAL STUDIES
The efficacy of RYZNEUTA to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs was evaluated in two randomized, controlled studies.
Study GC-627-04 [NCT02872103] was a randomized, double-blind, placebo-controlled study that employed doxorubicin 60 mg/m
Efficacy was based upon the mean duration of severe (Grade 4) neutropenia in cycle 1 which was lower for RYZNEUTA-treated patients as compared to placebo-treated patients (LS mean: 1.4 days versus 4.3 days, respectively, p<0.001 [95% CI: 2.4, 3.5]). The incidence of febrile neutropenia (defined as temperature ≥38.3℃, or >38.0℃ sustained for at least 1 hour, and ANC < 0.5 × 10
Study GC-627-05 [NCT03252431] was a randomized, active-controlled study that compared RYZNEUTA to pegfilgrastim. Study GC-627-05 employed docetaxel 75 mg/m
The study demonstrated that the mean days of severe (Grade 4) neutropenia of RYZNEUTA-treated patients did not exceed that of pegfilgrastim-treated patients by more than 0.6 days in cycle 1 of chemotherapy. The mean days of severe neutropenia in cycle 1 were 0.2 days in both the RYZNEUTA and pegfilgrastim arms (difference in means 0.0 days [95% CI -0.1, 0.1]).
Subgroup analyses of treatment effect were not useful due to small subgroup sizes.
8HOW SUPPLIED/STORAGE AND HANDLING
RYZNEUTA (efbemalenograstim alfa-vuxw) injection is a clear, colorless, preservative-free solution supplied in a prefilled single-dose syringe with a 27-gauge, 1/2-inch needle and an UltraSafe Passive™ Needle Guard, containing 20 mg of efbemalenograstim alfa-vuxw.
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.
RYZNEUTA is provided in a dispensing pack containing one 20 mg/mL prefilled syringe (NDC 72893-016-02).
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.
Store refrigerated at 2°C to 8°C (36°F 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 syringe if frozen.
9PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information)
Advise patients of the following risks and potential risks with RYZNEUTA:
- Rupture or enlargement of the spleen may occur. Symptoms include left upper quadrant abdominal pain or left shoulder pain. Advise patients to report pain in these areas to their healthcare provider immediately
- Dyspnea, with or without fever, progressing to acute respiratory distress syndrome, may occur. Advise patients to report dyspnea to their healthcare provider immediately
- Serious allergic reactions may occur, which may be signaled by rash, facial edema, wheezing, dyspnea, hypotension, or tachycardia. Advise patients to seek immediate medical attention if signs or symptoms of hypersensitivity reaction occur
- In patients with sickle cell disease, sickle cell crisis and death have occurred with use of human granulocyte colony-stimulating factors. Discuss potential risks and benefits for patients with sickle cell disease prior to the administration of RYZNEUTA
- Glomerulonephritis may occur. Symptoms include swelling of the face or ankles, dark colored urine or blood in the urine, or a decrease in urine production. Advise patients to report signs or symptoms of glomerulonephritis to their healthcare provider immediately
- Capillary leak syndrome may occur. Symptoms include hypotension and edema. Advise patients to report signs and symptoms of capillary leak syndrome to their healthcare provider immediately
- There may be an increased risk of Myelodysplastic Syndrome and/or Acute Myeloid Leukemia in patients with breast and lung cancer who receive RYZNEUTA in conjunction with chemotherapy and/or radiation therapy. Symptoms of MDS and AML may include tiredness, fever, and easy bruising or bleeding. Advise patients to report to their physician signs and symptoms of MDS/AML
- Aortitis may occur. Symptoms may include fever, abdominal pain, malaise, back pain, and increased inflammatory markers. Advise patients to report signs and symptoms of aortitis to their physician immediately
RYZNEUTA
Manufactured by:
EVIVE BIOTECHNOLOGY SINGAPORE PTE. LTD.
Distributed by: Acrotech Biopharma Inc, East Windsor, NJ 08520 USA
U.S. License No 2248
© 2023 Evive Biotechnology Singapore PTE. LTD.
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