Efbemalenograstim Alfa

Efbemalenograstim alfa-vuxw is a colony-stimulating factor that acts on hematopoietic cells by binding to specific cell surface receptors, thereby stimulating proliferation, differentiation, commitment, and end cell functional activation.

• 1. INDICATIONS 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.

• 4. CONTRAINDICATIONS 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 [see Warnings and Precautions ( 5.3 )] .contraindicated

2. DOSAGE AND ADMINISTRATION Recommended Dose: 20 mg administered subcutaneously once per chemotherapy cycle. ( 2.1 ) Administer approximately 24 hours after cytotoxic chemotherapy. Do not administer between 14 days before and 24 hours after administration of cytotoxic chemotherapy. ( 2.1 ) 2.1 Recommended Dosage The recommended dosage of RYZNEUTA is a single subcutaneous injection of 20 mg administered once per chemotherapy cycle at least 24 hours after cytotoxic chemotherapy. Do not administer RYZNEUTA within 14 days before and <24 hours after administration of cytotoxic chemotherapy. 2.2 Administration RYZNEUTA is administered subcutaneously via a single-dose prefilled syringe by a healthcare professional. Prior to use‚ remove the carton from the refrigerator (keeping the prefilled syringe inside the carton) for a minimum of 30 minutes to allow the product to reach room temperature. Discard any product left at room temperature for greater than 48 hours. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer RYZNEUTA if discoloration or particulates are observed. Caution: This product contains natural rubber latex which may cause allergic reactions. The needle cap on the prefilled syringe contains natural rubber; people with latex allergies should not administer this product.

5. WARNINGS AND PRECAUTIONS Fatal splenic rupture: Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture. ( 5.1 ) Acute respiratory distress syndrome (ARDS): Evaluate patients who develop fever, lung infiltrates, or respiratory distress. Discontinue RYZNEUTA in patients with ARDS. ( 5.2 ) Serious allergic reactions, including anaphylaxis: Permanently discontinue RYZNEUTA in patients with serious allergic reactions. ( 5.3 ) Sickle cell crises in Patients with Sickle Cell Disorders: Discontinue RYZNEUTA if sickle cell crisis occurs. ( 5.4 ) Glomerulonephritis: Evaluate and consider dose-reduction or interruption of RYZNEUTA if causality is likely. ( 5.5 ) Thrombocytopenia: Monitor platelet counts. ( 5.7 ) Capillary Leak Syndrome: Monitor patients with symptoms; consider intensive care. ( 5.8 ) Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) in Patients with Breast and Lung Cancer: Monitor patients with breast and lung cancer using RYZNEUTA in conjunction with chemotherapy and/or radiotherapy for signs and symptoms of MDS/AML. ( 5.10 ) 5.1 Splenic Rupture Splenic rupture, including fatal cases, can occur following the administration of recombinant human granulocyte colony-stimulating factor (rhG-CSF) products, such as RYZNEUTA. Evaluate for an enlarged spleen or splenic rupture in patients who report left upper abdominal or shoulder pain after receiving RYZNEUTA.

6. ADVERSE REACTIONS The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Splenic Rupture [see Warnings and Precautions ( 5.1 )] Acute Respiratory Distress Syndrome [see Warnings and Precautions ( 5.2 )] Serious Allergic Reactions [see Warnings and Precautions ( 5.3 )] Sickle Cell Crisis in Patients with Sickle Cell Disorders [see Warnings and Precautions ( 5.4 )] Glomerulonephritis [see Warnings and Precautions ( 5.5 )] Leukocytosis [see Warnings and Precautions ( 5.6 )] Thrombocytopenia [see Warnings and Precautions ( 5.7 )] Capillary Leak Syndrome [see Warnings and Precautions ( 5.8 )] Potential for Tumor Growth Stimulatory Effects on Malignant Cells [see Warnings and Precautions ( 5.9 )] Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) in Patients with Breast and Lung Cancer [see Warnings and Precautions ( 5.10 )] Aortitis [see Warnings and Precautions ( 5.11 )] Most common adverse reactions (≥10%) were nausea, anemia, and thrombocytopenia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Acrotech Biopharma Inc at 1-888-292-9617 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical 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 ( 14 )].

8. USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary Although available data with RYZNEUTA use in pregnant women are insufficient to establish whether there is a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes, there are available data from published studies in pregnant women exposed to other human G-CSF products. These studies have not established an association of G-CSF product use during pregnancy with major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal studies, no evidence of reproductive/developmental toxicity occurred in the offspring of pregnant rats and rabbits that received cumulative doses of efbemalenograstim alfa-vuxw approximately 2.6 and 0.7 times, respectively, the recommended human dose (based on body surface area). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Metabolism

The pharmacokinetics of efbemalenograstim alfa-vuxw was studied in female patients with breast cancer and healthy male subjects. Efbemalenograstim alfa-vuxw exhibited nonlinear and time-dependent pharmacokinetics over the dose range of 30 to 360 μg/kg.

10. OVERDOSAGE 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 [see Adverse Reactions ( 6 )] .

• Nov 16, 2023BLABLA761134Evive Biotechnology

1. 1Asthenia725%
2. 2Anaphylactic Shock621%
3. 3Dizziness518%
4. 4Dyspnoea414%
5. 5Hyperhidrosis414%
6. 6Pyrexia414%
7. 7Chest Discomfort311%
8. 8Nausea311%
9. 9Neutrophil Count Decreased311%
10. 10Palpitations311%
11. 11Atrial Flutter27.1%
12. 12Blood Pressure Decreased27.1%
13. 13Pain27.1%
14. 14Pallor27.1%
15. 15Peripheral Coldness27.1%

The 6 most recently updated of 6 ClinicalTrials.gov registrations naming Efbemalenograstim Alfa as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• 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
  Recruiting · Phase 2 · Interventional · 1,076 enrolled · Henan Cancer Hospital
  NCT07187908updated 2025-09-23
• A Multi-cohort Study of Efbemalenograstim Alfa Injection for Preventing ANC Reduction in Solid Tumor Patients Post Immune-chemotherapy.
  Not yet recruiting · Interventional · 200 enrolled · Shandong Cancer Hospital and Institute
  NCT06649448updated 2024-10-18
• Efbemalenograstim Alfa Injection for Ovarian or Cervical Cancer Receiving Chemotherapy Regimen
  Recruiting · Phase 2 · Interventional · 83 enrolled · Shandong University
  NCT06251947updated 2024-05-07
• Study of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy
  Completed · Phase 1 · Interventional · 18 enrolled · EVIVE Biotechnology
  NCT02527746updated 2024-02-23
• A Study of Efbemalenograstim Alfa Injection for Stage IIIB or IV NSCLC Recieving Moderate-risk Febrile Neutropenia (FN) Chemotherapy Regimen With Risk Factors
  Not yet recruiting · Phase 2 · Interventional · 99 enrolled · Tianjin Medical University Cancer Institute and Hospital
  NCT06143735updated 2023-11-22
• A Pharmacokinetics/Dynamics Ib Study of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy
  Completed · Phase 1 · Phase 2 · Interventional · 15 enrolled · EVIVE Biotechnology
  NCT02522234updated 2019-11-21

Frequently asked questions

How does Efbemalenograstim Alfa work?

Efbemalenograstim alfa-vuxw is a colony-stimulating factor that acts on hematopoietic cells by binding to specific cell surface receptors, thereby stimulating proliferation, differentiation, commitment, and end cell functional activation.

What is Efbemalenograstim Alfa used for?

According to FDA labeling, Efbemalenograstim Alfa carries indications including: 1. INDICATIONS 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Efbemalenograstim Alfa?

Efbemalenograstim Alfa is classified as Colony stimulating factors, Leukocyte Growth Factor, Macrophage Colony Stimulating Factor Receptor Interactions, Increased Immunologic Activity.

What are the brand names for Efbemalenograstim Alfa?

Efbemalenograstim Alfa is marketed under brand names including Ryzneuta.

What are the contraindications for Efbemalenograstim Alfa?

Efbemalenograstim Alfa labeling lists contraindications including: 4. CONTRAINDICATIONS 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 [see Warnings and Precautions ( 5.3 )] .. Always consult the full prescribing information and a clinician.