Ryzneuta Efbemalenograstim Alfa Injection

1. Indications and Usage
Chemotherapy-Induced Neutropenia: Indicated for the reduction of the incidence of febrile neutropenia in patients with non-myeloid malignancies receiving myelosuppressive antineoplastic therapy.
2. Dosage and Administration
Recommended Dose: The recommended dose is 20 mg administered as a single subcutaneous injection per chemotherapy cycle.
Timing: The injection should be administered after the administration of cytotoxic chemotherapy. It should not be administered within 14 days before chemotherapy or within 24 hours after the completion of chemotherapy.
Administration: It is supplied as a prefilled syringe containing 20 mg/1.0 mL and is not intended for intravenous administration.
3. Mechanism of Action
G-CSF Activity: Efbemalenograstim alfa is a recombinant granulocyte colony-stimulating factor (G-CSF) fused with a modified albumin-binding domain.
Stimulation of Neutrophils: It stimulates the proliferation, differentiation, and survival of neutrophil precursor cells in the bone marrow.
Prolonged Half-life: The albumin-binding domain allows for interaction with albumin in the circulation, extending the drug’s half-life and enabling effective once-per-cycle administration.
4. Safety and Warnings
Based on the drug monograph for Efbemalenograstim alfa injection, the most serious adverse reactions include splenic rupture, acute respiratory distress syndrome (ARDS), severe allergic reactions, and sickle cell crisis。
Splenic Rupture: Patients should be monitored for signs of splenic enlargement or rupture, such as pain in the left upper quadrant or shoulder.
Acute Respiratory Distress Syndrome (ARDS): Patients presenting with fever, pulmonary infiltrates, or respiratory distress after administration should be evaluated for ARDS and the drug should be discontinued if diagnosed.
Hypersensitivity: Severe allergic reactions, including anaphylaxis, have been reported. Patients with a history of severe hypersensitivity to this drug or E. coli-derived products should not use it.
5. Adverse Reactions and Clinical Research
Adverse Reactions: The most common adverse reactions (occurring in ≥5% of patients) are bone pain and back pain. Other frequently observed reactions include injection site reactions, fever, and headache.
Clinical Research: Clinical trials have demonstrated that single-dose administration of efbemalenograstim alfa per chemotherapy cycle is effective in preventing febrile neutropenia and has a lower incidence of bone pain compared to some pegylated G-CSF products.
6. Drug Interactions
Cytotoxic Chemotherapy: No direct pharmacokinetic interactions have been established, but the timing relative to chemotherapy is critical to avoid interfering with the cytotoxic effects on rapidly dividing cells and to prevent toxicity.
Other G-CSF Products: Concomitant use with other growth factors should be approached with caution to avoid excessive leukocytosis.
7. Pharmaceutical Information
Composition: The active ingredient is efbemalenograstim alfa. Excipients include sodium acetate, disodium EDTA, polysorbate 20, sorbitol, and water for injection.
Appearance: It is a clear to slightly opalescent, colorless to pale yellow solution.
Storage: Store in a refrigerator at 2°C to 8°C. Do not freeze or shake. Discard if left at room temperature for more than 48 hours.