Ryzneuta Efbemalenograstim alfa Application Scope

Used to reduce the duration of severe neutropenia and incidence of febrile neutropenia in adults with non-myeloid malignancies undergoing cytotoxic chemotherapy.

Ryzneuta Efbemalenograstim alfa Characteristics

Ingredients:
Efbemalenograstim alfa (recombinant granulocyte colony-stimulating factor fused to human IgG2 Fc)

Properties:
Long‑acting G-CSF receptor agonist stimulating bone marrow to produce neutrophils; once‑per‑cycle dosing.

Packaging Specification:
20 mg/mL single‑dose prefilled syringe or vial

Storage:
2–8 °C; do not freeze or shake

Expiry Date:
Refer to product label

Executive Standard:
Compliant with local pharmacopeia (e.g., China, US, EU standards)

Approval Number:
China NMPA approval in May 2023; FDA approval in Nov 2023; EU in Mar 2024

Date of Revision:
[Insert latest label update date]

Manufacturer:
Evive Biotechnology (Shanghai) Ltd. (developed), commercialized by regional partners under Ryzneuta brand

Guidelines for the Use of Ryzneuta Efbemalenograstim alfa

Dosage and Administration:
- Recommended Dose: 20 mg SC (single dose) administered once per chemotherapy cycle, ≥24 hours after last chemo, and ≥14 days before next.
- Administration: Inject subcutaneously; do not administer intravenously.
- Missed Dose: Administer as soon as possible after missed appointment; continue next cycle per schedule.
Adverse Reactions:
- Common Adverse Reactions: Bone pain, back pain, arthralgia, fatigue, headache, fever, nausea, rash, diarrhea
- Serious Adverse Reactions: Splenic rupture, acute respiratory distress, anaphylaxis, sickle cell crisis, glomerulonephritis, thrombocytopenia, capillary leak syndrome, leukemic transformation in certain high-risk patients
Contraindications: Known hypersensitivity to G-CSF products or any component of the formulation.
Precautions:
- Monitor for splenic enlargement and pause if severe abdominal pain occurs
- Use caution in patients with sickle cell disease
- Monitor pulmonary function; stop treatment if acute respiratory symptoms arise
- Periodically check blood counts during treatment

Ryzneuta Efbemalenograstim alfa Interactions

No significant drug–drug interactions reported. Avoid use within 24 hours before or after chemotherapy administration.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.