- Indications and Usage Indicated to decrease the incidence of febrile neutropenia in patients with non-myeloid malignancies receiving cytotoxic chemotherapy known to cause febrile neutropenia. It is not indicated for the mobilization of hematopoietic progenitor cells.
- Dosage and Administration Standard Dosage: The recommended dose is a fixed dose of 6 mg administered as a single subcutaneous injection. Administration Timing: Must be given 24 to 48 hours after cytotoxic chemotherapy. It should not be administered within 14 days before chemotherapy. Individualized Dosage: Dosage may be calculated based on patient body weight at 100 µg/kg.
- Mechanism of Action Mecapegfilgrastim is a PEGylated recombinant methionyl human granulocyte colony-stimulating factor (rhG-CSF). It stimulates the proliferation and differentiation of neutrophil progenitors and enhances the functional response of mature neutrophils.
- Safety and Warnings Sickle Cell Crisis: Sickle cell crisis has been reported and can be fatal. Patients should be monitored closely for signs of sickling. Adult Respiratory Distress Syndrome (ARDS): Acute respiratory distress syndrome may occur. Monitoring is required if signs and symptoms of ARDS appear. Hypersensitivity: Severe allergic reactions may occur. Permanent discontinuation is required in patients with a history of severe allergy to this product or recombinant rhG-CSF. Capillary Leak Syndrome: Patients should be monitored for signs and symptoms of capillary leak syndrome. Splenic Rupture: Fatal cases of splenic rupture have been reported. Evaluation is necessary for patients with signs of splenomegaly (e.g., left upper abdominal pain).
- Adverse Reactions and Clinical Research Common Adverse Events: The most frequently observed adverse reactions include bone pain, musculoskeletal pain, abdominal pain, nausea, vomiting, headache, and increased liver enzymes (ALT/AST). Clinical Research: Clinical trials demonstrate that long-acting PEG-rhG-CSF significantly reduces the duration of severe neutropenia compared to daily injections of non-PEGylated G-CSF and eliminates the need for daily injections after chemotherapy.
- Drug Interactions G-CSF or GM-CSF: Concomitant use with other growth factor products may increase the risk of severe adverse events such as splenic rupture and should be avoided. Chemotherapy: Cytotoxic chemotherapy administered too close to the time of injection may increase the susceptibility of marrow cells to the cytotoxic drug, which can aggravate the toxicity of the chemotherapy regimen.
- Pharmaceutical Information Active Ingredient: Mecapegfilgrastim (PEGylated rhG-CSF). Molecular Weight: 39 kD. Excipients: Sodium acetate, acetic acid, polysorbate 80, sorbitol, and water for injection. Storage: Store in a refrigerator at 2°C to 8°C. Do not freeze or shake.
Aiduo Mecapegfilgrastim Injection
Brand Name: 艾多 ®（Aiduo®）
Generic Name: Mecapegfilgrastim
Strength: 6 mg per single-dose prefilled syringe
Manufacturer: Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Marketing Authorization Holder: Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Approval Date in China: February 11, 2018
Registration Number: 国药准字S20180004
Storage: Store refrigerated at 2°C to 8°C, avoid freezing and direct sunlight. Do not shake violently. Refer to the full package insert for detailed storage specifications.
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