- Indications and Usage Severe Eosinophilic Asthma: Indicated as an add-on maintenance treatment for patients aged 6 years and older with severe asthma with an eosinophilic phenotype. Chronic Rhinosinusitis with Nasal Polyps (CRSwNP): Indicated for the treatment of CRSwNP in adults. Eosinophilic Granulomatosis with Polyangiitis (EGPA): Indicated for the treatment of EGPA in adults and adolescents aged 12 years and older. Hypereosinophilic Syndrome (HES): Indicated for the treatment of HES in patients aged 1 year and older.
- Dosage and Administration Standard Dosage: 100 mg administered via subcutaneous injection every 4 weeks. Pediatric Dosage: 6 to 11 years (40 mg every 4 weeks); 1 year to 5 years (dose determined by body weight). Administration Details: The injection should be administered by a healthcare professional or their caregiver. The drug is for subcutaneous use only and must not be administered intravenously. Injection Sites: Common sites include the thigh, abdomen (excluding the 5 cm area around the umbilicus), or the outer upper arm.
- Mechanism of Action IL-5 Binding: Mepolizumab is a humanized monoclonal antibody that binds with high affinity to human IL-5. Eosinophil Depletion: By sequestering IL-5, it prevents the interaction between IL-5 and its receptor on the surface of eosinophils, thereby inhibiting the growth, differentiation, activation, and survival of eosinophils.
- Safety and Warnings Hypersensitivity: Serious hypersensitivity reactions, including anaphylaxis and angioedema, may occur. Parasitic Infections: Patients with pre-existing parasitic infections may have reduced responsiveness to therapy and require appropriate antiparasitic treatment. Herpes Zoster: Cases of herpes zoster (shingles) have been reported. Corticosteroid Withdrawal: Mepolizumab should not be used to replace systemic or inhaled corticosteroids abruptly; corticosteroids should be tapered gradually when clinically appropriate.
- Adverse Reactions and Clinical Research Most Common Adverse Reactions: Headache, injection site reactions, back pain, fatigue, and pharyngolaryngeal pain. Clinical Research: Clinical trials have demonstrated that mepolizumab significantly reduces asthma exacerbation rates, nasal polyp size, and eosinophil counts while improving health-related quality of life.
- Drug Interactions Vaccines: Live vaccines should generally be avoided during treatment due to the immunomodulatory effects of monoclonal antibodies. Other Therapies: No specific pharmacokinetic drug-drug interactions have been identified, but it is often used in combination with corticosteroids.
- Pharmaceutical Information Chemical Composition: Active ingredient: Mepolizumab (recombinant DNA-derived humanized IgG1 kappa monoclonal antibody). Appearance: Colorless to slightly yellow liquid (for pre-filled syringe) or white to off-white lyophilized powder (for vial). Packaging: Supplied in single-use pre-filled syringes or vials. Storage: Store in a refrigerator at 2°C to 8°C. Do not freeze or shake. Protect from light.
Xinkelai Mepolizumab Injection
Brand Name:新可来 ®（Xinkelai®）
Generic Name: Mepolizumab
Strength: 100 mg (1 mL) per single-dose pre-filled autoinjector, 1 autoinjector per box
Manufacturer: Glaxo Operations UK Ltd.
Marketing Authorization Holder: GlaxoSmithKline (China) Investment Co., Ltd.
Approval Date in China: November 19, 2021
Registration Number: 国药准字SJ20210030
Storage: Store refrigerated at 2°C – 8°C in the original carton, protect from light. Do not freeze or shake violently. Refer to the full package insert for detailed storage specifications.
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