Nucala Mepolizumab Application Scope

It is indicated as add-on maintenance treatment for selected eosinophil-driven diseases, including:

Severe eosinophilic asthma (patients aged ≥6 years).
Chronic rhinosinusitis with nasal polyps (CRSwNP) (adults ≥18 years) for patients inadequately controlled with intranasal corticosteroids.
Eosinophilic granulomatosis with polyangiitis (EGPA) (adult patients).
Hypereosinophilic syndrome (HES) (patients aged ≥12 years with persistent unexplained eosinophilia ≥6 months). Eosinophilic phenotype chronic obstructive pulmonary disease (COPD) as add-on maintenance therapy in adults with inadequate control on standard therapy.

nucala mepolizumab

Nucala Mepolizumab Characteristics

Ingredients: Mepolizumab
Properties:
Packaging Specification:
- Single-dose vial: 100 mg powder for solution for injection
- Prefilled syringe: 100 mg/1 mL
Storage: Refrigerate at 2–8°C (36–46°F). Do not freeze. Protect from light. Refer to local product label for specific handling and transport instructions
Expiry Date: Refer to the expiration date printed on the packaging.
Executive Standard: Follows the standards set by the approving health authority (e.g., FDA, EMA, NMPA)
Approval Number: US: Biologics License Application (BLA) 125526 (NUCALA, original FDA approval Nov 4, 2015)
Date of Revision: he package insert should be consulted for the latest revision date.
Manufacturer: GlaxoSmithKline plc (GSK)

Guidelines for the Use of Nucala Mepolizumab

Dosage and Administration:
- Recommended Dose:
  - Severe Eosinophilic Asthma:
    - Adults and adolescents (12 years and older): 100 mg subcutaneously every 4 weeks.
    - Children (6 to 11 years old): 40 mg subcutaneously every 4 weeks.
  - EGPA: 300 mg subcutaneously (given as three separate 100 mg injections) every 4 weeks.
  - HES: 300 mg subcutaneously (given as three separate 100 mg injections) every 4 weeks.
- Administration: For subcutaneous injection into the upper arm, thigh, or abdomen. If multiple injections are required for a 300 mg dose, inject each 100 mg at least 5 cm (about 2 inches) apart. The injection should be performed by a healthcare professional or a patient/caregiver properly trained in injection technique.
- Missed Dose: If a dose is missed, administer it as soon as possible. Then, resume dosing every 4 weeks from the most recent dose. Consult a healthcare provider for specific guidance.
Adverse Reactions:
- Common Adverse Reactions: Headache, injection site reactions (pain, redness, swelling, itching), back pain, fatigue, joint pain, and urinary tract infections.
- Serious Adverse Reactions: Hypersensitivity reactions (including anaphylaxis, angioedema, urticaria, rash, bronchospasm), herpes zoster infections.
Contraindications: Hypersensitivity to mepolizumab or any excipient in the formulation.
Precautions:
- Hypersensitivity: Hypersensitivity reactions (e.g., anaphylaxis, angioedema) can occur. Discontinue immediately if such a reaction occurs.
- Acute Asthma Symptoms: Not for treating acute asthma attacks or status asthmaticus. Use rescue medication.
- Corticosteroid Reduction: Do not abruptly discontinue systemic or inhaled corticosteroids upon initiating Nucala. Reduce corticosteroids gradually under medical supervision.
- Parasitic (Helminth) Infections: Treat pre-existing parasitic infections before starting Nucala. If infected during treatment and not responding to anti-helminth treatment, discontinue Nucala.
- Vaccinations: Consider completing all appropriate immunizations (including herpes zoster vaccination) before starting treatment.
- Pregnancy and Breastfeeding: Use during pregnancy only if clearly needed. Consult a doctor regarding breastfeeding.

Nucala Interactions

Formal drug interaction studies have not been performed. When used concomitantly with corticosteroid therapy, reduce corticosteroids gradually under medical supervision and do not stop abruptly. Live vaccines should be administered at least 4 weeks before starting Nucala treatment.

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.