Nucala Mepolizumab Injection

1. Indications and Usage
Severe Eosinophilic Asthma (SEA):
Add-on maintenance treatment of patients aged 6 years and older with severe eosinophilic asthma.
Eosinophilic Granulomatosis with Polyangiitis (EGPA):
Treatment of adult patients with EGPA.
Chronic Rhinosinusitis with Nasal Polyps (CRSwNP):
Treatment of adult patients with severe refractory CRSwNP.
Hypereosinophilic Syndrome (HES):
Treatment of patients aged 12 years and older with HES.
2. Dosage and Administration
Route of Administration:
For Subcutaneous Injection ONLY.
Recommended Dosage:
Asthma / HES / CRSwNP:
Dose: 100 mg once every 4 weeks.
EGPA:
Dose: 300 mg once every 4 weeks.
Administration Note: Since the vial/syringe contains 100 mg, the 300 mg dose requires three separate injections administered at different sites (e.g., abdomen, thigh, or upper arm).
Administration:
May be administered by a healthcare professional or by the patient (if appropriately trained).
3. Mechanism of Action
Target:
Mepolizumab is an anti-IL-5 humanized monoclonal antibody (IgG1κ).
Blocking Signaling:
IL-5 is the major cytokine responsible for the growth, differentiation, recruitment, activation, and survival of eosinophils.
Mepolizumab binds to IL-5 with high affinity, preventing IL-5 from binding to its receptor complex on the eosinophil surface.
Result:
Inhibition of IL-5 signaling leads to a significant and sustained reduction in the number of eosinophils in the blood and tissues.
4. Safety and Warnings
Do Not Discontinue Asthma Medicines:
Do not discontinue systemic or inhaled corticosteroids when initiating Mepolizumab.
Not for Acute Attacks:
Not indicated for the relief of acute bronchospasm, acute exacerbations of asthma, or status asthmaticus.
Hypersensitivity Reactions:
Hypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria, rash) have been reported.
Herpes Zoster Infection:
An increased incidence of herpes zoster (shingles) has been observed in patients with asthma treated with Mepolizumab. Consider prophylactic vaccination.
Parasitic Infections:
Monitor patients for potential parasitic (helminth) infections, as eosinophils play a role in immune defense against parasites.
5.Adverse Reactions
Most Common (Asthma):
Headache, pharyngitis, back pain, fatigue, injection site reactions (e.g., erythema, pain, swelling), and fever.
Most Common (EGPA):
Headache, nasopharyngitis, and injection site reactions.
6.Drug Interactions
No Clinical Significance:
As a protein (monoclonal antibody), it is not metabolized by cytochrome P450 enzymes. No clinically significant drug interactions have been identified.
7.Pharmaceutical Information
Chemical Composition:
Active Ingredient: Mepolizumab.
Appearance: Clear to slightly opalescent, colorless to pale yellow solution.
Delivery System: Available as a single-dose prefilled autoinjector or prefilled safety syringe.
Storage: Store in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze or shake.