Fasenra Benralizumab Injection

1. Indications and Usage
Severe Eosinophilic Asthma:
Add-on maintenance treatment of patients with severe eosinophilic asthma aged 12 years and older.
2. Dosage and Administration
Route of Administration:
For Subcutaneous Injection ONLY.
Recommended Dosage:
Dose: 30 mg per injection.
Schedule:
Initial Phase: Once every 4 weeks for the first 3 doses.
Maintenance Phase: Once every 8 weeks thereafter.
Administration:
May be administered by a healthcare professional or by the patient (if appropriately trained).
Injection sites: Upper arm, thigh, or abdomen.
3. Mechanism of Action
Target:
Binds with high affinity to the alpha subunit of the human interleukin-5 receptor (IL-5Rα) expressed on the surface of eosinophils and basophils.
Dual Mechanism (Blocking + Killing):
Signaling Blockade: Blocks the binding of IL-5 to its receptor, inhibiting eosinophil proliferation and survival.
Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC): Through its Fc domain, it recruits Natural Killer (NK) cells to induce apoptosis (programmed cell death) of eosinophils.
Result:
Rapid and near-complete depletion of eosinophils in the blood and airway tissues.
4. Safety and Warnings
Do Not Discontinue Asthma Medicines:
Do not discontinue systemic or inhaled corticosteroids when initiating Benralizumab.
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, rash, urticaria) have been reported.
Parasitic Infections:
Eosinophils play a role in immune defense against parasites. Monitor patients for potential parasitic (helminth) infections.
Vaccinations:
Patients should be up to date with all vaccinations prior to initiating therapy. Avoid live vaccines during treatment.
5.Adverse Reactions
Most Common:
Headache, pharyngitis, fatigue, injection site reactions (e.g., erythema, pain), and fever.
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: Benralizumab.
Appearance: Clear to slightly opalescent, colorless to pale yellow solution.
Delivery System: Available as a single-dose prefilled syringe or a single-dose autoinjector.
Storage: Store in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze or shake.