Enyitan Omalizumab for Injection

1. Indications and Usage
Moderate-to-Severe Allergic Asthma: Treatment of patients (≥12 years) with moderate-to-severe persistent allergic asthma who remain uncontrolled with inhaled corticosteroids (ICS) and long-acting β2-agonists (LABA).
Chronic Spontaneous Urticaria (CSU): Treatment of adult and adolescent (≥12 years) patients with CSU who remain uncontrolled with H1-antihistamines.
Nasal Polyps: Adjunctive treatment for nasal polyps in adults who have inadequate response to regular inhalation of corticosteroids.
2. Dosage and Administration
Route of Administration: For Subcutaneous (SC) Injection ONLY. Intramuscular or intravenous administration is prohibited.
Recommended Dosage:
Asthma: 75 mg to 600 mg every 2 or 4 weeks, determined by baseline serum total IgE (IU/mL) and body weight (kg).
CSU and Polyps: 150 mg or 300 mg administered subcutaneously once every 4 weeks.
Critical Administration Instructions:
Injection Sites: Administer in the upper arm (deltoid region) or thigh. If a single dose exceeds 150 mg, administer at two separate injection sites.
Preparation: Reconstitute with the provided Sterile Water for Injection. Gently invert the vial; do not shake. Allow to stand at room temperature for approximately 20 minutes prior to administration.
3. Mechanism of Action
IgE Sequestration: Omalizumab selectively binds to free immunoglobulin E (IgE) in serum, preventing it from binding to high-affinity IgE receptors (FcεRI) on mast cells and basophils.
Receptor Downregulation: It causes a rapid and sustained reduction in the expression of FcεRI on these cells, thereby inhibiting the release of inflammatory mediators (e.g., histamine, leukotrienes) that drive allergic and urticarial responses.
4. Safety and Warnings
Anaphylaxis: Serious, life-threatening, or fatal anaphylactic reactions have been reported. Patients must be monitored for at least 2 hours after administration, and appropriate medical equipment for immediate anaphylaxis treatment must be available.
Malignancies: An increased incidence of malignancies was observed in clinical trials. The overall benefit-risk profile remains favorable, but patients should be monitored for potential cancer risks.
Eosinophilic Conditions: Rare cases of systemic eosinophilia and Churg-Strauss syndrome (EGPA) have been reported. These events may be mistaken for asthma exacerbation.
Vaccines: The immune response to vaccines may be altered; live or attenuated vaccines should be avoided if possible.
5. Adverse Reactions and Clinical Research
Most Common Adverse Reactions: Injection site reactions (pain, erythema, swelling), urticaria, headache, pyrexia, arthralgia, and parasitic infections (helminths).
Clinical Research Highlights: Phase 3 trials (e.g., EXTRA, POLARIS, CHRONOS) demonstrated significant reductions in asthma exacerbations, IgE-mediated symptoms, and nasal polyposis severity compared to placebo.
6. Drug Interactions
Antihistamines: Concomitant use with H1-antihistamines is common and does not require dose adjustment.
Parasitic Infections: Omalizumab may indirectly reduce the efficacy of anti-helminthic drugs due to IgE involvement in the immune response to helminths. Caution is advised in high-risk populations.
CYP450 Enzymes: Omalizumab is not metabolized by cytochrome P450 enzymes and has no significant pharmacokinetic interactions with small-molecule drugs.
7. Pharmaceutical Information
Chemical Composition: Recombinant humanized IgG1κ monoclonal antibody.
Appearance: White to off-white lyophilized powder.
Packaging: Single-use vial (150 mg or 300 mg), supplied with a pre-filled syringe of Sterile Water for Injection.
Storage: Store in the original carton at 2°C to 8°C. Do not freeze.