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RESPIRATORY SYSTEM › DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES › OTHER SYSTEMIC DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES › Other systemic drugs for obstructive airway diseases
omalizumab
R03DX05
Forms & Strengths
- Subcutaneous injection: 75 mg/0.5 mL prefilled syringe
- Subcutaneous injection: 150 mg/mL prefilled syringe
- Subcutaneous injection: 150 mg single-dose vial
Adult Dosing
- Moderate to severe persistent asthma: 75 mg to 375 mg subcutaneously every 2 or 4 weeks, based on pretreatment serum IgE level and body weight
- Chronic spontaneous urticaria: 150 mg or 300 mg subcutaneously every 4 weeks
- Chronic rhinosinusitis with nasal polyps: 75 mg to 600 mg subcutaneously every 2 or 4 weeks based on IgE and weight
- Food allergy: 75 mg to 600 mg subcutaneously every 2 or 4 weeks based on baseline IgE and body weight
Pediatric Dosing
- Asthma (Aged >= 6 years): 75 mg to 375 mg subcutaneously every 2 or 4 weeks based on baseline IgE and body weight
- Chronic spontaneous urticaria (Aged >= 12 years): 150 mg or 300 mg subcutaneously every 4 weeks
- Food allergy (Aged >= 1 year): 75 mg to 600 mg subcutaneously every 2 or 4 weeks based on baseline IgE and body weight
Indications
- Moderate to severe persistent asthma in patients with a positive skin test or in vitro reactivity to a perennial aeroallergen
- Chronic spontaneous urticaria in patients refractory to H1 antihistamine treatment
- Add-on maintenance treatment of chronic rhinosinusitis with nasal polyps in adults
- Reduction of allergic reactions (including anaphylaxis) to one or more foods in IgE-mediated food allergy
Mechanism of Action
- Recombinant humanized monoclonal antibody that selectively binds to human immunoglobulin E (IgE)
- Prevents binding of IgE to the high-affinity IgE receptor (FcεRI) on the surface of mast cells and basophils
- Reduces mediator release of the allergic response and downregulates FcεRI receptor expression on basophils
Contraindications
- Severe hypersensitivity to omalizumab or any of its excipients
Adverse Reactions
- Anaphylaxis (can occur hours to days after administration)
- Injection site reactions (pain, bruising, erythema)
- Viral infections, upper respiratory tract infection, sinusitis
- Headache and arthralgia
- Malignancies (slight numerical imbalance observed in clinical trials)
Drug Interactions
- No formal clinical drug interaction studies performed with omalizumab
- P450 enzymes are not involved in clearance; pharmacokinetic drug interactions are unlikely
- Concomitant immunosuppressants may affect IgE levels, though concurrent use with inhaled corticosteroids is standard in asthma
Curated Content: Needs Vetting Before Put to Clinical Use