過敏性氣喘、慢性自發性蕁麻疹 (Chronic Spontaneous Urticaria, CSU)

Monoclonal Antibody, Anti-Asthmatic

Onset of action: ~12 to 16 weeks.
Absorption: Slow following SUBQ injection.
Distribution: 78 mL/kg.
Bioavailability: 62%.
Half-life elimination: 26 days (asthma patients); 24 days (chronic spontaneous urticaria patients).
Time to peak: 7 to 8 days.
Excretion: Primarily via hepatic degradation; intact IgG may be secreted in bile.

Severe hypersensitivity reaction to omalizumab or any component of the formulation.

B

>10%: injection-site reaction, nervous system, headache (children: ≥3%; adolescents and adults: 6% to 12%).
1% to 10%: peripheral edema (≥2%), alopecia (≥2%), dermatitis (2%), pruritus (2%), urticaria (≥2%), upper abdominal pain (3%), urinary tract infection (≥2%), fungal infection (≥2%), anxiety (≥2%), dizziness (3%), fatigue (3%), migraine (≥2%), pain (7%), arthralgia (3% to 8%), bone fracture (2%), limb pain (2% to 4%), musculoskeletal pain (≥2%), myalgia (≥2%), otalgia (2%), asthma (≥2%), cough (2%), nasopharyngitis, oropharyngeal pain (≥2%), sinus headache (≥2%), sinusitis (5%), upper respiratory tract infection (3%), viral upper respiratory tract infection (≤2%), fever (≥2%).

Asthma, moderate to severe allergic, rhinosinusitis (chronic) with nasal polyps:
Dose and frequency based on body weight and pretreatment total IgE serum levels (30 to 700 units/mL). Due to elevated IgE levels during therapy, dosing should not be adjusted based on total IgE levels evaluated during treatment or <1 year following interruption of therapy. If therapy has been interrupted for ?1 year, total IgE levels may be re-evaluated for dosage determination. A minimum of 3 to 6 months of treatment is suggested to determine efficacy.
Urticaria, chronic spontaneous:
150 or 300 mg every 4 weeks. Dosing is not dependent on serum IgE (free or total) level or body weight.