QUERY ON OMALIZUMAB

Dosage Forms & Strengths

powder for injection
 150mg/1.2mL (125mg/mL) after reconstition

Allergic Asthma
Moderate-to-severe persistent asthma with a positive skin test or in
vitro reactivity to a perennial aeroallergen and symptoms
inadequately controlled with inhaled corticosteroids
150-375 mg SC q2-4Weeks
Determine precise dose and frequency by total IgE level and body
weight measured before starting therapy and then periodically (see
manufacturer’s prescribing information)
Chronic Idiopathic Urticaria
Indicated for chronic idiopathic urticaria (CIU) in patients who
remain symptomatic despite H1 antihistamine treatment
150-300 mg SC q4weeks
Dosing in CIU patients is not dependent on serum IgE level or body
weight
Treatment duration for CIU has not been evaluated; periodically
reassess the need for continued therapy
Dosing Considerations
Not indicated for treatment of other allergic conditions or other forms
of urticaria
Not indicated for the relief of acute bronchospasm or status
asthmaticus
Pharmacology
Mechanism of Action
Recombinant humanized monoclonal antibody; selectively binds to
IgE and inhibits binding to IgE receptors on surface of mast cells and
basophils
Absorption:
Bioavailability: 62%
Peak Plasma Time: 7-8 days
Distribution:
Vd: 78 +/- 32 mL/kg
Metabolism:
Hepatic
Elimination:
Half-Life: 26 days
Total Body Clearance: 2.4 +/- 1.1 mL/kg/day
Excretion: Bile

Adverse Effects:
Injection site reactions (45%)
Viral infections (23%)
URI (20%)
Sinusitis (16%)
Headache (15%)
Pharyngitis (11%)

Black Box Warnings

Anaphylaxis, presenting as bronchospasm, hypotension, syncope,
urticaria, and/or angioedema of the throat or tongue reported to occur
after administration
Anaphylaxis has occurred as early as after the first dose, but also has
occurred beyond 1 year after beginning regularly administered
treatment
Closely observe patients for an appropriate period of time after
administration
Health care providers should be prepared to manage anaphylaxis that
can be life-threatening
Inform patients of the signs and symptoms of anaphylaxis and
instructed them to seek immediate medical care should symptoms
occur