Omalizumab

Information about Omalizumab

Omalizumab

Omalizumab is a monoclonal antibody to human immunoglobulin E (IgE), which leads to a decrease in IgE binding to mast cells and basophils and a reduction in allergic symptoms of asthma and seasonal rhinitis.

Liver safety of Omalizumab

Omalizumab therapy has not been associated with serum enzyme elevations during therapy and has yet to be implicated in cases of clinically apparent drug induced liver injury with jaundice.

Mechanism of action of Omalizumab

Omalizumab (oh” ma liz’ ue mab) is a recombinant, human monoclonal antibody to IgE which binds avidly to circulating immunoglobulin E, preventing its attachment to high affinity receptors on mast cells and basophils. This receptor inhibition prevents the release of histamine and other mediators of the allergic immune response, reducing airway inflammation and spasm and alleviating symptoms of asthma and allergic rhinitis. Therapy with omalizumab has been shown to reduce the requirement for inhaled corticosteroids and lower the frequency of exacerbations of asthma and to decrease the severity and symptoms of chronic urticaria of unknown cause.

FDA approval information for Omalizumab

Omalizumab was approved for use in the United States in 2003 for therapy of patients with severe and persistent asthma despite corticosteroid inhalation therapy. The indications were extended in 2014 to include chronic idiopathic urticaria. Omalizumab has been evaluated in patients with seasonal rhinitis, but has yet to be approved for that use. Omalizumab is available in single use vials of 150 mg under the brand name Xolair.

Dosage and administration for Omalizumab

The recommended dose is 150 to 300 mg intravenously every 4 weeks or 225 to 375 mg every 2 weeks based upon body weight and IgE levels.

Side effects of Omalizumab

Common side effects include injection site reactions, rash, diarrhea, nausea and vomiting and epistaxis. Rarely, omalizumab can cause serious acute anaphylaxis or anaphylactoid reactions (~ 0.1%) and should be given under close medical supervision. Beta-2 Adrenergic Agonists

Albuterol, Bitolterol, Formoterol, Metaproterenol, Pirbuterol, Salbutamol, Salmeterol, Terbutaline

Leukotriene Receptor Antagonists

Montelukast, Zafirlukast

Monoclonal Antibodies

Benralizumab, Mepolizumab, Omalizumab, Reslizumab

Xanthine Derivatives

Theophylline Zileuton