Indicated for: 

Asthma:

• Adults and pediatric patients 6 years of age and older with moderate to severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids.

• XOLAIR is not indicated for the relief of acute bronchospasm or status asthmaticus.
• XOLAIR is not indicated for treatment of other allergic conditions.

Nasal Polyps:

• Add-on maintenance treatment of nasal polyps in adult patients 18 years of age and older with inadequate response to nasal corticosteroids.

Chronic Idiopathic Urticaria (CIU):

• The treatment of adults and adolescents 12 years of age and older with chronic idiopathic urticaria who remain symptomatic despite H1 antihistamine treatment.

XOLAIR is not indicated for treatment of other forms of urticaria.

The appropriate duration of therapy for CIU has not been evaluated.

Safety and efficacy in pediatric patients with asthma below 6 years of age have not been established. Safety and efficacy in pediatric patients with CIU below 12 years of age have not been established.

Total IgE levels are elevated during treatment and remain elevated for up to one year after the discontinuation of treatment. Therefore, re-testing of IgE levels during XOLAIR treatment cannot be used as a guide for dose determination. Do not use serum total IgE levels obtained less than 1 year following discontinuation to reassess the dosing regimen for asthma or nasal polyps patients, because these levels may not reflect steady state free IgE levels.

Anaphylaxis presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of XOLAIR. Anaphylaxis has occurred as early as after the first dose of XOLAIR, but also has occurred beyond 1 year after beginning regularly administered treatment. Because of the risk of anaphylaxis, initiate XOLAIR therapy in a healthcare setting and closely observe patients for an appropriate period of time after XOLAIR administration.

Health care providers administering XOLAIR should be prepared to manage anaphylaxis which can be life-threatening. Inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care should symptoms occur. Selection of patients for self-administration of XOLAIR should be based on criteria to mitigate risk from anaphylaxis.

The observed malignancies in XOLAIR-treated patients were a variety of types, with breast, non-melanoma skin, prostate, melanoma, and parotid occurring more than once, and five other types occurring once each. The majority of patients were observed for less than 1 year. The impact of longer exposure to XOLAIR  or use in patients at higher risk for malignancy (e.g., elderly, current smokers) is not known.

Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of XOLAIR therapy for asthma. Decrease corticosteroids gradually under the direct supervision of a physician. In CIU patients, the use of  XOLAIR in combination with corticosteroids has not been evaluated.

In rare cases, patients with asthma on therapy with XOLAIR may present with serious systemic eosinophilia sometimes presenting with clinical features of vasculitis consistent with Churg-Strauss syndrome, a condition which is often treated with systemic corticosteroid therapy.

Monitor patients at high risk of geohelminth infection while on XOLAIR therapy..

The data with XOLAIR use in pregnant women are insufficient to inform on drug associated risk. Monoclonal antibodies, such as omalizumab, are transported across the placenta in a linear fashion as pregnancy progresses; therefore, potential effects on a fetus are likely to be greater during the second and third trimesters of pregnancy.

There is no information regarding the presence of omalizumab in human milk, the effects on the breastfed infant, or the effects on milk production. However, omalizumab is a human monoclonal antibody (IgG1 kappa), and immunoglobulin (IgG) is present in human milk in small amounts.

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• Use in patients with asthma under 6 years of age and use in patients with chronic idiopathic urticaria under 12 years of age. GoToSource 

• Allergic rhinitis, peanut allergy, latex sensitivity, atopic dermatitis and allergic bronchopulmonary aspergillosis. GoToSource

Thrombocytopenia (low blood platelet count). GoToSource 

Increased white blood cell counts, with elevated myeloid cell counts. GoToSource 

Myocardial infarction, angina, ischemic heart disease, acute coronary syndrome and cardiovascular death. GoToSource

Pulmonary hypertension, blood clots in lungs and veins and arrhythmias. GoToSource

Churg-strauss syndrome (inflammation of blood vessels). GoToSource

Anaphylaxis (severe allergic reaction) including angioedema of the throat or tongue, bronchospasm, hypotension, syncope and urticaria (hives). GoToSource

Breast, prostate, melanoma and parotid tumors. GoToSource

Increased risk of geohelminth infection. GoToSource

Strokes. GoToSource

Lawsuits filed for heart attacks, strokes, anaphylactic reactions and death.