Omalizumab

Cerebrovascular events, including transient ischemic attack and ischemic stroke, have been reported.

In rare cases, patients may present with systemic eosinophilia, sometimes presenting with clinical features of vasculitis consistent with eosinophilic granulomatosis with polyangiitis (formerly known as Churg-Strauss), a condition which is often treated with systemic corticosteroid therapy. Health care providers should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients. A causal association between omalizumab and these underlying conditions has not been established.

Reports of a constellation of symptoms including fever, arthritis or arthralgia, rash, and lymphadenopathy have been reported with postmarketing use (symptoms resemble those seen in patients experiencing serum sickness, although circulating immune complexes or a skin biopsy consistent with a Type III hypersensitivity reaction were not seen with these cases). Onset of symptoms generally occurred 1 to 5 days following the first or subsequent doses. Discontinue therapy in any patient reporting this constellation of signs/symptoms.

Anaphylaxis, including delayed-onset anaphylaxis, has been reported following administration; anaphylaxis may present as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue. Anaphylaxis has occurred after the first dose and in some cases >1 year after initiation of regular treatment. Due to the risk, patients should be observed closely for an appropriate time period after administration and should receive treatment only under direct medical supervision. Healthcare providers should be prepared to administer appropriate therapy for managing potentially life-threatening anaphylaxis. Patients should be instructed on identifying signs/symptoms of anaphylaxis and to seek immediate care if they arise. In postmarketing reports, anaphylaxis usually occurred with the first or second dose and with a time to onset of ≤60 minutes; however, reactions have been reported with subsequent doses (after 39 doses) and with a time to onset of up to 4 days after administration. A case-control study showed that patients with a history of anaphylaxis to foods, medications, or other causes were at an increased risk of anaphylaxis. Discontinue therapy following any severe reaction.

Have been reported rarely with use in short-term studies; impact of long-term use is not known. Disease-related concerns:

Use with caution and monitor patients at high risk for parasitic (helminth) infections; risk of infection may be increased; appropriate duration of continued monitoring following therapy discontinuation has not been established. Concurrent drug therapy issues:

Gradually taper systemic or inhaled corticosteroid therapy; do not discontinue corticosteroids abruptly following initiation of omalizumab therapy. The combined use of omalizumab and corticosteroids in patients with chronic idiopathic urticaria has not been evaluated.

Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information. Other warnings/precautions:

Therapy has not been shown to alleviate acute asthma exacerbations; do not use to treat acute bronchospasm, status asthmaticus, or other allergic conditions. Do not use to treat forms of urticaria other than chronic idiopathic urticaria.

Dosing for asthma is based on body weight and pretreatment total IgE serum levels. IgE levels remain elevated up to 1 year following treatment; therefore, levels taken during treatment or for up to 1 year following treatment cannot and should not be used as a dosage guide. Dosing in chronic idiopathic urticaria is not dependent on serum IgE (free or total) level or body weight.