Omalizumab injection-site reactions

The most common adverse effect with omalizumab is injection-site reaction, reported in 45% of patients in clinical trials. Other adverse effects include viral and upper respiratory tract infections, sinusitis, headache, and pharyngitis. Rare cases of malignant neoplasms and anaphylaxis were reported during clinical trials of omalizumab in asthma. Patients should be monitored for at least 2 hours following the injection so that anaphylaxis and/or injection-site reactions may be managed.25... 

Omalizumab Humanized IgE antibody reduces circulating IgE Reduces frequency of asthma exacerbations Severe asthma inadequately controlled by above agents Parenteral duration 2-4 d Toxicity Injection site reactions (anaphylaxis extremely rare)... 

In a placebo-controUed study of subcutaneous omalizumab (50,150, and 300 mg before the ragweed season and every 3 or 4 weeks during the pollen season) in 536 patients with seasonal allergic rhinitis, injection site reactions were mild and infrequent, there were no clinically significant alterations in laboratory values, and anti-idiotypic antibodies to omalizumab were not detected there was no evidence of immune complex-related adverse events (5-7). 

The safety of omalizumab so far has been evaluated in only three large, randomized, placebo-controlled, multicenter studies. Omalizumab generally was well tolerated in several large, placebo-controlled, trials. The most frequent adverse effect was injection-site reactions (e.g., redness, stinging, bruising, and induration), but these reactions also were seen at comparable frequencies with placebo. Low titers of antibodies against omalizumab developed in 1 of 1723 treated patients, whereas anaphylaxis was seen in... 

IgE (3 X 10 units) is nearly equivalent to that for human IgE (1.7 X 10 units). Injection of omalizumab into the skin failed to elicit the wheal and flare reaction typical of mast cell degranulation, nor did it induce hive formation in monkey skin presensitized with human ragweed-specific IgE. Identical results were obtained when omalizumab was administered systemically. Doses as high as 50 mg/kg did not cause a systemic anaphylactic reaction confirming the safety of an anti-IgE binding free IgE at the same heavy chain site as EceRI. 

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