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Clinical Trials Experience
The most serious adverse reactions occurring in clinical trials with Xolair (omalizumab) were anaphylaxis and malignancies (see WARNINGS). Anaphylaxis was reported in 3 of 3507 (0.1%) patients in clinical trials. Anaphylaxis occurred with the first dose of Xolair (omalizumab) in two patients and with the fourth dose in one patient. The time to onset of anaphylaxis was 90 minutes after administration in two patients and 2 hours after administration in one patient.
In clinical trials the observed incidence of malignancy among Xolair (omalizumab) -treated patients (0.5%) was numerically higher than among patients in control groups (0.2%).
The adverse reactions most commonly observed among patients treated with Xolair (omalizumab) in clinical studies included injection site reaction (45%), viral infections (23%), upper respiratory tract infection (20%), sinusitis (16%), headache (15%), and pharyngitis (11%). These events were observed at similar rates in Xolair (omalizumab) -treated patients and control patients. These were also the most frequently reported adverse reactions resulting in clinical intervention (e.g., discontinuation of Xolair (omalizumab) , or the need for concomitant medication to treat an adverse reaction).
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of one drug cannot be directly compared with rates in the clinical studies of another drug and may not reflect the rates observed in medical practice.
The data described above reflect Xolair (omalizumab) exposure for 2076 adult and adolescent patients ages 12 and older, including 1687 patients exposed for six months and 555 exposed for one year or more, in either placebo-controlled or other controlled asthma studies. The mean age of patients receiving Xolair (omalizumab) was 42 years, with 134 patients 65 years of age or older; 60% were women, and 85% Caucasian. Patients received Xolair (omalizumab) 150 to 375 mg every 2 or 4 weeks or, for patients assigned to control groups, standard therapy with or without a placebo.
Table 4 shows adverse events that occurred ≥ 1% more frequently in patients receiving Xolair (omalizumab) than in those receiving placebo in the placebo-controlled asthma studies. Adverse events were classified using preferred terms from the International Medical Nomenclature (IMN) dictionary. Injection site reactions were recorded separately from the reporting of other adverse events and are described following Table 4.
Adverse Events ≥ 1% More Frequent in Xolair (omalizumab) -Treated Patients
|Adverse event|| Xolair (omalizumab)
|Body as a whole|
|Skin and appendages|
Age (among patients under age 65), race, and gender did not appear to affect the between group differences in the rates of adverse events.
Injection Site Reactions
Injection site reactions of any severity occurred at a rate of 45% in Xolair (omalizumab) -treated patients compared with 43% in placebo-treated patients. The types of injection site reactions included: bruising, redness, warmth, burning, stinging, itching, hive formation, pain, indurations, mass, and inflammation.
Severe injection-site reactions occurred more frequently in Xolair (omalizumab) -treated patients compared with patients in the placebo group (12% versus 9%).
The majority of injection site reactions occurred within 1 hour-post injection, lasted less than 8 days, and generally decreased in frequency at subsequent dosing visits.
Low titers of antibodies to Xolair (omalizumab) were detected in approximately 1/1723 ( < 0.1%) of patients treated with Xolair (omalizumab) . The data reflect the percentage of patients whose test results were considered positive for antibodies to Xolair (omalizumab) in an ELISA assay and are highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody positivity in the assay may be influenced by several factors including sample handling, timing of sample collection, concomitant medications, and underlying disease. Therefore, comparison of the incidence of antibodies to Xolair (omalizumab) with the incidence of antibodies to other products may be misleading.
Postmarketing Spontaneous Reports
Anaphylaxis: Based on spontaneous reports and an estimated exposure of about 57,300 patients from June 2003 through December 2006, the frequency of anaphylaxis attributed to Xolair (omalizumab) use was estimated to be at least 0.2% of patients. Diagnostic criteria of anaphylaxis were skin or mucosal tissue involvement, and, either airway compromise, and/or reduced blood pressure with or without associated symptoms, and a temporal relationship to Xolair (omalizumab) administration with no other identifiable cause. Signs and symptoms in these reported cases included bronchospasm, hypotension, syncope, urticaria, angioedema of the throat or tongue, dyspnea, cough, chest tightness, and/or cutaneous angioedema. Pulmonary involvement was reported in 89% of the cases. Hypotension or syncope was reported in 14% of cases. Fifteen percent of the reported cases resulted in hospitalization. A previous history of anaphylaxis unrelated to Xolair (omalizumab) was reported in 24% of the cases.
Of the reported cases of anaphylaxis attributed to Xolair (omalizumab) , 39% occurred with the first dose, 19% occurred with the second dose, 10% occurred with the third dose, and the rest after subsequent doses. One case occurred after 39 doses (after 19 months of continuous therapy, anaphylaxis occurred when treatment was restarted following a 3 month gap). The time to onset of anaphylaxis in these cases was up to 30 minutes in 35%, greater than 30 and up to 60 minutes in 16%, greater than 60 and up to 90 minutes in 2%, greater than 90 and up to 120 minutes in 6%, greater than 2 hours and up to 6 hours in 5%, greater than 6 hours and up to 12 hours in 14%, greater than 12 hours and up to 24 hours in 8%, and greater than 24 hours and up to 4 days in 5%. In 9% of cases the times to onset were unknown.
Twenty-three patients who experienced anaphylaxis were rechallenged with Xolair (omalizumab) and 18 patients had a recurrence of similar symptoms of anaphylaxis. In addition, anaphylaxis occurred upon rechallenge with Xolair (omalizumab) in 4 patients who previously experienced urticaria only.
Hematologic: Severe thrombocytopenia has been reported in postapproval use of Xolair (omalizumab) .
Skin: Hair loss has been reported in postapproval use of Xolair (omalizumab) .
Read the Xolair (omalizumab) Side Effects Center for a complete guide to possible side effects
Read the Xolair Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 7/24/2007
This monograph has been modified to include the generic and brand name in many instances.
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