"March 16, 2011 -- The asthma drug Xolair (omalizumab) improves asthma control, nearly eliminates seasonal flare-ups, and allows reductions in the doses of other asthma control medications in children as young as 6, according to a new study."...
Use of Xolair has been associated with:
- Anaphylaxis [see BOXED WARNING and WARNINGS AND PRECAUTIONS]
- Malignancies [see WARNINGS AND PRECAUTIONS]
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Clinical Trials Experience In Allergic Asthma
Adult and Adolescent Patients 12 years of Age and Older
The data described below reflect Xolair 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 was 42 years, with 134 patients 65 years of age or older; 60% were women, and 85% Caucasian. Patients received Xolair 150 to 375 mg every 2 or 4 weeks or, for patients assigned to control groups, standard therapy with or without a placebo.
The adverse events most frequently resulting in clinical intervention (e.g., discontinuation of Xolair, or the need for concomitant medication to treat an adverse event) were 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-treated patients and control patients.
Table 4 shows adverse reactions from four placebo-controlled asthma studies that occurred ≥ 1% and more frequently in patients receiving Xolair than in those receiving placebo. 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.
Table 4: Adverse Reactions ≥ 1% More Frequent in Xolair-Treated
Adult or Adolescent Patients 12 years of age and older
n = 738 (%)
|Body as a whole|
|Skin and appendages|
There were no differences in the incidence of adverse reactions based on age (among patients under 65), gender or race.
Injection Site Reactions
Injection site reactions of any severity occurred at a rate of 45% in Xolair-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-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.
Clinical Trials Experience In Chronic Idiopathic Urticaria
Adult and Adolescent Patients 12 years of Age and Older
The safety of Xolair for the treatment of CIU was assessed in three placebo-controlled, multiple-dose clinical studies of 12 weeks' (CIU Study 2) and 24 weeks' duration (CIU Studies 1 and 3). In CIU Studies 1 and 2, patients received Xolair 75, 150, or 300 mg or placebo every 4 weeks in addition to their baseline level of H1 antihistamine therapy throughout the treatment period. In CIU Study 3 patients were randomized to Xolair 300 mg or placebo every 4 weeks in addition to their baseline level of H1 antihistamine therapy. The data described below reflect Xolair exposure for 733 patients enrolled and receiving at least one dose of Xolair in the three clinical trials, including 684 patients exposed for 12 weeks and 427 exposed for 24 weeks. The mean age of patients receiving Xolair 300 mg was 43 years, 75% were women, and 89% were white. The demographic profiles for patients receiving Xolair 150 mg and 75 mg were similar.
Table 5 shows adverse events that occurred in ≥ 2% of patients receiving Xolair (150 or 300 mg) and more frequently than those receiving placebo. Adverse events are pooled from Study 2 and the first 12 weeks of Studies 1 and 3.
Table 5 : Adverse Events Occurring in ≥ 2 % in
Xolair-Treated Patients and More Frequently than in Patients Treated with
(Day 1 to Week 12)
|Adverse Events (by MedDRA Preferred Term)||CIU Studies 1, 2 and 3 Pooled|
|Nausea||2 (1.1%)||11 (2.7%)||6 (2.5%)|
|Infections and infestations*|
|Nasopharyngitis||16 (9.1%)||27 (6.6%)||17 (7.0%)|
|Sinusitis||2 (1.1%)||20 (4.9%)||5 (2.1%)|
|Upper respiratory tract infection||2 (1.1%)||14 (3.4%)||5 (2.1%)|
|Viral upper respiratory tract infection||4 (2.3%)||2 (0.5%)||0.00%|
|Musculoskeletal and connective tissue disorders*|
|Arthralgia||5 (2.9%)||12 (2.9%)||1 (0.4%)|
|Nervous system disorders*|
|Heachache||21 (12.0%)||25 (6.1%)||7 (2.9%)|
|Respiratory, thoracic, and mediastinal disorders*|
|Cough||2 (1.1%)||9 (2.2%)||3 (1.2%)|
|* MedDRA (15.1) System Organ Class|
Additional events reported during the 24 week treatment period in Studies 1 and 3 [ ≥ 2% of patients receiving Xolair (150 or 300 mg) and more frequently than those receiving placebo] included: toothache, fungal infection, urinary tract infection, myalgia, pain in extremity, musculoskeletal pain, peripheral edema, pyrexia, migraine, sinus headache, anxiety, oropharyngeal pain, asthma, urticaria, and alopecia.
Injection Site Reactions
Injection site reactions of any severity occurred during the studies in more Xolair-treated patients [11 patients (2.7%) at 300 mg, 1 patient (0.6%) at 150 mg] compared with 2 placebo-treated patients (0.8%). The types of injection site reactions included: swelling, erythema, pain, bruising, itching, bleeding and urticaria. None of the events resulted in study discontinuation or treatment interruption.
Antibodies to Xolair were detected in approximately 1/1723 ( < 0.1%) of patients treated with Xolair in the clinical studies for approval of asthma. There were no detectable antibodies in the patients treated in the phase 3 CIU clinical trials, but due to levels of Xolair at the time of anti-therapeutic antibody sampling and missing samples for some patients, antibodies to Xolair could only have been determined in 88% of the 733 patients treated in these clinical studies. The data reflect the percentage of patients whose test results were considered positive for antibodies to Xolair in ELISA assays and are highly dependent on the sensitivity and specificity of the assays. 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 with the incidence of antibodies to other products may be misleading.
The following adverse reactions have been identified during post-approval use of Xolair in adult and adolescent patients 12 years of age and older. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. 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 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 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 was reported in 24% of the cases.
Of the reported cases of anaphylaxis attributed to Xolair, 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 and 18 patients had a recurrence of similar symptoms of anaphylaxis. In addition, anaphylaxis occurred upon rechallenge with Xolair in 4 patients who previously experienced urticaria only.
Eosinophilic Conditions: Eosinophilic conditions have been reported [see WARNINGS AND PRECAUTIONS].
Fever, Arthralgia, and Rash: A constellation of signs and symptoms including arthritis/arthralgia, rash (urticaria or other forms), fever and lymphadenopathy similar to serum sickness have been reported in post-approval use of Xolair [see WARNINGS AND PRECAUTIONS].
Hematologic: Severe thrombocytopenia has been reported.
Skin: Hair loss has been reported.
Read the Xolair (omalizumab) Side Effects Center for a complete guide to possible side effects
No formal drug interaction studies have been performed with Xolair.
In patients with allergic asthma the concomitant use of Xolair and allergen immunotherapy has not been evaluated.
In patients with CIU the use of Xolair in combination with immunosuppressive therapies has not been studied.
Read the Xolair Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 4/10/2014
This monograph has been modified to include the generic and brand name in many instances.
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