Xolair Side Effects

Generic Name: omalizumab

Please note - some side effects for Xolair may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Xolair - for the Consumer

Xolair

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Xolair:

Bruising, itching, pain, redness, stinging, swelling, or warmth at the injection site; headache; itching and swelling of the skin; leg, arm, or ear pain; sinus inflammation.

Seek medical attention right away if any of these SEVERE side effects occur when using Xolair:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, tongue or throat); anxiety; calf pain, swelling, or tenderness; chest pain; confusion; cough; dizziness; fainting; fast, weak, or irregular heartbeat; feeling unusually warm; flushing; hoarseness; new or worsening breathing problems or shortness of breath; numbness or tingling; one-sided weakness; speech problems; swelling of a vein; symptoms of sinus or lung infection (congestion, cough, or fever); trouble swallowing; unusual bruising or bleeding; unusual lumps, growths, or moles; unusual swelling of the hands or feet; vision problems; wheezing.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Xolair Side Effects - for the Professional

Xolair

Use of Xolair has been associated with:

• Anaphylaxis [see Boxed Warning and Warning and Precautions (5.1)]
• Malignancies [see Warnings and Precautions (5.2)]

Anaphylaxis was reported in 3 of 3507 (0.1%) patients in clinical trials. Anaphylaxis occurred with the first dose of Xolair 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-treated patients (0.5%) was numerically higher than among patients in control groups (0.2%).

Clinical Trials Experience

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. 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 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: Four placebo-controlled asthma studies

Adverse reaction	Xolair n = 738 (%)	Placebo n = 717 (%)
Body as a whole
Pain	7	5
Fatigue	3	2
Musculoskeletal system
Arthralgia	8	6
Fracture	2	1
Leg pain	4	2
Arm pain	2	1
Nervous system
Dizziness	3	2
Skin and appendages
Pruritus	2	1
Dermatitis	2	1
Special senses
Earache	2	1

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.

Immunogenicity

Antibodies to Xolair were detected in approximately 1/1723 (< 0.1%) of patients treated with Xolair. The data reflect the percentage of patients whose test results were considered positive for antibodies to Xolair 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 with the incidence of antibodies to other products may be misleading.

Postmarketing Experience

The following adverse reactions have been identified during postapproval 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 (5.5)].

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 postapproval use of Xolair [see Warnings and Precautions (5.6)]

Hematologic: Severe thrombocytopenia has been reported.

Skin: Hair loss has been reported.

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Side Effects by Body System - for Healthcare Professionals

Hypersensitivity

Anaphylaxis usually occurred within two hours of receiving a omalizumab subcutaneous injection. However, recent reports include patients who had delayed anaphylaxis with onset two to 24 hours or even longer after receiving omalizumab treatment. Anaphylaxis may occur after any dose of omalizumab including the first dose. Health care professionals who administer omalizumab should be prepared to manage life-threatening anaphylaxis and should observe their omalizumab-treated patients for at least two hours after omalizumab is given. Patients under treatment with omalizumab should be fully informed about the signs and symptoms of anaphylaxis, their chance of developing delayed anaphylaxis following omalizumab treatment, and how to treat it when it occurs.

Hypersensitivity reactions including anaphylaxis, presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of omalizumab. Anaphylaxis has occurred as early as after the first dose of omalizumab, but also has occurred beyond 1 year after beginning regularly administered treatment. Because of the risk of anaphylaxis, patients should be closely observed for an appropriate period of time after omalizumab administration, and health care providers administering omalizumab should be prepared to manage anaphylaxis that can be life-threatening. Patients should also be informed of the signs and symptoms of anaphylaxis and instructed to seek immediate medical care should symptoms occur.

Local

Local side effects have included injection site reactions in 45% of patients, including bruising, redness, warmth, burning, stinging, itching, hive formation, pain, indurations, mass, and inflammation. Severe injection site reactions occurred in 12% of patients (vs 9% with placebo). Most reactions occurred within 1 hour after injection, lasted for 8 days or less, and decreased in frequency with subsequent doses.

Cardiovascular

Cardiovascular side effects have been reported including a study showing a disproportionate increase in ischemic heart disease, arrhythmias, cardiomyopathy, cardiac failure, pulmonary hypertension, cerebrovascular disorders, and embolic, thrombotic, and thrombophlebitic events in patients treated with omalizumab compared to a control group of patients not given the drug.

Dermatologic

Dermatologic side effects have included pruritus (2%) and dermatitis (2%).

Respiratory

Respiratory side effects have included upper respiratory tract infection (20%), sinusitis (16%), and pharyngitis (11%).

Nervous system

Nervous system side effects have included headache (15%) and dizziness (3%).

Musculoskeletal

Musculoskeletal side effects have included arthralgia (8%), fracture (2%), leg pain (4%), and arm pain (2%).

Oncologic

Oncologic side effects have included malignancies in 0.5% of patients (n=4127) compared with 0.2% of control patients (n=2236). The types of malignancies in omalizumab-treated patients included breast, skin (nonmelanoma), prostate, melanoma, and parotid.

Other

Other side effects have included viral infections (23%), pain (7%), fatigue (3%), and earache (2%). Three cases of Churg-Strauss syndrome have also been reported.

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