Xolair
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"Unusual symptoms of asthma
Patients suffering from episodes of asthma do not always have the typical symptoms of asthma such as shortness of breath, chest tightness, and wheezing (symptoms of airway narrowing). Instead, patients c"...
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Xolair
Xolair Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Xolair (omalizumab) is used to treat moderate to severe asthma that is caused by allergies in adults and children who are at least 12 years old. It is usually given after other asthma medications have been tried without successful treatment of symptoms. Xolair is an antibody that helps decrease allergic responses in the body. Common side effects include injection site itching, redness, stinging, or pain. Leg, arm or ear pain may also occur.
Xolair in a dose of 150 to 375 mg is administered by injection every 2 or 4 weeks. Before using Xolair, tell your doctor if you are receiving allergy shots. There may be other drugs that can interact with Xolair. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Xolair should be used only when prescribed during pregnancy. It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.
Our Xolair (omalizumab) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Xolair in Detail - Patient Information: Side Effects
Some people using omalizumab have had a severe, life-threatening allergic reaction to this medication, either right after the injection or hours later. Allergic reaction may occur even after using the medication regularly for a year or longer.
Get emergency medical help if you have any of these signs of an allergic reaction:
- wheezing, tightness in your chest, trouble breathing;
- hives or skin rash;
- feeling anxious or light-headed, fainting;
- warmth or tingling under your skin; or
- swelling of your face, lips, tongue, or throat.
Other serious side effects include easy bruising or bleeding, numbness, or unusual weakness.
Less serious side effects may include:
- pain;
- headache, tired feeling;
- joint or muscle pain;
- dizziness;
- ear pain;
- hair loss;
- mild itching or skin rash;
- sore throat or cold symptoms; or
- redness, bruising, warmth, burning, stinging, itching, pain, or swelling of your skin where the injection was given.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Xolair (Omalizumab) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Xolair Overview - Patient Information: Side Effects
Injection site itching, redness, stinging, or pain may occur. Leg, arm or ear pain may also occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: unusual lumps/growths/moles.
An allergic reaction to this drug is unlikely, but get medical help right away if it occurs. Symptoms of an allergic reaction include: rash, hives, itching/swelling (especially of the face/tongue/throat), dizziness, chest tightness, cough, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Xolair (Omalizumab)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Xolair FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS
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.
Table 4
Adverse Events ≥ 1% More Frequent in Xolair (omalizumab) -Treated Patients
| Adverse event | Xolair (omalizumab) 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 |
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.
Immunogenicity
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 entire FDA prescribing information for Xolair (Omalizumab) »
Additional Xolair Information
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