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Xolair
Omalizumab
$310.00
75mg · 1 vial
BrandBranded medicine· By Novartis
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75mg
150mg
FDA boxed warningAnaphylaxis
Anaphylaxis presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of XOLAIR. Anaphylaxis has occurred as early as after the first dose of XOLAIR, but also has occurred beyond 1 year after beginning regularly administered treatment. Because of the risk of anaphylaxis, initiate XOLAIR therapy in a healthcare setting and closely observe patients for an appropriate period of time after XOLAIR administration. Health care providers administering XOLAIR should be prepared to manage anaphylaxis which can be life-threatening. Inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care should symptoms occur. Selection of patients for self-administration of XOLAIR should be based on criteria to mitigate risk from anaphylaxis.
Anaphylaxis, presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of XOLAIR. Anaphylaxis has occurred after the first dose of XOLAIR but also has occurred beyond 1 year after beginning treatment. Initiate XOLAIR therapy in a healthcare setting, closely observe patients for an appropriate period of time after XOLAIR administration and be prepared to manage anaphylaxis which can be life-threatening. Inform patients of the signs and symptoms of anaphylaxis and have them seek immediate medical care should symptoms occur. Selection of patients for self-administration of XOLAIR should be based on criteria to mitigate risk from anaphylaxis.
About Xolair
Overview
Xolair (omalizumab) is a prescription antibody medicine given by injection under the skin. It treats moderate to severe persistent asthma in people aged 6 years and older with confirmed allergy to a year-round airborne allergen and symptoms inadequately controlled by inhaled corticosteroids; it is also an add-on maintenance treatment for adults with chronic rhinosinusitis with nasal polyps inadequately controlled by nasal corticosteroids, and treats chronic spontaneous urticaria in people aged 12 years and older who still have symptoms despite H1 antihistamines. For people aged 1 year and older with IgE-mediated food allergy, it helps reduce allergic reactions, including anaphylaxis, from accidental food exposure, but food allergens must still be avoided and it is not an emergency treatment. It works by selectively binding to immunoglobulin E (IgE), an antibody.
What it treats
- Moderate to severe persistent asthma in adults and children aged 6 years and older with a positive allergy test to a year-round airborne allergen and symptoms inadequately controlled by inhaled corticosteroids. - Chronic rhinosinusitis with nasal polyps in adults aged 18 years and older, as add-on maintenance treatment when nasal corticosteroids have not worked adequately. - IgE-mediated food allergy in adults and children aged 1 year and older, to reduce allergic reactions, including anaphylaxis, from accidental food exposure. Food allergens must still be avoided. - Chronic spontaneous urticaria (hives) in adults and adolescents aged 12 years and older who still have symptoms despite H1 antihistamine treatment. Not for acute asthma attacks, emergency treatment of allergic reactions including anaphylaxis, or other forms of urticaria.
Safety information
Side effects
Common side effects vary by the condition being treated: For asthma in adults and adolescents aged 12 years and older, these include joint pain, general pain, leg or arm pain, tiredness, dizziness, fractures, itching, skin inflammation and earache. In children aged 6 to under 12 years, these include cold symptoms, headache, fever, upper abdominal pain, strep throat, middle ear infection, viral stomach or bowel infection, insect bites and nosebleeds. For chronic rhinosinusitis with nasal polyps in adults, common side effects include headache, injection site reactions, joint pain, upper abdominal pain and dizziness. For IgE-mediated food allergy, common side effects include injection site reactions and fever. For chronic spontaneous urticaria, common side effects include nausea, cold symptoms, sinusitis, upper respiratory tract infections, joint pain, headache and cough. Serious allergic reactions, including life-threatening anaphylaxis, can occur. Seek emergency medical help for anaphylaxis. Treatment must begin in a healthcare setting equipped to manage it, with observation after administration. Xolair is not an emergency treatment for allergic reactions or sudden asthma symptoms. Contact your doctor promptly for a rash associated with inflamed blood vessels, worsening breathing symptoms, heart complications or nerve problems. These may occur with increased levels of a type of white blood cell called eosinophils, especially when oral corticosteroids are reduced. Do not abruptly stop corticosteroids when starting Xolair. Stop Xolair and contact your doctor if you develop fever, joint pain and rash suggestive of a serum sickness-like reaction. Cancers have also been observed in clinical studies.
FDA boxed warning
Anaphylaxis
Anaphylaxis presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of XOLAIR. Anaphylaxis has occurred as early as after the first dose of XOLAIR, but also has occurred beyond 1 year after beginning regularly administered treatment. Because of the risk of anaphylaxis, initiate XOLAIR therapy in a healthcare setting and closely observe patients for an appropriate period of time after XOLAIR administration. Health care providers administering XOLAIR should be prepared to manage anaphylaxis which can be life-threatening. Inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care should symptoms occur. Selection of patients for self-administration of XOLAIR should be based on criteria to mitigate risk from anaphylaxis.
Anaphylaxis, presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of XOLAIR. Anaphylaxis has occurred after the first dose of XOLAIR but also has occurred beyond 1 year after beginning treatment. Initiate XOLAIR therapy in a healthcare setting, closely observe patients for an appropriate period of time after XOLAIR administration and be prepared to manage anaphylaxis which can be life-threatening. Inform patients of the signs and symptoms of anaphylaxis and have them seek immediate medical care should symptoms occur. Selection of patients for self-administration of XOLAIR should be based on criteria to mitigate risk from anaphylaxis.
A boxed warning is the strongest warning the US Food and Drug Administration requires on a medicine label. Text is taken from the official label, with internal section references removed.
When to call your doctor
If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.
Before taking this medicine
Do not use Xolair (omalizumab) if you have had a severe allergic reaction to it or any of its ingredients. Xolair can cause anaphylaxis, a potentially life-threatening allergic reaction. Treatment must begin in a healthcare setting equipped to manage this reaction, with observation for an appropriate period after administration. Xolair must not be used to treat a sudden asthma attack, a prolonged severe asthma attack, or an emergency allergic reaction, including anaphylaxis. Do not abruptly stop corticosteroids when starting Xolair. Watch for increased eosinophils (a type of white blood cell), a rash linked to blood vessel inflammation, worsening breathing symptoms, heart complications or nerve problems, especially when oral corticosteroids are reduced. Stop Xolair if symptoms resembling serum sickness develop, such as fever, joint pain and rash. Cancers have been observed in clinical studies.
Interactions
No formal drug interaction studies have been performed with Xolair (omalizumab). Tell your doctor if you receive allergen immunotherapy for asthma, chronic rhinosinusitis with nasal polyps or IgE-mediated food allergy, as its use alongside Xolair has not been evaluated. If you have chronic spontaneous urticaria, tell your doctor if you use medicines that suppress the immune system. Their use in combination with Xolair has not been studied.
Using Xolair
Dosing
Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.
Storage
Store in the original carton to protect it from light. Check the pack for whether it must be refrigerated before first use. Keep all medicines out of the sight and reach of children.
Clinical information on this page is summarised from the US FDA label XOLAIR (OMALIZUMAB) INJECTION, SOLUTION XOLAIR PFS (OMALIZUMAB) INJECTION, SOLUTION XOLAIR (OMALIZUMAB) INJECTION, SOLUTION [GENENTECH, INC.] (DailyMed, retrieved 19 September 2026).
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