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Xolair

Generic name: omalizumabOH-ma-LIZ-oo-mab ]
Dosage forms: prefilled syringe 75 mg/0.5 mL, prefilled syringe 150 mg/mL, vial 150 mg for reconstitution
Drug class: Selective immunosuppressants

Medically reviewed by Melisa Puckey, BPharm. Last updated on Feb 19, 2024.

What is Xolair?

Xolair (omalizumab) injection is a medication used to treat types of allergic asthma, nasal polyps and chronic hives (chronic spontaneous urticaria). It may also be used to reduce the risk of allergic reactions (including anaphylaxis) in adults and children aged 1 year and older with Ig-E-mediated food allergies. Xolair works by reducing the release of inflammatory substances that cause allergy symptoms, thereby decreasing allergic responses in the body.

Xolair is a monoclonal antibody that is usually given every 2 or 4 weeks to maintain its therapeutic effects.

How does Xolair work?

If you have allergies, your overactive immune system produces antibodies called Immunoglobulin E (IgE) which bind to receptors on cells, triggering the release of chemicals like histamine that cause allergy symptoms. Xolair works by blocking the binding of IgE to receptors on cells, which in turn stops the release of the chemicals responsible for allergy symptoms. Xolair also reduces the number of IgE receptors on cells, resulting in further improvement of allergy symptoms.

What is Xolair used for?

Xolair is FDA-approved to treat:

Warnings

Some people using this injection have had a severe, life-threatening allergic reaction either right after the injection or hours later. Allergic reactions may occur even after using this injection regularly for a year or longer.

Get emergency medical help if you have any signs of an allergic reaction to Xolair: hives, rash; anxiety or fear; flushing (warmth, redness, or tingly feeling); feeling like you might pass out; chest tightness, wheezing, feeling short of breath, difficult breathing; fast or weak heartbeats; swelling of your face, lips, tongue, or throat.

Asthma is often treated with a combination of different drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice.

If you also use an oral steroid medication, do not stop using the steroid suddenly or you may have unpleasant withdrawal symptoms. Talk with your doctor if any of your asthma medications do not seem to work as well in treating or preventing attacks. Your symptoms may not improve right away once you start receiving Xolair. For best results, keep receiving the injection as directed. Talk with your doctor if your symptoms do not improve after a few weeks of treatment.

Xolair should not be used for the emergency treatment of allergic reactions, including anaphylaxis. It is only used in food allergy to reduce the risk of allergic reactions.

Use Xolair regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Before taking this medicine

You should not use this medicine if you are allergic to omalizumab, or any of the inactive ingredients.  Click here for a full list of ingredients: Xolair ingredients.

To make sure Xolair is safe for you, tell your doctor if you have:

Using this injection may increase your risk of certain types of cancers of the breast, skin, prostate, or salivary gland. Talk to your doctor about your individual risk.

While you are using this medicine, you may also have an increased risk of becoming infected with parasites (worms) if you live in or travel to areas where such infections are common. Talk with your doctor about what to look for and how to treat this condition.

Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant during treatment.   If you become pregnant while using this injection, call your doctor.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of Xolair on the baby.

Breastfeeding 

It is not known whether Xolair could harm a nursing baby. Tell your doctor if you are breastfeeding or planning to breastfeed a baby.

How should I use Xolair?

Before you start treatment with this medicine, your doctor may perform an allergy skin test or blood test to make sure this medicine is right for you.

Xolair is given as an injection under the skin (subcutaneous injection). When you first start your treatment, the injection will be given to you by your healthcare provider. 

You will be watched closely for a short time after receiving the injection to make sure you do not have an allergic reaction to the medication.

Your healthcare provider may decide that the injections can be administered by you or a caregiver, and you will receive training on the right way to prepare and inject this medicine. Do not try to inject Xolair until you have been shown the right way to use the prefilled syringe injections.

For children 12 years of age and older, the prefilled syringe may be self-injected under adult supervision. For children 6 to 11 years of age, the prefilled syringe should be injected by a caregiver.

Xolair is usually given every 2 or 4 weeks, depending on what condition you are treating.

Your condition may be treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice.

If you also use a steroid medicine, do not stop using it suddenly, or you may have unpleasant withdrawal symptoms. Talk with your doctor if any of your asthma medications do not seem to work as well in treating or preventing attacks.

While using this medicine, you may need frequent medical tests, such as allergy tests and lung function tests. Your stools may also need to be checked for parasites, especially if you travel.

Your condition may not improve right away. For best results, keep receiving the medication as directed. Talk with your doctor if your symptoms do not improve after a few weeks of treatment.

Xolair Prefilled Syringe instructions:

For more instructions, including diagrams for all Xolair device types and how to inject, click on this link: Xolair Instructions For Use.

Dosing information

Usual Adult and Pediatric Dose for Asthma:

Dose: Xolair 75 mg to 375 mg by subcutaneous injection every 2 or 4 weeks. Dose and frequency of injection is based on weight and pre-treatment IgE levels. Click on the link below "Detailed Xolair dosage information" for dose details.

Comments: 

Use: Management of moderate to severe persistent asthma in patients  (12 Years and Older) who are inadequately controlled with inhaled corticosteroids and with a positive skin test or in vitro reactivity to a perennial aeroallergen.

Usual Adult Dose for Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

Dose: 75 mg to 600 mg by subcutaneous injection every 2 or 4 weeks. The dose and frequency of injection are based on weight and pre-treatment IgE levels. Click on the link below "Detailed Xolair dosage information" for dose details.

Comments:

Use: As an add-on maintenance treatment for Chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18 years of age and older with inadequate response to nasal corticosteroids.

Usual Adult Dose for Chronic Spontaneous Urticaria (CSU):

Dose: 150mg or 300 mg subcutaneously every 4 weeks.

Comments:

Use: Chronic idiopathic urticaria in patients remaining symptomatic after H1 antihistamine treatment.

Usual Dose for IgE-Mediated Food Allergy:

Dose: 75 mg to 600 mg subcutaneously every 2 or 4 weeks.

Xolair is available as:

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Xolair side effects

Some people using Xolair have had a severe, life-threatening allergic reaction 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 signs of an allergic reaction to Xolair:

Call your doctor at once if you have:

Common Xolair side effects may include:

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 other drugs will affect Xolair?

Other drugs may interact with this medicine including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your healthcare providers about all medicines you use now and any medicine you start or stop using.
It is important to tell your doctor or healthcare provider if you have any of the following: allergy shots (a series of injections given regularly to prevent the body from developing allergic reactions to specific substances) and medications that suppress your immune system. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

This list is not complete. Many other drugs may interact with Xolair, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Storage

Ingredients 

Active ingredient: omalizumab

Inactive ingredients:

Xolair Prefilled syringe: L-arginine hydrochloride, L-histidine, L-histidine hydrochloride monohydrate, and polysorbate 20.

Xolair Vial: L-histidine, L-histidine hydrochloride monohydrate, polysorbate 20 and sucrose.

Manufacturer

Manufactured by:

Jointly marketed by:

Popular FAQ

Monoclonal antibodies (mAbs) are man-made proteins that mimic the natural antibodies produced by our immune systems. Monoclonal antibodies can be formulated into medicines to treat various types of illnesses, such as cancer, rheumatoid arthritis or psoriasis. Continue reading

Hair loss (alopecia), has been reported in Xolair clinical studies in at least 2% of people with chronic hives. Hair loss has also been noted in several case reports with Xolair. The hair loss effect appears to be transient, lasting from 3 to 4 months. Due to limited data, the exact cause of hair loss or how often it occurs is not known. Continue reading

Xolair is associated with a slightly higher risk of cancer, but cancer specialists have determined that this does not mean that Xolair causes cancer. Research has shown that cancer occurred in 20 out of 4127 trial participants (0.5% of Xolair-treated study volunteers) and 5 out of 2236 (0.2%) of people who were assigned an inactive treatment. Continue reading

If you are being treated with Xolair, you can be vaccinated with the COVID-19 vaccination at any time, but the ACAAI (American College of Allergy, Asthma, and Immunology) recommends that the COVID-19 vaccine and Xolair not be given on the same day since, if a reaction or a side effect occurs, it may be challenging to work out which injection was to blame. The ACAAI suggests separating the COVID-19 vaccination and Xolair by at least 24 hours. Others suggest 48 hours. There is no reason to stop Xolair until the patient completes the course of the COVID-19 vaccinations. Continue reading

The Xolair (generic name: omalizumab) prefilled syringe can be removed and put back in the refrigerator for a total combined time not to exceed 2 days. When in the refrigerator it should be stored at 2°C to 8°C (36°F to 46°F) in the original carton. Continue reading

Yes, Xolair can be used for food allergies. Xolair injection was approved on February 16, 2024 to reduce the risk of allergic reactions (including anaphylaxis) in adults and children aged 1 year and older with one or more Ig-E-mediated food allergies. It is not currently approved to treat other types of allergy, such as to medications, bee stings, or pollen. Continue reading

No, Xolair is not a steroid, but it does prevent inflammation. Xolair works by preventing IgE from binding to IgE receptors on mast cells and basophils, preventing the release of chemicals such as histamine, and reducing the number of IgE receptors on basophils. Histamine can cause inflammation and symptoms such as difficulty breathing (wheezing), a runny nose, watery eyes, tissue swelling, itchy skin, and hives. Xolair belongs to the class of medicines known as monoclonal antibodies. It may also be called a selective immunosuppressant. Continue reading

It is unknown if Xolair can safely be taken during pregnancy and the manufacturer of Xolair makes no recommendations regarding taking Xolair during pregnancy. Before prescribing Xolair during pregnancy, a doctor must weigh up the risks to the fetus, the risks to the mother of uncontrolled asthma, and the benefits of taking Xolair. Continue reading

More FAQ

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Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use atorvastatin only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.