US Healthcare Professionals

For people 1 year of age and older at risk of food allergic reactions after accidental exposure.

FAQ

Frequently asked questions about XOLAIR and food allergy

XOLAIR and food allergy

Food allergy is a condition in which eating certain foods leads to an abnormal immune response. Food allergies may be immunoglobulin E (IgE)-mediated or non–IgE-mediated. IgE-mediated reactions are associated with a rapid onset of allergic symptoms with the release of chemicals like histamine from mast cells.

  • Vomiting and/or stomach cramps
  • Hives
  • Shortness of breath
  • Wheezing
  • Repetitive cough
  • Tight, hoarse throat; trouble swallowing
  • Swelling of the tongue, affecting the ability to talk or breathe
  • Weak pulse
  • Pale or blue coloring of skin
  • Dizziness or feeling faint
  • Shock or circulatory collapse
  • Anaphylaxis, a severe, life-threatening allergic reaction

Many different foods can cause allergic reactions. Some of the most common foods that cause allergies include:

If you suspect you or your child have a food allergy, talk to your primary care doctor. They may recommend that you see an allergist. Allergists specialize in diagnosing and treating food allergies. 

XOLAIR is an injectable prescription medicine used to treat food allergy in people 1 year of age and older to reduce allergic reactions that may occur after accidentally eating one or more foods to which you are allergic. While taking XOLAIR, you should continue to avoid all foods to which you are allergic. It is not known if XOLAIR is safe and effective in people with food allergy under 1 year of age.

XOLAIR should not be used for the emergency treatment of any allergic reactions, including anaphylaxis.

Find out more about XOLAIR

Read the full Medication Guide for more information.

A food allergy is an abnormal immune response to food. It is often caused when your body makes too much of a type of antibody called IgE as a reaction to one or more foods. When you eat that food, IgE in your immune system drives food allergy reactions.

Your body weight and IgE levels will determine how much XOLAIR you need. You may need injections every 2 or 4 weeks. XOLAIR is given in 1-3 subcutaneous injections, depending on the dose your doctor has prescribed. If you have a significant weight change, your number of injections might change. 

Your healthcare provider will monitor you closely for symptoms of an allergic reaction while you are receiving XOLAIR and for a period of time after treatment is initiated. Your healthcare provider should talk to you about getting medical treatment if you have symptoms of an allergic reaction. You may not see improvement in your symptoms right after XOLAIR treatment. 

Do not decrease or stop taking any of your other medicines unless your healthcare provider tells you to. 

After you’ve established treatment in a doctor’s office or infusion center, your doctor will determine if you or a caregiver may inject XOLAIR. If your doctor decides that you or a caregiver may be able to give your own XOLAIR injections, you should receive training on the right way to prepare and inject XOLAIR. Do not try to inject your XOLAIR prefilled syringe or autoinjector until you have been shown the right way to give XOLAIR injections by your doctor. Talk to your doctor to learn more.

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XOLAIR is an injectable medication for people 1 year of age and older with food allergy that targets immunoglobulin E (IgE), an underlying cause of food allergy reactions. XOLAIR is proven to reduce allergic reactions to food. Patients who take XOLAIR must continue to avoid foods they are allergic to. XOLAIR should not be used for the emergency treatment of any allergic reactions, including anaphylaxis.

XOLAIR can be used to treat food allergies caused by IgE.

Learn more about XOLAIR

Do not decrease the dose of or stop taking any other medications unless instructed by your doctor. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Medication Guide

Severe allergic reaction. A severe allergic reaction called anaphylaxis can happen when you receive XOLAIR. The reaction can occur after the first dose, or after many doses. It may also occur right after a XOLAIR injection or days later. Anaphylaxis is a life-threatening condition and can lead to death. Go to the nearest emergency room right away if you have any of these symptoms of an allergic reaction:

  • Wheezing, shortness of breath, cough, chest tightness, or trouble breathing
  • Low blood pressure, dizziness, fainting, rapid or weak heartbeat, anxiety, or feeling of “impending doom”
  • Flushing, itching, hives, or feeling warm
  • Swelling of the throat or tongue, tightness of the throat, hoarse voice, or trouble swallowing

Your healthcare provider will monitor you closely for symptoms of an allergic reaction while you are receiving XOLAIR and for a period of time after treatment is initiated. Your healthcare provider should talk to you about getting medical treatment if you have symptoms of an allergic reaction. 

Do not receive XOLAIR if you are allergic to omalizumab or any of the ingredients in XOLAIR. 

Click below for more Important Safety Information regarding XOLAIR.

Important Safety Information

In people with food allergy, the most common side effects are injection site reactions and fever.

These are not all the possible side effects of XOLAIR. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555 or Novartis Pharmaceuticals Corporation at (888) 669-6682.

Please see full Prescribing Information, including Medication Guide, for additional Important Safety Information.

Read more Important Safety Information regarding XOLAIR.

Learn about XOLAIR side effects

Administering XOLAIR injections in the doctor’s office

When starting treatment, XOLAIR should be given by your healthcare provider in a healthcare setting. If your healthcare provider decides that you or a caregiver may be able to give your own XOLAIR prefilled syringe or autoinjector injections, you should receive training on the right way to prepare and inject XOLAIR. Do not try to inject XOLAIR until you have been shown the right way to give XOLAIR prefilled syringe or autoinjector injections by a healthcare provider.

Learn more about XOLAIR injections

Self-injecting XOLAIR at home

Your doctor will determine if you or a caregiver may inject XOLAIR.

A subcutaneous injection means an injection that is given under the skin, into a person’s fatty tissue. In the doctor’s office, your doctor or nurse will inject XOLAIR into your upper arm, front of thigh, or abdomen.. After you’ve established your XOLAIR treatment in a doctor’s office or infusion center, your doctor may determine that self-injection is right for you. Your doctor may ask you about your confidence with self-injection and about your at-home support team, if you require injection assistance.

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If you are giving the injection to your child (or another adult), you can use:

  • Front of thighs
  • Middle of thighs
  • Stomach area (abdomen). Do not inject within the 2-inch area directly around your belly button (navel)
  • Outer area of the upper arms (Do not use this area if you are giving the injection to yourself)

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If you are giving yourself the injection, you can inject into any of these sites:

  • Front of thighs
  • Middle of thighs
  • Stomach area (abdomen). Do not inject within the 2-inch area around your belly button (navel)

Learn more about XOLAIR injections

Call your doctor’s office and ask for another training session. You can also call 1-866-4XOLAIR (1-866-496-5247) if you have any questions, or click the button below.

Learn more about XOLAIR injections

Do not use XOLAIR if the packaging is damaged. It might not be safe to use. Call your doctor’s office for guidance. For additional information, you can also call 1-866-4XOLAIR (1-866-496-5247).

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Safely throw away the prefilled syringe or autoinjector in a sharps disposal container and contact your healthcare provider.

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DO NOT USE the prefilled syringe or autoinjector if the medicine is cloudy, discolored/brown, or contains particles. The medicine should be clear and colorless to pale brownish-yellow. You may see an air bubble, which is normal. If the medicine does not look as described or if the expiration date has passed, safely throw away the prefilled syringe or autoinjector in a sharps disposal container and contact your healthcare provider. For more information, call 1-866-4XOLAIR (1-866-496-5247).

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If the prefilled syringe or autoinjector does not reach room temperature, this could cause the injection to feel uncomfortable.

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On the 75 mg and 150 mg prefilled syringes, activating the syringe needle-shield too early could cause that dose of XOLAIR to no longer work. The needle-shield will totally cover the needle. It is there to prevent accidental needle sticks after use. Once the needle-shield is activated, even if the dose has not been administered, the prefilled syringe should be properly disposed of in a sharps container. If this happens, talk to your healthcare provider.

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Call your doctor to discuss when you should inject the next dose.

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Dispose of used prefilled syringes or autoinjectors immediately in a sharps disposal container.

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Store XOLAIR in your refrigerator between 36 °F and 46 °F. DO NOT FREEZE. (Do not use if the prefilled syringe or autoinjector has been frozen.) Store it in the original packaging to protect it from light.

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Temperature change may affect the medicine. The prefilled syringe or autoinjector should not be stored out of the refrigerator for more than 48 hours and should not be exposed to temperatures above 77 °F. If either of these situations happen, do not use the prefilled syringe or autoinjector, and call your doctor’s office.

Learn more about XOLAIR injections

Allow time for the prefilled syringe or autoinjector to warm up to room temperature:

  • For the 75 mg and 150 mg prefilled syringes, allow 15 to 30 minutes
  • For the 300 mg prefilled syringe, allow 30 to 45 minutes
  • For the autoinjector, allow 30 to 45 minutes

Leave the syringe or autoinjector in the box to protect it from light during this time.

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If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:

  • Made of a heavy-duty plastic
  • Can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out
  • Upright and stable during use
  • Leak-resistant, and
  • Properly labeled: Hazardous waste inside the container

Learn more about XOLAIR injections

No, XOLAIR should never be put in the freezer. It should stay in the refrigerator until ready for use.

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No, in addition to self-injection, you can have XOLAIR administered by your healthcare provider in a healthcare setting.

Learn more about XOLAIR injections

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IMPORTANT SAFETY INFORMATION & INDICATION

What is XOLAIR?

XOLAIR® (omalizumab) for subcutaneous use is an injectable prescription medicine used to treat food allergy in people 1 year of age and older to reduce allergic reactions that may occur after accidentally eating one or more foods to which you are allergic. While taking XOLAIR you should continue to avoid all foods to which you are allergic. It is not known if XOLAIR is safe and effective in people with food allergy under 1 year of age.

XOLAIR should not be used for the emergency treatment of any allergic reactions, including anaphylaxis.

What is the most important information I should know about XOLAIR?

Severe allergic reaction. A severe allergic reaction called anaphylaxis can happen when you receive XOLAIR. The reaction can occur after the first dose, or after many doses. It may also occur right after a XOLAIR injection or days later. Anaphylaxis is a life-threatening condition and can lead to death. Go to the nearest emergency room right away if you have any of these symptoms of an allergic reaction:

  • wheezing, shortness of breath, cough, chest tightness, or trouble breathing
  • low blood pressure, dizziness, fainting, rapid or weak heartbeat, anxiety, or feeling of “impending doom”
  • flushing, itching, hives, or feeling warm
  • swelling of the throat or tongue, throat tightness, hoarse voice, or trouble swallowing

Your healthcare provider will monitor you closely for symptoms of an allergic reaction while you are receiving XOLAIR and for a period of time after treatment is initiated. Your healthcare provider should talk to you about getting medical treatment if you have symptoms of an allergic reaction.

Do not receive and use XOLAIR if you are allergic to omalizumab or any of the ingredients in XOLAIR.

Before receiving XOLAIR, tell your healthcare provider about all of your medical conditions, including if you:

  • have a latex allergy or any other allergies (such as seasonal allergies). The needle cap on the XOLAIR prefilled syringe contains a type of natural rubber latex.
  • have sudden breathing problems (bronchospasm)
  • have ever had a severe allergic reaction called anaphylaxis
  • have or have had a parasitic infection
  • have or have had cancer
  • are pregnant or plan to become pregnant. It is not known if XOLAIR may harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if XOLAIR passes into your breast milk. Talk with your healthcare provider about the best way to feed your baby while you receive and use XOLAIR.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I receive and use XOLAIR?

  • When starting treatment, XOLAIR should be given by your healthcare provider in a healthcare setting.
  • If your healthcare provider decides that you or a caregiver may be able to give your own XOLAIR prefilled syringe or autoinjector injections, you should receive training on the right way to prepare and inject XOLAIR.
  • Do not try to inject XOLAIR until you have been shown the right way to give XOLAIR prefilled syringe or autoinjector injections by a healthcare provider. Use XOLAIR exactly as prescribed by your healthcare provider.
  • The XOLAIR autoinjector (all doses) is intended for use only in adults and adolescents aged 12 years and older. For children 12 years of age and older, XOLAIR prefilled syringe or autoinjector may be self-injected under adult supervision. For children 1 to 11 years of age, XOLAIR prefilled syringe should be injected by a caregiver.
  • See the detailed Instructions for Use that comes with XOLAIR for information on the right way to prepare and inject XOLAIR.
  • XOLAIR is given in 1 or more injections under the skin (subcutaneous), 1 time every 2 or 4 weeks.
  • In people with food allergy, a blood test for a substance called IgE must be performed before starting XOLAIR to determine the appropriate dose and dosing frequency.
  • Do not decrease or stop taking any of your food allergy medicine or allergen immunotherapy, unless your healthcare providers tell you to.
  • You may not see improvement in your symptoms right away after XOLAIR treatment. If your symptoms do not improve or get worse, call your healthcare provider.
  • If you inject more XOLAIR than prescribed, call your healthcare provider right away.

What are the possible side effects of XOLAIR?

XOLAIR may cause serious side effects, including:

  • Cancer. Cases of cancer were observed in some people who received XOLAIR.
  • Fever, muscle aches, and rash. Some people get these symptoms 1 to 5 days after receiving a XOLAIR injection. If you have any of these symptoms, tell your healthcare provider.
  • Parasitic infection. Some people who are at a high risk for parasite (worm) infections, get a parasite infection after receiving XOLAIR. Your healthcare provider can test your stool to check if you have a parasite infection.
  • Heart and circulation problems. Some people who receive XOLAIR have had chest pain, heart attack, blood clots in the lungs or legs, or temporary symptoms of weakness on one side of the body, slurred speech, or altered vision. It is not known whether these are caused by XOLAIR.

The most common side effects of XOLAIR in people with food allergy: injection site reactions and fever.

These are not all the possible side effects of XOLAIR. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555 or Novartis Pharmaceuticals Corporation at (888) 669-6682.

Please see full Prescribing Information, including Medication Guide, for additional Important Safety Information and Instructions for Use.