US Healthcare Professionals

For uncontrolled moderate to severe allergic asthma patients 6 years and older.

FAQ

Frequently asked questions

Find the answers you need about allergic asthma and XOLAIR.

XOLAIR and allergic asthma

Whether you have allergic asthma or another type of asthma, the symptoms are the same.

  • Wheezing and coughing
  • Chest tightness
  • Shortness of breath
  • Waking up during the night
  • Requiring rescue medication

Although symptoms are the same, what makes allergic asthma different is the allergic triggers that cause symptoms.

Read more about allergic asthma symptoms

If you or someone you love has asthma symptoms even with inhaled corticosteroids, visit either of the following asthma specialists:

  • An allergist specializes in diseases of the immune system (including allergic diseases such as allergic asthma)
  • A pulmonologist specializes in diseases of the lungs and breathing (including asthma)

Questions to ask your doctor

XOLAIR is an injectable prescription medicine used to treat moderate to severe persistent asthma in people 6 years of age and older whose asthma is not well controlled with asthma medicines called inhaled corticosteroids. A skin or blood test is performed if you have allergies to year-round allergens. It is not known if XOLAIR is safe and effective in people with asthma under 6 years of age.
XOLAIR is not used to treat sudden breathing problems.

Learn how XOLAIR can help

Read the Full Medication Guide for more information

XOLAIR® (omalizumab) 75mg and 150mg syringe

Not actual size

Your body weight and IgE (immunoglobulin E) levels will determine how much XOLAIR you need. You may need injections every 2 weeks, or every 4 weeks. Depending on your dose, you might need between 1 and 4 injections each time. If you gain or lose a lot of weight, your number of injections might change. Talk to your doctor to learn more.

Learn more about XOLAIR injections

XOLAIR was approved in 2003 for allergic asthma, and then in 2016 for patients age 6 and older.

Since 2003, XOLAIR has been prescribed to help reduce asthma attacks in people like you, aged 12 years and older. In fact, more than 305,000 patients 6 years of age and older have been treated with XOLAIR.*†

*Based on US data. This number refers to appropriate allergic asthma patients 6 years of age and older treated from June 2003 until 2022.
 †As of July 2016, XOLAIR has also been approved to treat appropriate allergic asthma patients age 6 to less than 12 years old. XOLAIR is the only approved biologic designed to target IgE and has been shown to reduce asthma attacks in moderate to severe allergic asthma patients.

Learn more about XOLAIR

When a person with allergic asthma breathes in an allergen such as pet dander, dust mites, or cockroach debris, the body responds by making a substance called IgE (immunoglobulin E). When the allergen is breathed in again, IgE attaches to the allergen and to the surface of the inflammatory cells. This releases substances that may cause inflammation (swelling and narrowing) in the airways. This inflammation can cause asthma symptoms that can lead to an attack.

To get a better understanding of which allergens may be causing your asthma attacks, talk to your doctor about an IgE test. 

How XOLAIR may work

Adding XOLAIR has been shown to:

  • Help reduce attacks and symptoms in appropriate allergic asthma patients 12 years of age and older*
  • Help reduce attacks in appropriate patients age 6 to less than 12 years old.* In a study of these patients, there was no difference in symptom reduction between patients taking XOLAIR and patients not taking XOLAIR

Your results may vary.

*View the full XOLAIR allergic asthma clinical study results to learn more.

View clinical trial results here

Do not decrease the dose of or stop taking any other asthma medications unless otherwise 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 adults and children 12 years of age and older with asthma: joint pain especially in your arms and legs, dizziness, feeling tired, itching, skin rash, bone fractures, and pain or discomfort of your ears
  • In children 6 to less than 12 years of age with asthma: swelling of the inside of your nose, throat, or sinuses, headache, fever, throat infection, ear infection, abdominal pain, stomach infection, and nose bleeds

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.

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.

Learn more about XOLAIR injections

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)

Learn more about XOLAIR injections

Injection self-administration site map.
Injection administration site map.

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

Injection self-administration site map.

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 how to inject XOLAIR

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).

Learn more about how to inject XOLAIR

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

Learn more about how to inject XOLAIR

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).

Learn more about XOLAIR injections

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

Learn more about how to inject XOLAIR

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.

Learn more about how to inject XOLAIR

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

Learn more about how to inject XOLAIR

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

Learn more about how to inject XOLAIR

Prefilled syringe disposal

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.

Learn more about how to inject XOLAIR

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 how to inject XOLAIR

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 the light during this time.

Learn more about how to inject XOLAIR

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 how to inject XOLAIR

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

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 moderate to severe persistent asthma in people 6 years of age and older whose asthma symptoms are not well controlled with asthma medicines called inhaled corticosteroids. A skin or blood test is performed to see if you have allergies to year-round allergens. It is not known if XOLAIR is safe and effective in people with asthma under 6 years of age.

XOLAIR is not used to treat sudden breathing problems.

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 (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 asthma, 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 other asthma medicine 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.
  • Inflammation of your blood vessels. Rarely, this can happen in people with asthma who receive XOLAIR. This usually, but not always, happens in people who also take a steroid medicine by mouth that is being stopped or the dose is being lowered. It is not known whether this is caused by XOLAIR. Tell your healthcare provider right away if you have rash; chest pain; shortness of breath; or a feeling of pins and needles or numbness of your arms or legs.
  • 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 adults and children 12 years of age and older with asthma: joint pain especially in your arms and legs, dizziness, feeling tired, itching, skin rash, bone fractures, and pain or discomfort of your ears.
  • In children 6 to less than 12 years of age with asthma: swelling of the inside of your nose, throat, or sinuses, headache, fever, throat infection, ear infection, abdominal pain, stomach infection, and nose bleeds.

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.