What is XOLAIR (omalizumab) Allergic Asthma Treatment?

XOLAIR for Allergic Asthma

  • XOLAIR is the only FDA-approved biologic drug to treat moderate to severe allergic asthma patients 6 years of age and older
  • XOLAIR significantly reduced asthma attacks.
  • XOLAIR is specifically designed to target IgE, an underlying cause of allergic asthma. XOLAIR captures the IgE in the body that may cause symptoms that can lead to an attack.
  • For appropriate patients, XOLAIR may provide flexibility on where it can be injected. It can be taken at your doctor's office or self-injected as determined by your doctor at home or outside of the healthcare setting.
  • XOLAIR is not inhaled, not a steroid, not something you take daily.
  • XOLAIR has been prescribed for over 17 years in allergic asthma patients 12 years of age and older.
  • XOLAIR has been prescribed for over 305,000* patients with allergic asthma.

    *Data on file (July 2020). Genentech USA, Inc. South San Francisco, CA.

    See XOLAIR allergic asthma treatment study results and learn how XOLAIR may help.  

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.

Additional XOLAIR Information

XOLAIR is a prescription medicine used to treat appropriate allergic asthma patients. XOLAIR is not a medicine you inhale, and it is not a corticosteroid. It is for injection, given under the skin every 2 or 4 weeks. If you or a child you care for has been diagnosed with allergic asthma, your asthma specialist may prescribe XOLAIR. To be prescribed XOLAIR, you must:

  • Have moderate to severe persistent allergic asthma
  • Be an adult or child who is 6 years of age or older
  • Have asthma symptoms that are not controlled—even though you are still taking inhaled corticosteroids. (Inhaled corticosteroids is a prescription medicine, breathed in through an inhaler, for people with asthma; it is intended for long-term, daily use to help prevent symptoms such as swelling in the lungs.)

If you think you may have allergic asthma, an asthma specialist can help with diagnosing and treatment options. Asthma specialists include either an allergist (specializes in diseases of the immune system, including allergic diseases and asthma) or a pulmonologist (specializes in diseases of the lungs and breathing, including asthma).

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 other allergic conditions or 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 (such as food allergy or 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 injections, you should receive training on the right way to prepare and inject XOLAIR.
  • Do not try to inject your XOLAIR prefilled syringe until you have been shown the right way to give XOLAIR injections by a healthcare provider. Use XOLAIR exactly as prescribed by your healthcare provider. For children 12 years of age and older, XOLAIR prefilled syringe may be self-injected under adult supervision. For children 6 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 asthma 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.