Why XOLAIR (Omalizumab) for Allergic Asthma Treatment?

Adding XOLAIR Was Proven to Help Reduce Asthma Attacks in Patients Uncontrolled on ICS with Moderate to Severe Allergic Asthma

XOLAIR is an injectable prescription medicine used to treat appropriate patients 6 years of age and older with moderate to severe persistent allergic asthma. If you or a child you care for has allergic asthma, inhaled corticosteroids (ICS) may not be enough. XOLAIR may be able to help reduce your or your child's allergic asthma attacks.

In clinical studies, 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 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.
Important Safety Information

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 your injection. Your healthcare provider should talk to you about getting medical treatment if you have symptoms of an allergic reaction after leaving the healthcare provider’s office or treatment center.

XOLAIR Clinical Studies and Results

What are clinical studies?

To learn how XOLAIR might help patients with moderate to severe allergic asthma, medical teams did research—this is known as clinical studies. Experts wanted to know how much XOLAIR could reduce:

  1. allergic asthma symptoms and asthma attacks when patients continued to take their prescribed corticosteroid
  2. allergic asthma symptoms and asthma attacks when patients lowered or adjusted their prescribed dose of inhaled corticosteroid

Not all clinical studies are the same. All people are unique—even if they do share a common condition such as allergic asthma. However, many factors, such as the number of people who participate, types of people, the location of the participants, and other external or internal matters, can play a role in the results of a clinical study. This is why they are so important to do—and why so many are done.

In the XOLAIR clinical trials, in addition to inhaled corticosteroids, patients were given either XOLAIR (the XOLAIR group) or a placebo (the Control group).

What is a "Control Group"?

In this group, patients received inhaled corticosteroid treatment and a placebo. A placebo is a look-alike treatment with no active medicine that can affect an illness. Placebos can take many forms, such as a pill, an injection, or even a procedure. In the XOLAIR clinical studies, the placebo was an injection.

Important Safety Information (continued)

Do not receive 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 any other allergies (such as food allergy or seasonal allergies)
  • 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 XOLAIR.

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

Clinical Studies 1 & 2

XOLAIR was studied in two 28-week clinical studies (Studies 1 and 2) to see if it could help appropriate allergic asthma patients, ages 12 years and older, decrease their asthma attacks and symptoms. Open the tab below to see the results of the studies and how they were done. Individual results may vary.

Clinical Studies 1 & 2: Patients 12 Years of Age and Older

Important Safety Information (continued)
How should I receive XOLAIR?
  • XOLAIR should be given by your healthcare provider, in a healthcare setting.
  • XOLAIR is given in 1 or more injections under the skin (subcutaneous), 1 time every 2 or 4 weeks.
  • In asthma patients, a blood test for a substance called IgE must be performed prior to 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.

Clinical Study 3

XOLAIR was studied for 32 weeks to see if it could help appropriate allergic asthma patients, ages 12 years and older, with severe allergic asthma. A reduction in asthma attacks was not seen in this study. Open the tab below to see the results of the study and how it was done. Individual results may vary.

Clinical Study 3: Patients 12 Years and Older with Severe Allergic Asthma

Important Safety Information (continued)
What are the possible side effects of XOLAIR?
XOLAIR may cause serious side effects, including:
  • See, “What is the most important information I should know about XOLAIR” regarding the risk of anaphylaxis.
  • 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 who take XOLAIR 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 this is caused by XOLAIR.

Clinical Study 4

XOLAIR was studied for 52 weeks to see if adding it to inhaled corticosteroid treatment, and additional asthma controller medications, could help decrease attacks in children with moderate to severe allergic asthma. Open the tab below to see the results of the study and how it was done. Individual results may vary.

Clinical Study 4: Pediatric Study of Patients 6 to < 12 Years Old

Important Safety Information (continued)
The most common side effects of XOLAIR:
  • In adults and children 12 years of age and older with asthma: pain especially in your arms and legs, dizziness, feeling tired, skin rash, bone fractures, and pain or discomfort of your ears.
  • In children 6 to less than 12 years of age with asthma: common cold symptoms, headache, fever, sore throat, pain or discomfort of your ear, abdominal pain, nausea, vomiting and nose bleeds.

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