US Healthcare Professionals

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

CLINICAL TRIAL RESULTS

You may experience a difference with XOLAIR

Since 2003, XOLAIR has been prescribed to help reduce asthma attacks in patients ages 12 and older.

More than 330,000 patients ages 6 and older have been treated with XOLAIR.*†

*Data on file (March 2023). Genentech USA, Inc. South San Francisco, CA.

†As of July 2016, XOLAIR has also been approved to treat appropriate allergic asthma children ages 6 to <12 years with allergic asthma. 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.

More than 330,000 patients ages 6 and older have been treated with XOLAIR.*†

*Data on file (March 2023). Genentech USA, Inc. South San Francisco, CA.

†As of July 2016, XOLAIR has also been approved to treat appropriate allergic asthma children ages 6 to <12 years with allergic asthma. 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.

In adults and teens ages 12 and older, XOLAIR significantly reduced asthma attacks and symptoms

In two clinical studies,

  • Up to 86% of people taking XOLAIR had no asthma attacks
  • Fewer patients taking XOLAIR had 1 or more asthma attacks than patients not on XOLAIR
  • Up to 86% of people taking XOLAIR had no asthma attacks
  • Fewer patients taking XOLAIR had 1 or more asthma attacks than patients not on XOLAIR

In two 28-week clinical studies‡ with 1,071 patients with moderate to severe persistent allergic asthma not controlled on inhaled corticosteroids.

 

Results for Study 1, first 16 weeks‡
During the first 16 weeks, of the people taking XOLAIR (n=268), 86% of people had no asthma attacks, 12% had 1 asthma attack, and 2% had 2 or more asthma attacks. In the control group (n=257), 77% of people had no asthma attacks, 17% had 1 asthma attack, and 7% had 2 or more asthma attacks.
Results for Study 1, next 12 weeks‡
During the next 12 weeks, of the people taking XOLAIR (n=268), 79% of people had no asthma attacks, 19% had 1 asthma attack, and 2% had 2 or more asthma attacks. In the control group (n=257), 68% of people had no asthma attacks, 28% had 1 asthma attack, and 4% had 2 or more asthma attacks.

Results of the second study were similar to those of Study 1 shown above. Individual results may vary.



‡In the 28-week studies, in the first 16 weeks, patients continued their prescribed dose of inhaled corticosteroids. For the following 12 weeks, patients’ inhaled corticosteroid use was slowly reduced.

§In the XOLAIR group, patients were given XOLAIR in addition to their regular inhaled corticosteroid treatment. In the Control group, patients were given a placebo in addition to their regular inhaled corticosteroid treatment. A placebo is a look-alike treatment with no active medicine that can affect an illness.
 

 

In one 32-week study with 341 severe allergic asthma patients, there was no difference in the number of asthma attacks between patients taking XOLAIR and patients who did not. Patients may have also received oral corticosteroids in addition to inhaled corticosteroids.

Results for Study 3, after 32 weeks:
Patients completed the corticosteroid reduction phase
Percentage of patients with asthma attacks
After 32 weeks the percentage of patients taking XOLAIR with asthma attacks were 22% (n=126) with inhaled corticosteroids only and 42% (n=50) with oral and inhaled corticosteroids. The percentage of patients in the control group with asthma attacks were 27% (n=120) with inhaled corticosteroids only and 42% (n=45) with oral and inhaled corticosteroids.

To ask questions or to obtain more information about these XOLAIR study results, please consult your doctor.

In children ages 6 to less than 12 years old,
XOLAIR significantly reduced asthma attacks

In a 52-week study in children with moderate to severe persistent allergic asthma not controlled on inhaled corticosteroids.

 

Results for Study 4
31% of children on XOLAIR had a relative decrease in the rate of asthma attacks.
43% of children on XOLAIR had a relative decrease in the rate of asthma attacks.

There was no difference in asthma symptom reduction between people taking XOLAIR and people not taking XOLAIR.

After 24 weeks the rate of asthma attacks for children in the control group (n=192) was 0.64 and the rate of asthma attacks in children taking XOLAIR (n=384) was 0.45. After 24 weeks, the relative decrease in the rate of asthma attacks for children taking XOLAIR was 31%. After 52 weeks the rate of asthma attacks for children in the control group (n=192) was 1.36 and the rate of asthma attacks in children taking XOLAIR (n=384) was 0.78. After 52 weeks, the relative decrease in the rate of asthma attacks for children taking XOLAIR was 43%.

Individual results may vary.

To ask questions or obtain more information about these XOLAIR study results, please consult your doctor.

‖In the XOLAIR group, patients were given XOLAIR. In the Control group, patients were given a placebo. During the first 24 weeks of the study, the children in both groups took their prescribed dose of inhaled corticosteroid treatment. Over the next 28 weeks, adjustment of their inhaled corticosteroid dose was allowed. Throughout this study, patients were allowed to take other controller medications. (n) represents the number of patients included in that study group.

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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.