US Healthcare Professionals

For people 12 years of age and older with chronic spontaneous urticaria (CSU) not controlled by H1 antihistamines.

CLINICAL TRIAL RESULTS

XOLAIR has been shown to help relieve the symptoms of chronic hives

XOLAIR can reduce itch severity*—and the number of hives†

In two clinical studies‡, XOLAIR was shown to help reduce the severity of itch* and the number of hives† in patients who continued to have symptoms that were not controlled by H1 antihistamine treatment. Individual results may vary.

Results of a CSU study in adults and adolescents§

XOLAIR was studied for 24 weeks to measure the severity of itch* and number of hives† (on a weekly basis) of patients with chronic hives who continued to have hives while on antihistamine therapy. Individual results may vary.

How the study was done‖

  • A total of 319 people with chronic hives who were already taking an antihistamine participated in the study
  • 81 were given 300 mg of XOLAIR
  • 80 were given 150 mg of XOLAIR
  • 80 were given a placebo
Graphic outlining results of the first clinical study of Xolair® (omalizumab) including results for itch severity, hive count, and complete response for a dose of 300 mg, 150 mg, and placebo. For a dose of 300 mg, 1 in 3 patients (36%) were completely itch and hive free. For a dose of 150 mg more than 1 in 6 patients (15%) were completely itch and hive free. For the placebo 1 in 10 (10%) were completely itch and hive free.

*To measure itch severity, patients were asked to write down how itchy they felt every morning and night on a scale of 0-3. The average daily score was then added together over 7 days for the weekly itch severity score.

†To measure the hive score, patients were asked to count the number of hives on their bodies twice daily. (0= no hives, 1= 1 to 6 hives, 2= 7 to 12 hives, 3= more than 12 hives.) The average daily score was ten added together over 7 days for the weekly hive count score.

‡Based on results from CSU Studies 1 and 2.

§Based on results from CSU Study 1, a 24-week clinical study.

‖77 patients were given 75 mg of XOLAIR. The 75 mg dose did not demonstrate consistent evidence of efficacy and is not approved for use.

A placebo does not contain any active medicine.

Image of woman’s neck with red hives typical of a chronic spontaneous urticaria (CSU) flare before treatment with Xolair® (omalizumab)

Before XOLAIR

Typical chronic hives symptoms before treatment with XOLAIR

Image of woman’s neck showing possible level of hive reduction (far fewer red hives than prior image) after treatment with Xolair® (omalizumab)

After XOLAIR

Shows how a 67% reduction of the weekly hive count score† can look after 12 weeks on XOLAIR (300 mg)

Possible level of hive reduction

After 12 weeks on XOLAIR*

  • At 300 mg, patients' weekly hive count score† was reduced by over 67%
  • At 150 mg, patients' weekly hive count score† was reduced by 50%

Images are for illustrative purposes only. Individual results may vary.

Image of woman’s arm with red hives typical of a chronic spontaneous urticaria (CSU) flare before treatment with Xolair® (omalizumab)

Before XOLAIR

Typical chronic hives symptoms before treatment with XOLAIR

Image of woman’s arm showing possible level of hive reduction (far fewer red hives than prior image) after treatment with Xolair® (omalizumab)

After XOLAIR

Possible complete response after 12 weeks on XOLAIR (300 mg)

Itch and hives resolved completely in more than 1 in 3 patients on 300 mg

After 12 weeks on XOLAIR*

  • At 300 mg, more than 36% of patients were completely itch‡ and hive†-free
  • At 150 mg, almost 15% of patients were completely itch‡ and hive†-free

Images are for illustrative purposes only. Individual results may vary.

 

These examples of improvement are based on results from Chronic Hives Study 1, a 24-week study.

Results of the second study

XOLAIR was studied for 12 weeks to measure the severity of itch* and number of hives† (on a weekly basis) of CSU patients who continued to have hives while on antihistamine therapy.

How the study was done#

  • A total of 322 patients already taking an antihistamine participated in the study
  • 79 were given 300 mg of XOLAIR
  • 82 were given 150 mg of XOLAIR
  • 79 were given a placebo
Graphic outlining results of the second clinical study of Xolair® (omalizumab) including results for itch severity, hive count, and complete response for a dose of 300 mg, 150 mg, and placebo. For a dose of 300 mg more than 4 in 10 patients (44%) were completely itch and hive free. For a dose of 150 mg more than 1 in 5 patients (22%) were completely itch and hive free. For the placebo 1 in 20 (5%) were completely itch and hive free.

#82 patients were given 75 mg of XOLAIR. The 75 mg dose did not demonstrate consistent evidence of efficacy and is not approved for use.

XOLAIR clinical studies

What are clinical studies?

To learn how XOLAIR might help patients with chronic hives, medical teams conducted research—this is known as clinical studies. Experts wanted to know how much XOLAIR could reduce 1) the severity of itch and 2) the number of hives.
 

Not all clinical studies are the same. 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 outcome of a clinical study. This is why they are so important to do—and why more than one study may be done. Also remember that all people are unique—even if they do share a common condition such as chronic hives.
 

Two studies were conducted looking at the effect of XOLAIR in patients with chronic hives. In the studies, all the patients remained on an H1 antihistamine. Patients were then split into 3 different groups. Two groups (the XOLAIR groups) received different doses of XOLAIR, and the third (the Control group) received a placebo.
 

What are control groups?

In this group, patients received H1 antihistamine 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 this case, it was an injection.

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Image of a Xolair® (omalizumab) single-dose prefilled injection syringe and its box label

The XOLAIR prefilled syringe and autoinjector is

AVAILABLE FOR
SELF-INJECTION

Ask your doctor if self-injection is right for you.

Learn more

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From diagnosis to treatment, your journey with chronic hives is unique.

The Support For You program is designed with YOU in mind.

Take advantage of free support resources that can help you at every step—from talking to a specialist to getting started to potentially saving on XOLAIR.

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IMPORTANT SAFETY INFORMATION & INDICATION

What is XOLAIR?

XOLAIR® (omalizumab) for subcutaneous use is an injectable prescription medicine used to treat chronic spontaneous urticaria (CSU, previously referred to as chronic idiopathic urticaria (CIU), chronic hives without a known cause) in people 12 years of age and older who continue to have hives that are not controlled with H1 antihistamine treatment. It is not known if XOLAIR is safe and effective in people with CSU under 12 years of age.

XOLAIR is not used to treat other forms of hives.

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 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.
  • 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.
  • 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 4 weeks.
  • In people with chronic hives, a blood test is not necessary to determine the dose or dosing frequency.
  • Do not decrease or stop taking any of your other hive medicine unless your healthcare providers tell you to.
  • You may not see improvement in your symptoms right away after XOLAIR treatment.
  • 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 chronic spontaneous urticaria: nausea, headaches, swelling of the inside of your nose, throat or sinuses, cough, joint pain, and upper respiratory tract infection.

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.