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XOLAIR May Help

Prescription XOLAIR has been shown to significantly reduce how much hives itch* as well as number of hives for chronic idiopathic urticaria (CIU) patients uncontrolled on H1 antihistamine treatment. Specialists, such as allergists and dermatologists, can diagnose and treat CIU. Be sure to talk with your doctor to ask about how XOLAIR may help.

What is XOLAIR?

  • XOLAIR is an injectable medicine for adults and children 12 years of age and older with chronic idiopathic urticaria (CIU; chronic hives without a known cause) who continue to have hives that are not controlled by H1 antihistamine treatment.
  • XOLAIR is not used to treat other forms of urticaria.

  • XOLAIR is the first monoclonal antibody approved to treat CIU. Monoclonal antibodies are made to be similar to natural antibodies found in the human body.

  • XOLAIR is a "biologic." Biologics are microorganisms that are made to be similar to natural antibodies found in the human body. Talk to your doctor to learn more.
  • Clinical results from XOLAIR CIU Study 1 and XOLAIR CIU Study 2 are summarized below.

Real patients speak up about CIU and XOLAIR

XOLAIR has helped many patients. Hear their stories.

 

 

 

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CIU Clinical Studies Results

In two clinical studies called CIU Study 1 and CIU Study 2, XOLAIR helped reduce the severity of itch* and number of hives in study participants who continued to have symptoms that were not controlled by antihistamines. Your results may vary.

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In CIU Study 1, a 24-week clinical study, severity of itch* and number of hives were measured weekly in people with CIU who continued to have hives while on antihistamine therapy.

A total of 319 people already taking an antihistamine participated in the study. These included people given different doses of XOLAIR or a "placebo."

A placebo is anything that seems to be a "real" medicine or medical treatment - but isn't. It can take many forms, such as a pill, injection, or even a procedure. Placebos do not contain any active substance that can affect an illness. The main reason for a placebo group is to understand how much the study results are caused by the treatment versus other possible factors.

The study results for the approved doses and placebo group are shown below. Your results may vary.

Week 12 study results of 81 people given 300 mg of XOLAIR, 80 people given 150 mg of XOLAIR, and 80 people given a placebo.

Talk to your doctor about whether XOLAIR may be right for you. Your doctor will decide what dose is appropriate for you.

*To measure itch severity, study participants 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 seven days for the weekly itch severity score.

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

‡ Based on results from CIU Study 1, a 24-week clinical study.

Based on results of CIU Study 1, XOLAIR has been shown to significantly reduce itch and hives in people whose CIU isn't controlled by antihistamines. Your results may vary.

Possible Level of Reduction

BEFORE XOLAIR
Typical CIU flare before treatment with XOLAIR.
AFTER 12 WEEKS ON XOLAIR 300 mg
Patients' weekly hive count score was reduced by two-thirds (66%)

Model for illustrative purposes only

Complete Response

BEFORE XOLAIR
Typical CIU flare before treatment with XOLAIR.
AFTER 12 WEEKS ON XOLAIR 300 mg
More than 1 in 3 patients (36%) were completely itch- and hive-free

Model for illustrative purposes only

Get the CIU Tracker mobile app

Record your number of hives and how much they itch from day to day — even upload photos. Share this information and more with your doctor.

 

What is XOLAIR?

XOLAIR® (omalizumab) for subcutaneous use is an injectable prescription medicine used to treat adults and children 12 years of age and older with chronic idiopathic urticaria (CIU; chronic hives without a known cause) who continue to have hives that are not controlled by H1 antihistamine treatment.

XOLAIR is not used to treat other forms of urticaria.

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.

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 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.

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 4 weeks.
  • In patients 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.

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.
  • 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.

The most common side effects of XOLAIR:

  • In people with chronic idiopathic 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.

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