What to Know About XOLAIR (Omalizumab) Chronic Idiopathic Urticaria (CIU) Treatment

XOLAIR Has Been Shown to Help Relieve CIU Symptoms

XOLAIR is a once-monthly injectable prescription medicine, given under the skin by a nurse or doctor, that treats CIU in patients 12 years of age and older who are not controlled by H1 antihistamines. H1 antihistamines are a type of medicine used to treat allergic reactions such as hay fever, hives, and insect bites and stings. XOLAIR is not used to treat other forms of urticaria.

In 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.

*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.
**Based on results from CIU Studies 1 and 2. 
To measure number of hives, 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, and 3 = more than 12 hives). The average daily score was then added together over 7 days for the weekly hive count score.

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 CIU, medical teams did 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 CIU.

Two studies were conducted looking at the effect of XOLAIR in patients with CIU. 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 is a "Control Group"?

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.

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 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 Study 1

XOLAIR was studied for 24 weeks to measure the severity of itch* and number of hives (on a weekly basis) of CIU patients who continued to have hives while on antihistamine therapy. Open the tab below to see the results of the study and how it was done. Individual results may vary.

*To measure itch severity, patients were asked to write down how itchy they felt every morning and night on a scale of 0-3 (0 = none, 1 = mild, 2 = moderate, 3 = severe). The average daily score was then added together over 7 days for the weekly itch severity score.
To measure number of hives, 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, and 3 = more than 12 hives). The average daily score was then added together over 7 days for the weekly hive count score.

Clinical Study 1

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 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.

Clinical Study 2

XOLAIR was studied for 12 weeks to measure the severity of itch* and number of hives (on a weekly basis) of CIU patients who continued to have hives while on antihistamine therapy. Open the tab below to see the results of the study and how it was done. Your results may vary.

Clinical Study 2: Itch and Hive Chart

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.
  • 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.