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What is chronic idiopathic urticaria (CIU)?

Before we start to talk about CIU, we want to make sure you know what urticaria is. Urticaria is another word for "hives". Hives are itchy red bumps or welts that can appear on your skin unexpectedly.

There are two main types of urticaria, or hives:

Acute hives

  • Acute hives last for up to 6 weeks, usually going away within a few days.
  • In most cases, the cause can be found.

Chronic hives

  • Chronic hives last 6 weeks or more.
  • In about 3 out of 10 cases, the cause can be found.

CIU is a type of chronic hives.

In fact, it's the most common type of chronic hives. That's because in 7 out of 10 cases of chronic hives, the cause can't be found. When this happens, the diagnosis is CIU.

Here are some more facts about chronic idiopathic urticaria you may want to know:

  • Most CIU symptoms, or flares, occur between the ages of 20 and 40.
  • Women are twice as likely as men to have CIU.
  • For most people with CIU, flares come and go for 1 to 5 years. Some patients have symptoms even longer than that.
For 7 out of 10 people with chronic hives, the cause of their hives remains unknown. This means it is CIU.

If your hives have lasted more than 6 weeks, ask your doctor if you may have CIU. If you do get a diagnosis of CIU, it may help to remember you're not alone.

Visit our YouTube channel to learn more about CIU from doctors and real patients.

 

 

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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?

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.
  • if you become pregnant while taking XOLAIR, talk to your healthcare provider about registering with the XOLAIR Pregnancy Registry. You can get more information and register by calling 1-866-4XOLAIR (1-866-496-5247) or visit www.XOLAIRpregnancyregistry.com.
  • are breastfeeding or plan to breastfeed. It is not known if XOLAIR passes into your breast milk.

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. People who receive treatment with XOLAIR may have a higher chance for getting certain types of cancer.
  • 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.
  • 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:

  • 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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