Xolair: The First FDA-Approved Injection for Chronic Hives

Medically Reviewed by Goldina I. Erowele, MBA, PharmD on July 18, 2024
8 min read

If you or someone you know has a condition called chronic spontaneous urticaria (CSU), you may have heard about Xolair. In 2014, Xolair became the first medicine to be approved for treating this condition. Although other medicines are sometimes used to treat CSU, they work very differently than Xolair. 

Xolair, which is injected into the body, works directly on the body’s immune system to help reduce symptoms of CSU.

Hives is a type of rash that causes the skin to become swollen, itchy, and red in certain areas. The rash can appear anywhere on the body and may also move around. In most cases, hives appear in response to a “trigger,” such as an infection, an insect bite, or a substance that causes allergies (called an allergen). When this happens, the rash usually goes away on its own within hours or days.

Chronic hives is a condition where the rash stays around for much longer, like months or years. In some people, the rash goes away on its own for a short period of time but then comes back. In some cases, chronic hives is caused by the same triggers as short-term hives. But in most cases, there is no clear cause of chronic hives. This type of chronic hives is called chronic spontaneous urticaria (CSU) or chronic idiopathic urticaria. It may be due to an overactive immune system. 

Most treatments for CSU work by managing symptoms and reducing the swelling (inflammation) caused by the overactive immune system. One common treatment for this condition, which is taken by mouth, is a type of medicine called an antihistamine. This medicine blocks histamine, a substance produced by the immune system that causes a rash, swelling, and itching. Some people may also use another type of medicine, called a corticosteroid, to help with the rash, swelling, and itching. Corticosteroids, which help reduce many of the activities of an overactive immune system, can be taken by mouth or applied directly to the rash in the form of a cream or ointment. 

The active ingredient in Xolair is a medicine called omalizumab, which works by blocking a substance in the body called immunoglobulin E (IgE). When IgE is blocked, certain receptors in the body become less active. These receptors play an important part in the body’s immune system. Blocking IgE and making its receptors less active can reduce the rash and itching in people with CSU.

Some people with CSU will be able to control their symptoms by using medicines that are taken by mouth or applied directly to the skin. For most people, this condition will eventually go away on its own. But this may take many years to happen. Until then, Xolair may be an option for people who are still having a lot of symptoms even when they are using an antihistamine every day. 

Two clinical studies were done to see if Xolair was safe and effective for treating chronic spontaneous urticaria (CSU). The people in these studies all had CSU for at least 6 months before the studies started. They also had a rash and itching for at least 2 months in a row before the studies started, even though they were already using an antihistamine. Everyone was at least 12 years old, with an average age of about 42 years. Most of the people in these studies were White (82%-84%) and most were female (72%-75%). In one study, 11% of people were Black and 7% were an unreported race. In the other study, 12% of people were non-White and race was unavailable for the other 4%.

Xolair was compared with a placebo. The people in the studies did not know whether they were receiving the drug or the placebo. Everyone was told to keep using their oral antihistamine every day during the studies.

These studies measured efficacy by having people rate their itching and rash on a scale. Everyone was asked to rate these symptoms before the studies started and keep rating them every day during the studies. These daily scores were added up every week and were used to provide two numbers:

  • Itching severity score: This scale rates a person’s itching. At the end of the week, this number can be 0-21. The lowest score (0) means there was no itching all week. The highest score (21) means the itching was severe every day of the week.
  • Hives severity score: This scale rates a person’s rash and itching. At the end of the week, this number can be 0-42. The lowest score (0) means there was no rash or itching all week. The highest score (42) means both the itching and rash were severe every day of the week.

     

Itching severity. Before the studies started, the average itching score for the week was 14 (on a scale of 0-21). After 3 months, people who used Xolair had lower itching scores than people who used the placebo. Here is some more information about these scores, depending on whether a person used Xolair or the placebo.

  • Xolair: Weekly scores decreased by about 6.5-10 points. This means that, on average, the itching score in people using Xolair was about 4-7 (out of 21). 
  • Placebo: Weekly scores decreased by about 3-5 points. This means that, on average, the itching score in people using the placebo was about 9-11 (out of 21).

Hives (itching and rash) severity. Before the studies started, the average score for the week was about 31 (on a scale of 0-42). After 3 months, people who used Xolair had lower scores than people who used the placebo. Here is some more information about these scores, depending on whether a person used Xolair or the placebo.

  • One study compared the score at the beginning of the study to the score at the end of the study:
    • Xolair: Weekly scores decreased by about 14-21 points, on average. This means the average score in people using Xolair was about 10-17 (out of 42).
    • Placebo: Weekly scores decreased by about 8 points, on average. This means the average score in people using the placebo was about 23 (out of 42). 
  • One study counted the number of people who had their weekly score drop to 6 or less. At the beginning of the study, no one in the study (0%) had a score this low. 
    • XolairAbout one-half to two-thirds (43-66%) of people using Xolair had their scores drop this low.
    • Placebo: About one-fifth (19%) of people using the placebo had their scores drop this low.

Xolair is a liquid that is injected under the skin every 4 weeks. It can be injected into the thigh, stomach, or outer area of the upper arm.

The first few times that you use Xolair, your health care provider will give you the dose in a health care setting. This will allow them to monitor you for any type of reaction to the dose. After the first few doses, you may continue to receive the dose in a health care setting. If you meet certain criteria, your health care provider may also give you the option to give yourself the dose at home.

The drug comes in two forms. The most common form is a pre-filled device called an autoinjector. This device is ready to inject the drug under the skin, so you do not need to learn how to use a syringe and needle. The other form is a pre-filled syringe with a needle, which is most often used in very young children. The pre-filled syringe contains latex, but the autoinjector does not contain latex. Let your health care provider know if you have an allergy to latex so that they can prescribe the right form of Xolair.

If you and your health care provider decide that you will start giving yourself doses at home, they will teach you how to inject the drug before you use it the first time. It is important to inject the drug properly so that you get the right dose. Your prescription should also come with “Instructions for Use,” which explains how to prepare and give a dose. 

If Xolair is working, you may notice an improvement in your symptoms within 1-2 weeks. You may continue to see improvements in symptoms, such as smaller rashes and less itching, for the next couple of months. 

Do not stop using Xolair or any other medicines without talking to your health care provider first, even if your rash and itching have gotten better. You should also not lower the dose of any of your other medicines without talking to your health care provider first. Your symptoms may get worse again if you stop or change any of your medicines. 

Tell your health care provider if Xolair does not seem to be improving your symptoms after a few months. Your health care provider may increase your dose, if you are not already at the highest dose, or may discuss other options for treating this condition.

People who use Xolair for chronic hives may be more likely to have infections of the airways. These include infections in the nose or throat, a sore throat, or common cold symptoms. The best way to prevent infection is to reduce your exposure to germs by washing your hands and avoiding people who are sick. You should also stay current on vaccinations, such as getting an annual flu vaccine. 

In rare cases, some people may have a serious allergic reaction (anaphylaxis) after their first dose of Xolair. Your first dose of Xolair will always be given in a health care setting, where you will be monitored for an allergic reaction. If anything happens, trained professionals will be there to manage any side effects.

These are not all of the possible side effects of Xolair. Talk with your health care provider if you are having symptoms that bother you. If you experience anything that you think may be caused by Xolair, you can also report side effects to the FDA at 800-FDA-1088 (800-332-1088).

There are no known interactions between Xolair and other medicines. But it is still important for your health care provider to be aware of all the prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, or other supplements you take or have recently taken. 

Xolair is a type of medicine called a “specialty” medicine. This means that you can only get it from a specialty pharmacy and that it may require prior authorization from your insurance company. Your first dose of Xolair will always be given by a health care provider in a health care setting.

There is a savings coupon available from the drugmaker that may allow you to pay $0 for your prescription. Whether you are eligible depends on whether you have prescription insurance, and what type of insurance you have. You can find out more at https://www.xolaircopay.com/.