Most people with asthma are able to control their symptoms by using inhaled medicines each day. But for some people with severe asthma, inhaled medicines are not enough to keep symptoms under control. In recent years, new medicines have been approved that work in a different way to manage symptoms of severe asthma. These medicines, which are injected into the body instead of inhaled, work directly on the body’s immune system to help reduce symptoms.
One of these injected medicines that may help treat symptoms in people with severe allergic asthma is called Xolair.
How Does Xolair Work for Asthma?
Asthma is a long-term (chronic) condition of the lungs that can make it hard to breathe. The airways can get narrowed from swelling (inflammation) and because the muscles in the airways tighten up. This swelling and tightness can make the airways very irritated and sensitive. The airways can also become clogged with mucus.
People with asthma can have asthma attacks, which can include coughing, wheezing, a hard time breathing, and tightness or pain in the chest. A lot of different “triggers” can cause an asthma attack. Some people with asthma have allergies that cause the body’s immune system to overreact to the presence of a specific substance (an allergen). For these people, allergens can also cause an asthma attack. Some examples of these allergens are listed below.
- Pollen
- Animal dander
- Dust mites
- Mold
The key to treating asthma is to reduce the amount of swelling and tightness in the lungs. This helps make it easier to breathe. It also makes the lungs less sensitive to triggers, which can reduce the number of asthma attacks.
The active ingredient in Xolair is a medicine called omalizumab, which works by blocking a substance in the body called immunoglobulin E (IgE). The body produces large amounts of IgE when it senses an allergen. For people with allergic asthma, blocking IgE can decrease the body’s response to allergens and reduce the swelling that happens in their lungs.
Can Anyone With Asthma Use Xolair?
Most people with asthma will be able to control their symptoms by using inhaled medicines. In some cases, adding certain medicines that are taken by mouth may also help to keep asthma symptoms under control.
Xolair is reserved for people who are still having symptoms even when they are using all of the recommended inhaled medicines. In order to use Xolair, you must also have a known allergy to an allergen that is present in the air for most of the year (called a perennial aeroallergen). These types of allergens include animal dander, dust mites, and mold.
How Was Xolair Studied for Treating Asthma?
Multiple clinical studies were done to find out if Xolair was safe and effective for treating allergic asthma. Three of these studies only included adults (18 years and older). The average age of the people in these studies was about 40 years old. Just over half of the people in the studies were female (about 55%) and most of the people in the studies were White. Another study included children who were 6-12 years old. The average age in this study was 8 years old. Most of the children were male (68%) and a little more than half of them were White (60%).
In all of these studies, everyone still had breathing issues even though they were already using the highest recommended dose of inhaled medicines each day. Everyone also had a confirmed allergy to a perennial aeroallergen, like animal dander or dust mites. For children to take part in the study, they had to have experienced at least two asthma attacks at some point in the past year or at least three asthma attacks at some point in the past 2 years.
Here is some important information about the medicines used during these studies:
- Xolair was compared with a placebo. The people in the studies did not know whether they were receiving the drug or the placebo.
- People were told to keep using their inhaled medicines as prescribed throughout the study. If they had sudden trouble breathing, they were told to use their rescue inhalers.
- During the first few months of each study, everyone kept using the same dose of inhaled medicines that they were using at the beginning of the study.
- After a few months, everyone started using a lower dose of a specific type of inhaled medicine, called a corticosteroid. In the studies with adults, the inhaled corticosteroid dose was lowered after 4 months. In the study in children, the dose was lowered after 6 months.
- If a person did not have more symptoms after lowering their inhaled corticosteroid dose, then the dose was reduced even more.
Most of these studies measured efficacy by counting the number of serious asthma attacks that happened while Xolair was being used. A serious asthma attack was an attack that required treatment with oral or injected corticosteroids, and/or a very large increase in the dose of inhaled corticosteroids. This was measured two times:
- During the months when the dose of the inhaled corticosteroid did not change (the first 4-6 months)
- During the months when the dose of the inhaled corticosteroid was being lowered
One of these studies measured efficacy by looking at how much people were able to reduce their daily dose of inhaled corticosteroid.
What Benefits Were Seen in These Clinical Studies?
Serious asthma attacks. Three studies, including the study in children, counted the number of serious asthma attacks that happened during treatment with Xolair.
- First, these studies looked at whether there were any serious asthma attacks while everyone was using the same dose of inhaled medicines each day. In both children and adults, the group using Xolair had fewer serious asthma attacks than the group using the placebo.
- Next, everyone in these studies started lowering their daily dose of inhaled corticosteroid. The group using Xolair had fewer serious asthma attacks than the group using the placebo, on average, even when they were using a lower dose of inhaled corticosteroid each day.
Dose of inhaled corticosteroid. One study looked at how much people were able to lower their dose of inhaled corticosteroid. Most people who used Xolair had a lower daily dose of inhaled corticosteroid than people who used the placebo. About three-quarters (75%) of people who used Xolair were able to cut their daily dose of inhaled corticosteroid in half, compared with about half (50%) of people who used the placebo.
How Do I Use It?
Xolair is a liquid that is injected under the skin every 2-4 weeks. Your health care provider will decide whether you should receive it every 2 weeks or every 4 weeks. This will depend on your age, your weight, and the amount of IgE in your blood. 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 give you a shot 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 they can prescribe the right form of Xolair.
If you and your health care provider decide that you will start giving your own 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.
How Quickly Will Xolair Work for Asthma?
If Xolair is working, you should have less trouble breathing after using it for a few weeks. Over time, this might mean that you will have fewer asthma attacks. You may also be able to reduce the dose of the inhaled corticosteroid that you use each day.
Do not stop using Xolair or any other asthma medicines without talking to your health care provider first, even if your breathing has gotten better. You should also not lower the dose of any of your other asthma medicines without talking to your health care provider first. Your breathing and 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 making it easier to breathe after a few months. Your health care provider may discuss other options for treating asthma.
Contact your health care provider right away if your breathing problems get worse or if you need to use your rescue inhaler more often than before.
How Can I Prevent or Manage Side Effects?
People who use Xolair for asthma may be more likely to have an infection of the airways. These include infections in the nose or throat, a sore throat, or common cold symptoms. The best way to prevent an 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).
Are There Any Interactions With Other Medicines?
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.
Are There Any Special Steps Required to Get Xolair?
Xolair is 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.
Is There a Coupon Card Available?
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/.
