Some people with very severe asthma symptoms have a condition called eosinophilic asthma. People with this type of asthma may need to use inhaled medicines along with a newer type of medicine that is injected into the body. These newer medicines work directly on the body’s immune system to reduce the number of eosinophils and reduce symptoms.
One of these new medicines, Fasenra, is approved for people with severe eosinophilic asthma who do not get enough benefit from other medicines.
How Does Fasenra 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, difficulty breathing, and tightness or pain in the chest. A lot of different “triggers” can cause an asthma attack. Some examples of common triggers are listed below.
- Infection
- Pollen
- Pet dander
- Dust mites
- Strong smells
- Smoke
- Cold air
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. Many inhaled medicines help to reduce the swelling and tightness in the lungs.
In some cases, asthma can cause very severe symptoms that do not respond to these treatments. Some people with very severe symptoms that are hard to control have eosinophilic asthma. In this form of asthma, a type of immune cell called an eosinophil collects in the lungs, causing more swelling. Many people with eosinophilic asthma still have symptoms even when they are using all of the recommended medicines.
The active ingredient in Fasenra is a medicine called benralizumab, which works by binding to eosinophils. This reduces the number of eosinophils in the lungs, which reduces the amount of swelling.
Can Anyone With Asthma Use Fasenra?
People with eosinophilic asthma may have severe symptoms that are not controlled with other medicines. Some of these people may also need to take a certain type of medicine called an oral corticosteroid (such as prednisone) every day to control their symptoms. Oral corticosteroids can cause serious side effects when taken for a long time.
If you still have serious symptoms of asthma even when using high doses of inhaled medicines, or if you are not able to stop taking an oral corticosteroid without having serious asthma symptoms, you and your health care provider may discuss using a medicine like Fasenra.
How Was It Studied?
Four clinical studies were done to see if Fasenra was safe and effective for treating severe asthma. Most of the people in these studies had high eosinophil levels (levels above 300 cells/mcL). Although some people had lower eosinophil levels (levels below 300 cells/mcL), the studies were not designed to measure benefit in these people. Since Fasenra is only approved for people with high eosinophil levels (eosinophilic asthma), only these people are discussed here.
The people in these studies were 12-75 years old, but almost all of them (97%) were 18 or older. The average age was about 49, and a little more than half (61%) of the people were female. Most (83%) were White, about 11% were Asian, about 3% were Black, and the race of the other people in the studies was not reported. Three of the studies reported that about 20% of people identified as Hispanic or Latino; the fourth study did not report this information.
In all four studies, Fasenra was compared with a placebo. No one knew whether they were receiving the medicine or the placebo.
The two largest studies included people who were still having breathing issues even though they were already using high doses of inhaled long-acting medicines each day. Here is some other important information about these studies:
- Everyone had experienced at least two asthma attacks at some point in the past year. On average, the people in these studies had about three attacks in the past year. An asthma attack included any breathing problem that required treatment with oral or intravenous (IV) corticosteroids or an increase in a person’s regular daily dose of oral corticosteroids.
- People were told to keep using their current inhaled or oral asthma medicines as prescribed throughout the study. If they had sudden trouble breathing, they were told to use their rescue inhalers.
- These studies measured effectiveness by looking at the average rate of asthma attacks over a full year. An asthma attack included any breathing problem that required treatment with oral or IV corticosteroids (or an increase in a person’s usual dose of oral corticosteroids), a visit to an emergency department or urgent care, and/or admission to the hospital. The studies also measured lung function over time.
The third study included people who were corticosteroid-dependent, meaning that they needed to take oral corticosteroids (such as prednisone) every day for at least 6 months to keep their symptoms under control. This study measured effectiveness by comparing the average dose of oral corticosteroids that people needed to keep their symptoms under control at the beginning of the study to the average dose at the end of the study.
The fourth (and smallest) study included people who still had symptoms even though they were using long-acting inhaled medicines each day. During the week before the study started, everyone had experienced symptoms that required the use of a rescue inhaler or had woken up overnight due to symptoms. This study measured efficacy by measuring lung function over time.
What Benefits Were Seen in These Clinical Studies?
Asthma attacks. Over about 1 year (48-56 weeks), the people who used Fasenra had fewer asthma attacks when compared with the people who used the placebo. On average, people who used Fasenra had about one-third to half (36% to 51%) as many asthma attacks as the people who used the placebo. This means that Fasenra helped to lower the rate of serious breathing issues.
Lung function. Some of these studies measured how well a person’s lungs were working by asking them to take a deep breath and then force as much air out of their lungs as possible. The amount of air that a person could force out of their lungs in 1 second was recorded. People using Fasenra were able to force more air out of their lungs than the people who used the placebo. This means that Fasenra helped the lungs to function better, allowing people to breathe easier.
Oral corticosteroid dose. One study only included people who needed to take an oral corticosteroid every day to manage their symptoms. After 6 months, people who used Fasenra were able to reduce their daily dose of corticosteroids by a greater amount than the people who were using placebo. This means that, on average, people who used Fasenra needed a lower dose of oral corticosteroids than people who used the placebo. Also, a little more than half of the people who used Fasenra (52%-56%) were able to stop oral corticosteroids completely, compared with about one-fifth (19%) of people who used the placebo.
Was This Medicine Studied in Children?
Fasenra is approved for use in children 6 years of age and older who have severe eosinophilic asthma. To support this approval, a small study was completed in children who were 6-11 years old. This study measured the levels of Fasenra and watched how these children responded to the medicine. It found that Fasenra works similarly in children and adults and is not expected to cause any unique safety issues in children.
How Do I Use It?
Fasenra is a liquid that is injected under the skin. When you first start using this medicine, you will have an injection every 4 weeks for the first three doses. Then, you will receive a dose every 8 weeks. It can be injected into the thigh, stomach, or outer area of the upper arm.
The drug comes in two forms. The most common form is a prefilled device that is ready to be injected under the skin, so you do not need to learn how to use a syringe and needle. The other form is a prefilled syringe with a needle. In either case, your health care provider will show you how to inject the drug before you use it the first time. The medicine is kept in the refrigerator. In order to make the injection more comfortable, it should be allowed to warm to room temperature for about 30 minutes before the injection is given.
It is important to inject the drug properly so that you get the right dose. Your prescription should come with “Instructions for Use,” which explains how to prepare and give a dose. Ask your pharmacist or other health care provider if you are unsure how to use Fasenra.
How Can I Tell If It’s Working?
If Fasenra is working, you may have less trouble breathing within the first month. Over time, you should continue to notice less trouble breathing and should also have fewer asthma attacks. If you take an oral corticosteroid every day, you may be able to reduce your dose of this medicine.
Do not stop using this 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, including oral corticosteroids, 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.
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. You should also let your health care provider know if Fasenra does not seem to be making it easier to breathe after a few months of use. They can discuss other options for treating your asthma.
What Are the Side Effects, and How Can I Prevent Them?
People who use Fasenra may be more likely to have an infection that causes a sore throat. 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.
These are not all of the possible side effects. 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 Fasenra, you can also report side effects to the FDA at 800-FDA-1088.
Are There Any Interactions With Other Medicines?
There are no known interactions between Fasenra 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 Fasenra?
Fasenra is a type of medicine called a “specialty” medicine. This means that you may have to get it from a specialty pharmacy, which may need to ship the medicine to you. This also means that it may require prior authorization from your insurance company.
Is There a Coupon Card Available?
There is a savings coupon available from the manufacturer 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 www.fasenra.com/savings-support.
