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, a new group of 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 to treat symptoms in certain people with severe asthma is called Nucala.
How Does Nucala Work for Asthma?
Asthma is a long-term (chronic) condition of the lungs that makes it hard to breathe. The airways can narrow from swelling (inflammation) and the muscles in the airways can tighten up. This swelling and tightness can make the airways very irritated and sensitive. The airways can also become clogged with mucus.
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 Nucala is a medicine called mepolizumab, which works by blocking certain proteins that send immune system signals in the body (interleukin-5). Blocking these proteins helps to reduce the number of a specific type of white blood cell called an eosinophil. This helps to reduce the swelling in the lungs of people with asthma.
How Do I Use Nucala?
Nucala is a liquid that is injected under the skin every 4 weeks. The dose you use will be determined by your health care provider based on your age. It can be injected into the thigh, stomach, or outer area of the upper arm.
The drug comes as a prefilled syringe and a prefilled-device that is ready to be injected under the skin. Your health care provider will show you how to inject the drug before you use it for the first time. Reach the instructions in detail. You can watch an instructional video on the drug maker’s website at www.nucala.com/np/taking-nucala. You can ask your pharmacist if you have any additional questions.
How Was It Studied for Severe Asthma?
For asthma, three initial studies were done to compare Nucala to a placebo containing no drug. The people in the studies did not know if they were getting Nucala or the placebo. All studies included people aged 12 and older with asthma and specific lung function tests, blood tests, and baseline asthma medications.
In the first and second studies, people needed to have two or more asthma exacerbations that needed to be treated with steroids in the past year. The first study took place over 52 weeks and the second study took place over 32 weeks. Most people in the studies were female and 46 to 51 years old. Most people had asthma for about 17 to 20 years. At the end of the study, the people who took Nucala had significantly fewer asthma exacerbations and fewer exacerbations requiring hospital admission or an emergency room visit.
In the third study, Nucala was investigated to see if it could help people to take a lower dose of their daily steroid. In this study, people first had to have their steroid medication optimized over the initial 4 weeks. Then, they were chosen to use either Nucala or placebo. During weeks 4 to 20, the people in the study had their steroid dose lowered slowly based on their asthma control and other factors. From week 20-24, no additional medication changes were made. At the end of the study (24 weeks), more people who took Nucala had a steroid dose that was lowered by 70%-100% than those that took placebo. For the people that used Nucala, the average decrease in steroid dose was 50%.
Your results may differ from what was seen in clinical studies.
How Long Does It Take for It to Work?
Nucala can start working within a few days. But a full response might not be seen until you have been taking Nucala for about 4 weeks. Tell your health care provider if your asthma symptoms do not improve. Consider keeping a symptom diary to keep track of your symptoms and their consistency. This can help you and your health care provider find out how well your medicines are working for you.
How Can I Prevent and Manage Side Effects?
The most common side effects seen with Nucala are headache, injection site reaction, back pain, and tiredness. An injection site reaction is a skin reaction where the needle went in, which may involve redness, pain, swelling, and/or bruising. The best way to decrease these reactions is to inject the drug into a different part of the body each time, which is called “rotating” the injection site. Also, don’t inject the drug into skin that is already tender, damaged, bruised, or scarred.
Some serious, rare side effects include risks for certain types of infections. One infection specifically is shingles. Shingles is usually seen as a painful, itchy rash typically on one side of the body. Since people taking Nucala have noted shingles infections during treatment, you should talk to your health care provider about the shingles vaccine to see if it is right for you. Nucala may make it harder for your body to fight off certain infections called helminth infections. These are commonly parasitic worms. If you have this type of infection, you should have it treated before starting Nucala. If you get this type of infection while taking Nucala, your health care provider will consider stopping Nucala until the infection gets better.
These are not all of the side effects of Nucala. 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 Nucala, you can also report side effects to the FDA at 800-FDA-1088.
What Kinds of Drug Interactions May Happen?
It is important for your health care provider to be aware of every medicine you are taking, especially medicines for asthma, before you start using Nucala.
The drug company that makes Nucala reports that no formal studies have been done to look at drug interactions.
Tell your pharmacist or health care provider about all the prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, or other supplements you take or have recently taken. This will help them to determine the best treatment plan for you.
Are There Any Special Steps Required to Get Nucala?
Nucala is a type of medicine called a “specialty” medicine. This means that you can only 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 Any Cost Assistance 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 the type of insurance. You can find out more at www.nucala.com/np/savings-support/copay-program.
