Nucala (mepolizumab)

What is Nucala?

Nucala is a brand-name prescription medication. It’s used to treat two conditions:

• severe eosinophilic asthma in adults and children ages 12 years and older. With this kind of severe asthma, you have high levels of eosinophils (a type of white blood cell). For treating this condition, Nucala is approved as an add-on treatment. This means that you take it in addition to your other asthma medications.
• eosinophilic granulomatosis with polyangiitis (EGPA) in adults. EGPA is a rare condition in which your blood vessels become inflamed (swollen). Another name for EGPA is Churg-Strauss syndrome.

Nucala contains mepolizumab, which is a type of drug called a biologic. It’s made from parts of living cells rather than from chemicals.

Nucala comes in three forms. Until recently, Nucala was only given by your healthcare provider as an injection under your skin (subcutaneous injection). But in June 2019, the Food and Drug Administration (FDA) approved two new forms of Nucala.

The drug now also comes as a prefilled autoinjector pen and a prefilled syringe. This means that instead of going to your doctor’s office to get injections, you can give yourself injections at home after receiving training.

Effectiveness

Nucala has been found effective in treating both eosinophilic asthma and EGPA.

For eosinophilic asthma

Clinical studies have found Nucala to be effective in reducing the number of severe asthma attacks in people with severe eosinophilic asthma. This includes asthma attacks that required a visit to the emergency room or a stay in the hospital.

Researchers examined people who received Nucala in addition to their usual asthma treatment. Over a one-year period, this group had about half the number of asthma attacks as people who received a placebo (no treatment).

For EGPA

Nucala has also been found to be effective in treating EGPA. In a year-long clinical study of people with EGPA, 40% of people treated with Nucala were in remission (free from symptoms) for up to 36 weeks. This was compared to 16% of people who received a placebo. And 13% of people treated with Nucala spent 36 weeks or more in remission, compared to 3% of people who received a placebo.

Nucala generic

Nucala is available only as a brand-name medication. It doesn’t currently have a generic form.

Nucala contains one active drug ingredient: mepolizumab.

Nucala side effects

Nucala can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Nucala. These lists do not include all possible side effects.

For more information on the possible side effects of Nucala, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be bothersome.

More common side effects

The more common side effects of Nucala can include:

• headaches
• injection site reactions, such as pain, redness, itching, swelling, or burning in the injection area
• back pain
• fatigue (lack of energy)

Most of these side effects may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk with your doctor or pharmacist.

Serious side effects

Serious side effects from Nucala aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency.

Serious side effects, explained in more detail below in “Side effect details,” can include the following:

Side effect details

You may wonder how often certain side effects occur with this drug, or whether certain side effects pertain to it. Here’s some detail on some of the side effects this drug may or may not cause.

Allergic reaction, including anaphylaxis

As with most drugs, some people can have a mild allergic reaction after taking Nucala. Symptoms of a mild allergic reaction can include:

• skin rash
• itchiness
• flushing (warmth and redness in your skin)

A more severe allergic reaction is rare but possible. Anaphylaxis is a very serious type of allergic reaction that can be life-threatening. Symptoms of a severe allergic reaction can include:

• angioedema (swelling under your skin, typically in your eyelids, lips, hands, or feet)
• swelling of your tongue, mouth, or throat
• difficulty swallowing
• trouble breathing
• feeling faint or dizzy

Call your doctor right away if you have a severe allergic reaction to Nucala. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency.

In clinical studies, allergic reactions occurred in 1% of people who took Nucala for severe eosinophilic asthma. And 4% of people who took the drug for eosinophilic granulomatosis with polyangiitis (EGPA) had allergic reactions.

Most of these reactions were mild, but some were serious. Most happened within a few hours after a Nucala injection was given. But some allergic reactions occurred a few days later.

Allergic reactions, including serious reactions such as anaphylaxis, have also been reported since Nucala has been on the market.

Herpes zoster infection (shingles)

In clinical studies, 0.76% of people treated with Nucala for severe asthma reported having a herpes zoster infection. This infection is better known as shingles. The virus that causes shingles is the same one that causes chickenpox. Anyone who’s had chickenpox can develop shingles.

It’s not fully known whether taking Nucala increases the risk of developing shingles.

Your doctor might want you to get the shingles vaccine before you start treatment with Nucala. This may help you avoid developing shingles while taking Nucala.

If you’re receiving Nucala and notice symptoms of shingles, tell your doctor right away. Symptoms of shingles can include:

• fever
• tingling or burning feeling
• blistering rash
• shooting pain in the area of the rash

Your doctor can recommend treatments to ease your symptoms and shorten how long shingles lasts.

Long-term side effects

Researchers have looked into the long-term safety of Nucala in treating severe eosinophilic asthma. In a clinical study of people treated with Nucala for up to 4.5 years, no new safety issues were reported. This means that the people didn’t develop side effects other than those reported in the initial clinical studies of Nucala for severe asthma.

There haven’t been any studies about the long-term safety of Nucala in treating EGPA.

If you’re concerned about how Nucala may affect you long term, talk with your doctor.

Weight gain (not a side effect)

Weight gain wasn’t reported in clinical studies of Nucala.

The oral corticosteroid medications that are often needed to treat severe eosinophilic asthma or EGPA are well known to cause weight gain. However, Nucala isn’t a steroid and shouldn’t cause you to gain weight.

If you’re concerned about weight gain, discuss it with your doctor. They can suggest helpful diet, exercise, and lifestyle tips or recommend a dietitian.

Weight loss (not a side effect)

Weight loss wasn’t reported as a side effect in clinical studies of Nucala.

People taking steroid tablets for long periods of time can often gain weight. If you’re able to use a lower amount of oral steroids due to your Nucala treatment, it’s possible that you may lose weight. However, this hasn’t been specifically studied.

If you’re concerned about weight loss, talk with your doctor. They can suggest helpful diet tips or recommend a dietitian to help make sure you get the proper nutrition.

Hair loss (not a side effect)

Hair loss wasn’t reported in clinical studies of Nucala.

But some other medications that help treat EGPA may cause hair loss. These include:

• methotrexate (Otrexup, Rasuvo, Xatmep)
• cyclophosphamide
• azathioprine (Azasan, Imuran)
• rituximab (Rituxan)

If you’re concerned about hair loss, talk with your doctor.

Alternatives to Nucala

Other drugs are available that can treat your condition. Some may be better suited for you than others. If you’re interested in finding an alternative to Nucala, talk with your doctor. They can tell you about other medications that may work well for you.

Note: Some of the drugs listed here are used off-label to treat these specific conditions.

Alternatives for severe eosinophilic asthma

Examples of other drugs that may be used to treat severe eosinophilic asthma include:

• benralizumab (Fasenra)
• dupilumab (Dupixent)
• reslizumab (Cinqair)
• omalizumab (Xolair)

Alternatives for eosinophilic granulomatosis with polyangiitis (EGPA)

Examples of other drugs that may be used to treat eosinophilic granulomatosis with polyangiitis (EGPA) include:

• methotrexate (Otrexup, Rasuvo, Rheumatrex, Trexall)
• cyclophosphamide (Cytoxan)
• azathioprine (Azasan, Imuran)
• mycophenolate (CellCept, Myfortic)
• rituximab (Rituxan)

Nucala vs. Fasenra

You may wonder how Nucala compares to other medications that are prescribed for similar uses. Here we look at how Nucala and Fasenra are alike and different.

General

Nucala and Fasenra are both biologic drugs, which are made from parts of living cells rather than from chemicals. Both medications work to reduce the number of eosinophils in your body. These are a type of white blood cell that’s involved in causing inflammation (swelling).

Nucala contains the drug mepolizumab. Fasenra contains the drug benralizumab.

Uses

The Food and Drug Administration (FDA) has approved both Nucala and Fasenra to treat a type of asthma called severe eosinophilic asthma. Both drugs are approved for use in adults and children ages 12 years and older. The medications are used as add-ons to your existing asthma treatment. This means that you take Nucala or Fasenra in addition to your other asthma medications.

Nucala is also FDA-approved to treat eosinophilic granulomatosis with polyangiitis (EGPA) in adults. EGPA is a rare condition in which your blood vessels become inflamed (swollen). Another name for EGPA is Churg-Strauss syndrome.

Drug forms and administration

Nucala comes in three forms:

• A single-dose vial of powder containing 100 mg of mepolizumab. Your healthcare provider will mix the powder with sterile water. They’ll give you this solution as an injection under your skin (subcutaneous injection).
• A single-dose prefilled autoinjector pen containing 100 mg of mepolizumab. Once your healthcare provider teaches you how to use the pen, you’ll be able to give yourself injections under your skin.
• A single-dose prefilled syringe containing 100 mg of mepolizumab. Once your healthcare provider teaches you how to use the syringe, you’ll be able to give yourself injections under your skin.

Fasenra comes as a single-dose prefilled syringe containing 30 mg of benralizumab. The drug is given as an injection under your skin by your healthcare provider.

Nucala is given once every four weeks. Fasenra is given once every four weeks for the first three doses. After that, Fasenra is given once every eight weeks.

Side effects and risks

Nucala and Fasenra can cause some similar side effects and some different side effects. Below are examples of these side effects.

More common side effects

These lists contain examples of more common side effects that can occur with Nucala, with Fasenra, or with both drugs (when taken individually).

• Can occur with Nucala:
• injection site reactions such as redness, itching, swelling, or burning in the injection area
• back pain
• fatigue (lack of energy)
• Can occur with Fasenra:
• throat infection, causing a sore throat
• fever
• allergic skin rashes, including urticaria (an itchy skin rash also known as hives)
• Can occur with both Nucala and Fasenra:

Serious side effects

These lists contain examples of serious side effects that can occur with Nucala or with both drugs (when taken individually).

• Can occur with Nucala:
• herpes zoster infection (shingles)
• Can occur with both Nucala and Fasenra:
• severe allergic reactions, including anaphylaxis

Effectiveness

The only condition that both Nucala and Fasenra are used to treat is severe eosinophilic asthma.

These drugs haven’t been directly compared in clinical studies, but studies have found both Nucala and Fasenra to be effective for treating this type of severe asthma. Nucala and Fasenra are used in addition to your existing asthma treatment.

Costs

Nucala and Fasenra are both brand-name drugs. There are currently no generic forms of either drug. Brand-name medications usually cost more than generics.

According to estimates on WellRx.com, Nucala generally costs less than Fasenra. The actual price you’ll pay for either drug depends on your insurance plan and your location.

Nucala vs. Xolair

Xolair is another drug that’s similar to Nucala. Here we look at how Nucala and Xolair are alike and different.

General

Nucala and Xolair are both biologic drugs, which are made from parts of living cells rather than from chemicals. Nucala works to reduce the number of eosinophils in your body. These are a type of white blood cell that’s involved in causing inflammation (swelling).

Xolair targets a substance called immunoglobulin E (IgE), which is involved in causing allergic reactions. By blocking IgE, Xolair helps reduce inflammation and lowers the number of eosinophils in your body.

Nucala contains the drug mepolizumab. Xolair contains the drug omalizumab.

Uses

The Food and Drug Administration (FDA) has approved Nucala to treat a type of asthma called severe eosinophilic asthma. The medication is approved for use in adults and children ages 12 years and older. You take Nucala in addition to your other asthma treatments.

Xolair is FDA-approved for treating moderate to severe persistent allergic asthma in adults and children ages 6 years and older. You take Xolair in addition to your current asthma treatments.

There are crossovers between these two types of severe asthma. It’s possible to have both allergic asthma and eosinophilic asthma.

Other uses

Nucala is also FDA-approved to treat eosinophilic granulomatosis with polyangiitis (EGPA) in adults. EGPA is a rare condition in which your blood vessels become inflamed (swollen). Another name for EGPA is Churg-Strauss syndrome.

Xolair is also FDA-approved to treat a skin condition called chronic idiopathic urticaria, an itchy skin rash also known as hives. The drug is for use in adults and children ages 12 years and older.

Drug forms and administration

Nucala comes in three forms:

• A single-dose vial of powder containing 100 mg of mepolizumab. Your healthcare provider will mix the powder with sterile water. They’ll give you this solution as an injection under your skin (subcutaneous injection).
• A single-dose prefilled autoinjector pen containing 100 mg of mepolizumab. Once your healthcare provider teaches you how to use the pen, you’ll be able to give yourself injections under your skin.
• A single-dose prefilled syringe containing 100 mg of mepolizumab. Once your healthcare provider teaches you how to use the syringe, you’ll be able to give yourself injections under your skin.

Xolair comes in two forms:

• A single-dose vial of powder containing 150 mg omalizumab. Your healthcare provider will mix the powder with sterile water. They’ll give you this solution as an injection under your skin.
• A single-dose prefilled syringe containing 75 mg or 150 mg of omalizumab. Your healthcare provider will give you this injection under your skin. You won’t inject it yourself.

Nucala is given once every four weeks.

Xolair may be given once every two weeks or once every four weeks. The dosage depends on your age, body weight, and IgE level before starting treatment.

Side effects and risks

Nucala and Xolair have some similar side effects and some different side effects. Below are examples of these side effects.

More common side effects

These lists contain examples of more common side effects that can occur with Nucala, with Xolair, or with both drugs (when taken individually).

• Can occur with Nucala:
• back pain
• headaches
• Can occur with Xolair:
• pain, particularly in your arms, legs, or joints
• dizziness
• earache
• skin rash
• Can occur with both Nucala and Xolair:
• fatigue (lack of energy)
• injection site reactions such as redness, itching, or burning in the injection area

Serious side effects

These lists contain examples of serious side effects that can occur with Nucala, with Xolair, or with both drugs (when taken individually).

• Can occur with Nucala:
• herpes zoster infections (shingles)
• Can occur with Xolair:
• symptoms similar to serum sickness (a type of allergic reaction), including fever, joint pain, rash, and swollen glands)
• possible risk of cancer
• Can occur with both Nucala and Xolair:
• severe allergic reactions, including anaphylaxis

Effectiveness

Nucala and Xolair have slightly different FDA-approved uses. Nucala is FDA-approved to treat severe eosinophilic asthma. Xolair is FDA-approved to treat severe allergic asthma. If you have severe allergic asthma, you’ll have high levels of eosinophils and IgE.

These drugs haven’t been directly compared in clinical studies, but studies have found both Nucala and Xolair to be effective for treating severe asthma. The choice between them depends on what is causing your asthma. Your doctor can determine this from the results of blood tests.

Costs

Nucala and Xolair are both brand-name drugs. There are currently no generic forms of either drug. Brand-name medications usually cost more than generics.

According to estimates on WellRx.com, Nucala generally costs more than Xolair. The actual price you’ll pay for either drug will depend on your insurance plan and your location.

Nucala dosage

The Nucala dosage your doctor prescribes depends on whether you have severe eosinophilic asthma or eosinophilic granulomatosis with polyangiitis (EGPA).The following information describes dosages that are commonly used or recommended.

Drug forms and strengths

Nucala comes in three forms. Your healthcare provider can give you the drug as an injection under your skin (subcutaneous injection). Nucala also comes as a prefilled autoinjector pen and a prefilled syringe, which you can use to give yourself an injection.

Dosage for severe eosinophilic asthma

You’ll have one injection (100 mg) once every four weeks. The dosage is the same for adults and children ages 12 years and older.

Dosage for eosinophilic granulomatosis with polyangiitis

You’ll have three injections (300 mg) on the same day, once every four weeks.

What if I miss a dose?

It’s important to keep having your injections as scheduled, even if you feel better. If you use a Nucala autoinjector pen or syringe and miss a dose, give yourself an injection as soon as possible. Then get back on track with your normal schedule. But if you miss a dose and it’s time for your next one, follow your normal schedule.

If your healthcare provider gives you injections of Nucala and you miss an appointment, call your healthcare provider as soon as possible. They can make a new appointment and adjust the timing of other visits if needed.

It’s a good idea to write your injection schedule on a calendar. You can also set a reminder in your phone so that you don’t miss a dose or an appointment. Other medication reminders can help, too.

Will I need to use this drug long term?

Nucala is meant to be used as a long-term treatment. If you and your doctor determine that Nucala is safe and effective for you, you’ll likely take it long term.

Nucala uses

The Food and Drug Administration (FDA) approves prescription drugs such as Nucala to treat certain conditions.

Nucala for asthma

Nucala is FDA-approved to treat severe eosinophilic asthma in adults and children ages 12 years and older. For treating this condition, Nucala is approved as an add-on treatment. This means that you take it in addition to your other asthma medications.

With severe eosinophilic asthma, you have high levels of eosinophils (a type of white blood cell) in your body. Eosinophils are important cells in helping fight infections. However, too many eosinophils can cause inflammation (swelling) in your airways. The higher the level of eosinophils, the greater the inflammation. This results in asthma symptoms that are more serious and harder to control.

People with severe asthma have frequent symptoms such as wheezing, being short of breath, coughing, and chest tightness. These symptoms can greatly affect your day-to-day life, including how active you are and how well you sleep. Several drugs are usually needed to control your symptoms, including steroid medications.

Steroids help reduce the inflammation (swelling) in your lungs. You take them by inhaler or as tablets and sometimes both. However, with severe asthma, even high doses of steroids don’t always control your symptoms. So severe asthma attacks happen frequently and often need to be treated in a hospital.

If your asthma isn’t controlled and your doctor is thinking about prescribing Nucala, they’ll test your blood to check your level of eosinophils. If your level is higher than 150 cells per microliter, you may benefit from Nucala treatment. People with higher levels of eosinophils are more likely to respond to Nucala.

Keep in mind that you won’t be given a Nucala injection to treat an asthma attack. The drug won’t work to relieve sudden breathing problems.

Effectiveness

Clinical studies examined people with severe eosinophilic asthma. Over a one-year period, those who received Nucala in addition to their usual asthma treatment had about half the number of severe asthma attacks as people who received a placebo (no treatment). This included asthma attacks that required a visit to the emergency room or a stay in the hospital.

In one clinical study, 54% of people treated with Nucala were able to reduce their oral steroid dose by at least 50%. This means that Nucala helped ease asthma symptoms, so the people were able to take a lower dose of steroids.

However, it’s vital to keep taking any steroid medications that your doctor has prescribed unless they tell you otherwise. Not everyone who is treated with Nucala will be able to reduce their use of steroids.

Nucala for eosinophilic granulomatosis with polyangiitis

Nucala is also FDA-approved to treat a rare condition called eosinophilic granulomatosis with polyangiitis (EGPA) in adults. This condition used to be called Churg-Strauss syndrome. It affects 1 to 3 out of every 100,000 adults in the United States.

With EGPA, high levels of eosinophils cause inflammation (swelling) in various tissues in the body and small blood vessels. Over time, inflammation in the blood vessels results in problems with blood flow through these vessels. This poor blood flow can lead to damage in vital organs, such as the lungs.

Some of the first symptoms of EGPA include asthma, hay fever (nasal allergies), and sinusitis (sinus infection).

EGPA can have many other symptoms, depending on what part of the body it affects. EGPA can also impact your:

• nose
• digestive system
• nerves
• kidneys
• heart
• skin

By reducing the number of eosinophils in your body, Nucala reduces inflammation. This can help ease the symptoms of EGPA.

Effectiveness

A 52-week clinical study examined people with EGPA. Researchers found that 41% of people treated with Nucala spent at least 12 weeks in remission. This was compared with 7% of people treated with a placebo (no treatment). In the study, remission meant that there was no active blood vessel inflammation while taking 4 mg or less of prednisone or prednisolone per day.

Of the people treated with Nucala, 19% were in complete remission by week 24. And they stayed in remission for the rest of the study. This is compared to the people who received a placebo. Just 1% of those people were in complete remission by week 24 and stayed in remission for the rest of the study.

The same study looked at the number of relapses (symptom flare-ups) that people had. People who received Nucala had half as many relapses over the 52 weeks as people who received a placebo.

Nucala for COPD (not an appropriate use)

Nucala isn’t FDA-approved for treating chronic obstructive pulmonary disease (COPD). In March 2019, the FDA voted against approving Nucala for this use. The FDA decided there wasn’t enough evidence from clinical studies to prove that Nucala was effective in treating COPD.

The FDA also decided that it would be hard to define who with COPD would most likely benefit from Nucala. This is because it’s not clear how eosinophils, a type of white blood cell, cause lung inflammation (swelling) in COPD. Specialists don’t currently agree on the level of eosinophils that should be used to diagnose someone with eosinophilic COPD.

That’s not to say that Nucala won’t be approved for COPD in the future. The manufacturer of the drug will have to provide evidence that Nucala is effective and address any other concerns the FDA has.

Nucala and children

Nucala isn’t currently FDA-approved for treating asthma in children younger than age 12 years. The drug also isn’t approved for treating EGPA in children younger than age 18 years.

Nucala use with other drugs

If your doctor prescribes Nucala, you’ll take it with your current treatment for severe eosinophilic asthma or eosinophilic granulomatosis with polyangiitis (EGPA).

Keep using all your current asthma or EGPA medications while taking Nucala, even if you start to feel better. Don’t stop taking your medications or reduce your doses unless your doctor tells you to. Stopping your other medications could make your symptoms come back or get worse.

This is especially important for any steroid medications. If you’ve been taking high-dose steroids for a long time, your body may rely on them. This means that if you suddenly stop taking the steroids, you may develop extra side effects.

For severe eosinophilic asthma

If you have severe eosinophilic asthma, you’ll likely use some of the following medications:

• a corticosteroid inhaler such as:
• beclomethasone (Qvar)
• budesonide (Pulmicort)
• fluticasone (Flovent)
• ciclesonide (Alvesco)
• mometasone (Asmanex)
• corticosteroid tablets such as:
• prednisone (Rayos)
• prednisolone
• a long-acting beta-agonist (LABA) inhaler such as:
• salmeterol (Serevent)
• formoterol (Perforomist)
• a combined steroid and bronchodilator inhaler such as:
• fluticasone and salmeterol (Advair Diskus)
• budesonide and formoterol (Symbicort)
• fluticasone and vilanterol (Breo Ellipta)
• fluticasone, vilanterol, and umeclidinium (Trelegy Ellipta)
• mometasone and formoterol (Dulera)
• a short-acting beta-agonist such as:
• albuterol (Proair, Proventil, Ventolin)
• terbutaline
• ipratropium bromide inhalation (Atrovent)
• montelukast (Singulair)
• zafirlukast (Accolate)
• theophylline

For EGPA

If you have EGPA, you may use one or more of the following medications:

• Corticosteroids such as:
• prednisone (Rayos)
• prednisolone
• immunosuppressants such as:
• azathioprine (Azasan, Imuran)
• methotrexate (Rasuvo, Otrexup, Trexall)
• mycophenolic acid (CellCept, Myfortic)

Nucala and alcohol

There aren’t any warnings about avoiding alcohol while you’re receiving Nucala. Alcohol doesn’t affect the medication itself. However, if you find that the Nucala injections give you a headache, drinking alcohol could worsen this side effect.

If you drink alcohol and are concerned about how it might interact with Nucala, talk with your doctor. They can tell you how much is safe for you to drink during your treatment.

Nucala interactions

No drug interaction studies have been done with Nucala. However, based on what’s known about how Nucala works in the body, the drug is unlikely to interact with other medications.

Before taking Nucala, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Nucala and herbs and supplements

No herbs or supplements are known to interact with Nucala. To be on the safe side, always check with your doctor or pharmacist before using treatments like these with Nucala.

Nucala cost

As with all medications, the cost of Nucala can vary. To find current prices for Nucala in your area, check out WellRx.com. The actual price you’ll pay depends on your insurance plan and your location.

Financial and insurance assistance

If you need financial support to pay for Nucala, or if you need help understanding your insurance coverage, help is available.

GlaxoSmithKline LLC, the manufacturer of Nucala, offers a program called Gateway to Nucala. For more information and to find out if you’re eligible for support, call 844‐4‐NUCALA (844‐468‐2252) or visit the program website.

How Nucala is given

Nucala comes in three forms: an injection given by your healthcare provider, a prefilled autoinjector pen, and a prefilled syringe. You can use the autoinjector pen or syringe to give yourself injections.

Healthcare provider injection

Your healthcare provider can give you Nucala as an injection under your skin (subcutaneous injection). You’ll go to their office or clinic for each dose. You may be given the injection in your upper arm, thigh, or abdomen (belly).

If you’re being treated for severe eosinophilic asthma, you’ll have one injection at each visit.

If you’re being treated for eosinophilic granulomatosis with polyangiitis (EGPA), you’ll be given three injections at each visit. The injection sites need to be at least 2 inches apart.

Autoinjector pen and syringe

Nucala also comes as a prefilled autoinjector pen and a prefilled syringe, which you can use to give yourself an injection. You’ll give yourself the injection in your upper arm, thigh, or abdomen (belly).

If you have severe eosinophilic asthma, you’ll need one injection every four weeks.

If you have EGPA, you’ll need three injections (one after the other) by using three syringes or three autoinjector pens. You’ll give yourself these injections every four weeks. Make sure that the injection sites are at least 2 inches apart.

Your healthcare provider will teach you how to give yourself an injection using the autoinjector pen or syringe. Once you’re at home, you can refer to the “Instructions for Use” that come with your autoinjector pen or syringe. You can also get help by calling your healthcare provider or the Nucala Nurse Support Line at 844‐4‐NUCALA (844‐468‐2252).

When Nucala is given

For both eosinophilic asthma and EGPA, you’ll need a Nucala injection once every four weeks.

It’s a good idea to write your injection schedule on a calendar. You can also set a reminder in your phone so that you don’t miss a dose or an appointment. Other medication reminders can help, too.

How Nucala works

Nucala works in a similar way to treat both eosinophilic asthma and eosinophilic granulomatosis with polyangiitis (EGPA).

What happens with asthma and EGPA

Asthma and EGPA are both conditions that are caused by inflammation (swelling).

With asthma, inflammation in your lungs makes your airways swollen. Inflammation also causes your airways to produce more mucus than usual. Both of these factors narrow your airways, making it harder to breathe in and out.

With eosinophilic asthma, the inflammation in your lungs is caused by a large amount of eosinophils, a type of white blood cell.

With EGPA, high levels of eosinophils cause inflammation in some of the tissues and small blood vessels in your body. The tissue inflammation causes some of the first symptoms of EGPA, which usually include:

• asthma
• hay fever (nasal allergies)
• nasal polyps (growths in the lining of your nose that aren’t cancerous)
• sinusitis (sinus inflammation)

The blood vessel inflammation limits blood flow to various parts of your body. As a result, your organs can become damaged.

How Nucala treats asthma and EGPA

Nucala is a biologic drug that was designed to specifically target your eosinophils. Biologic drugs are made from parts of living cells rather than from chemicals. Nucala contains mepolizumab, which is a type of biologic drug called a monoclonal antibody.

Nucala was designed to recognize and bind (attach) to a substance called interleukin 5 (IL-5), which is involved in making eosinophils. When Nucala binds to IL-5, the IL-5stops making eosinophils. As a result, the number of eosinophils drops.

With this specific type of asthma, having fewer eosinophils lessens lung inflammation. This helps reduce asthma symptoms and makes it easier to breathe. With EGPA, having fewer eosinophils causes blood vessels to be less inflamed. This helps your symptoms improve or go into remission (go away).

How long does it take to work?

Nucala doesn’t start to work right away. The drug gradually builds up an effect over time. The length of time it takes for symptoms to improve will vary from person to person.

In clinical studies, Nucala reduced the level of eosinophils in people with severe eosinophilic asthma by 84% within four weeks. In people with EGPA, Nucala reduced the number of eosinophils by 83% within four weeks.

If your symptoms don’t improve or if they get worse after starting Nucala treatment, see your doctor.

Nucala and pregnancy

At the moment, there’s not enough data to say whether Nucala is safe to use in pregnancy. Animal studies didn’t show that the drug harmed the developing fetus. However, animal studies don’t always predict what will happen in humans.

If you have asthma, it’s very important for you to manage it well during pregnancy. Women with asthma that’s poorly controlled during pregnancy have a higher risk of developing problems such as preeclampsia (high blood pressure). They also have a higher risk of their baby being born prematurely (too early) or with a low birth weight.

If you’re pregnant or want to plan a pregnancy while receiving Nucala, talk with your doctor. They can discuss the pros and cons.

Pregnancy registry

If you do decide to have Nucala treatment while pregnant, keep in mind that there’s a pregnancy exposure registry for the drug. If you’re interested in enrolling, talk with your doctor about how to do so.

The registry gathers health information about women with asthma who receive Nucala during their pregnancy. The registry also gathers information about the health of babies born to these women. The data collected will help show whether Nucala causes any unwanted side effects when used during pregnancy. This information will allow other pregnant women to make informed decisions about their asthma treatment in the future.

Nucala and breastfeeding

It’s not known whether Nucala passes into human breast milk. It’s also not known whether it affects the milk production of a pregnant woman taking the drug.

If you want to breastfeed while you’re receiving Nucala, talk with your doctor. They can discuss the pros and cons with you.

Common questions about Nucala

Here are answers to some frequently asked questions about Nucala.

Is Nucala a steroid?

No, Nucala isn’t a steroid. Steroids are medications that are used to reduce inflammation (swelling) in many different diseases. These drugs work in a number of ways. Nucala also reduces inflammation, but in a different and more specific way than steroids do. Nucala targets eosinophils, the blood cells that cause inflammation in severe eosinophilic asthma and eosinophilic granulomatosis with polyangiitis (EGPA).

You take Nucala along with your current steroid treatment. So the two drugs help reduce inflammation in two different ways. If your asthma or EGPA improves after you start taking Nucala, your doctor may reduce your dose of steroids. This may benefit you if you have a lot of side effects from your steroids.

If you have questions about steroids or Nucala, talk with your doctor.

Can Nucala cause cancer?

Clinical studies haven’t found cancer to be a side effect of taking Nucala. And post-marketing reports of the Nucala haven’t mentioned cancer. (These reports contain feedback from people who used Nucala after the Food and Drug Administration [FDA] approved the drug.)

Interestingly, Nucala is currently being investigated as a potential treatment for a rare type of cancer. This cancer is called chronic eosinophilic leukemia.

Does Nucala treat COPD?

No. The FDA hasn’t approved Nucala to treat chronic obstructive pulmonary disease (COPD). COPD is a group of progressive lung diseases that include emphysema and chronic bronchitis.

Eosinophils, a type of white blood cell, are involved in causing severe eosinophilic asthma and eosinophilic granulomatosis with polyangiitis (EGPA). It’s not clear whether eosinophils also play a role in lung inflammation (swelling) in COPD. And COPD specialists don’t agree on how high the level of eosinophils should be to diagnose someone with eosinophilic COPD.

Can Nucala treat other types of asthma?

Nucala is only used to treat severe asthma that involves raised levels of eosinophils, a type of white blood cell. The drug won’t help treat asthma symptoms that aren’t related to lung inflammation (swelling) caused by a large amount of eosinophils. Nucala isn’t used to treat asthma that’s mild or moderate.

Do I need to keep using other asthma drugs while receiving Nucala?

Yes. Nucala is an add-on treatment for your asthma. You must keep using the other asthma medications your doctor prescribes along with Nucala. This includes any steroid medications that you take with an inhaler or as tablets. Steroids are drugs that reduce inflammation (swelling) in your lungs and help keep your asthma under control.

People with severe asthma often need high doses of steroids, but these drugs can cause some serious side effects.

If your asthma symptoms ease and you have fewer severe asthma attacks after you start taking Nucala, your doctor may reduce your dose of steroids. However, don’t change your dose unless your doctor tells you to, or else your asthma could get worse.

Nucala precautions

Before taking Nucala, talk with your doctor about your health history. Nucala may not be right for you if you have certain medical conditions. These include:

• Allergic reaction to Nucala. If you’ve had an allergic reaction to Nucala or any of its ingredients, such as mepolizumab, you shouldn’t take the drug. If you’re unsure whether you’ve had an allergic reaction to Nucala or any of its ingredients in the past, talk with your doctor before you take Nucala.
• Helminth infection. If you have or recently had a helminth infection (a parasitic infection caused by worms), tell your doctor. The infection may need to be treated before you can start taking Nucala.

Note: For more information about the potential negative effects of Nucala, see the “Nucala side effects” section above.

Nucala overdose

Avoid using more than the dosage of Nucala prescribed by your doctor. Clinical studies have not shown dangerous effects at doses higher than recommended. However, high doses of Nucala could increase side effects.

What to do in case of overdose

If you think you’ve taken too much of this drug, call your doctor. You can also call the American Association of Poison Control Centers at 800-222-1222 or use their online tool. But if your symptoms are severe, call 911 or go to the nearest emergency room right away.

Nucala expiration, storage, and disposal

If you’re using a Nucala prefilled autoinjector or prefilled syringe, the expiration date will be printed on the packaging. The expiration date helps guarantee the effectiveness of the medication during this time. The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications. Don’t use the syringe or autoinjector if the expiration date has already passed.

Storage

How long a medication remains good can depend on many factors, including how and where you store the medication.

Keep Nucala prefilled autoinjector pens and prefilled syringes in your refrigerator at 36°F to 46°F (2°C to 8°C) until you need to use them. Don’t freeze Nucala. And don’t use the drug if it has been frozen. Keep the injection in its original box to protect it from light. Don’t shake the box.

If you need to, you can keep autoinjector pens or syringes out of the refrigerator for up to seven days. However, you must keep them unopened in the box at a temperature below 86°F (30°C). Don’t use the injection if it has gotten too hot or if it has been out of the refrigerator for more than seven days.

Only take Nucala autoinjector or syringe out of its box when you’re ready to use it. Don’t use the injection if it has been out of its box for more than eight hours.

Disposal

Carefully dispose of Nucala autoinjector pens and syringes in a sharps bin, whether you have used the injection or not.

The FDA website provides several useful tips on medication disposal. You can also ask your pharmacist for information on how to dispose of your medication.

Professional information for Nucala

The following information is provided for clinicians and other healthcare professionals.

Indications

Nucala is approved to treat severe eosinophilic asthma in adults and children ages 12 years and older. It’s approved as an add-on maintenance treatment for patients not controlled on their current medication. It should not be used to treat acute asthma symptoms or exacerbations.

Nucala is also approved to treat eosinophilic granulomatosis with polyangiitis (EGPA), formerly known as Churg-Strauss syndrome, in adults.

Mechanism of action

Nucala contains mepolizumab, a humanized monoclonal antibody that targets interleukin-5 (IL-5). Mepolizumab attaches to IL-5, stopping it from binding to its receptor complex on the surface of eosinophils. This blocks IL-5 signaling, which reduces production and survival of eosinophils.

Raised eosinophils levels are associated with inflammation. They are a feature of eosinophilic asthma and EGPA. It’s assumed that reducing eosinophils with mepolizumab reduces inflammation in these conditions. However, many other types of cells and cell signaling proteins are involved in causing inflammation, hence the exact mechanism of action is not fully understood.

Pharmacokinetics and metabolism

The pharmacokinetics of Nucala are not expected to be affected by age, sex, race, renal function, or hepatic function.

Nucala is metabolized throughout the body by proteolytic enzymes.

The mean half-life of Nucala ranged from 16 to 22 days following subcutaneous injection.

Contraindications

Nucala is contraindicated in people who have had a hypersensitivity reaction to mepolizumab or its excipients.

Storage

Nucala vials should be stored below 77°F (25°C). Do not freeze the vials. Protect them from light by keeping the vials in their original packaging.

Nucala prefilled autoinjectors and prefilled syringes should be stored in a refrigerator at 36°F to 46°F (2°C to 8°C). Do not freeze Nucala. Store in the original box to protect from light. Do not shake Nucala.

Nucala prefilled autoinjectors and syringes can be stored in unopened packaging for up to seven days below 86°F (30°C). Do not use a Nucala autoinjector or syringe if it has been out of its box for more than eight hours.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.