Nucala (mepolizumab)

Nucala generic or biosimilar

Nucala is a brand-name medication that contains mepolizumab, which is a biologic medication. It’s not available as a biosimilar. (Biosimilars are like a generic version of a biologic medication.)

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 concerning or bothersome.

More common side effects

Side effects of Nucala can vary depending on the condition you’re taking the drug for.

In clinical trials of people with eosinophilic asthma, eosinophilic granulomatosis with polyangiitis, or hypereosinophilic syndrome, more common side effects included:

• headaches
• injection site reactions, such as pain, redness or deepening of skin color, itching, swelling, or burning in the injection area
• back pain
• fatigue

In clinical trials of people with rhinosinusitis, more common side effects included:

• pain in the mouth and throat
• joint pain

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 can include:

• herpes zoster infection, also called shingles
• allergic reaction

ALLERGIC REACTION

Allergic reaction, including a severe reaction called anaphylaxis, is possible with Nucala.

In general, symptoms of an allergic reaction can be mild or serious. In clinical trials, 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.

Ways to manage

For mild allergic reaction symptoms, such as a mild rash, call your doctor right away. They may recommend treatments to help manage your symptoms. They’ll also let you know whether you should keep using Nucala.

For severe allergic reaction symptoms, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms require immediate medical care because they can become life threatening. If you’ve had a serious allergic reaction to Nucala, your doctor may recommend a different medication instead.

Nucala dosage

The Nucala dosage your doctor prescribes depends on the condition you’re taking Nucala to treat. The following information describes dosages that are commonly used or recommended.

Drug forms and strengths

Nucala is given as a subcutaneous injection. The drug comes in three forms and strengths, described in the following table. Strength is given in milligrams (mg) and mg per milliliter (mL).

Your doctor or a healthcare professional may show you (or a caregiver) how to inject Nucala at home, using the prefilled syringe or prefilled autoinjector.

Dosage for asthma

Nucala’s recommended dosage for eosinophilic asthma in adults and children ages 12 years and older is 100 mg (one injection) every four weeks.

For children ages 6 to 11 years, Nucala’s recommended dosage is 40 mg (one injection) every four weeks.

Dosage for COPD

The recommended Nucala dosage for COPD is 100 mg (one injection) every four weeks.

Dosage for eosinophilic granulomatosis with polyangiitis

The recommended Nucala dosage for eosinophilic granulomatosis with polyangiitis is 300 mg (three injections) on the same day, once every four weeks.

Dosage for chronic rhinosinusitis

The recommended Nucala dosage for chronic rhinosinusitis with nasal polyps is 100 mg (one injection) every four weeks.

Dosage for hypereosinophilic syndrome

The recommended Nucala dosage for hypereosinophilic syndrome is 300 mg (three injections) on the same day, once every four weeks.

What if I miss a dose?

If you miss giving yourself 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 almost time for your next one, follow your normal schedule. Call your doctor or a pharmacist if you’re not sure whether to give your missed injection right away or wait.

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

It’s important to keep having your injections as scheduled, even if your symptoms start to go away. It’s a good idea to note your injection schedule on your calendar. You can also set a reminder on 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 eosinophilic asthma

Nucala is FDA-approved to treat severe eosinophilic asthma in adults and children ages 6 years and older. For this use, Nucala is an add-on treatment. This means you take it in addition to your other asthma medications, typically corticosteroids (steroids).*

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 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.

Symptoms can include wheezing, being short of breath, coughing, and chest tightness. These symptoms can greatly affect your day-to-day life. You can refer to our asthma and allergies hub to learn more.

If you and your doctor are considering Nucala, your doctor will 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 Nucala injections do not work to treat asthma attacks or sudden breathing problems. You should instead use a rescue inhaler for this purpose.

* In clinical trials, some people were able to have their steroid dosage lowered after starting Nucala treatment. However, it’s important 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 COPD

Nucala is FDA-approved to treat COPD associated with high levels of eosinophils. This may be referred to as eosinophilic COPD or COPD with an eosinophilic phenotype. For this use, Nucala is an add-on treatment. This means you take it in addition to your other COPD medication.

COPD is group of lung diseases that includes emphysema (damage to the air sacs in your lungs) and chronic bronchitis (long-term inflammation in your airways that gets worse over time). Eosinophils are thought to contribute to airway inflammation in COPD.

Symptoms of COPD can include:

• difficulty breathing or breathlessness, especially with physical exertion
• chest tightness
• wheezing
• coughing that produces mucus
• lung infections that cause symptoms to flare up

Nucala works to decrease inflammation in your airways. It can also reduce how many COPD flare-ups you have (also called exacerbations) and how severe they are.

You’ll use use other COPD treatments along with monthly Nucala injections, including inhalers. Nucala should not be used to treat breathing emergencies such as severe COPD flare-ups. You should use a rescue inhaler, such as albuterol, in these situations.

Nucala for eosinophilic granulomatosis with polyangiitis

Nucala is FDA-approved to treat a rare condition called eosinophilic granulomatosis with polyangiitis (EGPA) in adults. This condition used to be called Churg-Strauss syndrome.

With EGPA, high levels of eosinophils cause inflammation 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. In Nucala’s clinical trials, some conditions went into remission, meaning people had no symptoms or symptoms that were mild enough to not affect their daily lives. People also had fewer relapses (symptom flare-ups) after starting Nucala.

Nucala for rhinosinusitis

Nucala is FDA-approved to treat chronic rhinosinusitis with nasal polyps in adults. It’s prescribed as an add-on treatment, meaning you take it in addition to your other rhinosinusitis medications. These other medications may include mometasone (Nasonex), triamcinolone (Nasacort), beclomethasone (Beconase AQ), or others.

Nucala is prescribed for rhinosinusitis that isn’t responding well to nasal corticosteroid treatment.

Chronic (long-term) rhinosinusitis causes long-term inflammation in your nose and sinuses. This condition can involve nasal polyps. These are benign (noncancerous) growths in your nose.

Possible symptoms of chronic rhinosinusitis with nasal polyps include:

• reduced sense of smell or loss of smell
• nose and sinus congestion
• mucus draining from the nose
• facial pain or pressure

Nucala for hypereosinophilic syndrome

Nucala is FDA-approved to treat hypereosinophilic syndrome (HES) in adults and children ages 12 years and older. It’s prescribed for HES that’s been present for at least 6 months and isn’t known to be caused by a blood condition such as cancer.

With HES, you have a very high level of eosinophils. Over time, the eosinophils spread into tissues throughout your body. This often affects the heart, skin, lungs, and nervous system. Symptoms vary depending on which part of the body is affected, and may include:

• rash
• shortness of breath
• dizziness
• fatigue
• cough
• mouth sores
• confusion or memory problems

Nucala and children

Nucala is approved to treat severe eosinophilic asthma in children ages 6 years and older. It’s also approved to treat HES in children ages 12 years and older.

Nucala isn’t currently approved to treat EGPA, COPD, or rhinosinusitis in children.

Common questions about Nucala

Here are answers to some frequently asked questions about Nucala.

Is Nucala a steroid?

No, Nucala isn’t a steroid. It’s a type of drug called a monoclonal antibody.

Steroids are medications that are used to reduce inflammation with many different conditions. 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, which are blood cells that cause inflammation in the conditions Nucala is approved to treat.

If you’re currently on steroid treatment, you’ll likely take Nucala along with your steroid. The two drugs help reduce inflammation in different ways. If your condition 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?

No, clinical studies haven’t found cancer to be a side effect of taking Nucala. And post-marketing reports of 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.

Is Nucala an immunosuppressant?

Nucala is not classified as an immunosuppressant, which is a drug that works by suppressing (reducing) immune system activity. But Nucala does have the effect of reducing some immune system activity. The drug reduces your levels of eosinophils (a type of white blood cell), which are part of the immune system.

Can Nucala treat other types of asthma?

No, Nucala is only used to treat severe asthma that involves increased levels of eosinophils, a type of white blood cell. The drug won’t help treat asthma symptoms that aren’t related to lung inflammation caused by a large amount of eosinophils. Nucala also 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.

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.

It’s also important to note that Nucala does not work to treat asthma or COPD attacks or sudden breathing problems. You should instead use your rescue inhaler as needed.

How Nucala works

The conditions Nucala treats are all thought to be caused by having high levels of eosinophils. These are a type of white blood cell that cause inflammation. Having too many eosinophils leads to too much inflammation in the body, which can cause symptoms such as trouble breathing, nasal polyps, and more.

Nucala contains the active ingredient mepolizumab, which is designed to specifically target eosinophils. It’s a type of biologic drug called a monoclonal antibody.

Nucala’s mechanism of action (how the drug works in the body) is 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-5 stops making eosinophils. As a result, the number of eosinophils decreases.

Having fewer eosinophils lessens inflammation. This may help reduce your symptoms or make symptoms go away. For example, if you have asthma or COPD, Nucala should make it easier to breathe.

How long does Nucala take to work?

Nucala doesn’t start to work right away. The drug gradually builds up an effect over time. In clinical trials, Nucala reduced people’s levels of eosinophils within four weeks. However, the length of time it takes for symptoms to ease will vary from person to person.

If your symptoms don’t ease or if they get worse after starting Nucala treatment, see 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 prescribed off-label. Off-label drug use means prescribing a drug for a purpose other than what it’s been approved for by the FDA.

Alternatives for 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 chronic obstructive pulmonary disease (COPD)

Examples of other drugs that may be used to treat COPD include:

• albuterol (ProAir, Ventolin)
• levalbuterol (Xopenex)
• formoterol (Perforomist, Brovana)
• budesonide (Pulmicort)
• fluticasone propionate/salmeterol (Advair, Flovent)
• budesonide/formoterol (Symbicort)

Alternatives for eosinophilic granulomatosis with polyangiitis (EGPA)

Examples of other drugs that may be used to treat EGPA include:

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

Alternatives for chronic rhinosinusitis with nasal polyps

Examples of other drugs that may be used to treat chronic rhinosinusitis with nasal polyps include:

• beclomethasone (Beconase AQ)
• ciclesonide (Omnaris, Zetonna)
• fluticasone (Flonase, Xhance)
• mometasone (Nasonex)

Alternatives for hypereosinophilic syndrome (HES)

Examples of other drugs that may be used to treat HES include:

• corticosteroids, such as methylprednisolone (Solu-Medrol)
• cyclophosphamide (Cytoxan)
• hydroxyurea (Hydrea)
• imatinib (Gleevec)

Nucala vs. Fasenra

Nucala and Fasenra (benralizumab) are both biologic drugs approved to treat:

• severe eosinophilic asthma in adults and children ages 6 years and older
• eosinophilic granulomatosis with polyangiitis in adults

Nucala is also approved for other conditions (see the “Nucala uses” section for details).

Both drugs are given as subcutaneous injections using a prefilled syringe or a prefilled autoinjector pen. 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.

These drugs can cause some similar side effects and some different ones as well. For example, shingles has been reported with Nucala but not with Fasenra.

Nucala vs. Xolair

Nucala and Xolair (omalizumab) are both biologic drugs that are approved to treat:

• Chronic rhinosinusitis with nasal polyps in adults.
• Asthma in certain situations, specifically:
  • Xolair is approved to treat moderate to severe persistent allergic asthma in adults and children ages 6 years and older.
  • Nucala is approved to treat severe eosinophilic asthma in adults and children ages 6 years and older.

Both drugs are approved for other uses as well.

Nucala and Xolair are each given as subcutaneous injections using a prefilled syringe or a prefilled autoinjector pen. Nucala is given once every four weeks. Xolair may be given once every two weeks or once every four weeks.

Nucala and Xolair have some similar side effects and some different ones as well. For example, both drugs can cause allergic reaction, including a severe reaction called anaphylaxis. Only Xolair has a boxed warning about this risk. (A boxed warning is the most serious warning from the Food and Drug Administration.)

Nucala vs. Dupixent

Dupixent (dupilumab) is approved for some of the same conditions as Nucala, including eosinophilic asthma, eosinophilic COPD, and chronic rhinosinusitis with nasal polyps. Dupixent is injected every 2 weeks, compared to every 4 weeks with Nucala. You can refer to this Nucala vs. Dupixent article for details.

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 with Nucala.

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. 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.

A Nucala Copay Program is available. 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 as a subcutaneous injection in three forms: an injection given by your healthcare professional, a prefilled autoinjector pen, and a prefilled syringe. You can use the autoinjector pen or syringe to give yourself injections.

Depending on the condition you’re taking Nucala for, you might have one or three Nucala injections. For multiple injections, the injection sites need to be at least 2 inches apart.

Healthcare professional injection

Your healthcare professional can give you Nucala doses at their office or clinic. You may be given the injection in your upper arm, thigh, or abdomen.

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 thigh or abdomen. If a caregiver (such as a family member or friend) gives you the injection, they can give it in your upper arm, as well.

Your healthcare professional 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. Nucala’s website also has video instructions and written instructions. And you can get help by calling your healthcare professional or the MyNucala Support Line at 844‐4‐NUCALA (844‐468‐2252).

When Nucala is given

Nucala injections are usually given once every four weeks.

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

Nucala and pregnancy

Currently there is not enough data to say whether Nucala is safe to use in pregnancy. You can refer to this article about Nucala’s safety during pregnancy or breastfeeding or talk with your doctor for more information.

Nucala and breastfeeding

It’s not known whether Nucala passes into human breast milk. It’s also not known whether it affects milk production. Refer to this article about Nucala’s safety during pregnancy or breastfeeding or talk with your doctor for more information.

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. 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.

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

Nucala overdose

Avoid injecting more than the dosage of Nucala prescribed by your doctor. Using more Nucala than your doctor recommends could increase the risk or severity of 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 America’s Poison Centers at 800-222-1222 or use its online tool. But if your symptoms are severe, call 911 or go to the nearest emergency room right away.

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.