Nucala
Pronunciation: new-KAH-la
Generic name: mepolizumab
Dosage form: injection for subcutaneous use (prefilled pen, autoinjector, vial)
Drug class: Interleukin inhibitors
What is Nucala?
Nucala (mepolizumab) is used for severe eosinophilic asthma, chronic rhinosinusitis with nasal polyps, eosinophilic granulomatosis with polyangiitis, and hypereosinophilic syndrome.
Nucala's mechanism of action involves reducing blood eosinophils (a type of white blood cell involved in allergic inflammation) and it does this by targeting interleukin-5 (IL-5), an immune system protein, preventing it from interacting with its receptor on eosinophils. By blocking this interaction, Nucala reduces eosinophil levels, reducing inflammation. See How does Nucala work?
Nucala injection is given every 4 weeks subcutaneously (under the skin). Nucala belongs to the drug class interleukin inhibitors and may also be called a monoclonal antibody or a biologic.
Nucala gained FDA approval on November 4, 2015. There is currently no Nucala generic.
Nucala cost
The cost of Nucala depends on your insurance plan. The MyNucala Patient Support Program can help you understand your company's insurance policies and estimate your out-of-pocket cost. The Nucala Copay Program can help eligible commercially insured patients with out-of-pocket costs for Nucala. Maximums apply.
Patients who are uninsured and meet certain eligibility requirements may qualify for the Patient Assistance Program, which offers free medicine. Patients with Medicare Part D or other insurance may also qualify.
See Nucala Prices, Coupons, Copay Cards & Patient Assistance for a guide to the cost of Nucala.
Nucala uses
Nucala is used together with other medicines to help control severe eosinophilic asthma in adults and children aged 6 years and older. Nucala helps prevent severe asthma attacks but is not a rescue medicine for asthma attacks.
Nucala is also used as an add-on treatment for chronic rhinosinusitis with nasal polyps (CRSwNP) in adults whose disease is not controlled with nasal corticosteroids. Nucala helps reduce symptoms such as nasal congestion, nasal discharge, mucus in the throat, and loss of smell; the size of your nasal polyps; and the use of oral corticosteroid medicines. Nucala also helps prevent surgery for your nasal polyps.
Nucala treats eosinophilic granulomatosis with polyangiitis (EGPA). Nucala helps reduce symptoms and flares, and it may allow a healthcare provider to reduce the dosage of oral corticosteroids.
Nucala also helps reduce symptoms and prevent flares in hypereosinophilic syndrome (HES) in adults and adolescents aged 12 and older.
Nucala side effects
The most common Nucala side effects are:
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headache
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feeling tired (fatigue)
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back pain
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pain, swelling, redness, burning, or itching where the medicine was injected.
Mouth, throat, and joint pain are also commonly reported in people taking Nucala for CRSwNP.
Weight gain has not been reported as a side effect of Nucala (see Can Nucala cause weight gain?).
Serious side effects and warnings
Nucala can cause the following serious side effects.
Allergic (hypersensitivity) reactions, including anaphylaxis. Serious allergic reactions can happen hours or days after you get your Nucala injection. Get emergency medical help if you have signs of an allergic reaction to Nucala: hives, rash; wheezing, chest tightness, difficulty breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat.
Herpes zoster infections. Herpes zoster infections that can cause shingles have happened in
people who received Nucala. Call your doctor at once if you have unusual pain or tiredness, burning or tingling anywhere in your body, or a red or blistering skin rash.
This is not a complete list of side effects and others may occur, see the Nucala PI for a full list. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Before taking
Do not use Nucala if you are allergic to mepolizumab, Nucala, or any of the inactive ingredients in the injection.
Nucala is not approved for use in asthma by a child younger than 6 years old. Nucala should not be used to treat HES in anyone younger than 12 years old, or EPGA or CRSwNP in anyone younger than 18 years old.
To make sure Nucala is safe for you, tell your doctor about all your medical conditions, including if you:
- have or have had a parasite infection (such as roundworms or tapeworms)
- are taking oral or inhaled corticosteroid medicines. Do not stop taking your corticosteroid medicines unless instructed by your healthcare provider. This may cause other symptoms that were controlled by the corticosteroid medicine to come back
- have a history of herpes zoster (also called shingles).
- are pregnant or plan to become pregnant
- are breastfeeding or plan to breastfeed.
You may be given a zoster (shingles) vaccine before you start using Nucala.
If you also use an oral or inhaled steroid medication, you should not stop using it suddenly. Follow your doctor's instructions about tapering your dose.
Your doctor may perform blood tests to make sure you do not have conditions that would prevent you from safely using Nucala.
Pregnancy
It is not known if Nucala may harm your unborn baby. Tell your doctor if you become pregnant while using Nucala. Your name may be listed on a pregnancy registry to track the effects of Nucala on the baby.
Breastfeeding
You and your healthcare provider should decide if you will use Nucala and breastfeed. You should not do both without talking with your healthcare provider first.
How is Nucala administered?
Nucala is injected under the skin, usually once every 4 weeks, either by a healthcare provider or it can be self-administered or given by a caregiver.
- A healthcare provider may teach you how to properly use the medication before self-administering it yourself. Follow all directions on your prescription label and read all medication guides or instruction sheets.
- Nucala may be prescribed as a single-dose prefilled autoinjector for people 12 years of age and older or as a single-dose prefilled syringe for people 6 years of age and older.
Read the Instructions for Use in the Nucala Package Insert that comes with Nucala for details about the right way to give your injections at home.
- You should inject Nucala under your skin (subcutaneously) into your thigh or stomach (abdomen). Also, a caregiver may give the injection in the upper arm.
- Each Nucala prefilled syringe or autoinjector is for one use only. Throw it away after one use, even if there is still medicine left inside.
- See also Can Nucala be self-administered? How is it injected?
Nucala is not a rescue medicine for asthma attacks. Use only fast-acting inhalation medicine for an attack. Seek medical attention if your breathing problems get worse quickly, or if you think your asthma medications are not working as well.
Nucala dosing
Severe eosinophilic asthma
Usual Nucala dose for severe eosinophilic asthma in patients 12 years and older: Nucala 100 mg SC 1 time every 4 weeks.
Usual Nucala dose for severe eosinophilic asthma in children aged 6 to 11 years: Nucala 40 mg SC 1 time every 4 weeks.
Chronic rhinosinusitis with nasal polyps (CRSwNP)
Usual Nucala dose for CRSwNP in adults: Nucala 100 mg SC 1 time every 4 weeks.
Eosinophilic Granulomatosis with Polyangiitis (EGPA)
Usual Nucala dose for EGPA in adults: Nucala 300 mg (as 3 separate 100mg injections) administered SC 1 time every 4 weeks.
Hypereosinophilic Syndrome (HES)
Usual Nucala dose for HES in adults and children aged 12 and older: Nucala 300 mg (as 3 separate 100mg injections) administered SC 1 time every 4 weeks.
Related/similar drugs
Tezspire, Dupixent, prednisone, fluticasone nasal, Symbicort, Breo Ellipta, Ventolin, Ventolin HFA, Xopenex, Dulera
What happens if I miss a dose?
If you miss a dose, inject a dose as soon as possible. Then continue (resume) your injection on your regular dosing schedule.
If you do not notice that you have missed a dose until it is time for your next scheduled dose, then inject the next scheduled dose as planned. Do not use two doses at one time. If you are not sure when to inject Nucala, call your healthcare provider.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while using Nucala?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
What other drugs will affect Nucala?
Tell your doctor about all your current medicines and any you start or stop using, especially:
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an oral (taken by mouth) or inhaled steroid medicine.
Other drugs may interact with Nucala, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your healthcare providers about all medicines you use now and any medicine you start or stop using. Formal drug interaction trials have not been performed with Nucala.
Nucala storage
Store the Nucala prefilled syringe or Nucala autoinjector in the original carton in a refrigerator. Do not freeze or shake the medicine. After removing the medicine from the carton, you must use the syringe or autoinjector within 8 hours.
You may store the prefilled syringe or autoinjector in the unopened carton at room temperature for up to 7 days. Throw away a syringe or autoinjector left out of the refrigerator for more than 7 days.
Safely throw away medicine that is out of date or no longer needed.
Keep out of the reach of children.
Nucala ingredients
Active Ingredient: mepolizumab.
Inactive Ingredients (vials): polysorbate 80, sodium phosphate dibasic heptahydrate, and sucrose.
Inactive Ingredients (prefilled autoinjectors and prefilled syringes): citric acid monohydrate, EDTA, disodium dihydrate, polysorbate 80, sodium phosphate dibasic heptahydrate, and sucrose.
Nucala for injection is available as:
- Nucala 100 mg of lyophilized powder in a single-dose vial for reconstitution
- Nucala 100 mg/mL, single-dose prefilled autoinjector or single-dose prefilled syringe
- Nucala 40 mg/0.4 mL, single-dose prefilled syringe.
Who makes Nucala?
GlaxoSmithKline LLC, makes Nucala.
Popular FAQ
How long does it take for Nucala to work?
Nucala starts working within 48 hours; however, it may take up to 4 weeks before the maximum effect of Nucala is seen for both asthma and eosinophilic granulomatosis with polyangiitis (EGPA). In asthma, the greatest reductions in eosinophils were seen with higher dosages, for example, a 64% reduction in eosinophils was seen with a 12.5mg SC dose and a 90% reduction was seen with a 250mg SC dose after 48 hours. Continue reading
Can Nucala cause weight gain?
Weight gain has not been reported as a side effect of Nucala during clinical trials. Medications such as corticosteroids that may be used to treat eosinophilic asthma are more likely to cause weight gain. Continue reading
Can Nucala be self-administered? How is it injected?
Yes, Nucala can be self-administered. Nucala is available as a prefilled syringe or autoinjector that can be self-administered after a doctor has shown you how to administer it. 99% of people can successfully self-administer the Nucala prefilled syringe and 89-95% can successfully administer the Nucala autoinjector. Continue reading
How does Nucala (mepolizumab) work? What is the MOA?
Nucala (mepolizumab) works by lowering the activity of white blood cells called eosinophils. Too many eosinophils can sometimes lead to inflammation in the body. Nucala is a monoclonal antibody that blocks a cytokine called interleukin-5 (IL-5). Continue reading
What is Nucala (mepolizumab) used for and how is it given?
Nucala (mepolizumab) is a biologic therapy used for the treatment of severe eosinophilic asthma, eosinophilic granulomatosis with polyangiitis (EGPA), and hypereosinophilic syndrome (HES). It is given by subcutaneous injection every four weeks. Continue reading
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