Nucala

What is Nucala?

Nucala is a prescription medicine:

• • for the add-on maintenance treatment of severe asthma in people 6 years of age and older whose asthma is not controlled with their current asthma medicines. Nucala helps prevent severe asthma attacks (exacerbations).
    Nucala is not used to treat sudden breathing problems that occur with asthma.
  • for the treatment of adults with eosinophilic granulomatosis with polyangiitis (EGPA). Nucala helps reduce symptoms and flares, and it may allow your healthcare provider to reduce your oral corticosteroid medicine.
  • for the treatment of people 12 years of age and older with hypereosinophilic syndrome (HES). Nucala helps reduce symptoms and prevent flares.

Medicines such as Nucala reduce blood eosinophils. Eosinophils are a type of white blood cells that may contribute to your disease.

• It is unknown if Nucala is safe and effective in children with severe asthma under 6 years of age.
• It is unknown if Nucala is safe and effective in children and adolescents with EGPA under 18 years of age.
• It is unknown if Nucala is safe and effective in children with HES under 12 years of age.

Description

Mepolizumab is a humanized IL-5 antagonist monoclonal antibody. Mepolizumab is produced by recombinant DNA technology in Chinese hamster ovary cells. Mepolizumab has a molecular weight of approximately 149 kDa.

NUCALA for injection is a sterile, preservative-free, white to off-white, lyophilized powder in a single-dose vial for subcutaneous injection after reconstitution. Upon reconstitution with 1.2 mL of Sterile Water for Injection, USP, the resulting concentration is 100 mg/mL and delivers 1 mL [see Dosage and Administration (2.5)]. Each vial delivers 100 mg of mepolizumab, polysorbate 80 (0.67 mg), sodium phosphate dibasic heptahydrate (7.14 mg), and sucrose (160 mg), with a pH of 7.0.

The vial stopper is not made with natural rubber latex.

NUCALA injection is a sterile, preservative-free, clear to opalescent, colorless to pale yellow to pale brown solution for subcutaneous use.

NUCALA injection is supplied in a single-dose, 1-mL, prefilled autoinjector with a fixed 29-gauge, half-inch needle and in a single-dose, 1-mL, prefilled syringe with a fixed 29‑gauge, half-inch needle with a needle guard. Each 1 mL delivers 100 mg mepolizumab, citric acid monohydrate (0.95 mg), EDTA disodium dihydrate (0.019 mg), polysorbate 80 (0.20 mg), sodium phosphate dibasic heptahydrate (4.16 mg), and sucrose (120 mg), with a pH of 6.3.

NUCALA injection is supplied in a single-dose, 0.4-mL, prefilled syringe with a fixed 29-gauge, half-inch needle with a needle guard. Each 0.4 mL delivers 40 mg mepolizumab, citric acid monohydrate (0.38 mg), EDTA disodium dihydrate (0.0074 mg), polysorbate 80 (0.08 mg), sodium phosphate dibasic heptahydrate (1.66 mg), and sucrose (48 mg), with a pH of 6.3.

The prefilled autoinjector and prefilled syringe are not made with natural rubber latex.

Mechanism of Action

Mepolizumab is an IL-5 antagonist (IgG1 kappa). IL-5 is the major cytokine responsible for the growth and differentiation, recruitment, activation, and survival of eosinophils. Mepolizumab binds to IL-5 with a dissociation constant of 100 pM, inhibiting the bioactivity of IL-5 by blocking its binding to the alpha chain of the IL-5 receptor complex expressed on the eosinophil cell surface. Inflammation is an important component in the pathogenesis of asthma, CRSwNP, EGPA, and HES.

Multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines) are involved in inflammation. Mepolizumab, by inhibiting IL-5 signaling, reduces the production and survival of eosinophils; however, the mechanism of mepolizumab action in asthma, CRSwNP, EGPA, and HES has not been definitively established.

Who should not use Nucala?

Do not use Nucala if you are allergic to mepolizumab or any of the ingredients in Nucala. See the end of this guide for a complete list of ingredients in Nucala.

What should I tell my healthcare provider before using Nucala?

Before receiving Nucala, tell your healthcare provider about all of your medical conditions, including if you:

• have a parasitic (helminth) infection.
• 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.
• are pregnant or plan to become pregnant. It is not known if Nucala may harm your unborn baby.
  • Pregnancy Registry. There is a pregnancy registry for women with asthma who receive Nucala while pregnant. The purpose of the registry is to collect information about the health of you and your baby. You can talk to your healthcare provider about how to take part in this registry or you can get more information and register by calling 1-877-311-8972 or go to www.mothertobaby.org/asthma.
• are breastfeeding or plan to breastfeed. 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.
• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
• Do not stop taking your other medicines unless instructed to do so by your healthcare provider.

How should I use Nucala?

Your healthcare provider will prescribe the dose that is right for you depending on what you are being treated for.

When injection is given by a healthcare provider:

• A healthcare provider will inject Nucala under your skin (subcutaneously) every 4 weeks.

When injection is given by a patient or patient caregiver with a prefilled syringe or prefilled autoinjector:

• Use Nucala every 4 weeks exactly as your healthcare provider tells you to.
• Read the Instructions for Use that comes with Nucala for instructions about the right way to give your injections at home.
• Nucala may be prescribed as a single-dose prefilled autoinjector or as a single-dose prefilled syringe for people 12 years of age and older.
• Before you use Nucala, your healthcare provider will show you or your caregiver how to give the injections.
• You should inject Nucala under your skin (subcutaneously) into your thigh or stomach (abdomen). Also, a caregiver may give the injection in your upper arm.
• 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. If you are not sure when to inject Nucala, call your healthcare provider.

What are the possible side effects of Nucala?

Nucala can cause serious side effects, including:

• allergic (hypersensitivity) reactions, including anaphylaxis. Serious allergic reactions can happen after you get your Nucala injection. Allergic reactions can sometimes happen hours or days after you get a dose of Nucala. Tell your healthcare provider or get emergency help right away if you have any of the following symptoms of an allergic reaction:
  • swelling of your face, mouth, and tongue
  • breathing problems
  • fainting, dizziness, feeling lightheaded (low blood pressure)
  • rash
  • hives

• herpes zoster infections. Herpes zoster infections that can cause shingles have happened in people who received Nucala.

The most common side effects of Nucala include: headache, injection site reactions (pain, redness, swelling, itching, or a burning feeling at the injection site), back pain, and weakness (fatigue).

These are not all the possible side effects of Nucala.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Nucala

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information guide. Do not give Nucala to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Nucala that is written for health professionals.

How should I store Nucala?

• Store prefilled autoinjectors and prefilled syringes in the refrigerator between 36°F to 46°F (2°C to 8°C).
• Keep prefilled autoinjectors and prefilled syringes in the original carton until time of use to protect from light.
• Do not freeze. Do not shake. Keep away from heat.
• If necessary, an unopened carton can be stored outside the refrigerator at up to 86°F (30°C) for up to 7 days.
• Safely throw away prefilled autoinjectors and prefilled syringes if the unopened carton is left out of the refrigerator for more than 7 days.
• Prefilled autoinjectors and prefilled syringes must be used within 8 hours after you take them out of the carton. Safely throw away if not used within 8 hours.
• Safely throw away medicine that is out of date or no longer needed.

Keep Nucala and all medicines out of the reach of children.

What are the ingredients in Nucala?

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.

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