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For NZ residents only

Risks and side effects

Safety information about NUCALA2

NUCALA is used to treat asthma by reducing the frequency of asthma flare ups in patients aged 12 and over who are already receiving asthma medicines, but whose asthma flare ups are not well controlled by medicines such as high-dose corticosteroid inhalers or beta-agonist inhalers.
NUCALA can also be used to help reduce the daily dose of oral corticosteroids in patients taking these medicines to control asthma symptoms and flare ups.
Just like most medications, there are some risks and side effects associated with NUCALA.
Below you can learn about the risks and side effects of NUCALA. This, however, is not all the safety information and does not replace talking to your healthcare provider about your medical condition or treatment. Please see the full Prescribing Information and Patient Information for NUCALA for more information, or ask your healthcare provider.

Please review this safety information

Who should not use NUCALA?

Do not use NUCALA to treat sudden breathing problems.
It is not known if NUCALA is safe and effective in children under 12 years of age.
Do not use NUCALA if you are allergic to mepolizumab or any of the ingredients in NUCALA (see "What are the ingredients in NUCALA?" below).

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

  • 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 parasitic (helminth) infection
  • are pregnant or plan to become pregnant. It is not known if NUCALA may harm your unborn baby
  • 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 asthma medicines unless instructed to do so by 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 that can cause shingles have happened in people who receive 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 tiredness (fatigue).
These are not all the possible side effects of NUCALA. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the Medsafe. Visit www.medsafe.govt.nz, or call 0800 808 500.
No tests have been done to see how NUCALA interacts with other drugs.

What are the ingredients in NUCALA?

Active ingredient: mepolizumab.
Inactive ingredients: citric acid monohydrate, EDTA disodium dihydrate, polysorbate 80, sodium phosphate dibasic heptahydrate, and sucrose.
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Important Safety Information:

Do not use NUCALA if you are allergic (hypersensitive) to mepolizumab or any of the ingredients in NUCALA.

Do not use to treat sudden breathing problems.

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

Tell your doctor or get emergency help right away if you think you are having an allergic reaction to NUCALA.

Any information provided on this website should be discussed with a healthcare professional and does not replace a healthcare professional's advice.

References:
  1. Data Sheet GlaxoSmithKline New Zealand. Nucala Data Sheet. GSK NZ; 2022. Available at http://www.medsafe.govt.nz/profs/datasheet/dsform.asp
  2. Consumer Medicine Information GlaxoSmithKline New Zealand. Nucala Consumer Medicine Information. GSK NZ; 2023. Available at https://www.medsafe.govt.nz/Medicines/infoSearch.asp
  3. Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention 2022. Available from: www.ginasthma.org
  4. Bernstein D, Pavord ID, Chapman KR et al. Usability of mepolizumab single-use prefilled autoinjector for patient self-administration. J Asthma 2019;28:1-12
Nucala (mepolizumab 100 mg) is a Prescription Medicine, available as a 100 mg powder for injection (100 mg/ mL after reconstitution) and as a 100 mg/mL pre-filled pen (auto-injector). Nucala is used as an add-on treatment for; severe eosinophilic asthma in patients 12 years and over, severe chronic rhinosinusitis with nasal polyps (CRSwNP) with an inadequate response to intranasal corticosteroids in adult patients 18 years and older, relapsing or refractory Eosinophilic Granulomatosis with Polyangiitis (EGPA) in adult patients aged 18 years and over, and in adult patients with inadequately controlled hypereosinophilic syndrome (HES) without an identifiable non-haematologic secondary cause. Nucala is given by injection under your skin (subcutaneous). Nucala is fully funded for severe eosinophilic asthma only; Special Authority criteria apply. Use strictly as directed. Nucala has risks and benefits. Do not stop taking your other asthma medications including inhaled and /or oral steroid asthma medications. Tell your doctor if: you have a parasitic (helminth) infection; you are taking prescription and over-the-counter medicines, vitamins, and herbal supplements; you are pregnant or plan to become pregnant; you are breastfeeding or plan to breastfeed. Nucala does not treat acute asthma symptoms, such as sudden asthma attack. Tell your healthcare professional or get emergency help immediately if you have any of the following symptoms of an allergic reaction: swelling of your face, mouth, and tongue, breathing problems, fainting, dizziness, feeling light-headed (low blood pressure), rash or hives. Side effects: headache, injection site reactions (pain, redness, swelling, itching, or a burning feeling at the injection site), back pain, and fatigue. Serious side effects may include allergic (hypersensitivity) reactions, including anaphylaxis. Serious allergic reactions can happen after you get your injection of Nucala. Allergic reactions can sometimes happen hours or days after you get a dose of Nucala. Herpes zoster infections that can cause shingles have happened in people who received Nucala. If symptoms continue or you have side effects, see your doctor, pharmacist or health care professional. For more information, see Nucala Consumer Medicine Information at www.medsafe.govt.nz. Ask your doctor if Nucala is right for you. Normal doctor's charges apply.

This website is intended for residents of New Zealand only.