For NZ residents only

Risks and side effects

Safety information about NUCALA1

Contraindications: hypersensitivity to mepolizumab or to any of the excipients.

Warnings & Precautions: EGPA: NUCALA treated patients may experience a return of EGPA symptoms upon cessation of NUCALA and other EGPA treatments may need to be increased accordingly if NUCALA is discontinued as patients may decrease their other EGPA treatments during NUCALA treatment.

Adverse Reactions: headache, joint pain, nausea, sinusitis, upper respiratory tract infection, diarrhoea, vomiting, injection site reaction.

Please refer to the NUCALA Consumer Medicine Information for more details.

NUCALA Consumer Medicine Information
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Please review this safety information

What side effects can NUCALA cause?1,11

As with all medications, NUCALA can cause side effects, although not everybody gets them. The side effects caused by NUCALA are usually mild to moderate, but can occasionally be serious, 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
The most common side effects of NUCALA in EGPA patients include: headache, joint pain, sinusitis, upper respiratory tract infection, nausea, injection site reactions, diarrhoea and vomiting.
These are not all the possible side effects that you may feel when taking NUCALA. If you experience any side effects not listed here, contact your healthcare professional.
If you get any side effects, tell your doctor or nurse immediately. This includes any possible side effects not listed here.

Storage information11

  • Store in the refrigerator between 2°C and 8°C
  • Keep 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 30° for up to 7 days
  • Safely throw away the pre-filled pen if it is left out of the refrigerator in the unopened carton for more than 7 days
  • The pre-filled pen must be used within 8 hours after you take it out of the carton. Safely throw it away if it is not used within 8 hours
  • Safely throw away medicine that is out of date or no longer needed

Warnings11

  • Do not use the pre-filled pen more than 1 time. Throw away the pre-filled pen according to local requirements after your injection. Ask your doctor or pharmacist for advice if necessary
  • Do not share the pre-filled pen with other people
  • Do not use the pre-filled pen if it was dropped onto a hard surface or looks damaged

Keep NUCALA and all medicines out of the reach of children.11

Frequently asked questions

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At-home Administration11

Your doctor will be able to help you with any more questions you might have.

You or your caregiver should inject a dose of NUCALA as soon as you remember. If you do not notice that you have missed a dose until it is time for your next scheduled dose, then just inject the next scheduled dose as planned. If you are not sure what to do, ask your doctor, pharmacist, or nurse.

Store in the refrigerator between 2°C to 8°C. Keep in the original carton until time of use to protect from light. Do not freeze. Do not shake. Keep away from heat. If needed, an unopened carton can be stored outside the refrigerator at up to 30°C for up to 7 days. Safely throw away the pre-filled pen if the unopened carton is left out of the refrigerator for more than 7 days.

Pre-filled pens must be used within 8 hours after you take them out of the carton. Safely throw away if not used within 8 hours.

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

Store in the refrigerator between 2°C to 8°C. Keep 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 30°C for up to 7 days. Safely throw away the pre-filled pen if the unopened carton is left out of the refrigerator for more than 7 days.

Pre-filled pens must be used within 8 hours after you take them out of the carton. Safely throw away if not used within 8 hours.

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

Do not use the pre-filled pen.

Contact GSK at 0800 808 500.

Pre-filled Pen11

Do not use the pre-filled pen.

Contact GSK for more information at 0800 808 500.

You may change (rotate) the injection site (thighs or abdomen) for each injection. If a caregiver is administering your injection you may also choose the upper arm injection site. When the yellow needle guard is pressed, your injection will start right away.

If this happens, you may not have received your full dose. Contact GSK for more information at 0800 808 500.

Do not use the pre-filled pen more than once. Throw away the pre-filled pen according to local requirements. Ask your doctor or pharmacist for advice if necessary.

Do not share the pre-filled pen with other people.

Do not use the pre-filled pen. Contact GSK at 0800 808 500.

Do not use the pre-filled pen. Contact GSK at 0800 808 500.

If you have any questions, speak to your doctor, nurse or pharmacist.

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Nucala Important Safety Information:1

Contraindications: hypersensitivity to mepolizumab or to any of the excipients.

Warnings & Precautions: EGPA: NUCALA treated patients may experience a return of EGPA symptoms upon cessation of NUCALA and other EGPA treatments may need to be increased accordingly if NUCALA is discontinued as patients may decrease their other EGPA treatments during NUCALA treatment.

Adverse Reactions: headache, joint pain, nausea, sinusitis, upper respiratory tract infection, diarrhoea, vomiting, injection site reaction. Please refer to the Nucala Consumer Medicine Information for more details.

References:
  1. GlaxoSmithKline New Zealand. Nucala Data Sheet. GSK NZ; 2023. Available at https://medsafe.govt.nz/profs/Datasheet/n/nucalainj.pdf. Last accessed 18/11/2024
  2. Fagni, F.; et al. (2021). Front Med. 24(8):627776.
  3. Fijolek, J. & Radzikowska, E. (2023). Front Med 10:1145257.
  4. Gioffredi, A.; et al. (2014). Front Immunol 5:549.
  5. Doubelt, I.; et al. (2021). ACR OpenRheumatol. 3(6): 404-412.
  6. Mohammad, N. & Ghazali, W.S.W. (2017). BMJ Case Rep.
  7. Cottin, V.; et al. (2016). Europ Respir Jour 48:1429-1441.
  8. Low, M.C.; et al. (2019). Int Forum Allergy Rhinol. 10(2): 217-222.
  9. Pagnoux, C., et al. (2007). Curr Opin Rheumatol 19(1): 25-32.
  10. Wechsler M.E.; et al. (2017) N Engl J Med. 376:1921-1932.
  11. GlaxoSmithKline New Zealand. Nucala Consumer Medicine Information. GSK NZ; 2023. Available at https://www.medsafe.govt.nz/Consumers/CMI. Last accessed 18/11/2024
  12. Khoury P; et al. (2014) Nat Rev Rheumatol.10;474-483.
  13. Vaglio A; et al. (2013) Allergy. 68;261-73.
  14. Steinfeld J; et al. (2019) The Journal of Allergy and Clinical Immunology 143(6);2170-2177.
  15. Wechsler ME; et al. (2017) N Engl J Med. 376;1921-1932 (supplementary).
  16. Bernstein D; et al. (2019) Journal of Asthma. 28;1-12.
  17. Klion AD; et al. (2020) Annual Review of Pathology: Mechanisms of Disease. 15;179-209
Nucala (mepolizumab 100 mg) is a Prescription Medicine, available as a 100 mg/mL pre-filled pen (auto-injector). Each pre-filled pen delivers 100 mg mepolizumab in 1 mL. 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 and EGPA 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. Adverse events involving GlaxoSmithKline products should be reported to GSK Medical Information on 0800 808 500.

This website is intended for residents of New Zealand only.

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