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Administration diagram

Dosing and administration

Simple fixed dosing 1

  • Nucala is available as a single fixed dose that is independent of the patient’s weight
  • Nucala 100mg is administered by a healthcare professional subcutaneously once every 4 weeks as a single injection to the upper arm, thigh or abdomen

Storing Nucala

The shelf-life of an unopened vial of Nucala is 4 years:

  • Store below 25°C
  • Do not freeze
  • Keep the vial in the outer carton in order to protect from light

Nucala is provided as a lyophilised powder in a single-use vial. Because Nucala does not contain a preservative, reconstitution should be carried out under aseptic conditions. 1

The simple steps to Nucala reconstitution 1

Watch this video to see how Nucala is reconstituted.

For demonstration purposes only. Please see the Nucala Summary of Product Characteristics for complete reconstitution and administration instructions.1

Reconstitute the contents of the vial with 1.2 mL of sterile water for injection.

Following reconstitution, Nucala should be visually inspected for particulate matter and clarity prior to use: 1

  • The solution should be clear to opalescent and colourless to pale yellow or pale brown, free of visible particles
  • Small air bubbles, however, are expected and acceptable
  • If particulate matter remains in the solution or if the solution appears cloudy or milky, the solution must be discarded.

Now Nucala is ready to be administered. If the reconstituted solution is not used immediately, it must be: 1

  • Protected from sunlight
  • Stored below 30°C, not frozen
  • Discarded if not used within 8 hours of reconstitution

See the SPC to find out more information on the reconstitution and administration of Nucala

Administering Nucala

Nucala should be administered by a healthcare professional. 1

In line with clinical practice for biologic agents, monitoring of signs and symptoms of hypersensitivity after administration should be considered.

1. For SC administration, a 1mL polypropylene syringe fitted with a disposable needle 21G to 27G x 0.5 inch (13mm) should preferably be used 1

2. Just prior to administration, remove 1mL of reconstituted Nucala 1
Do not shake the reconstituted solution during the procedure as this could lead to product foaming or precipitation 1

3. Administer the 1mL injection (equivalent to 100mg mepolizumab) subcutaneously into the upper arm, thigh, or abdomen 1

Acute and delayed systemic reactions, including hypersensitivity reactions (e.g. anaphylaxis, urticaria, angioedema, rash, bronchospasm, hypotension), have occurred following administration of Nucala. These reactions generally occur within hours of administration, but in some instances have a delayed onset (i.e. days). 1

See the SPC to find out more information on the reconstitution and administration of Nucala

References:

  1. Nucala Summary of Product Characteristics Last accessed: March 2019.

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Adverse events should be reported to the Health Products Regulatory Authority (HPRA) using an Adverse Reaction Report Form obtained either from the HPRA or electronically via the website at www.hpra.ie. Adverse reactions can also be reported to the HPRA by calling: (01) 6764971. Adverse events should also be reported to GlaxoSmithKline on 1800 244 255.

NUCALA is a registered trademark of the GlaxoSmithKline Group of Companies.