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Fortsett

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Dosage and administration

Starting your patients on Nucala

Nucala is indicated as an add-on treatment for severe refractory eosinophilic asthma in adults, adolescents and children aged 6 years and older. 1

The Nucala clinical development programme evaluated efficacy in a targeted group of patients with severe refractory eosinophilic asthma most likely to benefit from treatment, using 3 criteria:

  1. Current therapy – high doses of inhaled corticosteroids (ICS, e.g. fluticasone propionate ≥1000 μg or budesonide ≥1600 μg per day2) and an additional maintenance treatment(s)
  2. Exacerbation history – two or more exacerbations in the previous 12 months and/or dependency on systemic corticosteroids
  3. Blood eosinophil levels – ≥150 cells/μL (≥0.15 x 109cells/L) at initiation of treatment or ≥300 cells/μL (≥0.3 x 109cells/L) in the prior 12 months (determined through a routine blood test)

Dosing and administration 1

Nucala is for subcutaneous (SC) administration once every 4 weeks, 100mg (1.0mL) for adults and adolescents ≥12 years, 40mg (0.4mL) for children aged 6 to 11 years old.

There is no need to adjust dose for elderly patients or for those with renal or hepatic impairment.

Nucala is for SC injection only. Nucala should be administered by a healthcare professional as a subcutaneous injection into the upper arm, thigh or abdomen. It should be reconstituted prior to administration and should be used immediately upon withdrawal from the vial into a syringe.

Nucala is provided as a lyophilised powder in a single-use vial for SC injection only, that must be reconstituted prior to administration. Nucala does not contain a preservative, and therefore reconstitution should be carried out under aseptic conditions.

For information on how to reconstitute Nucala, watch the video

For more information on dosing and administration of Nucala, see the Summary of Product Characteristics

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

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

Step-by-step: how to prepare Nucala 1

1. Ensure you have everything you need to reconstitute Nucala

You will need: an unopened vial of Nucala, 1.2mL of sterile water for injection, a syringe (preferably 2 to 3mL) and a needle (preferably 21G)

Each pack of Nucala contains a single vial of lyophilised powder. All other required elements to be sourced separately.

2. Draw up 1.2mL of sterile water for injection into the syringe

3. Reconstitute the contents of the vial with 1.2mL of sterile water for injection. The stream of water should be directed vertically, onto the centre of the lyophilised cake. 1

4. Allow the vial to sit at room temperature during reconstitution, gently swirling the vial for 10 seconds with circular motion at 15-second intervals until the powder is dissolved.

If a mechanical reconstitution device (swirler) is used to reconstitute Nucala, reconstitution can be accomplished by swirling at 450rpm for no longer than 10 minutes. Alternatively, swirling at 1000rpm for no longer than 5 minutes is acceptable

Note: The reconstituted solution must not be shaken during the procedure as this may lead to product foaming or precipitation. Reconstitution is typically complete within 5 minutes after the water has been added, but it may take additional time.

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

6. The reconstituted solution, if not used immediately, must be: 1

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

7. Now Nucala is ready to be administered

Please see the Nucala Summary of Product Characteristics for complete reconstitution and administration instructions.

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

Step-by-step: how to administer Nucala 1

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

  1. For subcutaneous 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 the required dose 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 injection subcutaneously into the upper arm,thigh, or abdomen. 1

Please see full Prescribing Information for complete reconstitution and administration instructions.

Disposal

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Storage

  • The shelf-life of Nucala before reconstitution is 4 years:
    • Do not open vial
    • Store below 25°C
    • Do not freeze
    • Keep the vial in the outer carton in order to protect from light

References:

  1. Nucala SmPC.
  2. Chung KF, Wenzel SE, Brozek JL et al. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J 2014; 43(2):343-73

Nucala is a trademark of the GSK group of companies