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Fortsett

Tilbake

Pre-filled pen

Pre-filled syringe

Lyophilised powder

Once-monthly dosing1

Nucala is a once-monthly* asthma biologic with a single fixed dose.**

The Nucala pen: Easy to use2

In patients with severe eosinophilic asthma and caregivers:

found the pen very or extremly easy to use (94/102 and 44/51)2

successfully used the pen (102/103 and 53/54)2

Posology

Nucala is a once-monthly* asthma biologic with a single first dose.**1

Find out full posology information for Nucala.
See the SmPC

Administration

Nucala: The power to choose

The Nucala pre-filled pen or pre-filled syringe should be used for subcutaneous injection only. For self-administration the recommended injection sites are the abdomen or thigh. A caregiver can also inject Nucala into the upper arm.1

Watch Instructions for use videos

Get complete information in the dosing and administration of Nucala. 

See the SmPC

See an illustrated guide to administering Nucala 100mg solution in pre-filled pen.

The recommended dose of Nucala is 100mg SC once every 4 weeks in adults and adolescents 12 years and older, available in pre-filled pen, pre-filled syringe or as lyophilised powder. The licensed dose of Nucala in children 6 – 11 years is 40 mg regardless of weight and is available as a lyophilised powder.2

Storage and disposal

The shelf-life of Nucala 100mg powder is 4 years. The shelf-life of Nucala 100mg solution for injection in pre-filled pen and pre-filled syringe is 2 years.

Nucala pen and pre-filled syringe

  • Store in a refrigerator (2 – 8◦ C)
  • Do not freeze
  • Store in the original carton in order to protect from light

If necessary, the pen and pre-filled syringe can be removed from the refrigerator and kept in the unopened pack for up to 7 days at room temperature (up to 30◦ C), when protected from light. The pack should be discarded if left out of the refrigerator for more than 7 days. The pen or pre-filled syringe must be administered within 8 hours once the pack is opened. The pack should be discarded if not administered within 8 hours.

Lyophilised powder
The reconstituted solution, if not used immediately, must be:

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

Chemical and physical stability of the reconstituted medicinal product have been demonstrated for 8 hours when stored below 30◦ C.

From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.

Disposal1
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Access more information on the storage and disposal of Nucala.
See the SmPC

SC, subcutaneous; SEA, severe eosinophilic asthma

*Every 4 weeks1
**The recommended dose of Nucal ais 100mg SC once every 4 weeks in adults and adolescents 12 years and older, available in pre-filled pen, pre-filled syringe or as lyophilised powder. The licensed dose of Nucala in children aged 6 – 11 years is 40mg SC regardless of weight, and is available as a lyophilised powder
† A 12-week open-label, single-arm study assessing correct use of the Nucala pre-filled pen in 159 patients with SEA following training on proper pen technique at baseline. One group used a pen with pictogram (n=104) and one without pictogram label (n=55). Successful use was determined using a checklist of steps based on instructions for use and visual inspection of the pen (155 of 157 attempted injections). Ease of use was measured through a patient questionnaire at the end of the study using a 5-point scale (not at all, a little, moderately, very and extremely). Of the patients who successfully self-administered at primary endpoint week 8 (n=155), 151 patients completed the questionnaire. Two patients were withdrawn from the study (1 physician decision and 1 adverse event). Primary endpoint (successful injection week 8, third dose of Nucala) was achieved by 99% (102/103, 95% CI 95-100%) using pen with pictogram label and 98% (53/54, 95% CI 90-100%) using pen with standard label. 92% (94/102) of patients using the pen with pictogram and 86% (44/51) of patients using the pen without pictogram found Nucala pen "very" or "extremely" easy to self-administer at home.
2

Nucala pre-filled pen and pre-filled syringe may be self-administered by the patient or administered by a caregiver if their healthcare professional determines that it is appropriate, and the patient or caregiver are trained in injection techniques.

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., typically within several days). These reactions may occur for the first time after a long duration of treatment.

References:

  1. Nucala SmPC.
  2. Bernstein D et al. Journal of Asthma 2019 June 28: 1-12. doi: 10.1080/02770903.2019.1630641.

Nucala is a trademark of the GSK group of companies