Nucala: Power to choose
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
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.
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.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Access more information on the dosing, storage and disposal of Nucala.
See the SmPC
SC, subcutaneous; SEA, severe eosinophilic asthma
Nucala is generally well tolerated. In clinical trials, Nucala had a similar incidence of adverse events vs. placebo with the exception of injection site reactions (8% vs. 3%), which occurred mainly within first 3 injections. 1
*Every 4 weeks 1
**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
†Combined primary endpoint analysis of a 12-week, open-label study that assessed the correct use of the Nucala pre-filled pen in patients with SEA following training on proper pen technique at baseline. Successful use was determined using a checklist of steps based on instructions for use and visual inspction 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, a little, moderately , very, and extremely). Of the patients who successfully self-administered at primary endpoint (n=155), 151 patients completed the questionnaire 2