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Nucala: Power to choose

Once-monthly dosing 1

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

The Nucala pen: Easy to use 2

In patients with severe eosinophilic asthma and caregivers:

POSOLOGY

Nucala is the only 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 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

STORAGE AND DISPOSAL 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 pre-filled pen

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

If necessary, the pre-filled pen can be removed from the refrigerator and kept in the unopened pack for up to 7 days at room temperature (up to 30C), when protected from light. The pack should be discarded if left out of the refrigerator for more than 7 days. The pre-filled pen 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 25C
  • 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 30C.

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.

Disposal 1
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 weeks 1
**The recommended dose of Nucala is ais 100mg SC once every 4 weeks in adults and adolescents 12 years and older, available in pre-filled pen, 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

References:

  1. Nucala SmPC.
  2. GlaxoSmithKline Data on File REF-26268.

Πρόσκληση για αναφορά εικαζόμενων/πιθανολογούμενων ανεπιθύμητων ενεργειών του προϊόντος: Παρακαλείστε να αναφέρετε οποιεσδήποτε ανεπιθύμητες ενέργειες που μπορεί να παρουσιαστούν με την χρήση αυτού του προϊόντος. Κατά την αναφορά, παρακαλείστε να παρέχετε όσο το δυνατόν περισσότερες πληροφορίες, συμπεριλαμβανομένων των πληροφοριών σχετικά με το ιατρικό ιστορικό, οποιαδήποτε συγχορήγηση με άλλο προϊόν, καθώς και τις ημερομηνίες εμφάνισης και θεραπείας της ανεπιθύμητης ενέργειας. Υπενθυμίζεται ότι οι ανεπιθύμητες ενέργειες μπορούν να αναφέρονται στην GSK (Cyprus) Ltd Τηλ. 22397000 Email: cy.safety@gsk.com, ή σύμφωνα με το εθνικό σύστημα αυθόρμητων αναφορών στην Επιτροπή Φαρμακοεπαγρύπνησης, Φαρμακευτικές Υπηρεσίες, 1475 Λευκωσία (Fax 22608639) συμπληρώνοντας την Κίτρινη Κάρτα που είναι διαθέσιμη στα κρατικά φαρμακεία ή ηλεκτρονικά στην ιστοσελίδα www.kitrinikarta.gov.cy

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Prescription Only Medicine

Before prescribing please consult the full SPC which you can request from GSK or access on the website of the Pharmaceutical Services of the Ministry of Health http://www.phs.moh.gov.cy/web/guest/drug-search

Retail Price: Nucala powder for solution for injection 100MG/VIAL 1189,14 Euros 

Nucala 100mg in pre-filled pen €1116.49