Emgality ® ▼ (galcanezumab)

This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information.For current prescribing information for all Lilly products, including Summaries of Product Characteristics, Patient Information Leaflets and Instructions for Use, please visit: www.medicines.org.uk (England, Scotland, Wales) or www.emcmedicines.com/en-GB/northernireland/ (Northern Ireland).

How should Emgality®▼ (galcanezumab) be stored?

Store galcanezumab in a refrigerator (2 °C to 8 °C) and in the original package to protect it from light. Do not freeze the medicine.

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Instructions for storage, handling and light exposure

Store in the original package to protect galcanezumab from all types of light (i.e. artificial indoor light, filtered daylight, or outdoor lighting). During dose administration it is acceptable to expose the medicine to indoor light.

  • Do not expose the medicine in the device to indoor light for more than 1 hour.1

If galcanezumab is exposed to temperatures and handling outside the recommended conditions, Eli Lilly and Company (Lilly) personnel can perform a product quality assessment to determine the potential impact on the product. This assessment is not intended to replace the product's recommended storage or handling conditions.1

Lilly can only assess the potential impact of the temperature or light exposure to the product on a case-by-case basis and after the event has occurred and the product has been returned to the recommended storage conditions. Therefore, you must provide the batch number, the amount of time, what temperatures, and what type of light (if applicable) galcanezumab was exposed to outside of the recommended storage and handling conditions.1

Do not use the device if it's damaged, or the medicine inside is cloudy or contains particles.2

Do not shake the device as this can damage the medicine inside.1,3

Room temperature allowance strictly for patients or caregivers  - NOT for healthcare providers

Galcanezumab may be stored unrefrigerated for a single period up to 7 days at temperatures up to 30 °C. If the device is stored at a higher temperature or for a longer period it must be discarded.2

If galcanezumab has been intentionally stored at room temperature, it should not be returned to the refrigerator. Discard if not used within 7 days.1

Healthcare facilities (e.g. doctor’s office, pharmacy, etc.) and wholesalers or distribution centers cannot use any part of the patient’s 7-day room temperature storage time.1

Expiration date

The medicine should not be used after the expiry date which is stated on the label and on the carton after “EXP.”. The expiry date refers to the last day of that month.2

References

1Data on file, Eli Lilly and Company and/or one of its subsidiaries.

2Emgality [package leaflet]. Eli Lilly Nederland B.V., The Netherlands.

3Emgality [instructions for use]. Eli Lilly Nederland B.V., The Netherlands.

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.

Date of Last Review: 14 January 2022


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