Emgality® ▼ (galcanezumab)

This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information. Please refer to the link for full prescribing information: Emgality Summary of Product Characteristics (SmPC)

Emgality®▼ (galcanezumab): Storage and Stability

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

Product in the Possession of the Patient or Caregiver - Summary of Product Characteristics

Emgality may be stored unrefrigerated for single period up to 7 days when stored at temperatures up to 30 °C. If the device is stored at a higher temperature or for a longer period it must be discarded.1

The medicine should not be shaken as this can damage the medicine inside the device.2,3

Once the device has been intentionally stored at room temperature, it should not be returned to the refrigerator and  should be discarded, if unused, within 7 days.2

The medicine should not be used if the device is damaged, or the medicine is cloudy or has particles in it.1

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.1

The medicine should be kept out of the sight and reach of children.1

Product in the Possession of the Healthcare Provider

The 7-day room temperature storage is reserved for patient/caregiver use only.2

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.2

If Emgality is exposed to temperatures outside the recommended storage and handling range, Lilly personnel can perform a product quality assessment to determine potential impact to the product. This product quality assessment is not intended to replace the recommended storage or handling conditions for the product.2

Lilly can only assess the potential impact of the temperature exposure to the product on a case-by-case basis and after the event has occurred. You must be able to provide the batch number, the amount of time, what temperatures and what type of light (if applicable) the Emgality was exposed to outside of the recommended storage and handling conditions. The product quality assessment must occur after the temperature or light exposure has ended and the products have been returned to the recommended storage conditions.2

References

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

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

3. Emgality [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: February 18, 2019

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