How long can Kesimpta (ofatumumab) be left unrefrigerated?
Kesimpta can be kept unrefrigerated for a limited time at room temperature. The prescribing information allows a single period of up to 7 days when the pen/syringe is not stored in the refrigerator, as long as it stays within the specified temperature range and is then returned to refrigeration or used according to the product instructions [1].
What happens if you exceed the allowed unrefrigerated time?
If Kesimpta is left unrefrigerated longer than the allowed single period (up to 7 days), it should not be used. You should discard it and use a properly stored dose instead, following the medication guidance you were given by your pharmacist or the product instructions [1].
Does the “up to 7 days” rule mean more than one time out of the fridge?
The instructions describe a maximum single unrefrigerated time window. If you already used the allowed time outside the refrigerator, you should not extend it with additional time out of the fridge; use or discard based on the product directions and storage rules [1].
How should you store it after it’s been out of the refrigerator?
After the allowed unrefrigerated period, Kesimpta should be returned to the refrigerator if it will be used later, and used in accordance with the instructions for that specific device (pen vs. syringe) [1]. If you are unsure whether the timing/temperature conditions were met, check with your pharmacist.
Practical questions people ask during travel or delays
If you’re traveling or missed a refrigeration window, the key factors are (1) how many days it was unrefrigerated and (2) whether it stayed within the permitted temperature range during that time. Keep the device in its labeled storage condition during transit (for example, with a validated cooler if recommended by your pharmacist) to avoid exceeding the permitted window [1].
Sources:
[1] https://www.novartis.com/us-en/our-products/product/kesimpta-prescribing-information