Here is My Question:
Kesimpta is offering for the first time the possibility not to travel to an infusion centre twice a year in order to get a B-cell therapy (Ocrevus). Self administration at home sounds like more "freedom“.
However - What about traveling under Kesimpta? As far as I know, it must continously be cooled. When traveling intercontinentally this can be difficult to achieve depending on the destination.
Are there any guidelines or ideas how to manage this? Would it be a solution to take an additional "shot“ just before leaving for a three weeks trip? Or would it be safe to delay the next injection till returned home?
According to the data provided in the package insert, Kesimpta does need to be continuously cooled at a stable refrigeration temperature (2ºC to 8ºC (36ºF to 46ºF)) until the time of use. It would be possible to maintain this in certain types of travel but not others as you mention.
The best way to navigate travel and the injection schedule will be determined on an individual basis.
Some predictions can be made based on how the drug works in the body and how long those effects last. Kesimpta binds to the CD20 cell surface antigen on certain B cells and destroys these cells. We are able to measure the depletion of these B cells using blood tests. The clinical trials for Kesimpta measured B cells to determine the optimal dosing for their product. Early dose finding trials showed a significant effect of treatment (on MRIs) even when dosed every 12 weeks (doses ranged from 3mg to 60mg). They also found that when people stopped treatment, the median time to B cell repletion was 40 weeks. This suggests that people can go at least 12 weeks between injections without a return of MRI disease activity.
Assuming that a person has been on the treatment for 12 weeks (the point at which over 99% of patients in clinical trials had B cells below the lower limits of normal) then it would be safe to assume that the majority of people would be okay delaying their dose until they return home.
Revere P (Rip) Kinkel, MDProfessor of Clinical Neurosciences
Director of the Multiple Sclerosis Program
Clinical Neurosciences Director
University of California San Diego
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