Research Gilenya and the Pill

Background: Fingolimod has a novel mechanism of action in MS, being a first-in-class sphingosine 1-phosphate receptor modulator. Because of a potential risk of foetal toxicity based on animal studies, women of childbearing potential are advised to take effective contraceptive measures during and for 2 months after stopping fingolimod therapy.

Aim: To assess whether the efficacy of a combined oral contraceptive (OC) could be compromised during fingolimod therapy, a steady-state, drug-drug interaction study of fingolimod with ethinylestradiol/levonorgestrel was performed in healthy female volunteers.

Objective: To assess the interaction between fingolimod 0.5 mg once daily and ethinylestradiol 30 μg/ levonorgestrel 150 μg once daily at a steady state.

Methods: 31 healthy women received the combined OC only on Days 1 – 14, followed by OC plus fingolimod on Days 15 – 28.

Results: In the presence of fingolimod, ethinylestradiol pharmacokinetics were unchanged, and levonorgestrel maximum plasma concentration at steady state and area under the concentration-time curve during a dosing interval increased by factors of 1.10 (90% CI 1.05 – 1.16) and 1.22 (90% CI 1.18 – 1.27), respectively.

Conclusions: Fingolimod therapy does not alter the pharmacokinetics of the combined OC ethinylestradiol/ levonorgestrel to a clinically significant degree. Ethinylestradiol/levonorgestrel does not alter the pharmacokinetics of fingolimod. Women receiving fingolimod therapy are able to use a combined OC as a means of effective birth control.

“The conclusions of this study are clear. This should be good news for woman with MS as they can now take fingolimod and not worry about it interacting with the pill. I assume taking the pill with fingolimod will help improve adherence. May be I am wrong?”

“Did you know in the fingolimod trial programme more woman fell pregnant accidently on fingolimod than on placebo? Why? Not sure, but I have interpreted that woman on fingolimod feel so much better that they are more sexually active hence more likely to fall pregnant. In other words fingolimod increases your quality of life, your libido and chance of falling pregnant.”

“Pity we don’t have the option of using fingolimod as a first-line therapy in Europe! This alone is a compelling case for it making a difference to the lives if MSers.”

“Evolutionary biologists tell us that the purpose of life as a population is to procreate. If this is the case fingolimod contributes to this in MSers.”

“Please note that you should not fall pregnant on fingolimod. You should plan your pregnancies.”

CoI: multiple

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