Drug Interactions between Gilenya and Menveo

MONITOR: The administration of inactivated, killed, or otherwise noninfectious vaccines during fingolimod therapy is generally safe but may be associated with a diminished or suboptimal immunologic response. Vaccination may be less effective during and for up to two months after discontinuation of fingolimod therapy. In healthy volunteers administered keyhole limpet Hemocyanin (KLH) and pneumococcal polysaccharide vaccine (PPV-23), antigen-specific IgM titers were decreased by 91% and 25% in response to KLH and PPV, respectively, in subjects receiving fingolimod 0.5 mg compared to placebo. Similarly, IgG titers were decreased by 45% and 50% in response to KLH and PPV, respectively, in subjects receiving fingolimod 0.5 mg compared to placebo. The responder rate for fingolimod 0.5 mg as measured by the number of subjects with a >4-fold increase in KLH IgG was comparable to placebo and 25% lower for PPV-23 IgG, while the number of subjects with a >4 fold increase in KLH and PPV-23 IgM was 75% and 40% lower, respectively, compared to placebo.

MANAGEMENT: Immune response to vaccines may be reduced during and for up to two months after discontinuation of fingolimod therapy. In patients who have recently been vaccinated, fingolimod therapy should preferably be postponed for one month to allow the full effect of vaccination to occur.

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