Gilenya: FDA-approved Oral MS Medication

Sep 22 2010

Gilenya ( also known as fingolimod, FTY720) was just FDA-approved for the treatment of relapsing forms of MS to reduce the number of relapses and delay the development of disability.  Gilenya is taken as a once-day 0.5 mg capsule and will be available for prescribing on Oct. 4, 2010.

Compared to both placebo and Avonex in two trials, Gilenya reduced relapses over half (52% less than Avonex, 54% less than placebo).  Gilenya also lowered the likelihood of worsening disability by 30% compared to placebo.  New MRI lesions were decreased significantly compared to placebo (new or enlarging T2 lesions were reduced 74% and T1 contrast enchancing lesions reduced 82% on Gilenya).

Because of the risk of slow heart rate the first six hours on Gilenya, monitoring of blood pressure and heart rate are important the first six hours after the first dose.  The infusion center at Missouri Baptist Medical Center is set-up to provide this outpatient monitoring for our patients.  Baseline EKG’s are recommended for certain patients.

Serious infections can occur.  Patients will need a white blood count in the past 6 months prior to starting Gilenya (fingolimod).  Two deaths have occurred from herpes infections (chicken pox and viral encephalitis) in patients in the fingolimod studies (over 3600 patients in Phase III clinical trials).  In both cases, the individuals were on higher dose of fingolimod (1.25 mg) and received high dose steroids.  If you have not had chicken pox or not sure, let your healthcare provider know to you can be tested and/or vaccinated prior to treatment.

Swelling in the back of the eye (macular edema) can occur, especially in diabetics or people with uveitis.  Retina eye exam will be done prior to starting Gilenya and 3-4 months on treatment.  Liver blood tests can be high on fingolimod.  Baseline liver blood test is recommended prior to starting treatment.  Mild breathing test abnormalities were seen in the trials but no tests required on treatment unless breathing problems develop.  Elevation of blood pressure can occur.  Because of potential risk to the fetus if becoming pregnant of Gilenya, the recommendation is to use effective contraception on treatment and 2 months following stopping Gilenya.

BY: Barry Singer, MD DATE: September 22, 2010 TOPIC: MS Research News