On September 22, 2010, Novartis announced that the US Food and Drug Administration (FDA) has approved Gilenya (fingolimod) as a first-line treatment for relapsing forms of multiple sclerosis (MS). According to Novartis, Gilenya is the first oral medication approved for this indication.
Gilenya is considered a sphingosine 1-phosphate receptor modulator. Gilenya's mechanism of action in the treatment of MS is unknown. It is believed that the drug reduces the immune system's attack on the central nervous system by retaining lymphocytes in the lymph nodes, thus helping reduce demyelination. This action is reversible if Gilenya treatment is discontinued.
According to Novartis, Gilenya has a well-studied safety and tolerability profile, which has been characterized in over 2,600 clinical trial patients, some of whom are in their seventh year of treatment.
The FDA regulatory application for approval of Gilenya included data showing that use of the drug (at an oral dose of 0.5 mg daily) reduced relapses by 52% (P < .001) at 1 year compared with the use of intramuscularly administered interferon beta-1a (Avonex). Gilenya use was also associated with a reduction in disease activity as measured by the number of new and newly enlarged T2 lesions seen on magnetic resonance imaging, compared with the use of interferon beta-1a (1.6 vs 2.6, respectively, P = .002) at 1 year. In addition, data from a 2-year placebo-controlled study showed a reduction in relapse rate (54% reduction [P < .001] compared with placebo) and in the risk of disability progression among patients treated with Gilenya (30% reduction confirmed at 3-month follow-up visit [P = .02] compared with placebo).
The most common adverse effects experienced by patients receiving Gilenya were headache, influenza, diarrhea, back pain, cough, and abnormal liver studies.
Before treatment with Gilenya is started, consideration should be given to obtaining white blood cell counts and liver function studies. After the first dose, patients should be observed for 6 hours so that they may be appropriately monitored for serious adverse events
Gilenya is considered a sphingosine 1-phosphate receptor modulator. Gilenya's mechanism of action in the treatment of MS is unknown. It is believed that the drug reduces the immune system's attack on the central nervous system by retaining lymphocytes in the lymph nodes, thus helping reduce demyelination. This action is reversible if Gilenya treatment is discontinued.According to Novartis, Gilenya has a well-studied safety and tolerability profile, which has been characterized in over 2,600 clinical trial patients, some of whom are in their seventh year of treatment.
The FDA regulatory application for approval of Gilenya included data showing that use of the drug (at an oral dose of 0.5 mg daily) reduced relapses by 52% (P < .001) at 1 year compared with the use of intramuscularly administered interferon beta-1a (Avonex). Gilenya use was also associated with a reduction in disease activity as measured by the number of new and newly enlarged T2 lesions seen on magnetic resonance imaging, compared with the use of interferon beta-1a (1.6 vs 2.6, respectively, P = .002) at 1 year. In addition, data from a 2-year placebo-controlled study showed a reduction in relapse rate (54% reduction [P < .001] compared with placebo) and in the risk of disability progression among patients treated with Gilenya (30% reduction confirmed at 3-month follow-up visit [P = .02] compared with placebo).
The most common adverse effects experienced by patients receiving Gilenya were headache, influenza, diarrhea, back pain, cough, and abnormal liver studies.
Before treatment with Gilenya is started, consideration should be given to obtaining white blood cell counts and liver function studies. After the first dose, patients should be observed for 6 hours so that they may be appropriately monitored for serious adverse events
Bradycardia can occur with the use of Gilenya and may be especially evident after the first dose. Bradycardia will usually resolve within approximately 1 month of Gilenya therapy. Patients should be instructed to contact their physician if they experience dizziness, fatigue, or heart rhythm disturbances.
Patients receiving Gilenya have an increased risk of serious infections, but this risk is ameliorated within about 2 months of stopping therapy. Patients should be advised to contact their physician immediately if they experience fever, fatigue, body aches, chills, nausea, or vomiting.
A patient's vision should be tested before starting Gilenya, after 3 to 4 months of treatment, or any time they notice vision changes during treatment because a risk for macular edema exists. This risk may be higher in patients with diabetes or uveitis. Patients should be advised to contact their physician if they experience blurred vision, shadows or blind spots in their visual field, light sensitivity, or changes in color perception
