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Gilenya (fingolimod): Drug Safety Communication - FDA Warns About Cases of Rare Brain Infection

AUDIENCE: Neurology, Pharmacy

ISSUE: FDA is warning that a case of definite progressive multifocal leukoencephalopathy (PML) and a case of probable PML have been reported in patients taking Gilenya (fingolimod) for multiple sclerosis (MS). These are the first cases of PML reported in patients taking Gilenya who had not been previously treated with an immunosuppressant drug for MS or any other medical condition. As a result, information about these recent cases is being added to the drug label.

BACKGROUND: Gilenya is an immunomodu-lator shown to benefit patients with relapsing forms of MS. This type of MS causes attacks or relapses, which are periods of time when symptoms get worse. Immunomodulators alter the immune system to reduce inflammation. PML is a rare and serious brain infection caused by the John Cunningham (JC) virus. The JC virus is a common virus that is harmless in most people but can cause PML in some patients who have weakened immune systems, including those taking immunosuppressant drugs.

In an August 2013 Drug Safety Communication, FDA reported that a patient developed PML after taking Gilenya. PML could not be conclusively linked to Gilenya in this case because prior to Gilenya treatment the patient had been treated with an immunosuppressant drug that can cause PML and during Gilenya treatment the patient had received multiple courses of intravenous corticosteroids, which can weaken the immune system.

RECOMMENDATION: Patients taking Gilenya should contact their health care professionals right away if they experience symptoms such as new or worsening weakness; increased trouble using their arms or legs; or changes in thinking, eyesight, strength, or balance. Patients should not stop taking Gilenya without first discussing it with their health care professionals. Health care professionals should stop Gilenya and perform a diagnostic evaluation if PML is suspected. See the Drug Safety Communication for additional recommendations.

Read the MedWatch safety alert, including a link to the FDA drug safety communication, at:

美國FDA發布藥物安全警訊,有關罹患多發性硬化症(multiple sclerosis, MS)病人使用Gilenya (fingolimod)治療後出現進行性多灶性白質腦病(leukoencephalopathy, PML)之案例報告。此為首例病人未曾接受免疫抑制劑治療,在給予Gilneya後發生PML之案例,因此,美國FDA認為應將此資訊列於藥品仿單之中。

Gilenya為免疫調節劑,用於治療復發型多發性硬化症。此類藥品可調節體內免疫系統,降低發炎反應。而PML為一種由John Cunningham病毒造成之罕見且嚴重的腦部感染,對大部份人而言不會造成影響,但免疫力低下,如曾服用免疫抑制劑的病人則可能會受到感染。