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Medication Safety Alerts

Gilenya® MedWatch

8/04/2015

On August 4, 2015, the United States Food and Drug Administration (FDA) issued a Drug Safety Communication warning that cases of definite progressive multifocal leukoencephalopathy (PML) have been reported in patients taking Gilenya (fingolimod) for multiple sclerosis (MS). PML is a rare and usually fatal brain infection. 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.

The FDA has provided the following information for patients and caregivers:

  • One patient has developed progressive multifocal leukoencephalopathy (PML) after taking Gilenya, and one patient has developed probable PML.
  • 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.
  • Seek medical attention immediately if you experience symptoms that concern you, such as:
  • new or worsening weakness
  • trouble using your arms or legs
  • changes in thinking, eyesight, strength, or balance
  • Do not stop taking Gilenya without first talking to your doctor.
  • Read the Medication Guide you receive with your Gilenya prescription.
  • Discuss any questions or concerns about Gilenya and the risk of PML with your doctor.
  • Report side effects from Gilenya to the FDA.

CVS/caremark Response:

Please note: This product is carried by the CVS/caremark Specialty Pharmacies only. For more information, please call your Specialty pharmacy toll-free at the number on your prescription label.

If you are currently taking Gilenya and have questions, please call your doctor or call the FDA consumer inquiry line toll-free at 1‑888‑INFO‑FDA (1‑888‑463‑6332) or visit https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm457183.htm.

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