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FDA Warning - Gilenya Rebound Possible

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    FDA Warning - Gilenya Rebound Possible

    FDA is warning that when the multiple sclerosis (MS) medicine Gilenya (fingolimod) is stopped, the disease can become much worse than before the medicine was started or while it was being taken. This MS worsening is rare but can result in permanent disability.


    RECOMMENDATION:

    Healthcare professionals should:

    - Inform patients before starting treatment about the potential risk of severe increase in disability after stopping Gilenya.

    - Patients should be carefully observed for evidence of an exacerbation of their MS and treated appropriately when Gilenya is stopped.

    - Patients should be advised to seek immediate medical attention if they experience new or worsened symptoms of MS after Gilenya is stopped.

    - Test for new or enhancing lesions by magnetic resonance imaging (MRI) if an increase in disability occurs and begin appropriate treatment as needed.

    - Encourage patients to read the patient Medication Guide they receive with their Gilenya prescriptions, which explains the benefits and risks of the medicine.




    Patients who have been instructed to stop Gilenya, should contact your health professional immediately if you experience new or worsened symptoms such as:

    - weakness

    - trouble using arms or legs

    - changes in thinking, eyesight or balance.

    Patients should not stop taking the medicine on their own and should speak to their health professional first, as stopping treatment can lead to worsening MS symptoms.

    Full FDA Alert: https://www.fda.gov/Safety/MedWatch/.../ucm626264.htm

    #2
    I am wondering how many missed doses would potentially cause a rebound? I was just switched to the generic and it has cause a spike in my blood pressure. I have called my doctor but they haven’t returned my call… no surprise there. Now it’s the weekend and I am not planning on taking anymore of this medication. I assume I will have to switch to another treatment, but who knows how long I will have to wait.
    K9 Love heals

    Comment


      #3
      I'm so sorry to read about your difficulties.

      Because Gilenya lasts in the blood for a long time, and lymphocyte counts take 1 to 2 months to return to baseline after stopping therapy, a person’s immune system will remain compromised for up to two months after stopping Gilenya treatment.


      In a small study, 11% of patients had a rebound event between 4 weeks and 16 weeks after stopping Gilenya.

      https://multiplesclerosisnewstoday.c...%20who,weeks%2 0after%20discontinuation%20of%20treatment.

      Other references:


      https://jamanetwork.com/journals/jam...rticle/2516773

      https://onlinelibrary.wiley.com/doi/10.1111/ene.13694

      https://www.sciencedirect.com/scienc...892?via%3Dihub

      Comment


        #4
        Originally posted by pangleb View Post
        I was just switched to the generic and it has cause a spike in my blood pressure.
        The quickest solution might be your neurologist documenting an adverse reaction to the generic fingolimod, and getting you approved for the branded Gilenya.

        I wish you well.

        Comment


          #5
          Thank you so much for the information. I am approved for the brand but the “Go Program” no longer exists which meant my copay would be over $400 a month so that is why I switched. I am currently researching other options. Thank you again.
          K9 Love heals

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