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    Gilenya clean out period

    Does anyone know if there's a "cleaning out" period from previous meds, before starting Gilenya?

    #2
    There is no "official" wash-out period for previous MS meds stated in the prescribing information or other documentation for Gilenya, only to "use caution when switching patients from long-acting therapies with immune effects such as natalizumab or mitoxantrone" in order to reduce the risk of increased immunosuppression and infection.

    Considering how detailed the risk-management recommendations are (as required by the FDA), if there were an "official" wash-out period recommendation, it would have been included. The recommendations may change in the future, as Gilenya goes into general use and more becomes known about it. If the FDA deems that the labeling information should be changed, the manufacturer will be required to update the prescribing information and all of the documentation. But for now there isn't one for pretreatment wash-out.

    However, the clinical trials for Gilenya can be used as precedent. In two of the trials, participants were off of Tysabri (natalizumab) for 6 months before starting Gilenya, and in one of the trials, participants were off of the CRABS for 3 months before starting. I'm going to venture that those periods were chosen based on research showing that that's about how long those meds and their effects are present in blood and cerebrospinal fluid.

    From what I've been gleaning from across the web, many doctors are using those wash-out periods for their patients before starting them on Gilenya. Since Copaxone doesn't really contribute to immunosuppression, some docs are using a shorter wash-out time for their patients who have been on Copaxone. The prescribing guidelines leave the wash-out period up to doctors to determine based on the risk-benefit ratio for each individual patient.

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      #3
      I have been taking Copaxone and I asked that question of the Novartis Support Nurse assigned to me. She said that for Copaxone there is no clean out period necessary. In spite of which my Dr. is having me wait a week between my last shot and starting Gilenya.

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        #4
        Thanks for the input "guys" .

        Abby, how long did it take for Novartis to contact you after the initial form was sent in?

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          #5
          Schnick, I was contacted within a couple of days. They have actually called me three times in the last two and a half weeks.

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            #6
            schnick, actually, now that I think about it, The first time I spoke with the drug company support people I had some questions my Dr. couldn't answer, so I called them (1-877 408-4974). The nurse who picked up the phone talked with me for a moment, then checked to see if I was "in their computer" yet. I was, and she asked if I wanted to speak to the nurse assigned to my case. I did, and she went through a scripted talk and asked me a bunch of questions. She was helpful and told me how to reach her without getting lost in the phone system. Anyway, if you are anxious to be contacted why don't you call them? It might help move things along.

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              #7
              Thanks Abby. It was faxed to them Monday...today is Thursday. If I don't here from them by tomorrow, I'll call them.

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