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Gilenya and Solumedrol

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    #1

    Gilenya and Solumedrol

    I just started my Gilenya treatment on Dec 3 and love not having to administer anymore shots! I've had a flare up since Nov 22 and can't seem to get rid of it on it's own, and my doctor's don't know enough about Gilenya and Solumedrol being taken in conjunction. Has anyone experienced a flare up while being on Gilenya? If so, were you given Solumedrol to help suppress the flare up? If you were, how many days were you given??

    Thanks!

    Nick
    Tags: None
    #2
    Just started Gilenya 3 days ago and not currently in a flare. I would call the Gilenya support people 1-877-408-4974 I am sure they can answer this for you.

    Hope you are feeling better soon and that the Gilenya works well for you!!!! (and me too!!)

    CrazyCatLady
    MS Does Not Define Me.....My Love of Tea Does! LOL!

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      #3
      Sorry. I didn't see this post before posting on the other thread. Call your Gilenya support nurse or just the Gilenya support line. They should be able to get in touch with you or your doctor with this info.

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        #4
        Sorry for multiple postings but I just remembered that I was told by my neuro about a couple deaths during the studies that relate.

        Two study patients who were taking gilenya and steroids to treat a flare up at the same time developed infections (one chicken pox and one herpes) and died from the infections.

        While it's not a sure fire reason to not take the steroids, I'd definitely think long and hard about it first.

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          #5
          Originally posted by Just a small town girl View Post
          Two study patients who were taking gilenya and steroids to treat a flare up at the same time developed infections (one chicken pox and one herpes) and died from the infections.
          The two study subjects who died during the TRANSFORMS trial were taking a higher dose than the one approved by the FDA. From the prescribing information for Gilenya: "Two patients died of herpetic infections during GILENYA controlled studies in the premarketing database (one disseminated primary herpes zoster and one herpes simplex encephalitis)."

          I haven't been able to find any source that indicates that these two subjects were also on steroids for an exacerbation during the study.

          Just a small town girl, can you cite a source for the information that both of these study subjects were on steroids during the trial?

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            #6
            Originally posted by Redwings View Post
            The two study subjects who died during the TRANSFORMS trial were taking a higher dose than the one approved by the FDA. From the prescribing information for Gilenya: "Two patients died of herpetic infections during GILENYA controlled studies in the premarketing database (one disseminated primary herpes zoster and one herpes simplex encephalitis)."

            I haven't been able to find any source that indicates that these two subjects were also on steroids for an exacerbation during the study.

            Just a small town girl, can you cite a source for the information that both of these study subjects were on steroids during the trial?
            Like I said before, I was told this by my neuro, she's running our local studies on cladribine and a couple other oral medications. So she's pretty up on this.

            As far as what I found from my little google search

            Two patients died of herpetic infections during Gilenya controlled studies in the premarketing database (one disseminated primary herpes zoster and one herpes simplex encephalitis). In both cases, the patients were receiving a fingolimod dose (1.25 mg) higher than recommended for the treatment of MS (0.5 mg), and had received high dose corticosteroid therapy for suspected MS relapse. No deaths due to viral infections occurred in patients treated with Gilenya 0.5 mg in the premarketing database.

            http://www.drugs.com/pro/gilenya.html

            Two patients died of herpetic infections during GILENYA controlled studies in the premarketing database (one
            disseminated primary herpes zoster and one herpes simplex encephalitis). In both cases, the patients were receiving a
            fingolimod dose (1.25 mg) higher than recommended for the treatment of MS (0.5 mg), and had received high dose
            corticosteroid therapy for suspected MS relapse. No deaths due to viral infections occurred in patients treated with
            GILENYA 0.5 mg in the premarketing database.

            (This is actually section 5.2 on the incredibly long label that comes with your Gilenya. I found a copy online.)

            http://www.pharma.us.novartis.com/pr...df/gilenya.pdf


            As Redwings pointed out this was at a higher dose, but my neuro did mention these occurrences to me when we were discussing the drug and whether to go on it.

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              #7
              Thank you! That's exactly what I was looking for.

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