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Exelixis, Inc. Message Board

  • wilderguide wilderguide Dec 14, 2012 1:28 AM Flag

    NIH Dailymed site


    The NIH-sponsored primer on daily medications has posted a reference site for Cometriq use. It's a bit too technical for me, but for those inclined to view the statistical breakdowns on AE's, DDI's, dosing structures, and hyper-specific pharmacokinetic performance data - it would all appear to be found here.

    I found it simply by cruising the NIH site, but if you Google "Dailymed" and go to the NIHdotgov version you'll find the info easily by using the homepage search engine - "Cometriq" should take you right to it. Whole lot of technical info all in one stop.


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    • Are you going to the J.P. Morgan Jan.7-10 meeting in S.F.? If so who is allowed to attend and what do I need to do to attend?Thanks.

      • 1 Reply to clemcaldwell
      • $$$$

        Hey Clem,

        No, I'll just catch the JP Morgan web-audio. I was thinking about attending the annual meeting. I expect the date will be announced at the Feb ER, as I believe past shareholder meeting dates have been set for the April/May timeframe. Once a date is set, I'll repost w/ specifics as I can.

        I've got no idea how to get you in the door of the investor conference, but I'd bet a phone call to Charles Butler at IR would figure that out in a hurry.

    • $$$$

      The excerpt below is from the NIH dailymed site on managing AE's, and makes me question why there is no mention of dosing potential lower than 60mg.
      Maybe one of the local docs can answer for me...

      Based upon the robust results of the 40mg trials in PC...could you further reduce dosage with your MTC patient to the 40mg level, citing the low-dose efficacy/improved tolerability trials as JCO peer-reviewed reference?
      As currently published by NIH, would the 40mg dose be considered off-label use in MTC?

      "2.2 Dosage Adjustments
      For Adverse Reactions

      Withhold COMETRIQ for NCI CTCAE Grade 4 hematologic adverse reactions, Grade 3 or greater non-hematologic adverse reactions or intolerable Grade 2 adverse reactions.

      Upon resolution/improvement of the adverse reaction (i.e., return to baseline or resolution to Grade 1), reduce the dose as follows:

      •If previously receiving 140 mg daily dose, resume treatment at 100 mg daily (one 80-mg and one 20-mg capsule)
      •If previously receiving 100 mg daily dose, resume treatment at 60 mg daily (three 20-mg capsules)
      •If previously receiving 60 mg daily dose, resume at 60 mg if tolerated, otherwise, discontinue COMETRIQ"

      Thanks in advance. GLTA

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