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Comment by lkey | Hacker News Reader

Why on Earth did you not bother to look it up before asserting your opinion...?

https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/76... Body Weight Based on population pharmacokinetic analysis, higher body weight was associated with lower exposure. However, the effect of body weight on exposure had no meaningful impact on efficacy or safety and does not require dose adjustment.

Assuming that grandparent comment is correct about morbid obesity exclusion, then you were the one spouting nonsense right? Doctors will definitely give this to patients regardless of weight with a note like that.

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Both my note and the download you discuss are clear about this.

You have linked to the the package insert, not the label, and it clearly states at the very top

    HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use
    TEZSPIRE safely and effectively. See full prescribing information for
    TEZSPIRE.

As I wrote in my comment:

> ... this kind of info is on the label (prescribing information) even if it doesn’t make it into the short summary (package insert, typically only a dozen pages or so) given to patients. Doctors do read those, you know, and within their specialities know what kinds of things to look for.

You are simply quoting the short summary and drawing a conclusion based on the limited information that appears on it. Perhaps the author of the blog post made the same error. The doctor reads the actual prescribing information and the evaluation population must be specified there.

The second page starts the "FULL PRESCRIBING INFORMATION"; the body weight quote above comes from section 12.3 of it and there is no mention of a weight exclusion in the discussion of the clinical studies in section 14. AFAIK, "label" typically refers to this sort of ~20 page prescribing information, but is there a different label you have in mind? I believe the one-page package insert is the last page, page 17.

Am I losing my gdmn mind here? You say look at the label not the insert, the FDA will have it. I link you to the FDA's label. The link literally had the word 'label' in it drugsatfda_docs >>> label <<<

Inside the document there are 3 things the 'HIGHLIGHTS OF PRESCRIBING INFORMATION', AND the 'FULL PRESCRIBING INFORMATION' AND finally 'PATIENT INFORMATION'

I cite the relevant information about weight from them 'FULL PRESCRIBING INFORMATION: CONTENTS: PART 12 CLINICAL PHARMACOLOGY and you act like I not you have performed some sort of bait and switch...

You are the one claiming expertise here, so enlighten me, where is the the carve out for "we didn't test this at all on the morbidly obese" in place a doctor will find it if not in 'FULL PRESCRIBING INFORMATION'?

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