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biopharm

02/23/14 2:36 PM

#162545 RE: PhoenixRising #162542

I approve of Bavi with anything CANCER related;IMO PPHM should focus on that for now IMO.



That is my point, approval of Bavi with anything cancer related and I do believe Peregrine Pharmaceuticals is in some sort of zone at this moment to make sure everyone sees it through and there is no possibility of Bavi becoming back burnered somewhere. Bavi has "NO WHERE" near the number of extreme side affects associated with it as any FDA approved chemo out there, so its best to look at one FDA approved site for all information regarding FDA approvals.

As for the FDA site... that was for all to see, because "MOST" people when looking up side affects do not go through the FDA website, but just google and look up the side affects from some other websites. Those are the facts, because the web traffic to that FDA website does not match the number of FDA drug approvals that are out there and side affects that you may know about, but "Millions" of people take FDA approved drugs, where they are not reading up on their side affects on "non-FDA-approved" websites.

https://rm2.scinet.fda.gov/druglabel/#simsearch-2

WARNING: IMMUNE-MEDIATED ADVERSE REACTIONS
See full prescribing information for complete boxed warning.

YERVOY can result in severe and fatal immune-mediated adverse reactions due to T-cell activation and proliferation. These immune-mediated reactions may involve any organ system; however, the most common severe immune-mediated adverse reactions are enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis), neuropathy, and endocrinopathy. The majority of these immune-mediated reactions initially manifested during treatment; however, a minority occurred weeks to months after discontinuation of YERVOY.

Permanently discontinue YERVOY and initiate systemic high-dose corticosteroid therapy for severe immune-mediated reactions. (2.2)

Assess patients for signs and symptoms of enterocolitis, dermatitis, neuropathy, and endocrinopathy and evaluate clinical chemistries including liver function tests and thyroid function tests at baseline and before each dose. (5.1, 5.2, 5.3, 5.4, 5.5)

https://rm2.scinet.fda.gov/druglabel/rs/spl/by-id/95627/95627.html