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Tuesday, November, 24, 2009
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FDA Delays Approval of Actemra

Christine Miller
Christine Miller
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I was diagnosed as a toddler with JRA and since then have gone...

Christine Miller

Friday, September 19, 2008
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            The FDA has delayed approval for Actemra pending submission of extra product manufacturing and product label information by the drug manufacturer, Roche Holding AG.  This comes a week after requiring ordering label changes for Ri...
  1. Actema is a infusion drug, 1 hour per month.
    katrina bixby
    Tuesday, October 07, 2008 at 02:35 PM

    You made an error in the article and it appears some of you adverse effect info is from the TNF drugs not Actemra.

    Reply
    re: Actema is a infusion drug, 1 hour per month.
    Christine Miller
    Tuesday, October 07, 2008 at 05:45 PM

    Thanks.  You are correct, I misspoke, it is not a self-injected drug.  The reccommended dosage is 8mg/kg given by 60-minute IV drip infusion once every 4 weeks.

     

    I took the adverse reaction information from the Roche website (www.rocheusa.com) and the FDA website  (www.fda.gov) (Roche's Actemra applications and addenda) as well as other articles that I have read.  As I said in the post, it does appear that several of the adverse events reported for Actemra are similar to those reported for TNF inhibitors and rituxan- most commonly serious infections and infusion reactions (hypersensitivity reactions and anaphylaxis).

     

     

     

     

    Reply
    re: re: Actema is a infusion drug, 1 hour per month.
    jason simian
    Sunday, October 12, 2008 at 10:58 PM

    Guys, let's stop fighting over petty details and tone down the technical talk.  Are we forgetting that this is a blog about RA, not a course in pharmacology?  I want to hear about personal stories that relate to RA, not info from Roche's website.  Thanks.

     

    Jason

    Reply
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