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Cephalon Receives FDA Approval for Risk Evaluation and Mitigation Strategy for FENTORA and ACTIQ
Date:7/21/2011

tions occurred in 10% of patients in FENTORA clinical trials and ranged from paresthesia to ulceration and bleeding
  • Full and partially consumed ACTIQ units contain medicine that can be fatal to a child.  Ensure proper storage and disposal.  Interim safe storage container available (ACTIQ Child Safety Kit)

  • Adverse Reactions:

    • For ACTIQ, most common adverse reactions during titration phase (frequency greater than or equal to 5%): nausea, dizziness, somnolence, vomiting, asthenia and headache.  Most common adverse reactions during longer-term treatment (frequency greater than or equal to 5%): dyspnea, constipation, anxiety, confusion, depression, rash and insomnia
    • For FENTORA, most common adverse reactions during titration phase (frequency greater than or equal to 10%): nausea and dizziness. Most common adverse reactions during longer-term treatment (frequency greater than or equal to 10%): nausea, vomiting, fatigue, anemia, dizziness, peripheral edema, constipation, asthenia, dehydration and headache

    Drug Interactions:

    • Monitor patients who begin therapy with, or increase dose of, inhibitors of CYP 3A4 for signs of opioid toxicity
    • Monitor patients who stop therapy with, or decrease dose of, inducers of CYP 3A4 for signs of opioid toxicity

    Use in Specific Populations:

    • Administer FENTORA with caution to patients with severe hepatic or renal disease.  Please see accompanying full prescribing information.

    Please see full prescribing information, including boxed warning, at www.actiq.com and www.fentora.com.  

    About Cephalon, Inc.

    Cephalon is a global biopharmaceutical c
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    SOURCE Cephalon, Inc.
    Copyright©2010 PR Newswire.
    All rights reserved

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