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FDA Approves Shared REMS (Risk Evaluation and Mitigation Strategy) Program for all TIRF (Transmucosal Immediate Release Fentanyl) Pain Treatments
Date:12/30/2011

ref="http://www.tirfremsaccess.com/">www.TIRFREMSAccess.com or call 1-866-822-1483.

About ABSTRAL®

ABSTRAL® (fentanyl) sublingual tablets, a rapidly disintegrating sublingual tablet formulation of fentanyl citrate designed for oral transmucosal delivery, is approved in the U.S. for the management of breakthrough pain in cancer patients 18 years of age or older who are already receiving, and who are tolerant to, opioid therapy for their underlying persistent cancer pain. ABSTRAL is available in strengths of 100 mcg, 200 mcg, 300 mcg, 400 mcg, 600 mcg and 800 mcg. ABSTRAL offers an alternative therapeutic choice to patients and clinicians with a simple, patient-friendly and predictable way of delivering fentanyl transmucosally, while retaining the individualized dose titration aspects required for optimal treatment of breakthrough pain.

ABSTRAL is in-licensed by ProStrakan for Europe, the U.S., Canada, and Mexico from Sweden-based Orexo AB.

Important ABSTRAL® Safety Information

IMPORTANT:

Do not use ABSTRAL unless you are regularly using another opioid pain medicine around-the-clock for your cancer pain and your body is used to these medicines (this means that you are opioid tolerant).

Keep ABSTRAL in a safe place away from children. 

Get emergency medical help right away if:

  • a child takes ABSTRAL. ABSTRAL can cause an overdose and death in any child who takes it.
  • an adult who has not been prescribed ABSTRAL takes it
  • an adult who is not already taking opioids around-the-clock, takes ABSTRAL

These are medical emergencies that can cause death.  If possible, try to remove ABSTRAL from the mouth.

ABSTRAL can cause life-threatening breathing problems that can lead to death.  Breathing prob
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SOURCE ProStrakan, Inc.
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