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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

to do these activities.

ABSTRAL is only available through a program called the ABSTRAL REMS program.  To receive ABSTRAL, you must talk to your healthcare provider, understand the benefits and risks of ABSTRAL, agree to all of the instructions, and sign the Patient-Prescriber Agreement form.

You or a family member should call your healthcare provider or get emergency medical help right away if you:

  • Have trouble breathing
  • Have drowsiness with slowed breathing
  • Have shallow breathing (little chest movement with breathing)
  • Feel faint, very dizzy, confused, or have other unusual symptoms

These symptoms can be a sign that you have taken too much ABSTRAL or the dose is too high for you.  These symptoms may lead to serious problems or death if not treated right away.  If you have any of these symptoms, do not take any more ABSTRAL until you have talked to your healthcare provider.

ABSTRAL can cause your blood pressure to drop.  This can make you feel dizzy or lightheaded if you get up too fast from sitting or lying down.

The most common side effects of ABSTRAL are nausea, sleepiness, and headache.

Constipation (not often enough or hard bowel movements) is a very common side effect of pain medicines (opioids) including ABSTRAL.  Talk to your healthcare provider about dietary changes, and the use of laxatives (medicines to treat constipation) while you are taking ABSTRAL.

Please see full Prescribing Information and Medication Guide, including Boxed Warning.

About ProStrakan

ProStrakan is a rapidly growing specialty pharmaceutical company engaged in the development and commercialization of prescription medicines for the treatment of unmet therapeutic needs in major markets.

ProStrakan is a subsidiary of Kyowa Hakko Kirin Co. Ltd., the Japan-based global specialty pharmaceutical company.

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SOURCE ProStrakan, Inc.
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