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U.S. Department of Health and Human Services

Safety

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Actiq (fentanyl citrate) oral transmucosal

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

 

July 2011

Summary View

MEDICATION GUIDE (new with approved REMS)

 

November 2009

Summary View

 

BOXED WARNING

the following sentences were added to the boxed warning

  • The substitution of Actiq for any other fentanyl product may result in fatal overdose.
  • When prescribing, do not convert patients on a mcg per mcg basis to Actiq from other fentanyl products.
  • When dispensing, do not substitute an Actiq prescription for other fentanyl products. Substantial differences exist in the pharmacokinetic profile of Actiq compared to other fentanyl products that result in clinically important differences in the extent of absorption of fentanyl. As a result of these differences, the substitution of Actiq for any other fentanyl product may result in fatal overdose.