Label Changes for:

Vyvanse (lisdexamfetamine dimesylate) capsules

December 2013

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

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

 

December 2013

ADVERSE REACTIONS

  • frequent or prolonged erections 

 

 

September 2011

ADVERSE REACTIONS

Postmarketing Reports
  • Psychiatric Disorder: dermatillomania

 

November 2010

PRECAUTIONS

Drug Interactions
Agents Whose Blood Levels May be Impacted by Vyvanse
  • Extended release guanfacine: In a drug interaction study (N=40), administration of an extended release guanfacine (4 mg) in combination with Vyvanse (50mg) increased guanfacine maximum plasma concentration=by 19%, whereas, exposure (area under the curve; AUC) was increased by 7%. These small changes are not expected to be clinically meaningful. In this study, no effect on d-amphetamine exposure was observed following co-administration of extended release guanfacine and Vyvanse.


ADVERSE REACTIONS

Postmarketing Reports
Immune System Disorders: anaphylactic reaction
 

 

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