Label Changes for:
Vyvanse (lisdexamfetamine dimesylate) capsules
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)
- frequent or prolonged erections
- Psychiatric Disorder: dermatillomania
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.
Immune System Disorders: anaphylactic reaction