Label Changes for:

Apokyn (apomorphine hydrochloride) injection

September 2010

Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – September 2010

 

WARNINGS

Hallucinations / Psychotic-Like Behavior
  • In one randomized, double-blind, placebo-controlled study, hallucinations or confusion occurred in 10 % of patients treated with Apokyn and 0 % of patients treated with placebo.
  • Post marketing reports indicate that patients may experience new or worsening mental status and behavioral changes, which may be severe, including psychotic-like behavior after starting or increasing the dose of Apokyn. Other drugs prescribed to improve the symptoms of Parkinson’s disease can have similar effects on thinking and behavior. This abnormal thinking and behavior can consist of one or more of a variety of manifestations, including paranoid ideation, delusions, hallucinations, confusion, disorientation, aggressive behavior, agitation, and delirium.
  • Patients with a major psychotic disorder should ordinarily not be treated with Apokyn because of the risk of exacerbating psychosis. In addition, certain medications used to treat psychosis may exacerbate the symptoms of Parkinson's disease and may decrease the effectiveness of Apokyn.

PRECAUTIONS

Information for Patients
  • ...or other manifestations of psychotic-like behavior can occur. Patients should also be advised that, if they have a major psychotic disorder, that Apokyn should not ordinarily be used because of the risk of exacerbating the psychosis. Patients with a major psychotic disorder should also be aware that many treatments for psychosis may decrease the effectiveness of Apokyn.
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