Label Changes for:

Kytril (granisetron hydrochloride) injection, tablets and oral solution

October 2009

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

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- October 2009

PRECAUTIONS

  • An adequate QT assessment has not been conducted, but QT prolongation has been reported with Kytril. Therefore, Kytril should be used with caution in patients with pre-existing arrhythmias or cardiac conduction disorders, as this might lead to clinical consequences. Patients with cardiac disease, on cardio-toxic chemotherapy, with concomitant electrolyte abnormalities and/or on concomitant medications that prolong the QT interval are particularly at risk.
Drug Interactions
  • QT prolongation has been reported with Kytril. Use of Kytril in patients concurrently treated with drugs known to prolong the QT interval and/or are arrhythmogenic, this may result in clinical consequences.

ADVERSE REACTIONS

  • QT prolongation has been reported with Kytril.
Postmarketing Experience
  • QT prolongation has been reported with Kytril.
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