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.
