Has been reported in 2% patients in clinical trials. Reports of interstitial changes including pulmonary fibrosis leading to hospitalization and death rarely reported in post marketing surveillance.
Most cases were reversible with discontinuation and occurred within first 3 months of therapy
Monitoring data
Perform chest x-ray and possibly pulmonary function tests at baseline
Patients should report new or worsening dyspnea
Immediately discontinue until symptoms are determined to be drug related