- 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 RECOMMENDATIONS RELATED TO BLACK BOX 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
Patient Counseling Information
Updated January 2018