|INCIDENCE OF TRANSAMINASE ELEVATIONS1,2
|ELEVATED ALT OR AST
||6 TO <12 MONTH COHORT n/N (%)
||12 TO <24 MONTH COHORT n/N (%)
ALT, alanine aminotransferase. AST, aspartate aminotransferase. ULN, upper limit of normal.
Please see Important Safety Information for additional information on liver-related serious adverse events.
- No patients in either cohort had elevations in total bilirubin, or discontinued ivacaftor treatment due to transaminase elevations1
- 6 to <12 month cohort: During the course of this study, no patient interrupted treatment because of adverse events of elevated liver function tests2
- On the last day of the study, 1 patient had an LFT elevation that resulted in subsequent treatment interruption2
- 12 to <24 month cohort: 2 patients had study drug interrupted because of adverse events of elevated liver function tests3
- 1 patient had adverse events of ALT increased and AST increased that led to study drug interruption5
- 1 patient had adverse events of ALT increased, AST increased, and GGT increased that led to study drug interruption5
- Both resumed treatment following a period of study drug interruption with no further elevations3
Please see Important Safety Information for more information about transaminase elevations reported in patients with CF receiving KALYDECO.