- The proportion of patients who had an increase in systolic blood pressure of >140 mmHg and 10 mmHg from baseline on at least two occasions:
- 4% of patients treated with TRIKAFTA and 1% of placebo-treated patients
- The proportion of patients who had an increase in diastolic blood pressure of >90 mmHg and 5 mmHg from baseline on at least two occasions:
- 1% of patients treated with TRIKAFTA and 2% of placebo-treated patients
Safety Data from Post-marketing Experience1
Adverse reactions have been identified during post approval use of TRIKAFTA and include liver failure leading to transplantation in a patient with pre-existing cirrhosis and portal hypertension, and liver injury characterized by concomitant transaminase (ALT and AST) and total bilirubin elevationsd
dBecause these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.