REVOLADE has a favorable safety profile in SAA1
The safety profile of REVOLADE in treatment-naive patients was consistent with that seen in refractory SAA patients1
Adverse reactions were observed differently in the treatment-naive (N=153) than in
refractory SAA patients
Newly observed skin discoloration including skin hyperpigmentation (5.4%)
Higher frequency of increase in blood bilirubin (17.4%)
The safety profile in pediatric patients (n=37) was consistent with the safety profile
observed in the overall population1
Fifteen (10%) patients had a cytogenetic abnormality reported, including 7 patients
1 patient of whom the bone marrowwho had loss of chromosome 7 and had features of dysplasia1
SAA, severe aplastic anemia.
*Representative of Cohorts 1, 2, and 3.
† Two patients (1 in Cohort 2 and 1 in Cohort 3) experienced a severe adverse reaction and discontinued REVOLADE as a result.