Testing and monitoring patients before and during SKYCLARYS treatment
Obtain ALT, AST, bilirubin, BNP, and lipid parameters prior to initiating SKYCLARYS and during treatment1
Aminotransferases1
Monitor ALT, AST, and total bilirubin before starting SKYCLARYS. There were no cases of concomitant elevation of transaminases and total bilirubin observed in the clinical trial. Maximum increases in ALT and AST occurred within 12 weeks after starting SKYCLARYS. Increases in serum aminotransferases were generally asymptomatic and reversible following discontinuation of SKYCLARYS
If levels are >5x ULN, or >3x ULN with evidence of liver dysfunction, immediately discontinue SKYCLARYS and repeat liver function tests as soon as possible
If levels stabilize or resolve, SKYCLARYS may be reinitiated with an appropriate increased frequency of monitoring of liver function
ALT=alanine aminotransferase; AST=aspartate aminotransferase; ULN=upper limit of normal.
B-type natriuretic peptide (BNP)1
Monitor patients for the signs and symptoms of fluid overload, such as sudden weight gain (3 pounds or more of weight gain in one day or 5 pounds or more of weight gain in a week), peripheral edema, palpitations, and shortness of breath. Management of fluid overload and heart failure may require discontinuation of SKYCLARYS
Lipid abnormalities1
Manage lipid abnormalities according to clinical guidelines