Biochemical Abnormalities Seen in about 40% of those taking Roaccutane.
Rises in alanine and aspartate aminotransferase enzymes (ALT and AST) have been reported. Liver
function tests, especially AST and blood lipids should be measured before therapy and at monthly intervals
during therapy and at the end of treatment. When transaminase levels exceed the normal levels, reduction
of the dose or discontinuation of treatment may be necessary.
Isotretinoin causes elevation of serum triglycerides and cholesterol as well as a decrease in H.D.L., which
appear to be related to duration of treatment and are reversible on cessation of treatment. The degree of
elevation may also be dose dependent although this has not been conclusively established.
ROACCUTANE Product Information
5.
At doses of greater than 1 mg/kg/day, approximately one in four patients have been found to develop
elevated triglycerides while taking ROACCUTANE. At lower doses triglyceride levels elevated above the
normal range are uncommon.
Some patients have been able to reverse triglyceride elevations by weight reduction and restriction of
dietary fat and alcohol while continuing to take ROACCUTANE. Serum lipid values usually return to
normal on reduction of the dose or discontinuation of treatment.
Acute pancreatitis, which is potentially fatal, sometimes associated with serum triglycerides levels > 8g/L,
has been reported. Hence, ROACCUTANE should be discontinued if uncontrolled hypertriglyceridemia
or symptoms of pancreatitis occur.
Serum lipids (fasting value) should be determined one month prior to therapy and again after about 4
weeks of therapy and subsequently at three month intervals unless more frequent monitoring is clinically
indicated.
Predisposing factors such as a family history of lipid metabolism disorders, obesity, alcoholism, diabetes
and smoking should be assessed. In high risk patients (with diabetes, obesity, alcoholism or lipid
metabolism disorder) undergoing treatment with ROACCUTANE, more frequent checks of serum values
for lipids and/or blood glucose may be necessary.