| A case of fulminant hepatic failure requiring liver transplantation
in a patient who initiated Rebif ® therapy while taking another
potentially hepatotoxic (liver damaging substance) medication has been
reported from a non-U.S. postmarketing source.
Severe liver dysfunction,
leading to hepatic failure and liver transplantation, has been reported
very rarely in patients taking Rebif ®.
Symptomatic hepatic dysfunction, primarily presenting as jaundice,
has been reported as a rare complication of Rebif ® use.
Asymptomatic elevation of hepatic transaminases (particularly SGPT
†) is common
with interferon therapy.
Asymptomatic elevation of hepatic transaminases (particularly SGPT
†) is common with
interferon therapy.
Rebif ® should be initiated with caution in patients with
active liver disease, alcohol abuse, increased serum SGPT
† (>2.5 times ULN), or a
history of significant liver disease.
Dose reduction should be considered if SGPT
† rises above 5 times the
upper limit of normal.
The dose may be gradually re-escalated when enzyme levels have normalized.
Treatment with Rebif ® should be stopped if jaundice or
other clinical symptoms of liver dysfunction appear.
† SGPT = serum
glutamic-pyruvic transaminase
|
