PROMACTA ® (eltrombopag) was studied in the 7-year EXTEND clinical trial
Only oral once-daily TPO receptor agonist 1
Convenient dosing, so your patients can take it at home, at work, or on the go 1
The first time patients relapse after corticosteroids, it’s time to move on
to a long-term, second-line treatment. Learn more at www.promacta.com.
Hepatotoxicity
PROMACTA may increase the risk of severe and potentially life-threatening hepatotoxicity. Measure serum alanine
aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin prior to initiation of PROMACTA, every 2 weeks
during the dose-adjustment phase, and monthly following establishment of a stable dose. PROMACTA inhibits UGT1A1
and OATP1B1, which may lead to indirect hyperbilirubinemia. If bilirubin is elevated, perform fractionation. Evaluate abnormal
serum liver tests with repeat testing within 3 to 5 days. If the abnormalities are confirmed, monitor serum liver tests weekly
until resolved or stabilized.
Discontinue PROMACTA if ALT levels increase to ≥3 times the upper limit of normal (ULN) in patients with normal liver function
or ≥3 times baseline in patients with pretreatment elevations in transaminases and are progressively increasing; or persistent
for ≥4 weeks; or accompanied by increased direct bilirubin; or accompanied by clinical symptoms of liver injury or evidence for
hepatic decompensation.
If the potential benefit for reinitiating treatment with PROMACTA outweighs the risk for hepatotoxicity, then consider cautiously
reintroducing PROMACTA and measure serum liver tests weekly during the dose-adjustment phase. Hepatotoxicity may reoccur
if PROMACTA is reinitiated. If liver test abnormalities persist, worsen, or recur,
then permanently discontinue PROMACTA.
Isolated cases of severe liver injury were identified in clinical trials. The elevation of liver
laboratory values occurred approximately 3 months after initiation of PROMACTA. In all
cases, the event resolved following PROMACTA discontinuation.
Please see continued Important Safety Information and Brief Summary
of full Prescribing Information for PROMACTA on adjacent pages.