Promacta is a medication that lowers the risk of bleeding by stimulating bone marrow to produce more platelets. The drug is marketed as Revolade in the European Union and Canada.
Promacta (eltrombopag) was approved by the U.S. Food & Drug Administration (FDA) in 2008. It was developed by GlaxoSmithKline, and is now marketed by Novartis. Its current indications include:
The safety and efficacy of Promacta has not been established for:
The prescribing information for Promacta includes a black box warning regarding the potential for serious liver problems. The drug may increase the risk of liver problems in people with chronic hepatitis C virus who take Promacta with interferon and ribavirin treatment.
The Warning and Precautions section of the Promacta label also advises that liver function should be monitored during treatment due to a potential for hepatotoxicity.
Promacta patients should tell their doctor right away if they experience any of the following symptoms:
Serious side effects associated with Promacta include:
A full list of possible Promacta side effects, as well as other important safety information, can be found in the drug’s prescribing information.
In August 2016, Health Canada warned that eltrombopag (sold as Revolade in Canada, Promacta in the U.S.) can cause severe hepatoxicity and potentially fatal liver injury. The regulator advised healthcare providers to measure liver functions every two weeks during the dose adjustment phase. Testing should continue on a monthly basis once a stable dose has been established. Eltrombopag should be discontinued if serum alanine aminotransferase (ALT) levels are more than three times the upper limit of normal in patients with normal liver function, or if they increase or are greater than three times the baseline or greater than five times the upper normal limit in patients who already had elevated ALT levels before treatment.
The Revolade label in Canada was modified to reflect this information.
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