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Promacta

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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.

What is Promacta Used For?

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:

• Treatment of thrombocytopenia in adult and pediatric patients 1 years and older with chronic immune (idiopathic) thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
• Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy.
• Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy.

The safety and efficacy of Promacta has not been established for:

• The treatment of pediatric patients 1 years and younger with chronic ITP.
• The treatment of pediatric patients with thrombocytopenia associated with chronic hepatitis C and severe aplastic anemia.

Promacta Black Box Warning

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:

• Yellowing of the skin or the whites of the eyes (jaundice)
• Unusual darkening of the urine
• Unusual tiredness
• Pain in the right upper stomach area
• Confusion
• Swelling of the stomach area

Promacta Side Effects

Serious side effects associated with Promacta include:

• Abnormal liver function tests
• Higher risk of blood clots due to high platelet count
• New or worsened cataracts

A full list of possible Promacta side effects, as well as other important safety information, can be found in the drug’s prescribing information.

Health Canada Alert for Eltrombopag

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.