For your adult patients with persistent or chronic ITP who failed their first therapy …
See How PROMACTA
Fits With the Experts ’ Guidelines 1 , 2
Patient portrayal .
Important Safety Information for PROMACTA ® ( eltrombopag ) ( continued )
Hepatotoxicity PROMACTA may increase the risk of severe and potentially life-threatening hepatotoxicity .
Treatment of ITP , chronic hepatitis C , and refractory severe aplastic anemia
• 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 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
Thrombotic / Thromboembolic Complications
• Thrombotic / thromboembolic complications may result from increases in platelet counts with PROMACTA
• Reported thrombotic / thromboembolic complications included both venous and arterial events , and were observed at low and at normal platelet counts
• Portal vein thrombosis has been reported in patients with chronic liver disease receiving PROMACTA
• To minimize the risk for thrombotic / thromboembolic complications , do not use PROMACTA in an attempt to normalize platelet counts . Follow the dose-adjustment guidelines to achieve and maintain target platelet counts
Increased Risk of Death and Progression of Myelodysplastic Syndromes ( MDS ) to Acute Myeloid Leukemia ( AML )
• In a clinical trial of patients with intermediate- to high-risk MDS and thrombocytopenia receiving PROMACTA , an increased number of progressions from MDS to AML and deaths have been observed compared to placebo
• PROMACTA is not indicated for the treatment of patients with MDS
Cataracts
• Development or worsening of cataracts with PROMACTA has been reported with a frequency of 5 % to 11 % in 6 clinical studies
• Perform a baseline ocular examination prior to initiating PROMACTA . Regularly monitor patients for signs and symptoms of cataracts while on PROMACTA
Please see additional Important Safety Information for PROMACTA and Brief Summary of full Prescribing Information , including Boxed WARNING , on adjacent pages .