ASH Clinical News October 2017 | Page 42

Important Safety Information for PROMACTA ® ( eltrombopag ) ( continued )

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 . Consider the potential for an increased risk of thromboembolism when administering PROMACTA to patients with known risk factors for thromboembolism . 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 .

In 2 controlled clinical trials in patients with chronic hepatitis C and thrombocytopenia , 3 % ( 31 / 955 ) treated with PROMACTA experienced a thrombotic event compared to 1 % ( 5 / 484 ) on placebo . The majority of events were of the portal venous system ( 1 % in patients treated with PROMACTA vs < 1 % for placebo ).

In a controlled trial in patients with chronic liver disease undergoing elective invasive procedures ( N = 292 ), 7 thrombotic complications ( 6 patients ) were reported within the group that received PROMACTA and 3 thrombotic complications ( 2 patients ) within the placebo group . All of the thrombotic complications reported in the group that received PROMACTA were portal vein thrombosis , with thrombotic complications occurring in 5 of the 6 patients at a platelet count above 200 × 10 9 / L . PROMACTA is not indicated for the treatment of thrombocytopenia in patients with chronic liver disease in preparation for invasive procedures .

Cataracts

In the 3 controlled clinical trials in chronic ITP , cataracts developed or worsened in 15 ( 7 %) patients who received 50-mg PROMACTA daily and 8 ( 7 %) placebo-group patients . In the extension trial , cataracts developed or worsened in 11 % of patients who underwent ocular examination prior to therapy with PROMACTA .

Cataracts were observed in toxicology studies of eltrombopag in rodents . Perform a baseline ocular examination prior to administration of PROMACTA and , during therapy with PROMACTA , regularly monitor patients for signs and symptoms of cataracts .

Laboratory Monitoring

In patients with chronic ITP , monitor serum liver tests . During therapy with PROMACTA , assess complete blood counts ( CBCs ) with differentials , including platelet counts , weekly until a stable platelet count has been achieved . Monitor platelet counts monthly thereafter . Obtain CBCs with differentials , including platelet counts , weekly for at least 4 weeks following discontinuation of PROMACTA .

When switching between the oral suspension and tablet , assess platelet counts weekly for 2 weeks , then follow standard monthly monitoring .

Drug Interactions

PROMACTA must be taken at least 2 hours before or 4 hours after any medications or products containing polyvalent cations such as antacids , calcium-rich foods , and mineral supplements .

Adverse Reactions

The most common adverse reactions in 3 placebo-controlled clinical trials in adult patients with chronic ITP ( ≥3 % and greater than placebo ) for PROMACTA vs placebo were nausea ( 9 % vs 3 %), diarrhea ( 9 % vs 7 %), upper respiratory tract infection ( 7 % vs 6 %), vomiting ( 6 % vs < 1 %), increased ALT ( 5 % vs 3 %), myalgia ( 5 % vs 2 %), urinary tract infection ( 5 % vs 3 %), oropharyngeal pain ( 4 % vs 3 %), increased AST ( 4 % vs 2 %), pharyngitis ( 4 % vs 2 %), back pain ( 3 % vs 2 %), influenza ( 3 % vs 2 %), paresthesia ( 3 % vs 2 %), and rash ( 3 % vs 2 %).

The most common adverse reactions in 2 placebo-controlled clinical trials in chronic ITP patients 1 year and older ( ≥3 % and greater than placebo ) for PROMACTA vs placebo were upper respiratory tract infection ( 17 % vs 6 %), nasopharyngitis ( 12 % vs 4 %), cough ( 9 % vs 0 %), diarrhea ( 9 % vs 2 %), pyrexia ( 9 % vs 8 %), rhinitis ( 9 % vs 6 %), abdominal pain ( 8 % vs 4 %), oropharyngeal pain ( 8 % vs 2 %), toothache ( 6 % vs 0 %), ALT increased ( 6 % vs 0 %), rash ( 5 % vs 2 %), AST increased ( 4 % vs 0 %), and rhinorrhea ( 4 % vs 0 %).

Please see Important Safety Information for PROMACTA , including Boxed WARNING , and Brief Summary of full Prescribing Information on adjacent pages .

Reference : 1 . Promacta [ prescribing information ]. East Hanover , NJ : Novartis Pharmaceuticals Corp ; 2017 .