EFFICACY & SAFETY

PROMACTA worked fast—rapid response seen as early as Week 1^1,2

Nearly 9 of 10 patients responded at Week 2 (platelet count ≥50,000/mcL)^1,2

In the TRA100773A pivotal trial:

• The primary end point, response at Day 43, was 70% (19/27) with the 50-mg dose vs 11% (3/27) with placebo^2,†

• Response rate at Day 8 was 44% (12/27) vs 7% (2/27) with placebo²

• The incidence of adverse events was consistent across all groups while on treatment²

• In the 3 placebo-controlled pivotal trials, serum liver test abnormalities (predominantly grade 2 or lower in severity) were reported in 11% and 7% of patients in the PROMACTA and placebo groups, respectively² 

TRA100773A was a phase 2, 12-week, double-blind, placebo-controlled trial of 117 adult patients with previously treated ITP.^1,2
Response was defined as a shift from baseline platelet count <30,000/mcL to ≥50,000/mcL at any time during the treatment period up to 42 days of dosing with 30 mg, 50 mg, or 75 mg of eltrombopag.^1,2

Up to 7 years of continuous response in the EXTEND trial—the longest results ever reported in persistent or chronic ITP^1,3,5-7

Year over year, median platelet count remained ≥50,000/mcL^1,3

In the EXTEND long-term trial:

• In the primary end point, no new adverse reactions were identified at 6 years of therapy^1,3

The open-label EXTEND study evaluated the long-term safety and efficacy of eltrombopag in adults with ITP who had completed a previous eltrombopag study.^1,3,8 The median baseline platelet count was 19,000/mcL prior to administration of PROMACTA.^1,3 This study reviewed more than 8 years of continuous treatment.^3,8 PROMACTA was administered to 302 patients in EXTEND; 218 completed 1 year, 180 completed 2 years, 107 completed 3 years, 75 completed 4 years, 34 completed 5 years, and 18 completed 6 years of therapy, with 3 patients evaluable at Year 7.^1,3 Median platelet counts ≥50,000/mcL by Week 2 and at least that throughout.^1,3,8 The primary end points were safety and tolerability.³

Consistent safety profile in short-term trials, including <3% risk of bleeding-related adverse reactions¹

• In pooled data from short-term trials, no occurrence ≥3% (and more frequent than with placebo) of contusion, epistaxis, gingival bleeding, or petechiae (n=241)¹

^a Includes urinary tract infection, cystitis, urinary tract infection bacterial, and bacteriuria.

• In clinical trials, hemorrhage was the most common serious adverse reaction, and most hemorrhagic reactions followed discontinuation of PROMACTA. Other serious adverse reactions included thrombotic/thromboembolic complications¹

In the long-term EXTEND trial, no new adverse reactions at 6 years^1,3

• In the long-term EXTEND study, no new safety signals despite increased duration of exposure to PROMACTA

• 302 patients were enrolled in the EXTEND trial; not all patients were evaluable at 6 years^1,3

— Primary end points were safety and tolerability assessed via laboratory tests³

• In the long-term EXTEND study, no increased risk of venous thromboembolism with PROMACTA³

• No increase in incidence of previously identified safety concerns (thromboembolic events and hepatobiliary laboratory abnormalities)³

• No clinically relevant increase in bone marrow reticulin or collagen fibers³ 

• In clinical trials, discontinuation due to adverse events was reported in 7% of patients treated with PROMACTA 50 mg in TRA100773A (n=2/30), 4% in TRA100773B (n=3/76), 10% in RAISE (n=13/135), and 14% in EXTEND (n=42/302)^1-3,9,10

DOSING & ADMINISTRATION

The convenience of once-daily oral dosing¹

Patients can take PROMACTA without food or with food that is low in calcium (≤50 mg)¹

• PROMACTA should be taken at least 2 hours before or 4 hours after medications such as antacids and mineral supplements or foods high in calcium¹

• PROMACTA can be taken any time of day, at the same time each day¹

• No need for weekly office visits for injections, and with PROMACTA tablets, there is less unused medication to discard^1,4

Dosing flexibility, even for patients who have difficulty swallowing a pill¹

PROMACTA offers simplified titration to help maintain response over time¹

^a For patients of Asian ancestry, initiate at 25 mg/day. For patients with mild, moderate, or severe hepatic impairment, initiate at a reduced dose of 25 mg once daily; for patients of Asian ancestry with hepatic impairment, consider initiating at a reduced dose of 12.5 mg once daily.
^b Do not exceed a dose of 75 mg daily. For patients taking 25 mg once daily, increase daily dose by 25 mg; for patients taking 12.5 mg once daily, increase dose to 25 mg daily before increasing the dose amount by 25 mg.
^c Wait 2 weeks to assess the effects of this and any subsequent dose adjustments. For patients taking 25 mg once daily, decrease the dose to 12.5 mg once daily.
^d Increase the frequency of platelet monitoring to twice weekly. Once the platelet count is <150,000/mcL, reinitiate therapy at a daily dose reduced by 25 mg. For patients taking 25 mg once daily, reinitiate therapy at a daily dose of 12.5 mg.

• Monitor clinical hematology and liver tests regularly throughout therapy¹

• If platelet counts do not increase to a level sufficient to avoid clinically important bleeding after 4 weeks at 75 mg, discontinue therapy¹

ALT, alanine aminotransferase; AST, aspartate aminotransferase; ITP, immune thrombocytopenia.