• 90% of patients had bridging
fibrosis and cirrhosis as indicated
by noninvasive testing1
• Approximately 30% of patients
had been previously treated with
interferon and ribavirin1
• 69% of patients had genotypes 1,
4, or 6; 31% had genotypes 2 or 31
• SVR data include genotypes 1, 2, 3,
4, and 61
ENABLE- 1 ENABLE- 2
PROMACTA tablets + peginterferon + ribavirin Placebo + peginterferon + ribavirin
SVR=sustained virologic response defined as the percentage of patients with undetectable HCV-RNA at 24 weeks after completion of
antiviral treatment. 1
ENABLE- 1 and ENABLE- 2 were randomized, double-blind, placebo-controlled, multicenter, Phase lll trials that evaluated the efficacy and
safety of PROMACTA tablets in patients with chronic hepatitis C–associated thrombocytopenia. Patients were randomized to receive either
PROMACTA tablets or a placebo in combination with peginterferon and ribavirin. 1, 2
Important Safety Information for PROMACTA (cont’d)
In the 2 controlled clinical trials in patients with chronic hepatitis C and thrombocytopenia, cataracts
developed or worsened in 8% patients treated with PROMACTA and 5% patients treated with placebo.
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.
PROMACTA must not be taken within 4 hours of any medications or products containing polyvalent cations
such as antacids, dairy products, and mineral supplements.
The most common adverse reactions in 2 randomized placebo-controlled clinical trials in thrombocytopenic
patients with chronic hepatitis C (≥10% and greater than placebo) for PROMACTA versus placebo were: anemia
(40% vs. 35%), pyrexia (30% vs. 24%), fatigue (28% vs. 23%), headache (21% vs. 20%), nausea (19% vs. 14%),
diarrhea (19% vs. 11%), decreased appetite (18% vs. 14%), influenza-like illness (18% vs. 16%), asthenia
(16% vs. 13%), insomnia (16% vs. 15%), cough (15% vs. 12%), pruritus (15% vs. 13%), chills (14% vs. 9%),
myalgia (12% vs. 10%), alopecia (10% vs. 6%), and peripheral edema (10% vs. 5%).
Please see Brief Summary of the full Prescribing Information,
including Boxed Warning, for PROMACTA on following pages.
For more information, please call 1-888-825-5249
or visit www.gsksource.com.
References: 1. PROMACTA® (eltrombopag) Tablets [package insert]. Research Triangle Park, NC: GlaxoSmithKline;
2012. 2. Data on file. GlaxoSmithKline.
PROMACTA tablets is a registered trademark of GlaxoSmithKline. The following are registered trademarks
of their respective owners: PEGASYS/Hoffmann-La Roche Inc.; PEGINTRON/Schering Corporation.
In the ENABLE- 1 and ENABLE- 2 Phase III, randomized, double-blind, placebo-controlled, multicenter trials1, 2
PROMACTA tablets Enabled Interferon-based Therapy to Achieve
Significantly Higher SVR Rates Compared to Placebo1, 2