Gastroenterology - Volume 14, Part 3, September 2013

P e rc e n t a ge of P at ie n t s

• 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

P<0.05

ENABLE- 1 ENABLE- 2

P<0.05 SVR 14%

(33/232) 2

19%

(97/506) 2

13% (32/253) 2

23%

(104/450) 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)

Cataracts:

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.

Drug Interactions:

PROMACTA must not be taken within 4 hours of any medications or products containing polyvalent cations such as antacids, dairy products, and mineral supplements.

Adverse Reactions:

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.