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Ligand Partner GlaxoSmithKline Receives FDA Approval For New Indication For PROMACTA® (eltrombopag)

Hepatic Decompensation:

Chronic hepatitis C patients with cirrhosis may be at risk of hepatic decompensation and death when treated with alfa interferons. Monitor patients with low albumin levels or with MELD score ≥10 at baseline.

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 versus <1% for placebo).

In a controlled trial in non-ITP thrombocytopenic patients with chronic liver disease undergoing elective invasive procedures (N=292), seven thrombotic complications (six patients) were reported within the group that received PROMACTA and three thrombotic complications (two 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 five of the six patients at a platelet count above 200 x 10 9/L. PROMACTA is not indicated for the treatment of thrombocytopenia in patients with CLD in preparation for invasive procedures.

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%).

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