Please see Important Safety Information continued on following pages.
Please see Brief Summary of the full Prescribing Information, including
Boxed Warning, for PROMACTA on following pages.
95%
Target platelet counts:
≥90,000/mcL in ENABLE- 1 (N=715)
≥100,000/mcL in ENABLE- 2 (N=805)
ENABLE- 1 and ENABLE- 2 Trials*
• Evaluated the efficacy and safety
of PROMACTA tablets for the
treatment of thrombocytopenia
in adult patients with chronic
hepatitis C1
• Primary endpoint: Sustained
virologic response (SVR) at
24 weeks after completion of
antiviral treatment period1
• Select secondary endpoints
included platelet count response
to PROMACTA tablets and
initiation of antiviral therapy2
*During the open-label pre-antiviral treatment phase, patients with platelet counts <75,000/mcL (N=1520) were initiated on PROMACTA tablets 25 mg
once daily for 2 weeks. 1 Dose increases by 25 mg were allowed every 2 to 3 weeks as needed for up to a maximum of 9 weeks to achieve target
platelet counts (≥90,000/mcL in ENABLE- 1 and ≥100,000/mcL in ENABLE- 2) for the initiation of antiviral therapy. 1 The median baseline platelet counts
were approximately 60,000/mcL in both treatment groups at the start of the pre-antiviral treatment phase. 1 Patients achieving target platelet counts
were randomized 2: 1 to receive a regimen consisting of either: PROMACTA tablets + Pegasys® (peginterferon alfa-2a) or PegIntron® (peginterferon
alfa-2b) + ribavirin; or, placebo + Pegasys or PegIntron + ribavirin. 1, 2 Pegasys was used in ENABLE- 1; PegIntron was used in ENABLE- 2. 1 PROMACTA
tablets or matched placebo was administered at the same dose as at the end of the open-label phase. 1, 2 Antiviral treatment was administered for
up to 48 weeks. 1, 2 ENABLE- 1 evaluated 715 patients; ENABLE- 2 evaluated 805 patients. 1
ENABLE=Eltrombopag to INitiate and Maintain Interferon Antiviral Treatment to Benefit Subjects with Hepatitis C Related Liver DiseasE. 2
• Median baseline platelet counts
were approximately 60,000/mcL1
• The median time to achieve the
target platelet count ≥90,000/mcL
was approximately 2 weeks1
In the ENABLE- 1 and ENABLE- 2 Phase III, randomized, double-blind, placebo-controlled, multicenter trials* 1, 2
PROMACTA tablets Enabled 95% of Patients to Achieve
Target Platelet Counts and Initiate Interferon-based Therapy1
Important Safety Information for PROMACTA (cont’d)
Additional Safety Information Regarding Risk of Hepatotoxicity:
Reinitiating treatment with PROMACTA is not recommended. If the potential benefit for reinitiating
treatment with PROMACTA is considered to outweigh the risk for hepatotoxicity, then cautiously
reintroduce PROMACTA and measure serum liver tests weekly during the dose adjustment phase. If liver
test abnormalities persist, worsen or recur, then permanently discontinue PROMACTA.
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.
Bone Marrow Reticulin Formation and Risk for Bone Marrow Fibrosis:
PROMACTA may increase the risk for development or progression of reticulin fiber deposition within the bone
marrow. Clinical studies have not demonstrated clinical consequences to date. If new or worsening blood
morphological abnormalities or cytopenias occur, consider a bone marrow biopsy including staining for fibrosis.
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.
