• A greater proportion of patients on PROMACTA tablets did not require any antiviral
dose reduction as compared with placebo (45% versus 27%, respectively)
Platelet Counts ≥50,000/mcL
PROMACTA tablets +
peginterferon + ribavirin
peginterferon + ribavirin
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.
Important Safety Information for PROMACTA (cont’d)
Thrombotic/Thromboembolic Complications (cont’d):
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 109/L.
PROMACTA is not indicated for the treatment of thrombocytopenia in patients with CLD in preparation
for invasive procedures.
Complete Blood Counts (CBCs): Obtain CBCs with differentials (including platelet counts) weekly during the
dose adjustment phase of therapy with PROMACTA and then monthly following establishment of a stable dose
of PROMACTA. Obtain CBCs with differentials (including platelet counts) weekly for at least 4 weeks following
discontinuation of PROMACTA.
Liver tests: Monitor serum liver tests (ALT, AST, and bilirubin) prior to initiation of PROMACTA, every 2 weeks
during the dose adjustment phase, and monthly following establishment of a stable dose. PROMACTA
inhibits UGT1A1 and OATP1B1, which may lead to indirect hyperbilirubinemia. If bilirubin is elevated, perform
fractionation. If abnormal levels are detected, repeat the tests within 3 to 5 days. If the abnormalities are
confirmed, monitor serum liver tests weekly until the abnormality(ies) resolve, stabilize, or return to baseline
levels. Discontinue PROMACTA for the development of important liver test abnormalities.
In the ENABLE- 1 and ENABLE- 2 Phase III, randomized, double-blind, placebo-controlled, multicenter trials1, 2
PROMACTA tablets Maintained Platelet Counts ≥50,000/mcL
in More Patients Than Placebo1, 2