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GLAXOSMITHKLINE
SAFETY ADVISORY
Date: May 4, 2010
Dear Health Care Professional,
Promacta (eltrombopag) Notification Of Safety Information:
Portal Venous System Thromboses in a Study of Patients With
Chronic Liver Disease (ELEVATE)
GlaxoSmithKline (GSK) would like to inform you of a new
safety finding concerning eltrombopag in patients with thrombocytopenia
due to chronic liver disease.
Promacta is a thrombopoietin receptor agonist approved for
the treatment of thrombocytopenia in adult patients with
chronic immune (idiopathic) thrombocytopenic purpura (ITP).
Key
Messages
In
a study of thrombocytopenic patients with chronic liver
disease of diverse etiology, patients were treated with
eltrombopag 75mg or matching placebo for 14 days prior to
undergoing an elective invasive procedure. The study was
terminated following the identification of an imbalance
of thrombosis of the portal venous system in the patients
treated with eltrombopag.
Six patients (4%) in the eltrombopag group and 1 (1%) in
the placebo group experienced a thrombotic event of the
portal venous system. Five of the six patients treated with
eltrombopag experienced the portal venous thrombosis at
platelet counts above 200,000/mcL.
The
risk for development of thromboembolic events is included
in the Warnings and Precautions section of the product information
for eltrombopag.
Eltrombopag is indicated for the treatment of chronic immune
(idiopathic) thrombocytopenic purpura (ITP) and is not indicated
for the treatment of thrombocytopenia in patients with chronic
liver disease.
Actions Taken by GlaxoSmithKline
GSK
has communicated this safety finding to clinical trial investigators
and regulatory agencies. GSK is working with regulatory
agencies to include this safety information in the label.
To
conduct a comprehensive analysis of the clinical trial data
GSK terminated the ELEVATE study. This data has been publicly
presented at an international scientific meeting.
GSK's highest priority is patient safety. GSK will continue
to review new safety data for eltrombopag, including information
arising from clinical trials across all the indications
under study and from post-marketing adverse event reports.
Action
required by Health Care Professionals
Health Care Professionals are reminded that Promacta is
indicated for the treatment of thrombocytopenia in adult
patients with chronic immune (idiopathic) thrombocytopenic
purpura (ITP) and is not indicated for the treatment of
thrombocytopenia in patients with chronic liver disease.
Treatment
with Promacta should be aimed at increasing the platelet
count to a level that reduces the risk of bleeding; Promacta
should not be used in an attempt to normalize the platelet
count.
Use
caution when administering Promacta to patients with known
risk factors for thromboembolism.
Exercise
caution when administering Promacta to patients with hepatic
disease. Use a lower starting dose (25mg once daily) of
Promacta in patients with moderate to severe hepatic disease
and monitor closely.
Supporting
Information
The
ELEVATE study was a randomized, double-blind, placebo-controlled,
multinational study conducted to assess the safety and efficacy
of eltrombopag to reduce the need for platelet transfusion
in thrombocytopenic patients with chronic liver disease
undergoing elective invasive procedures.
In
this study, thrombocytopenic patients with mild, moderate
and severe hepatic impairment of diverse etiology, were
treated with eltrombopag 75 mg or matching placebo for 14
days prior to undergoing an elective invasive procedure.
Patients with concomitant malignancies were allowed to enroll.
An Independent Data Safety Monitoring Committee identified
an imbalance of thrombosis of the portal venous system in
the patients treated with eltrombopag. GSK terminated the
study to conduct a comprehensive analysis of the study data.
Six patients (4%) in the eltrombopag group and 1 (1%) in
the placebo group experienced a thrombotic event of the
portal venous system, and an additional patient in the placebo
group was diagnosed with a myocardial infarction. Five of
the six patients treated with eltrombopag experienced the
portal venous thrombosis at platelet counts above 200,000/µL.
This data
was presented at an international scientific meeting
(European
Association for the Study of the Liver, April 2010).
GSK
will continue to carefully evaluate all thromboembolic events
from clinical trials and post marketing reports to improve
its understanding of eltrombopag's role in these events.
Further
Information
Should
you require additional information about Promacta please
refer to the Prescribing Information (which can also be
found at http://www.promactacares.com/prescribing_information.pdf)
or contact GlaxoSmithKline Medical Information via the GSK
Customer Response Center at 1-888-825-5249.
GlaxoSmithKline
reminds Health Care Professionals to continue to report
adverse reactions to FDA MedWatch at 1-800-FDA-1088 or www.fda.gov/medwatch
in accordance with the national spontaneous reporting system
rules. GlaxoSmithKline encourages Health Care Professionals
to continue to report suspected adverse reactions, pregnancy,
overdose and unexpected benefits of PROMACTA at 1-888-825-5249.
Sincerely,
Manuel
Aivado, MD
Director, Global Clinical Development Oncology
GlaxoSmithKline
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