WARNING: RISK FOR HEPATOTOXICITY
PROMACTA may cause hepatotoxicity:
ā—¸Measure serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin prior to initiation of PROMACTA, every 2 weeks during the dose adjustment phase and monthly following establishment of a stable dose. If bilirubin is elevated, perform fractionation.
ā—¸Evaluate abnormal serum liver tests with repeat testing 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.
ā—¸Discontinue PROMACTA if ALT levels increase to ≥3X the upper limit of normal (ULN) and are:
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ā—¸progressive, or
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ā—¸persistent for ≥4 weeks, or
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ā—¸accompanied by increased direct bilirubin, or
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ā—¸accompanied by clinical symptoms of liver injury or evidence for hepatic decompensation.
Because of the risk for hepatotoxicity and other risks [see Warnings and Precautions (5.1-5.6)], PROMACTA is available only through a restricted distribution program called PROMACTA CARES. Under PROMACTA CARES, only prescribers, pharmacies, and patients registered with the program are able to prescribe, dispense, and receive PROMACTA. To enroll in PROMACTA CARES, call 1-877-9-PROMACTA [see Warnings and Precautions].
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PROMACTA SUMMARY
PROMACTA (eltrombopag) Tablets contain eltrombopag olamine, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag interacts with the transmembrane domain of the TPO receptor (also known as cMpl) leading to increased platelet production. Each tablet contains eltrombopag olamine in the amount equivalent to 25 mg or 50 mg of eltrombopag free acid.
PROMACTA is indicated for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. PROMACTA should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increases the risk for bleeding. PROMACTA should not be used in an attempt to normalize platelet counts.
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NEWS HIGHLIGHTS
Published Studies Related to Promacta (Eltrombopag)
Population pharmacokinetics of eltrombopag in healthy subjects and patients with chronic idiopathic thrombocytopenic purpura. [2011.06]
The population pharmacokinetics of eltrombopag were characterized in healthy subjects (n = 111) and patients with idiopathic thrombocytopenic purpura (ITP) (n = 88) using nonlinear mixed-effects modeling. The final model was evaluated via graphical diagnostics and through predictive check and nonparametric bootstrap procedures...
Clinical pharmacokinetics, platelet response, and safety of eltrombopag at supratherapeutic doses of up to 200 mg once daily in healthy volunteers. [2011.03]
This was a double-blind, placebo-controlled, randomized, parallel, dose-escalation study to assess the pharmacokinetics, platelet response, safety, and tolerability of supratherapeutic doses of eltrombopag (100 mg, 150 mg, and 200 mg once daily) administered for 5 days to 33 healthy adult volunteers...
Eltrombopag for management of chronic immune thrombocytopenia (RAISE): a 6-month, randomised, phase 3 study. [2011.01.29]
BACKGROUND: Eltrombopag is an oral thrombopoietin receptor agonist for the treatment of thrombocytopenia. We aimed to compare the response to once daily eltrombopag versus placebo in patients with chronic immune thrombocytopenia during a 6-month period... INTERPRETATION: Eltrombopag is effective for management of chronic immune thrombocytopenia, and could be particularly beneficial for patients who have not responded to splenectomy or previous treatment. These benefits should be balanced with the potential risks associated with eltrombopag treatment. FUNDING: GlaxoSmithKline. Copyright (c) 2011 Elsevier Ltd. All rights reserved.
Clinical pharmacokinetics, platelet response, and safety of eltrombopag at
supratherapeutic doses of up to 200 mg once daily in healthy volunteers. [2011]
This was a double-blind, placebo-controlled, randomized, parallel,
dose-escalation study to assess the pharmacokinetics, platelet response, safety,
and tolerability of supratherapeutic doses of eltrombopag (100 mg, 150 mg, and
200 mg once daily) administered for 5 days to 33 healthy adult volunteers...
Eltrombopag (75 mg) does not induce photosensitivity: results of a clinical pharmacology trial. [2010.10]
Background/purpose: Eltrombopag is an oral, small molecule, thrombopoietin receptor agonist approved in the United States for the treatment of chronic immune thrombocytopenic purpura and under investigation for treatment of thrombocytopenia due to other etiologies... Eltrombopag is well tolerated and does not induce photosensitivity.
Clinical Trials Related to Promacta (Eltrombopag)
EXTEND (Eltrombopag Extended Dosing Study) [Recruiting]
An open-label, dose-adjustment, extension study to evaluate the safety and efficacy of
eltrombopag for the treatment of subjects with idiopathic thrombocytopenic purpura (ITP) who
have previously been enrolled in an eltrombopag trial. This study will allow adjustment of
the eltrombopag dose to achieve an individualized dose and schedule for each subject. In
addition, the ability to reduce the dose of concomitant ITP medications in the presence of
eltrombopag, while maintaining platelet counts = 50,000/microL will be investigated.
Efficacy of Eltrombopag to Improve Thrombocytopenia of MYH9-related Disease [Recruiting]
The term MYH9-related disease (MYH9RD) includes four genetic disorders: May-Hegglin anomaly,
Sebastian syndrome, Fechtner syndrome, and Epstein syndrome. All these disorders derive from
mutation of a unique gene, named MYH9, and they have been recognized as different clinical
presentations of a single illness that was named MYH9RD. All patients affected by MYH9RD
present since birth with thrombocytopenia, which can result in a variable degree of bleeding
diathesis; some of them subsequently develop additional clinical manifestations, such as
renal damage, sensorineural hearing loss, and/or presenile cataracts. Eltrombopag is an oral
thrombopoietin receptor agonist that stimulates proliferation and differentiation of
megakaryocytes, the bone marrow cells that produce blood platelets. This drug is effective
in increasing platelet count in healthy volunteers, as well as in patients affected by some
acquired thrombocytopenias, such as idiopathic thrombocytopenic purpura and HCV related
thrombocytopenia. The purpose of this study is to determine if eltrombopag, administered
orally at the dose of 50 or 75 mg/daily for up to 6 weeks, is effective in increasing
platelet count of patients affected by MYH9RD. Further aims of this study are to test if
eltrombopag is effective in reducing bleeding tendency of MYH9RD patients; to evaluate
safety and tolerability of eltrombopag in patients with MYH9RD; to evaluate in vitro
function of platelets produced during therapy in patients responding to this drug.
Trial of Eltrombopag During Consolidation Therapy in Adults With AML in Complete Remission [Recruiting]
Patients with Acute Myeloid Leukemia (AML) in complete remission will receive eltrombopag
while undergoing consolidation chemotherapy with high-dose cytarabine. Eltrombopag may help
increase the number of platelets during chemotherapy and may help prevent the risk of
bleeding.
Phase I will study the side effects, best dose and platelet effects of eltrombopag when
given with consolidation chemotherapy. After the maximum safe and tolerated dose and
schedule is found in Phase I, the study will proceed to Phase II. Phase II will confirm the
dose and schedule of eltrombopag identified in Phase I that can increase platelet counts in
patients receiving consolidation therapy.
Platelet Function in Idiopathic Thrombocytopenic Purpura (ITP) Patients With Eltrombopag [Recruiting]
This is a single-center, prospective, controlled study with one eltrombopag treatment group
and 2 control groups, one on standard steroid treatment, and another one untreated.
The aim of the study is to determine the effect of Thrombopoietin Receptor (MPL) agonists on
shear-induced platelet activation.
Milk-only Lactation Study for Patients on Eltrombopag [Not yet recruiting]
This is a Phase IV study to evaluate eltrombopag concentrations in breast milk of nursing
mothers taking marketed eltrombopag (PROMACTA®). Up to 10 subjects (mother-infant pairs) at
as many as 10 study centers in the US will be enrolled. Nursing mothers who are registered
with the PROMACTA Pregnancy Registry will be offered the option to participate in this trial
if they continue to take commercial eltrombopag post-delivery and decide to breastfeed their
infant. Information will be collected in a diary. Breast milk samples will be collected
before and after infant feedings for a 24 hour period after eltrombopag dosing to evaluate
the eltrombopag concentrations in the breast milk. Mothers will also be given the option to
have a pharmacokinetic (PK) blood sample collected from the infant.
Reports of Suspected Promacta (Eltrombopag) Side Effects
Death (78),
Drug Ineffective (59),
Platelet Count Decreased (41),
Thrombocytopenia (38),
Myelodysplastic Syndrome (28),
Platelet Count Increased (28),
Liver Disorder (23),
Fatigue (23),
Anaemia (22),
Pulmonary Embolism (19), more >>
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Page last updated: 2013-02-10
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