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Promacta (Eltrombopag Olamine) - Summary

 
 



WARNING: RISK FOR HEPATIC DECOMPENSATION IN PATIENTS WITH CHRONIC HEPATITIS C

In patients with chronic hepatitis C, PROMACTA® in combination with interferon and ribavirin may increase the risk of hepatic decompensation [see Warnings and Precautions] .

 

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.


See all Promacta indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Promacta (Eltrombopag)

Promacta Approval Expanded to Kids With Rare Blood Disorder
Source: MedicineNet Diarrhea Specialty [2015.08.25]
Title: Promacta Approval Expanded to Kids With Rare Blood Disorder
Category: Health News
Created: 8/24/2015 12:00:00 AM
Last Editorial Review: 8/25/2015 12:00:00 AM

FDA Expands Age Indication for Eltrombopag (Promacta) in ITP
Source: Medscape Family Medicine Headlines [2015.08.24]
The agency just extended the indication of the drug for the rare blood disorder to children 6 years of age and older in June.
FDA Approvals

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Published Studies Related to Promacta (Eltrombopag)

Efficacy of eltrombopag in management of bleeding symptoms associated with chronic immune thrombocytopenia. [2013]
Bleeding is of particular clinical importance in the management of chronic immune thrombocytopenia (ITP), which involves impaired platelet production and accelerated destruction. We report the first comprehensive analysis of the impact of eltrombopag on bleeding in five clinical studies of adult chronic ITP: two 6-week phase 2 (TRA100773A) and phase 3 (TRA100773B) studies; a 6-month phase 3 study (RAISE); a phase 2 repeat-dose study (REPEAT); and a phase 3 extension study (EXTEND)...

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...

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Clinical Trials Related to Promacta (Eltrombopag)

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.

Clinical Evaluation of SB-497115-GR in Chronic Idiopathic Thrombocytopenic Purpura (ITP) [Completed]
This is a Phase II/III multicenter study comprising of the double-blind, followed by open-label phases to evaluate and compare the efficacy and tolerability of eltrombopag (SB-497115-GR) in chronic ITP patients

Safety and Efficacy of Eltrombopag at Escalated Doses [Recruiting]
Study rationale is based on the data that in previous clinical studies of eltrombopag in ITP there are some patients who have been reported as non responders at the maximal approved dose of 75 mg daily. The trend in both normal volunteers and in patients with ITP suggest and increasing response rate with increased doses of eltrombopag up to a dose of 75mg. Previously published data has shown no overt increase in toxicity in normal volunteers, oncology patients and aplastic anemia patients treated with escalated doses as high or higher than those proposed in this study. It therefore seems possible that in ITP patients who did not respond to a dose of 75mg daily, eltrombopag could be more effective at a higher dose. We propose a double blind randomized controlled trial in ITP patients who have been defined as non-responders at the maximum dose (75mg) of eltrombopag, assessing efficacy and toxicity at higher daily doses (100mg, 125 mg, 150 mg)

Milk-only Lactation Study for Patients on Eltrombopag [Withdrawn]
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.

EXTEND (Eltrombopag Extended Dosing Study) [Completed]
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.

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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 >>


Page last updated: 2015-08-25

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