Aa
Just some platelet/eltrombopag information.
Just some public info on eltrombopag. I remember somebody was on a clinical trial using eltrombopag or a facsimilie and I think the trial was halted within the first couple of weeks. At least it was halted for the person in it, as I remember. I'm just passing this information onward in case it is of interest to anyone. I thought eltrombopag was still in clinical trial, obviously I'm just here living and learning same as many.
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Message 3
From: U.S. Food & Drug Administration (FDA)
Date: Dec, Tue 6 2011 13:19 -0500 (EST)
Subject: Drug Information Update- FDA Drug Safety Communication: Modified Risk Evaluation and Mitigation Strategies (REMS) for Nplate (romiplostim) and Promacta (eltrombopag
The U.S. Food and Drug Administration (FDA) has approved modifications to the Risk Evaluation and Mitigation Strategies (REMS) for platelet-booster drugs Nplate (romiplostim) injection and Promacta (eltrombopag) tablets. The modifications include the removal of certain elements of the REMS, including the requirements for restricted distribution and additional safety data collection.
Prescribers, healthcare institutions, pharmacies, and patients no longer have to enroll in the REMS programs in order to prescribe, dispense or take these drugs.
Healthcare professionals and patients should be aware, however, that serious risks still exist with Nplate and Promacta. The physician labels and patient Medication Guides have been updated to reflect the current data on the risks with each therapy.
For more information please visit: PlateletREMS
http://www.fda.gov/Drugs/DrugSafety/ucm280165.htm
------------------------
Message 3
From: U.S. Food & Drug Administration (FDA)
Date: Dec, Tue 6 2011 13:19 -0500 (EST)
Subject: Drug Information Update- FDA Drug Safety Communication: Modified Risk Evaluation and Mitigation Strategies (REMS) for Nplate (romiplostim) and Promacta (eltrombopag
The U.S. Food and Drug Administration (FDA) has approved modifications to the Risk Evaluation and Mitigation Strategies (REMS) for platelet-booster drugs Nplate (romiplostim) injection and Promacta (eltrombopag) tablets. The modifications include the removal of certain elements of the REMS, including the requirements for restricted distribution and additional safety data collection.
Prescribers, healthcare institutions, pharmacies, and patients no longer have to enroll in the REMS programs in order to prescribe, dispense or take these drugs.
Healthcare professionals and patients should be aware, however, that serious risks still exist with Nplate and Promacta. The physician labels and patient Medication Guides have been updated to reflect the current data on the risks with each therapy.
For more information please visit: PlateletREMS
http://www.fda.gov/Drugs/DrugSafety/ucm280165.htm
More details.....
GSK presents phase III results for eltrombopag in hepatitis C virus related thrombocytopenia
Issued: Monday 07 November 2011, London UK
Full results from ENABLE 1 and initial data from ENABLE 2 presented at the 62nd Annual Meeting of the American Association for the Study of Liver Diseases
Findings from the ENABLE clinical trials, which evaluated the ability of eltrombopag to raise and maintain platelet levels in patients with chronic hepatitis C virus (HCV) infection and low platelet levels that would preclude initiation of interferon-based antiviral therapy, were presented today at the 62nd Annual Meeting of the American Association for the Study of Liver Diseases in San Francisco. Use of eltrombopag to treat thrombocytopenia in patients with chronic HCV infection is not approved anywhere in the world.
In ENABLE 1, patients who received eltrombopag along with Pegasys® (peginterferon alfa-2a) and ribavirin antiviral therapy achieved a statistically significant improvement in the primary endpoint of sustained virologic response (SVR), a clinically validated endpoint that means there is no detectable hepatitis C virus in a patient’s blood. 23% of patients in the eltrombopag group achieved SVR compared to 14% of patients receiving placebo (p=0.0064). Serious adverse events were reported in 20% of eltrombopag and 15% of placebo patients. During the entire study period death occurred in 2% of patients in the eltrombopag and 3% in the placebo group. Thromboembolic events were reported in 2% of eltrombopag patients and 2% of placebo patients. Elevations in liver enzymes were similar in both groups. Events consistent with worsening of liver function were reported in 13% of eltrombopag patients and 8% of placebo patients.
The ENABLE 1 trial enrolled 716 adults with HCV and platelet levels less than 75,000/µL into an open label eltrombopag treatment period. Those who achieved platelet levels greater than or equal to 90,000/µL were randomly assigned on a 2 to 1 basis to eltrombopag or placebo plus peginterferon alfa-2a and ribavirin.
Initial data from ENABLE 2, a randomised Phase III trial of eltrombopag plus PEG-Intron® (peginterferon alfa-2b) and ribavirin were also presented. The ENABLE 2 trial met its primary endpoint of improved SVR, with 19% of eltrombopag patients and 13% of placebo patients achieving SVR (p=0.0202). Serious adverse events were reported in 20% of eltrombopag and 15% of placebo patients. Death occurred in 4% of patients in the eltrombopag and 2% of placebo group. Thromboembolic events were reported in 4% of eltrombopag patients and less than 1% of placebo patients. Elevations in liver enzymes were similar in both groups. Events consistent with worsening of liver function were reported in 15% of eltrombopag patients and 8% placebo patients.
The ENABLE 2 trial enrolled 805 adults with HCV and platelet levels less than 75,000/µL into an open label eltrombopag treatment period and those who achieved platelet levels greater than or equal to 100,000/µL were randomly assigned on a 2 to 1 basis to eltrombopag or placebo plus peginterferon alfa-2b and ribavirin. Analyses are ongoing and full study results will be submitted for presentation at a future medical meeting.
“The ENABLE trials provide insight into a population that has generally been excluded from clinical trials because they are unable to initiate interferon therapy.” said Rafael Amado, Senior Vice President, Oncology Development “We will fully examine the efficacy and safety findings of both studies to evaluate the overall clinical benefit to these patients.”
About eltrombopag (PROMACTA®/Revolade®)
Eltrombopag is in development as a potential treatment for thrombocytopenia associated with chronic hepatitis C virus infection. It is subject to evaluation of the benefits and risk by regulatory authorities before being made available for use in this setting.
Eltrombopag, known by the brand name PROMACTA®/Revolade® is approved in 78 countries around the world as a treatment for thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP).
In Europe, Revolade® is indicated for the treatment of thrombocytopenia in splenectomised adult patients with chronic ITP who are refractory to other treatments, such as corticosteroids and immunoglobulins. Revolade may also be considered as second-line treatment for adult non‑splenectomised patients, where surgery is contraindicated.
In the United States, PROMACTA® is indicated for the treatment of thrombocytopenia in patients with chronic ITP who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy.
BOXED WARNING and Important Safety Information
PROMACTA may cause hepatotoxicity. Increases in serum aminotransferase levels and bilirubin were observed. Liver chemistries must be measured before the initiation of treatment and regularly during treatment. See Full Prescribing Information for BOXED WARNING.
Because of the risk of hepatotoxicty and other risks including bone marrow reticulin formation, risk for bone marrow fibrosis, thrombotic/thromboembolic complications, recurrence of thrombocytopenia and hemorrhage risk after PROMACTA cessation, hematologic malignancies and progression of malignancies, and cataracts, PROMACTA is available only through a restricted distribution program called PROMACTA CARES.
Pegasys®(peginterferon alfa-2a) is manufactured by Roche, Ltd.
PEG-Intron®(peginterferon alfa-2b) is manufactured by Schering Corp, a subsidiary of Merck and Co, Inc.
GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com
Hector
GSK presents phase III results for eltrombopag in hepatitis C virus related thrombocytopenia
Issued: Monday 07 November 2011, London UK
Full results from ENABLE 1 and initial data from ENABLE 2 presented at the 62nd Annual Meeting of the American Association for the Study of Liver Diseases
Findings from the ENABLE clinical trials, which evaluated the ability of eltrombopag to raise and maintain platelet levels in patients with chronic hepatitis C virus (HCV) infection and low platelet levels that would preclude initiation of interferon-based antiviral therapy, were presented today at the 62nd Annual Meeting of the American Association for the Study of Liver Diseases in San Francisco. Use of eltrombopag to treat thrombocytopenia in patients with chronic HCV infection is not approved anywhere in the world.
In ENABLE 1, patients who received eltrombopag along with Pegasys® (peginterferon alfa-2a) and ribavirin antiviral therapy achieved a statistically significant improvement in the primary endpoint of sustained virologic response (SVR), a clinically validated endpoint that means there is no detectable hepatitis C virus in a patient’s blood. 23% of patients in the eltrombopag group achieved SVR compared to 14% of patients receiving placebo (p=0.0064). Serious adverse events were reported in 20% of eltrombopag and 15% of placebo patients. During the entire study period death occurred in 2% of patients in the eltrombopag and 3% in the placebo group. Thromboembolic events were reported in 2% of eltrombopag patients and 2% of placebo patients. Elevations in liver enzymes were similar in both groups. Events consistent with worsening of liver function were reported in 13% of eltrombopag patients and 8% of placebo patients.
The ENABLE 1 trial enrolled 716 adults with HCV and platelet levels less than 75,000/µL into an open label eltrombopag treatment period. Those who achieved platelet levels greater than or equal to 90,000/µL were randomly assigned on a 2 to 1 basis to eltrombopag or placebo plus peginterferon alfa-2a and ribavirin.
Initial data from ENABLE 2, a randomised Phase III trial of eltrombopag plus PEG-Intron® (peginterferon alfa-2b) and ribavirin were also presented. The ENABLE 2 trial met its primary endpoint of improved SVR, with 19% of eltrombopag patients and 13% of placebo patients achieving SVR (p=0.0202). Serious adverse events were reported in 20% of eltrombopag and 15% of placebo patients. Death occurred in 4% of patients in the eltrombopag and 2% of placebo group. Thromboembolic events were reported in 4% of eltrombopag patients and less than 1% of placebo patients. Elevations in liver enzymes were similar in both groups. Events consistent with worsening of liver function were reported in 15% of eltrombopag patients and 8% placebo patients.
The ENABLE 2 trial enrolled 805 adults with HCV and platelet levels less than 75,000/µL into an open label eltrombopag treatment period and those who achieved platelet levels greater than or equal to 100,000/µL were randomly assigned on a 2 to 1 basis to eltrombopag or placebo plus peginterferon alfa-2b and ribavirin. Analyses are ongoing and full study results will be submitted for presentation at a future medical meeting.
“The ENABLE trials provide insight into a population that has generally been excluded from clinical trials because they are unable to initiate interferon therapy.” said Rafael Amado, Senior Vice President, Oncology Development “We will fully examine the efficacy and safety findings of both studies to evaluate the overall clinical benefit to these patients.”
About eltrombopag (PROMACTA®/Revolade®)
Eltrombopag is in development as a potential treatment for thrombocytopenia associated with chronic hepatitis C virus infection. It is subject to evaluation of the benefits and risk by regulatory authorities before being made available for use in this setting.
Eltrombopag, known by the brand name PROMACTA®/Revolade® is approved in 78 countries around the world as a treatment for thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP).
In Europe, Revolade® is indicated for the treatment of thrombocytopenia in splenectomised adult patients with chronic ITP who are refractory to other treatments, such as corticosteroids and immunoglobulins. Revolade may also be considered as second-line treatment for adult non‑splenectomised patients, where surgery is contraindicated.
In the United States, PROMACTA® is indicated for the treatment of thrombocytopenia in patients with chronic ITP who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy.
BOXED WARNING and Important Safety Information
PROMACTA may cause hepatotoxicity. Increases in serum aminotransferase levels and bilirubin were observed. Liver chemistries must be measured before the initiation of treatment and regularly during treatment. See Full Prescribing Information for BOXED WARNING.
Because of the risk of hepatotoxicty and other risks including bone marrow reticulin formation, risk for bone marrow fibrosis, thrombotic/thromboembolic complications, recurrence of thrombocytopenia and hemorrhage risk after PROMACTA cessation, hematologic malignancies and progression of malignancies, and cataracts, PROMACTA is available only through a restricted distribution program called PROMACTA CARES.
Pegasys®(peginterferon alfa-2a) is manufactured by Roche, Ltd.
PEG-Intron®(peginterferon alfa-2b) is manufactured by Schering Corp, a subsidiary of Merck and Co, Inc.
GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com
Hector
Excellent info. Promacta for hcv-treatment is currently only available off-label (at physician's discretion) and should only be used under strict guidance and management by experienced physicians. Risks for use were significant enough to prevent it from being approved by FDA for use other than for ITP, but in the right circumstances it can be used to help the hard-to-treat population attain viral suppression. Best of luck BigDaddy.
~eureka
~eureka
Glad to hear it's helping you. Good thing you added some of what you know here, you never know who might benefit from what they read. good luck with your journey.
Good point fretboard!
Promacta is currently only OK'd for the treatment of ITP but it is used off label for people (like myself) whose platelets drop (thrombocytopenia) when on Interferon based therapy for Hep C.
My last treatment using Infergen dropped my platelets down to 6K and I had to stop and my hepa said I was done with Interferon unless something changed and then NPlate and Promacta came out and she wants me to give it another shot which I am all for especially with success of the PI's
Before starting on the triple therapy, I am on it to try and raise and keep my platelets at ~50k while on Tx. I am being monitored by a oncologic hematologist.
You must be enrolled in the Promacta Cares program to receive it and it includes starting at the lowest dose and (intially) weekly monitoring of liver functions. I believe that only certain pharmacies may dispense it.
The Promacta Cares website is here:
http://www.promactacares.com/
My platelets started at 42 and after 4 weeks I am up to 64 and all my liver function tests are within acceptable levels.
I am cirrhotic and hopefully this will enable me to successfully complete (SVR baby!) triple therapy so if and when I do need a transplant, I won't have to worry about my new liver becoming cirrhotic which often happens within 5 years after a transplant if you still have Hep C.
If you are going to take Promacta, you and your medical team need to be fully aware of the risks BEFORE starting!!!
Chris
Promacta is currently only OK'd for the treatment of ITP but it is used off label for people (like myself) whose platelets drop (thrombocytopenia) when on Interferon based therapy for Hep C.
My last treatment using Infergen dropped my platelets down to 6K and I had to stop and my hepa said I was done with Interferon unless something changed and then NPlate and Promacta came out and she wants me to give it another shot which I am all for especially with success of the PI's
Before starting on the triple therapy, I am on it to try and raise and keep my platelets at ~50k while on Tx. I am being monitored by a oncologic hematologist.
You must be enrolled in the Promacta Cares program to receive it and it includes starting at the lowest dose and (intially) weekly monitoring of liver functions. I believe that only certain pharmacies may dispense it.
The Promacta Cares website is here:
http://www.promactacares.com/
My platelets started at 42 and after 4 weeks I am up to 64 and all my liver function tests are within acceptable levels.
I am cirrhotic and hopefully this will enable me to successfully complete (SVR baby!) triple therapy so if and when I do need a transplant, I won't have to worry about my new liver becoming cirrhotic which often happens within 5 years after a transplant if you still have Hep C.
If you are going to take Promacta, you and your medical team need to be fully aware of the risks BEFORE starting!!!
Chris
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