Nplate and Promacta

[Birgitta-A]

Hi All,
The FDA approved changes to the risk evaluation for Nplate and Promacta to remove the restricted distribution programs and the safety reporting requirements.

Healthcare professionals and patients should be aware that the serious risks still exist with Nplate and Promacta, and note that the physician prescribing information and patient Medication Guides have been updated to reflect the current perspective on the risks associated with each drug.

http://www.ons.org/news.aspx?id=183
Kind regards
Birgitta-A

[Neil Cuadra]

The prescribing information for Promacta (eltrombopag) states its current "on-label" use:

PROMACTA is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.

PROMACTA is not indicated for the treatment of thrombocytopenia due to diseases or treatments that cause thrombocytopenia (e.g., myelodysplasia or chemotherapy) other than chronic ITP.

Research, like this Phase II trial, continues on the use of Promacta for MDS patients.

[Sally C]

Originally Posted by Neil Cuadra

PROMACTA is not indicated for the treatment of thrombocytopenia due to diseases or treatments that cause thrombocytopenia (e.g., myelodysplasia or chemotherapy) other than chronic ITP.
Research, like this Phase II trial, continues on the use of Promacta for MDS patients.

Hey Neil and Birgitta,
My husband is in the above clinical trial - he was NIH's first patient with MDS in this trial. He is taking 150mg./day of Promacta - double the recommended amount. He started in March with an every two week dosage increase until reaching the max dosage.
He is tolerating Promacta very well. After being very transfusion dependent - especially for platelets since 1/09 - he hasn't needed platelets since June. As with their AA patients, it also has stimulated his red cells. On his last CBC his platelets were 46,000 and RBC 10.1. Whites are now normal. All 3 lines were affected upon initial diagnosis. He also received Campath at NIH in April, 2009 and had a partial response. He hasn't had counts like this since before his
12/08 diagnosis.
He will get a sedated BMB in January at NIH to check for fibrosis, etc. He finally got tired of the pain during BMB and so he is going to be sedated.
Part of this response could also be due to 15-20mg. Prednisone/day for ulcerative colitis.
Will let you know what the BMB shows in Jan.
Best wishes,
Sally

[Birgitta-A]

Hi Sally,
Wonderful results with Promacta ! Now we hope that the BMB won't show increased fibrosis.
Kind regards
Birgitta-A

[Sally C]

Thank you Birgitta,
Always nice to hear from you and your kind words.
Will keep you posted.
Best wishes,
Sally