Thursday, February 17, 2011

QMS Everolimus Immunoassay prevention of kidney rejection

Monitoring the drug level will help in preventing kidney rejection. US FDA approved test to monitor blood level of drug used to prevent kidney rejection after kidney transplant.  

United states FDA on 11 Feb 2011 approved a test which help in monitoring the blood level of drug everolimus which is used as an immunosuppressant drug to prevent organ rejection (kidney) after kidney transplantation surgery. This test approved is known as QMS Everolimus Immunoassay, with this test doctors can monitor the blood level of immunosuppressant drugs everolimus it is manufactured by Waltham, Mass.-based Thermo Fisher Scientific.

Patients receiving organ transplants are given immunosuppressant drugs to lower the amount and rate of formation of antibodies against the transplanted organ, otherwise the transplanted organ are attacked by persons immune system and are destroyed by immune response of recipients body leading to life threatening complications. Generally immunosuppressants given after organ transplant to prevent organ rejection are everolimus, cyclosporine, basiliximab, and corticosteroids.

It is also important that immunosuppressant drug’s concentration in blood of receiving patient are required to be monitored as immunosuppressant drugs also produce toxic side effects which may damage transplanted kidneys it self. Therefore maintaining blood concentration of a immunosuppressant drug is also very important as the patient may have to take the Immunosuppressant drug for rest of his life .
Everolimus is a drug which is a 40-O-(2-hydroxyethyl) derivative of sirolimus, and sirolimus also known as Rapamycin which is a macrolide antifungal agent, which was developed as an antifungal but treatment with which produced immunosuppressantion in higher degree in patients, then sirolimus is able to establish itself as a useful immunosuppressant drug.

Mode of action of everolimus:
Everolimus bring about immunosuppressant action by inhibiting mTOR protein, it inhibit selectively mTORC1 protein and not the mTORC2 protein which result in hyper activation of the kinase AKT which in turn is responsible for regulation of cellular process which are responsible for triggering immune response or antibody production against incoming infection or a foreign body here it will be the kidney tissue.
Everolimus, is marketed as with trade name as “Zortess” In Apr 2010 Zotress was approved by US FDA as immune immunosuppressant for treating adult patients who are at high risk of organ rejection after receiving kidney transplant. Zortress is marketed by East Hanover, N.J.-based Novartis.

QMS Everolimus is the one of the tests which are approved by FDA , with which a physician monitor and maintain the level of immunosuppressant drugs other tests approved are tests for cyclosporine, tacrolimus, and sirolimus while QMS Everolimus helps in monitoring blood level of everolimus.

Also see

ELISA :Enzyme linked immunosorbent assay

Radioimmunoassay (RIA) ,tool for estimation of antigens, and drug concentration in blood serum

US FDA limits dosage of acetaminophen to 325 mg per unit dosage form,Requires boxed warning on lables as over dose may cause liver damage

What is autoimmunity and autoimmune diseases , what is an antigen ?

Pharmaceutical process validation

No comments: