Approval of new medicinal agent for kidney transplant patients

In order to prevent acute rejection in adult patients, who have had a kidney transplant, FDA approved a medicinal agent i.e. belatacept (brand name: Nulojix) on June 15, 2011.

The drug is helpful for kidney transplant patients, if it is used with other immunosuppressants such as corticosteroids, mycophenolate mofetil and basiliximab. (Immunosuppressants are those drugs which cause reduction of immunity of the body).

Belatacept is a fusion protein made by composition of a human immunoglobulin and a T-lymphocyte antigen.

Mechanism of action:

Belatacept is a selective T-cell costimulation blocker i.e. blocking the effect of some white blood cells. (T-cells are the types of white blood cells).

Indications:

It is used to stop organ rejection of the patients after kidney transplant to keep the new kidney working. It is found to be safe and effective for stopping the acute organ rejection

Usage manner:

It is given in the form of 30 minute intravenous infusions.

Adverse effects:

It may cause anemia, kidney or bladder infection, constipation, swollen legs, ankles or feet.

It has Boxed Warning for an increased risk of developing post-transplant lymphoproliferative disorder (PTLD). It is a type of cancer in which white blood cells start growing out of control after kidney transplant. Belatacept and other immunosuppressants may cause serious infections.

Marketing:

Nulojix is marketed by Princeton, N.J.-based Bristol-Myers Squibb Company.

Further Reading:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm259184.htm accessed June 16, 2011.

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