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Myfortic Label Revised to Warn of Anemia Risk

Sep 4, 2009 | Parker Waichman LLP

The transplant drug Myfortic has been associated with a type of  anemia called pure red cell aplasia (PRCA), prompting a revision of the drugs' label.  Information regarding PRCA has been added to the "WARNINGS" and "ADVERSE REACTIONS" sections of the Myfortic prescribing information.

Myfortic is used to suppress the immune system to prevent rejection in kidney transplant patients.  It is administered in combination with cyclosporine and corticosteroids.

According to a "Dear Healthcare Professional" letter sent to prescribers, cases of PRCA have been reported in patients treated with mycophenolate mofetil (brand name  CellCept) in combination with other immunosuppressive agents. Mycophenolate mofetil is converted to mycophenolic acid, the active ingredient in Myfortic, following oral or IV administration,  the letter said.

An autoimmune disorder,  PRCA affects the precursors to red blood cells. In PRCA, the bone marrow ceases to produce red blood cells. The disorder can cause fatigue, lethargy or abnormal paleness of the skin. Approximately 5% of all cases of PRCA are drug induced.

PRCA was found to be reversible with dose reduction or cessation of mycophenolate mofetil therapy.  In transplant patients, however, reduced immunosuppression may place the graft at risk, the letter said.

Last month, "WARNINGS" and "ADVERSE REACTIONS" sections of the CellCept label was also  revised to reflect its association with PRCA.

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