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Anemia Risk Posed by Myfortic, Label Revised

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The label of the Myfortic has been revised to reflect the drug’s link to a type of  anemia called pure red cell aplasia (PRCA).

An autoimmune disorder,  PRCA affects the precursors to red blood cells, and causes the bone marrow to stop producing 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.

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.

Information regarding PRCA has been added to the “WARNINGS” and “ADVERSE REACTIONS” sections of the Myfortic prescribing information.

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.

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

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