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Myfortic (mycophenolic acid)
[Posted in FDA website on 09/03/2009] Novartis and FDA notified healthcare professionals that cases of
Pure Red Cell Aplasia (PRCA) have been reported in patients treated with mycophenolate mofetil (MMF) in
combination with other immunosuppressive agents. Mycophenolate mofetil is metabolized to mycophenolic
acid (MPA), the active ingredient in Myfortic and the active form of the drug. The WARNINGS and ADVERSE
REACTIONS sections of the Myfortic Prescribing Information have been revised to reflect this new safety
PRCA is a type of anemia in which there is a selective reduction of red blood cell precursors on bone marrow
examination. Patients with PRCA may present with fatigue, lethargy, and/or abnormal paleness of the skin
(pallor). In some cases, PRCA was found to be reversible with dose reduction or cessation of Mycophenolate
mofeti therapy. In transplant patients, however, reduced immunosuppression may place the graft at risk.
Myfortic® (mycophenolic acid) delayed-release tablets are an enteric formulation of mycophenolate sodium
that delivers the active moiety mycophenolic acid (MPA). Myfortic is an immunosuppressive agent. Myfortic, as
the sodium salt, is a white to off-white, crystalline powder and is highly soluble in aqueous media at
physiological pH and practically insoluble in 0.1 N hydrochloric acid. Myfortic is available for oral use as
delayed-release tablets containing either 180 mg or 360 mg of mycophenolic acid.
Pharmacology and Pharmacokinetics:
In vitro studies demonstrated that the enteric-coated Myfortic® (mycophenolic acid) tablet does not release
MPA under acidic conditions (pH <5) as in the stomach but is highly soluble in neutral pH conditions as in the
intestine. Following Myfortic oral administration without food in several pharmacokinetic studies conducted in
renal transplant patients, consistent with its enteric-coated formulation, the median delay (Tlag) in the rise of
MPA concentration ranged between 0.25 and 1.25 hours and the median time to maximum concentration
(Tmax) of MPA ranged between 1.5 and 2.75 hours.
Myfortic should be taken on an empty stomach, as food intake alters the pharmacokinetics.
myfortic is indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal transplants,
administered in combination with cyclosporine and corticosteroids.
myfortic is contraindicated in patients with a hypersensitivity to mycophenolate sodium, mycophenolic acid,
mycophenolate mofetil, or to any of its excipients.
Side Effects (In General):
The incidence of side effects for Myfortic® (mycophenolic acid) was determined in randomized, comparative,
active-controlled, double-blind, double-dummy trials in prevention of acute rejection in de novo and
maintenance kidney transplant patients.
The principal side effects associated with the administration of Myfortic include constipation, nausea, and
urinary tract infection in de novo patients and nausea, diarrhea and nasopharyngitis in maintenance patients.
This article highlights some key informations of Myfortic. Users should discuss with their medical
doctors for detailed information.