The product was launched at the recently concluded Philippine Society of Nephrology dinner-symposium held at the EDSA Shangri-La Hotel.
Mycophenolate sodium is an advanced enteric-coated formulation that delivers the active moiety mycophenolic acid (MPA ) — the same active moiety that is delivered by mocophenolate mofetil (MMF) taken by more than 80 percent of new kidney transplant recipients in the United States as part of their immunosuppressive regimens.
Novartis officials said mycophenolate sodium in combination with ciclosporin gives patients and physicians a treatment option that offers the full benefits of mycophenolic acid therapy in an enteric-coated formulation.
The mycophenolate acid delayed-release tablets are to be used along with ciclosporin and corticosteroids to prevent acute rejection of kidney allografts in adult patients.
The enteric-coated mycophenolate sodium is the newest option to kidney transplant recipients.
Results of two global multicenter trials involving more than 700 patients indicate that mycophenolate sodium and MMF are therapeutically equivalent in de novo renal transplant patients and that the conversion to mycophenolate sodium from MMF is safe in maintenance renal transplant patients.
Studies have reported that up to 70 percent of patients taking MMF required at least one dose change due to drug-related adverse effects, as patients who underwent an initial reduction in MMF dose were eight times more likely to suffer acute organ rejection than those who had not had a dose adjustment.
Mycophenolate sodium’s enteric coating, meanwhile, delays the release of mycophenolic acid in the gastrointestinal tract until exposure to a neutral pH, typically in the small intestine.
Because of this delay in dissolution and consequently absorption, the labeling warns against interchanging the mycophenolic and mycophenolate products "without physician supervision."
Mycophenolate sodium successfully completed the European Mutual Recognition Procedure (MRP) and was approved for the prevention of acute rejection in kidney allografts (transplants) in adult patients in February 2004 by the US Food and Drug Administration, receiving its first regulatory approval from Switzerland in October 2002.
The recommended dosage of mycophenolate sodium in adults is 720 mg twice daily, taken one hour before food intake or two hours afterwards — which is also the maximum dosage recommended.
Pediatric patients with a body surface area of 1.19-1.58 square meters are to receive 540 mg of mycophenolic acid twice daily; larger patients are to receive 720 mg twice daily.
Because the product is available in only two strengths — 180 mg and 360 mg — and the tablets must not be cut or crushed, there is no recommended dosage for pediatric patients with a body surface area less than 1.19 square meters.
The new drug, however, should not be used in pregnant women unless the potential benefit justifies the potential risk of the fetus; and if pregnancy does occur during treatment, the physician and patient should discuss the potential risk to the fetus.
Mycophenolate sodium has been administered in combination with the following agents in clinical trials: antithymocyte/lymphocyte immunoglobulin, muromonab-CD3, basiliximab, daclizumab, ciclosporin, and corticosteroids, with delayed-release tablets indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal transplants, administered in combination with ciclosporin and corticosteroids.