MYCOPHENOLATE SODIUM

The main ingredient of this product is mycophenolate sodium.

Azathioprine: Since studies with this drug have not been performed, the concomitant use of mycophenolate sodium with azathioprine is not recommended (see Precautions). Live vaccines: Live vaccines should not be used in immunocompromised patients. Antibody responses to other vaccines may also be impaired (see Precautions). Acyclovir: Elevated plasma concentrations of MPAG (mycophenolic acid glucuronide) and acyclovir may occur in the presence of renal insufficiency. Therefore, there may be competition for tubular secretion of these two drugs, leading to further increases in MPAG and acyclovir concentrations. In such cases, patients should be carefully followed. Antacids containing magnesium and aluminum hydroxides: The use of antacids reduces the absorption of mycophenolate sodium. The concomitant use of mycophenolate sodium and antacids containing magnesium and aluminum hydroxides resulted in a 37% decrease in overall MPA exposure and a 25% decrease in the maximum MPA concentration. Careful follow-up is recommended when mycophenolate sodium is used in combination with antacids containing magnesium and aluminum hydroxides. Cholestyramine and other drugs that interfere with enterohepatic circulation: Cholestyramine may reduce the overall exposure of mycophenolic acid (MPA) due to its effect of blocking the enterohepatic circulation of drugs. The effect of mycophenolic acid sodium may be reduced when co-administered with cholestyramine and other drugs that interfere with enterohepatic circulation, and caution should be used. Ganciclovir: The pharmacokinetic properties of mycophenolic acid (MPA) and MPAG are not affected by the addition of ganciclovir. The therapeutic dose of mycophenolic acid (MPA) has no effect on the clearance of ganciclovir. However, when mycophenolic acid sodium and ganciclovir are co-administered in patients with renal insufficiency, the recommended dose of ganciclovir and patient monitoring should be carefully observed. Tacrolimus: In a crossover study of calcineurin in stable renal transplant patients, the steady-state pharmacokinetic parameters of mycophenolic acid sodium were measured during treatment with cyclosporine (Neoral) and tacrolimus. The mean area under the curve (AUC) of mycophenolic acid (MPA) increased by 19%, and the maximum concentration (Cmax) decreased by approximately 20%. In contrast, both the AUC and Cmax of MPAG were reduced by approximately 30% with tacrolimus compared with cyclosporine. Oral contraceptives: Oral contraceptives undergo oxidative metabolism, whereas mycophenolate sodium undergoes glucuronidation. Clinically, oral contraceptives are not expected to affect the pharmacokinetics of mycophenolate sodium. However, the long-term effects of mycophenolate sodium on the pharmacokinetics of oral contraceptives are unknown, and the effectiveness of oral contraceptives may be adversely affected. Cyclosporine A: In a study of stable renal transplant patients, the pharmacokinetics of cyclosporine A were not affected by a stable dose of mycophenolate sodium.

The main ingredient of this product is mycophenolate sodium.

Azathioprine: Since studies with this drug have not been performed, the concomitant use of mycophenolate sodium with azathioprine is not recommended (see Precautions). Live vaccines: Live vaccines should not be used in immunocompromised patients. Antibody responses to other vaccines may also be impaired (see Precautions). Acyclovir: Elevated plasma concentrations of MPAG (mycophenolic acid glucuronide) and acyclovir may occur in the presence of renal insufficiency. Therefore, there may be competition for tubular secretion of these two drugs, leading to further increases in MPAG and acyclovir concentrations. In such cases, patients should be carefully followed. Antacids containing magnesium and aluminum hydroxides: The use of antacids reduces the absorption of mycophenolate sodium. The concomitant use of mycophenolate sodium and antacids containing magnesium and aluminum hydroxides resulted in a 37% decrease in overall MPA exposure and a 25% decrease in the maximum MPA concentration. Careful follow-up is recommended when mycophenolate sodium is used in combination with antacids containing magnesium and aluminum hydroxides. Cholestyramine and other drugs that interfere with enterohepatic circulation: Cholestyramine may reduce the overall exposure of mycophenolic acid (MPA) due to its effect of blocking the enterohepatic circulation of drugs. The effect of mycophenolic acid sodium may be reduced when co-administered with cholestyramine and other drugs that interfere with enterohepatic circulation, and caution should be used. Ganciclovir: The pharmacokinetic properties of mycophenolic acid (MPA) and MPAG are not affected by the addition of ganciclovir. The therapeutic dose of mycophenolic acid (MPA) has no effect on the clearance of ganciclovir. However, when mycophenolic acid sodium and ganciclovir are co-administered in patients with renal insufficiency, the recommended dose of ganciclovir and patient monitoring should be carefully observed. Tacrolimus: In a crossover study of calcineurin in stable renal transplant patients, the steady-state pharmacokinetic parameters of mycophenolic acid sodium were measured during treatment with cyclosporine (Neoral) and tacrolimus. The mean area under the curve (AUC) of mycophenolic acid (MPA) increased by 19%, and the maximum concentration (Cmax) decreased by approximately 20%. In contrast, both the AUC and Cmax of MPAG were reduced by approximately 30% with tacrolimus compared with cyclosporine. Oral contraceptives: Oral contraceptives undergo oxidative metabolism, whereas mycophenolate sodium undergoes glucuronidation. Clinically, oral contraceptives are not expected to affect the pharmacokinetics of mycophenolate sodium. However, the long-term effects of mycophenolate sodium on the pharmacokinetics of oral contraceptives are unknown, and the effectiveness of oral contraceptives may be adversely affected. Cyclosporine A: In a study of stable renal transplant patients, the pharmacokinetics of cyclosporine A were not affected by a stable dose of mycophenolate sodium.