Sanofetil Dosage/Direction for Use

Standard dosage for prophylaxis of renal rejection: The initial dose of SANOFETIL should be given orally within 72 hours following transplantation. Although a dose of 1.5 g administered twice daily (daily dose of 3 g) was used in clinical trials and was shown to be safe and effective, no efficacy advantage could be established for renal transplant patients.
Standard dosage for prophylaxis of cardiac rejection: The initial dose of SANOFETIL should given orally within 5 days following transplantation. A dose of 1.5 g administered twice a day (daily dose of 3 g) is recommended for use in cardiac transplant patients.
Special dosage instructions: Patients with neutropenia: If neutropenia develops (absolute neutrophil count < 1.3 x 10³/mcl), dosing with cellcept should be interrupted or the dose reduced (see Precautions).
Physician should perform appropriate diagnostic test, manage the patients appropriately.
Patients with severe renal impairment: In renal transplant patients with severe chronic renal impairment (glomerular filtration rate < 25 mL/min/1.73 m²), outside of the immediate post-transplant period or after treatment of acute or refractory rejection, doses greater than 1 g administered twice a day should be avoided (see PRECAUTIONS). No data are available for cardiac transplant patients with severe chronic renal impairment.
Patients with severe hepatic impairment: No dose adjustments are needed for renal patients with severe hepatic parenchymal disease.
No data are available for cardiac transplant patients with severe hepatic parenchymal disease.
Elderly (≥65 years): The recommended oral doses of 1 g b.i.d. for renal transplant patients and 1.5 g b.i.d. for cardiac transplant patients area appropriate for elderly patients (see PRECAUTIONS).