Mycophenolatedosage

ADULTS DOSAGE Kidney Transplant 1 g twice daily, orally Heart Transplant 1.5 g twice daily orally Liver Transplant 1.5 g twice daily orally PEDIATRICS Kidney Transplant 600 mg/m 2 orally twice daily, up to maximum of 2 g daily Heart Transplant 600 mg/m 2 orally twice daily, (starting dose) up to a maximum of 900 mg/m 2 twice daily (3 g) Liver Transplant 600 mg/m 2 orally twice daily,daily (starting dose) up to a maximum of 900 mg/m 2 twice daily (3 g) Reduce or interrupt dosing in the event of neutropenia. See full prescribing information (FPI) for: adjustments for renal impairment and neutropenia

2.1 Important

Administration Instructions Mycophenolate mofetil should not be used without the supervision of a physician with experience in immunosuppressive therapy. Mycophenolate Mofetil Capsules and Tablets Mycophenolate mofetil oral dosage forms (capsules or tablets) should not be used interchangeably with mycophenolic acid delayed-release tablets without supervision of a physician with experience in immunosuppressive therapy because the rates of absorption following the administration of mycophenolate mofetil oral dosage forms and mycophenolic acid delayed-release tablets are not equivalent. Mycophenolate mofetil tablets should not be crushed and mycophenolate mofetil capsules should not be opened or crushed. Patients should avoid inhalation or contact of the skin or mucous membranes with the powder contained in mycophenolate mofetil capsules and oral suspension. If such contact occurs, they must wash the area of contact thoroughly with soap and water. In case of ocular contact, rinse eyes with plain water. The initial oral dose of mycophenolate mofetil should be given as soon as possible following kidney, heart or liver transplant. It is recommended that mycophenolate mofetil be administered on an empty stomach. In stable transplant patients, however, mycophenolate mofetil may be administered with food if necessary. Patients should be instructed to take a missed dose as soon as they remember, except if it is closer than 2 hours to the next scheduled dose; in this case, they should continue to take mycophenolate mofetil at the usual times.

2.2 Dosage Recommendations for

Kidney Transplant Patients Adults The recommended dosage for adult kidney transplant patients is 1 g orally or intravenously infused over no less than 2 hours, twice daily (total daily dose of 2 g). Pediatrics (3 months and olderer) Pediatric dosing is based on body surface area (BSA).The recommended dosage of mycophenolate mofetil oral suspension for pediatric kidney transplant patients 3 months and older is 600 mg/m 2, administered twice daily (maximum total daily dose of 2 g or 10 mL of the oral suspension). Pediatric patients with BSA ≥1.25 m 2 may be dosed with capsules or tablets as follows: Table 1 Pediatric Kidney Transplant: Dosage Using Capsules or Tablets Body Surface Area Dosage 1.25 m 2 to <1.5 m 2 Mycophenolate mofetil capsule 750 mg twice daily (1.5 g total daily dose) ≥ 1.5 m 2 Mycophenolate mofetil capsules or tablets 1 g twice daily (2 g total daily dose)

2.3 Dosage Recommendations for

Heart Transplant Patients Adults The recommended dosage of mycophenolate mofetil for adult heart transplant patients is 1.5 g orally twice daily (total daily dose of 3 g). Pediatric patients with BSA ≥1.25 m 2 may be started on therapy with capsules or tablets as follows: Table 2 Pediatric Heart Transplant: Pediatric Starting Dosage Using Capsules or Tablets Body Surface Area Starting Dosage Maximum maintenance dose: 3 g total daily. 1.25 m 2 to <1.5 m 2 Mycophenolate mofetil capsule 750 mg twice daily (1.5 g total daily dose) ≥ 1.5 m 2 Mycophenolate mofetil capsules or tablets 1 g twice daily (2 g total daily dose)

2.4 Dosage Recommendations for

Liver Transplant Patients Adults The recommended dosage of mycophenolate mofetil for adult liver transplant patients is 1.5 g administered orally twice daily (total daily dose of 3 g). Pediatric patients with BSA ≥1.25 m 2 may be started on therapy with capsules or tablets as follows: Table 3 Pediatric Liver Transplant: Pediatric Starting Dosage Using Capsules or Tablets Body Surface Area Starting Dosage Maximum maintenance dose: 3 g total daily. 1.25 m 2 to <1.5 m 2 Mycophenolate mofetil capsule 750 mg twice daily (1.5 g total daily dose) ≥ 1.5 m 2 Mycophenolate mofetil capsules or tablets 1 g twice daily (2 g total daily dose)

2.5 Dosage Modifications:

Patients with Renal Impairment, Neutropenia Renal Impairment No dosage modifications are needed in kidney transplant patients with delayed graft function postoperatively. In kidney transplant patients with severe chronic impairment of the graft (GFR <25 mL/min/1.73 m 2 ), do not administer doses of mycophenolate mofetil greater than 1 g twice a day. These patients should be carefully monitored. Neutropenia If neutropenia develops (ANC <1.3 × 10 3 /µL), dosing with mycophenolate mofetil should be interrupted or reduced, appropriate diagnostic tests performed, and the patient managed appropriately.