Myfortic® (mycophenolic acid) delayed-release tablets are indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal transplants, administered in combination with cyclosporine and corticosteroids.

The recommended dose of Myfortic® (mycophenolic acid) is 720 mg administered twice daily (1440 mg total daily dose) on an empty stomach, one hour before or two hours after food intake (see CLINICAL PHARMACOLOGY, Food Effect).

Myfortic delayed-release tablets and mycophenolate mofetil (MMF) tablets and capsules should not be used interchangeably without physician supervision because the rate of absorption following the administration of these two products is not equivalent.

Patients are to be instructed that Myfortic tablets should not be crushed, chewed, or cut prior to ingesting. The tablets should be swallowed whole in order to maintain the integrity of the enteric coating.

Pediatric: Based on a pharmacokinetic study conducted in stable renal pediatric transplant patients, the recommended dose of Myfortic in stable pediatric patients is 400 mg/m² body surface area (BSA) administered twice daily (up to a maximum dose of 720 mg administered twice daily). Patients with a BSA of 1.19 to 1.58 m² may be dosed either with three Myfortic 180 mg tablets or one 180 mg tablet plus one 360 mg tablet twice daily (1080 mg daily dose). Patients with a BSA of > 1.58 m² may be dosed either with four Myfortic 180 mg tablets or two Myfortic 360 mg tablets twice daily (1440 mg daily dose). Pediatric doses for patients with BSA < 1.19 m² cannot be accurately administered using currently available formulations of Myfortic tablets.

Geriatrics: The maximum recommended dose is 720 mg administered twice daily.

Treatment During Rejection Episodes

Renal transplant rejection does not lead to changes in MPA pharmacokinetics; dosage reduction or interruption of Myfortic is not required.

Patients with Renal Impairment

No dose adjustments are needed in patients experiencing delayed renal graft function postoperatively. Patients with severe chronic renal impairment (GFR < 25 mL/min/1.73 m² BSA) should be carefully followed for potential adverse reactions due to increase in free MPA and total MPAG concentrations (see CLINICAL PHARMACOLOGY, Pharmacokinetics: Special Populations).

Patients with Hepatic Impairment

No dose adjustments are needed for renal transplant patients with hepatic parenchymal disease. However, it is not known whether dosage adjustments are needed for hepatic disease with other etiologies (see CLINICAL PHARMACOLOGY, Pharmacokinetics).

Myfortic® (mycophenolic acid) delayed-release tablets

360 mg tablet: Pale orange-red film-coated ovaloid tablet with imprint (debossing) “CT” on one side, containing 360 mg mycophenolic acid (MPA) as mycophenolate sodium.

Bottles of 120……………………………………NDC 0078-0386-66

180 mg tablet: Lime green film-coated round tablet with bevelled edges and the imprint (debossing) “C” on one side, containing 180 mg mycophenolic acid (MPA) as mycophenolate sodium.

Bottles of 120……………………………………NDC 0078-0385-66

Storage

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from moisture.

Dispense in a tight container (USP).

Handling

Tablets should not be crushed or cut.

Last reviewed on RxList: 7/6/2012
This monograph has been modified to include the generic and brand name in many instances.