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Myfortic

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Myfortic

Myfortic

INDICATIONS

Prophylaxis of Organ Rejection in Kidney Transplant

Myfortic® (mycophenolic acid) is indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant.

Myfortic is indicated for the prophylaxis of organ rejection in pediatric patients 5 years of age and older who are at least 6 months post kidney transplant.

Myfortic is to be used in combination with cyclosporine and corticosteroids.

Limitations of Use

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.

DOSAGE AND ADMINISTRATION

Dosage in Adult Kidney Transplant Patients

The recommended dose of Myfortic is 720 mg administered twice daily (1440 mg total daily dose).

Dosage in Pediatric Kidney Transplant Patients

The recommended dose of Myfortic in conversion (at least 6 months post-transplant) pediatric patients age 5 years and older is 400 mg/m² body surface area (BSA) administered twice daily (up to a maximum dose of 720 mg administered twice daily).

Administration

Myfortic tablets should be taken on an empty stomach, 1 hour before or 2 hours after food intake [see CLINICAL PHARMACOLOGY].

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 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.

HOW SUPPLIED

Dosage Forms And Strengths

Myfortic is available as 360 mg and 180 mg tablets.

Table 1: Description of Myfortic (mycophenolic acid) Delayed-Release Tablets

Dosage Strength 360 mg tablet 180 mg tablet
Active ingredient mycophenolic acid as mycophenolate sodium mycophenolic acid as mycophenolate sodium
Appearance Pale orange-red film-coated ovaloid tablet Lime green film-coated round tablet with bevelled edges
Imprint “CT” on one side “C” on one side

Storage And Handling

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 120NDC 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 120NDC 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

Keep out of reach and sight of children. Myfortic tablets should not be crushed or cut in order to maintain the integrity of the enteric coating.

Teratogenic effects have been observed with mycophenolate sodium [see WARNINGS AND PRECAUTIONS]. If for any reason, the Myfortic tablets must be crushed, avoid inhalation of the powder, or direct contact of the powder, with skin or mucous membranes.

Manufactured by: Novartis Pharma Stein AG Stein, Switzerland. Distributed by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936. September 2013

Last reviewed on RxList: 10/14/2013
This monograph has been modified to include the generic and brand name in many instances.

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