Mycophenolic Acid

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Manufacturer Warnings

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FDA Labeling Changes

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Uses

1.1 Prophylaxis of Organ Rejection in Kidney Transplant

Mycophenolic acid is indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant.

Mycophenolic acid 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.

Mycophenolic acid is to be used in combination with cyclosporine and corticosteroids.

1.2 Limitations of Use

Mycophenolic acid 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.

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History

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Other Information

Mycophenolic acid delayed-release tablets are an enteric formulation of mycophenolate sodium that delivers the active moiety mycophenolic acid (MPA). Mycophenolic acid is an immunosuppressive agent. As the sodium salt, MPA is chemically designated as (E)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1,3-dihydroisobenzofuran-5-yl)-4-methylhex-4-enoic acid sodium salt.

Its molecular formula is C17H19O6 Na. The molecular weight is 342.32 and the structural formula is

Mycophenolic acid, as the sodium salt, is a white to off-white, crystalline powder and is highly soluble in aqueous media at physiological pH and practically insoluble in 0.1N hydrochloric acid.

Mycophenolic acid is available for oral use as delayed-release tablets containing 180 mg or 360 mg of mycophenolic acid. Inactive ingredients include methylcellulose, sodium lauryl sulfate, stearic acid, colloidal silicon dioxide, hypromellose and polyethylene glycol. The enteric coating of the tablet consists of triethyl citrate, talc, titanium dioxide, yellow ferric oxide (180 mg and 360 mg), indigotine al lake (180 mg), methacrylic acid and ethyl acrylate copolymer dispersion, and red ferric oxide (360 mg).

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Mycophenolic Acid Manufacturers

American Health Packaging

Mycophenolic Acid | American Health Packaging

2.1 Dosage in Adult Kidney Transplant Patients
The recommended dose of mycophenolic acid delayed-release tablets is 720 mg administered twice daily (1440 mg total daily dose).
2.2 Dosage in Pediatric Kidney Transplant Patients
The recommended dose of mycophenolic acid 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).
2.3 Administration
Mycophenolic acid delayed-release tablets should be taken on an empty stomach, 1 hour before or 2 hours after food intake [see Clinical Pharmacology (12.3)].

Mycophenolic acid delayed-release 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 mycophenolic acid 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 mycophenolic acid 180 mg tablets, or two mycophenolic acid 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 mycophenolic acid tablets.

No Recall
Golden State Medical Supply, Inc.

Mycophenolic Acid | Golden State Medical Supply, Inc.

2.1 Dosage in Adult Kidney Transplant Patients
The recommended dose of mycophenolic acid delayed-release tablets is 720 mg administered twice daily (1440 mg total daily dose).
2.2 Dosage in Pediatric Kidney Transplant Patients
The recommended dose of mycophenolic acid 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).
2.3 Administration
Mycophenolic acid delayed-release tablets should be taken on an empty stomach, 1 hour before or 2 hours after food intake [see Clinical Pharmacology (12.3)].

Mycophenolic acid delayed-release 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 mycophenolic acid 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 mycophenolic acid 180 mg tablets, or two mycophenolic acid 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 mycophenolic acid tablets.

No Recall
Mylan Pharmaceuticals Inc.

Mycophenolic Acid | Mylan Pharmaceuticals Inc.

2.1 Dosage in Adult Kidney Transplant Patients
The recommended dose of mycophenolic acid delayed-release tablets is 720 mg administered twice daily (1440 mg total daily dose).
2.2 Dosage in Pediatric Kidney Transplant Patients
The recommended dose of mycophenolic acid delayed-release tablets 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).
2.3 Administration
Mycophenolic acid delayed-release tablets should be taken on an empty stomach, one hour before or 2 hours after food intake [see Clinical Pharmacology (12.3)].
Mycophenolic acid delayed-release 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 mycophenolic acid delayed-release 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 mycophenolic acid delayed-release 180 mg tablets, or two mycophenolic acid delayed-release 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 mycophenolic acid delayed-release tablets.

No Recall
Mylan Institutional Inc.

Mycophenolic Acid | Mylan Institutional Inc.

2.1 Dosage in Adult Kidney Transplant Patients
The recommended dose of mycophenolic acid delayed-release tablets is 720 mg administered twice daily (1440 mg total daily dose).
2.2 Dosage in Pediatric Kidney Transplant Patients
The recommended dose of mycophenolic acid delayed-release tablets 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).
2.3 Administration
Mycophenolic acid delayed-release tablets should be taken on an empty stomach, one hour before or 2 hours after food intake [see Clinical Pharmacology (12.3)].

Mycophenolic acid delayed-release 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 mycophenolic acid delayed-release 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 mycophenolic acid delayed-release 180 mg tablets, or two mycophenolic acid delayed-release 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 mycophenolic acid delayed-release tablets.

No Recall
Apotex Corp

Mycophenolic Acid | Apotex Corp

2.1 Dosage in Adult Kidney Transplant Patients
The recommended dose of mycophenolic acid delayed-release tablets is 720 mg administered twice daily (1440 mg total daily dose).
2.2 Dosage in Pediatric Kidney Transplant Patients
The recommended dose of mycophenolic acid 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).
2.3 Administration
Mycophenolic acid delayed-release tablets should be taken on an empty stomach, 1 hour before or 2 hours after food intake [see Clinical Pharmacology (12.3)].

Mycophenolic acid delayed-release 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 mycophenolic acid 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 mycophenolic acid 180 mg tablets, or two mycophenolic acid 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 mycophenolic acid tablets.

No Recall