Mycophenolic Acid Dosage

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Usual Adult Dose for:

Usual Geriatric Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Rejection Prophylaxis

Initial dose: 720 mg orally twice a day

Doses should be taken on an empty stomach, one hour before or two hours after food intake.

Usual Geriatric Dose for Rejection Prophylaxis

Dose: 720 mg twice a day

Doses should be taken on an empty stomach, one hour before or two hours after food intake.

The maximum dosage recommended for use in geriatric patients is 720 mg twice a day.

Usual Pediatric Dose for Rejection Prophylaxis

5 years to 16 years:

Dose: 400 mg/m2 twice a day (up to a maximum of 720 mg twice a day)

Pediatric doses for patients with a body surface area less than 1.19 m2 cannot be accurately administered using currently available formulations of the delayed-release tablets.

Renal Dose Adjustments

No dosage adjustments are needed in patients experiencing delayed renal graft function postoperatively.

Patients with severe chronic renal impairment (GFR less than 25 mL/min) should be carefully followed for potential adverse reactions due to increased mycophenolic acid and total mycophenolic acid glucuronide concentrations.

Liver Dose Adjustments

No dosage adjustments are needed for renal transplant patients with hepatic parenchymal disease.

It is not know if dosage adjustments are needed for hepatic disease with other etiologies.

Dose Adjustments

Complete blood counts should be performed weekly during the first month, twice monthly for the second and third month of treatment, then monthly through the first year. If neutropenia develops (ANC less than 1.3 x 1000/mcL) dosing with mycophenolic acid should be interrupted or the dose reduced, appropriate tests performed, and the patient managed accordingly.

Dialysis

Although dialysis may be used to remove the inactive metabolite mycophenolic acid glucuronide, it would not be expected to remove clinically significant amounts of the active moiety mycophenolic acid. This is in large part due to the high plasma protein binding of mycophenolic acid.

Other Comments

The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for mycophenolate. It includes a medication guide and elements to assure safe use. Additional information is available at www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm

The drug is to be administered in combination with cyclosporine and corticosteroids.

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

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