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Mycophenolate Mofetil Dosage

Applies to the following strength(s): 250 mg ; 500 mg ; 200 mg/mL

The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.

Usual Adult Dose for:

Usual Geriatric Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Organ Transplant - Rejection Prophylaxis

-RENAL TRANSPLANTATION: 1 g orally or IV 2 times a day (2 gm per day); [in clinical trials, 1.5 g orally or IV 2 times a day (3 gm per day) was used effectively, however, the safety profile for 3 gm a day was lower]
-CARDIAC TRANSPLANTATION: 1.5 g orally or IV 2 times a day (3 gm per day)
-HEPATIC TRANSPLANTATION: 1.5 gm orally or 1 gm IV 2 times a day (3 gm per day orally or 2 gm per day IV)

Comments:
-This drug should be used concomitantly with cyclosporine and corticosteroids.
-The IV formulation should be administered over no less than 2 hours.
-IV administration is recommended in patients unable to take oral medication; oral administration should be initiated as soon as possible.

Usual Geriatric Dose for Organ Transplant - Rejection Prophylaxis

-RENAL TRANSPLANTATION: 1 g orally or IV 2 times a day (2 gm per day)
-CARDIAC TRANSPLANTATION: 1.5 g orally or IV 2 times a day (3 gm per day)
-HEPATIC TRANSPLANTATION: 1.5 gm orally or 1 gm IV 2 times a day (3 gm per day orally or 2 gm per day IV)

Comments:
-This drug should be used concomitantly with cyclosporine and corticosteroids.
-The IV formulation should be administered over no less than 2 hours.
-IV administration is recommended in patients unable to take oral medication; oral administration should be initiated as soon as possible.

Usual Pediatric Dose for Organ Transplant - Rejection Prophylaxis

-RENAL TRANSPLANTATION:
3 months to 18 years of age:
Oral Suspension: 600 mg/m2 orally 2 times a day up to a maximum of 2 grams per day
-Pediatric patients with a body surface area of 1.25 to 1.5 m2 may be dosed with the oral capsules at 750 mg orally 2 times a day (1.5 g per day)
-Pediatric patients with a body surface area greater than 1.5 m2 may be dosed with the oral capsules at 1 g orally 2 times a day (2 g per day)

Comments:
-This drug should be used concomitantly with cyclosporine and corticosteroids.
-The IV formulation should be administered over no less than 2 hours.-IV administration is recommended in patients unable to take oral medication; oral administration should be initiated as soon as possible.

Renal Dose Adjustments

CrCl less than 25 mL/min: Doses greater than 1 gm 2 times a day should be avoided

Liver Dose Adjustments

Data not available

Dose Adjustments

-If a patient develops neutropenia (absolute neutrophil count less than 1300/mm³), dosing should be stopped or the dose reduced, and the patient should be managed appropriately.
-Close clinical monitoring is recommended if this drug is used in patients with liver disease.
-Doses greater than 2 g/day (especially in renal dysfunction) are not recommended.
-Higher doses may lead to more severe gastrointestinal adverse reactions and enhanced immunosuppression.

Precautions

US BOXED WARNINGS:
-Use of this drug during pregnancy is associated with increased risks of first trimester pregnancy loss and congenital malformations. Females of reproductive potential should be counseled regarding pregnancy prevention and planning.
-Immunosuppression may lead to increased susceptibility to infection and possible development of lymphoma. Only physicians experienced in immunosuppressive therapy and management of renal, cardiac or hepatic transplant patients should prescribe this drug.
-Patients receiving this drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient.

The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for mycophenolate. It includes a medication guide and elements to assure safe use. For additional information: www.fda.gov/REMS.

Safety and efficacy have not been established in patients younger than 3 months.

Consult WARNINGS section for additional precautions.

Dialysis

Mycophenolic acid (the active metabolite) and the inactive glucuronide metabolite are not removed in significant amounts by hemodialysis.

Other Comments

Administration advice:
-The IV formulation should be administered within 24 hours following transplantation. The IV formulation can be administered for up to 14 days.
-Patients should be switched to the oral formulation as soon as they can tolerate oral medication.
-The IV formulation should only be administered by a slow IV infusion over at least 2 hours. It should never be administered by rapid or bolus IV injection.
-The IV formulation incompatible with 0.9% normal saline, Ringers and lactated Ringers solutions, and should not be mixed or given via the same catheter with other IV drugs or admixtures.
-The oral tablets or capsules should not be crushed or chewed.
-Doses may be taken with or without food.

Monitoring:
-Patients should be monitored for the development of neutropenia.
-CBCs should be performed weekly during the first month, then twice a month during the second and third month, and then monthly for the remainder of the first year of treatment.

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