WARNING: EMBRYOFETAL TOXICITY, MALIGNANCIES and SERIOUS INFECTIONS Use during pregnancy is associated with increased risks of first trimester pregnancy loss and congenital malformations. Avoid if safer treatment options are available. Females of reproductive potential must be counseled regarding pregnancy prevention and planning [see Warnings and Precautions (5.1) , Use in Special Populations (8.1 , 8.3) ] . Increased risk of development of lymphoma and other malignancies, particularly of the skin [see Warnings and Precautions (5.2) ] . Increased susceptibility to bacterial, viral, fungal and protozoal infections, including opportunistic infections and viral reactivation of hepatitis B and C, which may lead to hospitalizations and fatal outcomes [see Warnings and Precautions (5.3) ] . WARNING: EMBRYOFETAL TOXICITY, MALIGNANCIES and SERIOUS INFECTIONS See full prescribing information for complete boxed warning Use during pregnancy is associated with increased risks of first trimester pregnancy loss and congenital malformations. Avoid if safer treatment options are available. Females of reproductive potential must be counseled regarding pregnancy prevention and planning [see Warnings and Precautions (5.1) ]. Increased risk of development of lymphoma and other malignancies, particularly of the skin [see Warnings and Precautions (5.2) ] . Increased susceptibility to infections, including opportunistic infections and severe infections with fatal outcomes [see Warnings and Precautions (5.3) ].
Adult Dosing
General dosing
ADULTS DOSAGE Kidney Transplant 1 g twice daily, orally Heart Transplant 1.5 g twice daily orally Liver Transplant 1.5 g twice daily orally PEDIATRICS Kidney Transplant 600 mg/m 2 orally twice daily, up to maximum of 2 g daily Heart Transplant 600 mg/m 2 orally twice daily, (starting dose) up to a maximum of 900 mg/m 2 twice daily (3 g) Liver Transplant 600 mg/m 2 orally twice daily,daily (starting dose) up to a maximum of 900 mg/m 2 twice daily (3 g) Reduce or interrupt dosing in the event of neutropenia. See full prescribing information (FPI) for: adjustments for renal impairment and neutropenia 2.1 Important Administration Instructions Mycophenolate mofetil should not be used without the supervision of a physician with experience in immunosuppressive therapy.
recommended dosage for adult kidney transplant patients is 1 g orally or intravenously infused over no less than 2 hours, twice daily (total daily dose of 2 g). Pediatrics (3 months and olderer) Pediatric dosing is based on body surface area (BSA).The recommended dosage of mycophenolate mofetil oral suspension for pediatric kidney transplant patients 3 months and older is 600 mg/m 2 , administered twice daily (maximum total daily dose of 2 g or 10 mL of the oral suspension). Pediatric patients with BSA ≥1.25 m 2 may be dosed with capsules or tablets as follows: Table 1 Pediatric Kidney Transplant: Dosage Using Capsules or Tablets Body Surface Area Dosage 1.25 m 2 to <1.5 m 2 Mycophenolate mofetil capsule 750 mg twice daily (1.5 g total daily dose) ≥ 1.5 m 2 Mycophenolate mofetil capsules or tablets 1 g twice daily (2 g total daily dose) 2.3 Dosage Recommendations for Heart Transplant Patients Adults The recommended dosage of mycophenolate mofetil for adult heart transplant patients is 1.5 g orally twice daily (total daily dose of 3 g).
Max: 2 g or 10 mL of the oral suspension)
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