Mycophenolate

Brands

DEA Class; Rx

Common Brand Names; CellCept, Myfortic, MMF

  • Immunosuppressants
 

Immunosuppressant with mycophenolic acid (MPA) as active component; similar efficacy with mofetil or sodium formulas
Used for organ rejection prophylaxis in conjunction with other immunosuppressants, in adult and pediatric patients 3 months and older
May increase the risk of fetal harm (birth defects) and miscarriage in the first trimester of pregnancy; the Mycophenolate REMs program manages these risks

Indicated for

  • Kidney Transplant, Prophylaxis of organ rejection in patients receiving allogeneic renal transplants; use concomitantly with cyclosporine and corticosteroids
  • Heart Transplant, Prophylaxis of organ rejection in patients receiving allogeneic renal transplants; use concomitantly with cyclosporine and corticosteroids
  • Liver Transplant, Prophylaxis of organ rejection in patients receiving allogeneic renal transplants; use concomitantly with cyclosporine and corticosteroids

Hypersensitivity

IV formulation (CellCept) in patients allergic to polysorbate 80

  • Hyperglycemia (44%)
  • Hypercholesterolemia (41%)
  • Hypomagnesemia (39%)
  • Dyspnea (37%)
  • Back pain (35%)
  • Increased blood urea nitrogen (BUN) (35%)
  • Leukopenia (34%)
  • Pleural effusion (34%)
  • Urinary tract infection (34%)
  • Increasing frequency of cough (31%)
  • Hypocalcemia (30%)
  • Hypertension (28%)
  • Abdominal pain (27%)
  • Peripheral edema (27%)
  • Anemia (26%)
  • Fever (23%)
  • Nausea (23%)
  • Hyperkalemia (22%)
  • Diarrhea (21%)
  • Infection (21%)
  • Headache (16%)

Pure red-cell aplasia reported in patients treated with MMF or MPA in combination with other immunosuppressive agents

Avoid use in hypoxanthine-guanine phosphoribosyltransferase (HGPRT) deficiency (Lesch-Nyhan, Kelley-Seegmiller syndrome)

Risk of miscarriage and congenital malformations, especially external ear and other facial abnormalities including cleft lip and palate, and anomalies of the distal limbs, heart, esophagus, kidney and nervous system (see Black Box Warnings); females of reproductive potential must be made aware of risks and must be counseled regarding pregnancy prevention and planning; avoid use of MMF during pregnancy if safer treatment options are available

Drug increases risk of developing lymphoma; risk appears to be related to intensity and duration of immunosuppression rather than to use of any specific agent; for patients with increased risk for skin cancer, exposure to sunlight and UV light should be limited by wearing protective clothing and using a broad-spectrum sunscreen with a high protection factor

MPA not indicated for hepatic or cardiac transplants

Use may be rarely associated with gastric or duodenal ulcers, GI bleeding and/or perforation

Safety and effectiveness of MPA for de novo pediatric renal transplant not established

Neutropenia may occur (may require dose reduction)

Must not be administered by rapid or bolus IV injection; increases risk of local adverse reactions such as phlebitis and thrombosis

Toxicity may increase in renal impairment; use caution

Patients should not donate blood during therapy and for at least 6 weeks following discontinuation of therapy because their blood or blood products might be administered to a female of reproductive potential or a pregnant woman

Based on animal data, men should not donate semen during therapy and for 90 days following discontinuation of drug Phenylalanine can be harmful to patients with phenylketonuria (PKU)

Use of mycophenolate mofetil (MMF) during pregnancy is associated with an increased risk of first-trimester pregnancy loss and an increased risk of multiple congenital malformations in multiple organ systems

There are no data on presence of drug in human milk, or effects on milk production; there are limited data in the National Transplantation Pregnancy Registry on effects of mycophenolate on a breastfed child; studies in rats treated with MMF have shown mycophenolic acid (MPA) to be present in milk

Adults

For mycophenolate mofetil tablets, capsules, or intravenous solution: maximum 2 g/day (kidney transplant) or 3 g/day (heart or liver transplant) PO or IV.
For mycophenolate sodium delayed-release tablets: 1,440 mg/day PO.

Geriatric

For mycophenolate mofetil tablets, capsules, or intravenous solution: maximum 2 g/day (kidney transplant) or 3 g/day (heart or liver transplant) PO or IV.
For mycophenolate sodium delayed-release tablets: 1,440 mg/day PO.

Adolescents

For the mycophenolate mofetil oral suspension: 1,200 mg/m2/day PO, not to exceed 2 g/day PO, for kidney transplant rejection prophylaxis. Maximum 1,800 mg/m2/day, not to exceed 3 g/day, for heart or liver transplant rejection prophylaxis.
For mycophenolate mofetil capsules and tablets: 1,500 mg/day PO for BSA 1.25 to less than 1.5 m2 for kidney transplant rejection prophylaxis and maximum maintenance dose of 3 g/day for heart or liver transplant rejection prophylaxis. Maximum is 2 g/day PO for BSA of 1.5 m2 or greater for kidney transplant rejection prophylaxis and maximum maintenance dose of 3 g/day for heart or liver transplant rejection prophylaxis.
For mycophenolate sodium delayed-release tablets: 800 mg/m2/day PO (Max: 1,440 mg/day PO) for BSA greater than 1.19 m2 for kidney transplant rejection prophylaxis. Safety and efficacy have not been established for BSA of 1.19 m2 or less.

Children

Children 5 years and older:
For the mycophenolate mofetil oral suspension: 1,200 mg/m2/day PO, not to exceed 2 g/day PO, for kidney transplant rejection prophylaxis. Maximum 1,800 mg/m2/day, not to exceed 3 g/day, for heart or liver transplant rejection prophylaxis.
For mycophenolate mofetil capsules and tablets: 1,500 mg/day PO for BSA 1.25 to less than 1.5 m2 for kidney transplant rejection prophylaxis and maximum maintenance dose of 3 g/day for heart or liver transplant rejection prophylaxis. Maximum is 2 g/day PO for BSA of 1.5 m2 or greater for kidney transplant rejection prophylaxis and maximum maintenance dose of 3 g/day for heart or liver transplant rejection prophylaxis.
For mycophenolate sodium delayed-release tablets: 800 mg/m2/day PO (Max: 1,440 mg/day PO) for BSA greater than 1.19 m2 for kidney transplant rejection prophylaxis. Safety and efficacy have not been established for BSA of 1.19 m2 or less.
Children 1 to 4 years:
For the mycophenolate mofetil oral suspension: 1,200 mg/m2/day PO, not to exceed 2 g/day PO, for kidney transplant rejection prophylaxis. Maximum 1,800 mg/m2/day, not to exceed 3 g/day, for heart or liver transplant rejection prophylaxis.
For mycophenolate mofetil capsules and tablets: 1,500 mg/day PO for BSA 1.25 to less than 1.5 m2 for kidney transplant rejection prophylaxis and maximum maintenance dose of 3 g/day for heart or liver transplant rejection prophylaxis. Maximum is 2 g/day PO for BSA of 1.5 m2 or greater for kidney transplant rejection prophylaxis and maximum maintenance dose of 3 g/day for heart or liver transplant rejection prophylaxis.
For mycophenolate sodium delayed-release tablets: Safety and efficacy have not been established.

Infants

3 months and older: For the mycophenolate mofetil oral suspension: 1,200 mg/m2/day PO (not to exceed 2 g/day PO), for kidney transplant rejection prophylaxis. Maximum 1,800 mg/m2/day PO (not to exceed 3 g/day) for heart or liver transplant rejection prophylaxis. The safety and efficacy of other dosage forms has not been established.
Less than 3 months: Safety and efficacy have not been established.

Neonates

Safety and efficacy have not been established.

Mycophenolate

capsule

  • 250mg (generic; MMF)

tablet

  • 500mg (generic, CellCept; MMF)

oral suspension

  • 200mg/mL (generic, CellCept; MMF)

powder for injection

  • 500mg/vial (generic, CellCept; MMF)

tablet, delayed release (generic, Myfortic, MPA)

  • 180mg

  • 360mg

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