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mycophenolate mofetil

MYCOPHENOLATE MOFETIL

Manufacturer: AvPAK

Score: 148.0

Quick Summary

Mycophenolate mofetil is an immunosuppressant drug used to prevent organ rejection in patients who have received a kidney, heart, or liver transplant. It works by decreasing the activity of the immune system to prevent it from attacking the transplanted organ. The drug has several key clinical findings and indications, including the prevention of acute rejection episodes in transplant patients. However, it also has important safety information and contraindications, such as an increased risk of infections, lymphoma, and other malignancies. The main dosing recommendations vary depending on the type of transplant and the patient's age and weight. Special population considerations include pregnancy, nursing mothers, pediatric use, and geriatric use.

Key Clinical Findings and Indications

  • Prevention of acute rejection episodes in kidney transplant patients
  • Prevention of acute rejection episodes in heart transplant patients
  • Prevention of acute rejection episodes in liver transplant patients

Important Safety Information

Warning

Use during pregnancy is associated with increased risks of first trimester pregnancy loss and congenital malformations. Avoid if safer treatment options are available.

Contraindications

  • Hypersensitivity to mycophenolate mofetil or any component of the drug product
  • Hypersensitivity to mycophenolic acid or any component of the drug product

Adverse Reactions

  • Diarrhea
  • Leukopenia
  • Infection
  • Vomiting

Dosing Recommendations

General Guidance

Reduce or interrupt dosing in the event of neutropenia.

Kidney transplant

Adult Dose

1g twice daily

Pediatric Dose

600mg/m2 twice daily (up to a maximum of 2g daily)

Heart transplant

Adult Dose

1.5g twice daily

Pediatric Dose

600mg/m2 twice daily (up to a maximum of 3g daily)

Liver transplant

Adult Dose

1.5g twice daily

Pediatric Dose

600mg/m2 twice daily (up to a maximum of 3g daily)

Special Population Considerations

Pregnancy

  • Use during pregnancy is associated with increased risks of first trimester pregnancy loss and congenital malformations.
  • Avoid if safer treatment options are available.

Nursing Mothers

  • Mycophenolate mofetil has been detected in the milk of lactating women.
  • The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for mycophenolate mofetil and any potential adverse effects on the breastfed infant from mycophenolate mofetil or from the underlying maternal condition.

Pediatric Use

  • Safety and effectiveness have been established in pediatric patients 3 months and older for the prophylaxis of organ rejection of allogenic kidney, heart, or liver transplants.
  • Use of mycophenolate mofetil in pediatric patients is supported by evidence from adequate and well-controlled studies of mycophenolate mofetil in adults with additional data from one open-label, pharmacokinetic and safety study of mycophenolate mofetil in pediatric patients after receiving allogeneic kidney transplant.

Geriatric Use

  • Clinical studies of mycophenolate mofetil did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
  • In general, dose selection for a geriatric patient should take into consideration the presence of decreased hepatic, renal, or cardiac function and of concomitant drug therapies.
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