Usual Adult Dose for Organ Transplant - Rejection Prophylaxis

720 mg orally 2 times daily

Comments:

• This drug should be used in combination with cyclosporine and corticosteroids.
• Take on an empty stomach 1 hour before or 2 hours after food.
• Swallow tablets whole; do not crush, chew, or divide.

Use: For prophylaxis of organ rejection in kidney transplant

Usual Pediatric Dose for Organ Transplant - Rejection Prophylaxis

5 years and older:

• In conversion (at least 6 months posttransplant): 400 mg/m2 orally 2 times a day (up to a maximum dose of 720 mg 2 times a day)

Note: Pediatric patients with a BSA of 1.19 to 1.58 m2 may be dosed either with three of the 180 mg tablets, or one 180 mg tablet plus one 360 mg tablet 2 times a day. Patients with a BSA greater than 1.58 m2 may be dosed either with four of the 180 mg tablets, or two of the 360 mg tablets twice daily. Pediatric doses for patients with BSA less than 1.19 m2 cannot be accurately administered using currently available formulations of this drug.

Comments:

• This drug should be used in combination with cyclosporine and corticosteroids.
• Take on an empty stomach 1 hour before or 2 hours after food.
• Swallow tablets whole; do not crush, chew, or divide.

Use: For the prophylaxis of organ rejection in pediatric patients 5 years of age and older who are at least 6 months post kidney transplant

Renal Dose Adjustments

Mild to moderate renal impairment: No adjustment recommended.
Severe renal impairment (CrCl less than 25 mL/min): Caution recommended.

Liver Dose Adjustments

No adjustment recommended.

Precautions

The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for mycophenolate. It includes elements to assure safe use. For additional information: http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm

US BOXED WARNINGS:
EMBRYOFETAL TOXICITY:

• Use of this drug during pregnancy is associated with increased risk of pregnancy loss and congenital malformations.
• Females of reproductive potential should be counseled regarding pregnancy prevention and planning.

MALIGNANCIES:

• This drug is associated with an increased risk for development of lymphoma and other malignancies, particularly of the skin, due to immunosuppression.

SERIOUS INFECTIONS:

• This drug is associated with increased susceptibility to bacterial, viral, fungal, and protozoal infections, including opportunistic infections.

ADMINISTRATION WARNINGS:

• Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe this drug.
• Patients 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.

Safety and efficacy have not been established in patients younger than 5 years.

Consult WARNINGS section for additional precautions.

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

Administration advice:

• Some manufacturers recommend this drug be taken on an empty stomach and others recommend that it can be taken with or without food if the patient is consistent.
• Swallow tablets whole; do not crush, chew, or divide.

General:

• Only qualified transplant specialists or healthcare providers experienced in this field should initiate and maintain therapy with this drug.
• Mycophenolic acid delayed-release tablets and mycophenolate mofetil (MMF) tablets and capsules should not be used interchangeably without physician supervision because the rate of absorption following the administration of these two products is not equivalent.

Monitoring:

• 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.

Patient advice:

• Patients should be instructed to immediately report any evidence of infection, unexpected bruising, bleeding, or any other manifestation of bone marrow suppression.