Mycophenolate Mofetil

MYCOPHENOLATE MOFETIL- mycophenolate mofetil injection, powder, lyophilized, for solution
Akorn

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 Specific 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)] .

1 INDICATIONS AND USAGE

Mycophenolate mofetil (MMF) is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies (14.1)], heart [see Clinical Studies (14.2)] or liver transplants [see Clinical Studies (14.3)] , in combination with other immunosuppressants.

2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Instructions

Mycophenolate mofetil should not be used without the supervision of a physician with experience in immunosuppressive therapy.

Mycophenolate Mofetil for Injection

Mycophenolate mofetil for injection is recommended for patients unable to take oral mycophenolate mofetil. Mycophenolate mofetil for injection should be administered within 24 hours following transplant. Mycophenolate mofetil for injection can be administered for up to 14 days; however, patients should be switched to oral mycophenolate mofetil as soon as they can tolerate oral medication.

Mycophenolate mofetil for injection must be reconstituted before use [see Dosage and Administration (2.6)]. Mycophenolate mofetil for injection is incompatible with other intravenous infusion solutions and should not be mixed or administered concurrently via the same infusion catheter with other intravenous drugs or infusion admixtures.

Mycophenolate mofetil for injection must not be administered as a bolus. Following reconstitution, mycophenolate mofetil for injection must be administered by slow intravenous infusion over a period of no less than 2 hours by either peripheral or central vein, as rapid infusion increases the risk of local adverse reactions such as phlebitis and thrombosis [see Adverse Reactions (6.1)].

2.2 Dosage Recommendations for Kidney Transplant Patients

Adults

The recommended dose for adult kidney transplant patients is 1 g orally or intravenously infused over no less than 2 hours, twice daily (daily dose of 2 g).

Pediatrics (3 months and older)

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/m2 , administered twice daily (maximum daily dose of 2 g or 10 mL of the oral suspension). Pediatric patients with BSA ≥ 1.25 m2 may be dosed with capsules or tablets as follows:

Table 1 Pediatric Kidney Transplant: Dosing Using Capsules or Tablets
Body Surface Area Dosing
1.25 m2 to < 1.5 m2 Mycophenolate mofetil capsule 750 mg twice daily (1.5 g daily dose)
≥ 1.5 m2 Mycophenolate mofetil capsules or tablets 1 g twice daily (2 g daily dose)

2.3 Dosage Recommendations for Heart Transplant Patients

Adults

The recommended dose of mycophenolate mofetil for adult heart transplant patients is 1.5 g orally or intravenously infused over no less than 2 hours administered twice daily (total daily dose of 3 g).

Pediatrics (3 months and older)

The recommended starting dosage of mycophenolate mofetil oral suspension for pediatric heart transplant patients 3 months and older is 600 mg/m2 , administered twice daily. If well tolerated, the dose can be increased to a maintenance dosage of 900 mg/m2 twice daily (maximum total daily dose of 3 g or 15 mL of the oral suspension). The dose may be individualized based on clinical assessment.

Pediatric patients with BSA ≥ 1.25 m2 may be started on therapy with capsules or tablets as follows:

Table 2 Pediatric Heart Transplant: Pediatric Starting Dosage Using Capsules or Tablets

*Maximum maintenance dose: 3 g total daily.

Body Surface Area Starting Dosing*
1.25 m2 to < 1.5 m2 Mycophenolate mofetil capsule 750 mg twice daily (1.5 g daily dose)
≥ 1.5 m2 Mycophenolate mofetil capsules or tablets 1 g twice daily (2 g daily dose)

2.4 Dosage Recommendations for Liver Transplant Patients

Adults

The recommended dosage of mycophenolate mofetil for adult liver transplant patients is 1.5 g administered orally twice daily (total daily dose of 3 g) or 1 g infused intravenously over no less than 2 hours, twice daily (daily dose of 2 g).

Pediatrics (3 months and older)

The recommended starting dosage of mycophenolate mofetil oral suspension for pediatric liver transplant patients 3 months of age and older is 600 mg/m2 , administered twice daily. If well tolerated, the dose can be increased to a maintenance dosage of 900 mg/m2 twice daily (maximum total daily dose of 3 g or 15 mL of the oral suspension). The dose may be individualized based on clinical assessment.

Pediatric patients with BSA ≥ 1.25 m2 may be started on therapy with capsules or tablets as follows:

Table 3 Pediatric Liver Transplant: Pediatric Starting Dosage Using Capsules or Tablets

*Maximum maintenance dose: 3 g total daily.

Body Surface Area Starting Dosing*
1.25 m2 to < 1.5 m2 Mycophenolate mofetil capsule 750 mg twice daily (1.5 g daily dose)
≥ 1.5 m2 Mycophenolate mofetil capsules or tablets 1 g twice daily (2 g daily dose)

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