Mycophenolate Mofetil

MYCOPHENOLATE MOFETIL — mycophenolate mofetil tablet, film coated
MYCOPHENOLATE MOFETIL — mycophenolate mofetil capsule
Ascend Laboratories, LLC

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)].

1 INDICATIONS & 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 & ADMINISTRATION

2.1 Important Administration Instructions

Mycophenolate Mofetil Capsules, Tablets and Oral Suspension
Mycophenolate mofetil should not be used without the supervision of a physician with experience in immunosuppressive therapy.

Mycophenolate mofetil oral dosage forms (capsules, tablets or oral suspension) should not be used interchangeably with mycophenolic acid delayed-release tablets without supervision of a physician with experience in immunosuppressive therapy because the rates of absorption following the administration of mycophenolate mofetil oral dosage forms and mycophenolic acid delayed-release tablets are not equivalent.

Mycophenolate mofetil tablets should not be crushed and mycophenolate mofetil capsules should not be opened or crushed. Patients should avoid inhalation or contact of the skin or mucous membranes with the powder contained in mycophenolate mofetil capsules and oral suspension. If such contact occurs, they must wash the area of contact thoroughly with soap and water. In case of ocular contact, rinse eyes with plain water.

The initial oral dose of mycophenolate mofetil should be given as soon as possible following kidney, heart or liver transplant. It is recommended that mycophenolate mofetil be administered on an empty stomach. In stable transplant patients, however, mycophenolate mofetil may be administered with food if necessary [see Clinical Pharmacology (12.3)]. Once reconstituted, mycophenolate mofetil for oral suspension must not be mixed with any liquids prior to dose administration. If needed, mycophenolate mofetil for oral suspension can be administered via a nasogastric tube with a minimum size of 8 French (minimum 1.7 mm interior diameter).

Patients should be instructed to take a missed dose as soon as they remember, except if it is closer than 2 hours to the next scheduled dose; in this case, they should continue to take mycophenolate mofetil at the usual times.

2.2 Dosage Recommendations for Kidney Transplant Patients

Adults

The 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 older)

Pediatric dosing is based on body surface area (BSA). The recommended dosage of mycophenolate mofetil for oral suspension for pediatric kidney transplant patients 3 months and older is 600 mg/m2 , administered twice daily (maximum total daily dose of 2g 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: Dosage Using Capsules or Tablets

Body Surface Area Dosage
1.25 m2 to less than 1.5 m2 Mycophenolate mofetil capsule 750 mg twice daily (1.5 g total daily dose)
Greater than and equal to 1.5 m2 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 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

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

* Maximum maintenance dose: 3 g total daily.

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 (total 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

Body Surface Area Starting Dosage*
1.25 m2 to less than 1.5 m2 mycophenolate mofetil capsule 750 mg twice daily (1.5 g total daily dose)
≥ 1.5 m2 mycophenolate mofetil capsules or tablets 1 g twice daily (2 g total dailydose)

* Maximum maintenance dose: 3 g total daily.

2.5 Dosage Modifications: Patients with Renal Impairment, Neutropenia

Renal Impairment

No dosage modifications are needed in kidney transplant patients with delayed graft function postoperatively [see Clinical Pharmacology (12.3)]. In kidney transplant patients with severe chronic impairment of the graft (GFR less than 25 mL/min/1.73 m2), do not administer doses of mycophenolate mofetil greater than 1 g twice a day. These patients should be carefully monitored [see Clinical Pharmacology (12.3)].

Neutropenia

If neutropenia develops (ANC less than 1.3 x 103 /mcL), dosing with mycophenolate mofetil should be interrupted or reduced, appropriate diagnostic tests performed, and the patient managed appropriately [see Warnings and Precautions (5.4) and Adverse Reactions (6.1)].

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