Mycophenolate Mofetil

MYCOPHENOLATE MOFETIL — mycophenolate mofetil tablet, film coated
Aurobindo Pharma Limited

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 AND USAGE

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

Mycophenolate Mofetil Tablets

Mycophenolate mofetil tablets 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 tablets and mycophenolic acid delayed-release tablets are not equivalent.

Mycophenolate mofetil tablets should not be crushed.

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)].

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 tablets 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, twice daily (total daily dose of 2 g).

Pediatrics (3 months and older)

Pediatric dosing is based on body surface area (BSA). Pediatric patients with BSA ≥ 1.25 m2 may be dosed with tablets as follows:

Table 1 Pediatric Kidney Transplant: Dosage Using Tablets

Body Surface Area Dosage
≥ 1.5 m 2 Mycophenolate mofetil 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 tablets for adult heart transplant patients is 1.5 g orally administered twice daily (total daily dose of 3 g).

Pediatrics (3 months and older)

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

Table 2 Pediatric Heart Transplant: Pediatric Starting Dosage Using Tablets

Body Surface Area Starting Dosage*
≥ 1.5 m 2 Mycophenolate mofetil 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 tablets for adult liver transplant patients is 1.5 g administered orally twice daily (total daily dose of 3 g).

Pediatrics (3 months and older)

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

Table 3 Pediatric Liver Transplant: Pediatric Starting Dosage Using Tablets

Body Surface Area Starting Dosage*
≥ 1.5 m 2 Mycophenolate mofetil tablets 1 g twice daily (2 g total daily dose)

* 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 <25 mL/min/1.73 m2), do not administer doses of mycophenolate mofetil tablets greater than 1 g twice a day. These patients should be carefully monitored [see Clinical Pharmacology (12.3)].

Neutropenia

If neutropenia develops (ANC <1.3 x 103 /μL), dosing with mycophenolate mofetil tablets 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)].

3 DOSAGE FORMS AND STRENGTHS

Mycophenolate Mofetil Tablets USP, 500 mg are purple colored, modified capsule shaped, film-coated tablets debossed with “M1” on one side and plain on the other side.

4 CONTRAINDICATIONS

Allergic reactions to mycophenolate mofetil tablets have been observed; therefore, mycophenolate mofetil tablets are contraindicated in patients with a hypersensitivity to mycophenolate mofetil (MMF), mycophenolic acid (MPA) or any component of the drug product.

5 WARNINGS AND PRECAUTIONS

5.1 Embryofetal Toxicity

Use of MMF during pregnancy is associated with an increased risk of first trimester pregnancy loss and an increased risk of 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. Females of reproductive potential must be made aware of these risks and must be counseled regarding pregnancy prevention and planning. Avoid use of MMF during pregnancy if safer treatment options are available [see Use in Specific Populations (8.1, 8.3)].

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