MYCOPHENOLATE MOFETIL

MYCOPHENOLATE MOFETIL — mycophenolate mofetil capsule
Lupin Pharmaceuticals, Inc.

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 (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 capsules and tablets

Mycophenolate mofetil oral dosage forms (capsules or 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 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. 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)].

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, 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 capsules or tablets as follows:

Table 1 Pediatric Kidney Transplant: Dosage Using Capsules or Tablets
Body Surface Area Dosage
1.25 m2 to <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)

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 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 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 <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)

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).

Pediatrics (3 months and older)

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 <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)

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 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 × 103 /µL), 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)].

3 DOSAGE FORMS AND STRENGTHS

Mycophenolate mofetil is available in the following dosage form and strength:

Capsules 250 mg mycophenolate mofetil, White to off white granular powder filled in size ‘1’ hard gelatin capsule with opaque blue cap imprinted “C3 250” and opaque brown body.
Tablets 500 mg mycophenolate mofetil, Lavender-colored, caplet-shaped, film coated tablets, debossed with “C4” on one side and plain on the other side

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