Prescription Drug Information: Mycophenolate Mofetil

MYCOPHENOLATE MOFETIL- mycophenolate mofetil capsule
MYCOPHENOLATE MOFETIL- mycophenolate mofetil tablet, film coated
Mylan Institutional 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 recipients 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 Dosing for Kidney Transplant Patients: Adults and Pediatrics

Adults

The recommended dose for adult kidney transplant patients is 1 g orally twice daily (daily dose of 2 g).

Pediatrics (3 months and older)

Pediatric dosing is based on body surface area (BSA). The recommended dose of mycophenolate mofetil oral suspension for pediatric kidney transplant patients 3 months and older is 600 mg/m 2 , administered twice daily (maximum daily dose of 2 g or 10 mL of the oral suspension). Pediatric patients with BSA ≥ 1.25 m 2 may be dosed with capsules or tablets as follows:

Table 1. Pediatric Dosing Using Capsules or Tablets for Pediatric Kidney Transplant

Body Surface Area

Dosing

1.25 m 2 to < 1.5 m 2

Mycophenolate mofetil capsules 750 mg twice daily (1.5 g daily dose)

≥ 1.5 m 2

Mycophenolate mofetil capsules or tablets 1 g twice daily (2 g daily dose)

2.3 Dosing for Heart Transplant Patients: Adults

The recommended dose of mycophenolate mofetil for adult heart transplant patients is 1.5 g orally twice daily (daily dose of 3 g).

2.4 Dosing for Liver Transplant Patients: Adults

The recommended dose of mycophenolate mofetil for adult liver transplant patients is 1.5 g administered orally twice daily (daily dose of 3 g).

2.5 Dosing Adjustments: Patients with Renal Impairment, Neutropenia

Renal Impairment

No dose adjustments 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 m 2), 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 x 10 3 /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 Capsules, USP are available containing 250 mg of mycophenolate mofetil, USP.

  • The 250 mg capsules are hard-shell gelatin capsules with a caramel opaque cap and a lavender opaque body filled with white to off-white powder. The capsules are axially printed with MYLAN over 2250 in black ink on both the cap and body.

Mycophenolate Mofetil Tablets, USP are available containing 500 mg of mycophenolate mofetil, USP.

  • The 500 mg tablets are light pink, film-coated, oval, unscored tablets debossed with MYLAN on one side of the tablet and 472 on the other side.

4 CONTRAINDICATIONS

Allergic reactions to mycophenolate mofetil have been observed; therefore, mycophenolate mofetil is 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)] .

5.2 Lymphoma and Other Malignancies

Patients receiving immunosuppressants, including mycophenolate mofetil, are at increased risk of developing lymphomas and other malignancies, particularly of the skin [see Adverse Reactions (6.1)] .The risk appears to be related to the intensity and duration of immunosuppression rather than to the use of any specific agent. For patients with increased risk for skin cancer, exposure to sunlight and UV light should be limited by wearing protective clothing and using a broad-spectrum sunscreen with a high protection factor.

Post-transplant lymphoproliferative disorder (PTLD) developed in 0.4% to 1% of patients receiving mycophenolate mofetil (2 g or 3 g) with other immunosuppressive agents in controlled clinical trials of kidney, heart and liver transplant patients [see Adverse Reactions (6.1)]. The majority of PTLD cases appear to be related to Epstein Barr Virus (EBV) infection. The risk of PTLD appears greatest in those individuals who are EBV seronegative, a population which includes many young children.In pediatric patients, no other malignancies besides PTLD were observed in clinical trials [see Adverse Reactions (6.1)] .

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