Mycophenolate Mofetil

MYCOPHENOLATE MOFETIL- mycophenolate mofetil capsule
MYCOPHENOLATE MOFETIL- mycophenolate mofetil tablet, film coated
Golden State Medical Supply, 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 dosage 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 dosage 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 dosage 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 dosage 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.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.