Mycophenolate Mofetil

MYCOPHENOLATE MOFETIL- mycophenolate mofetil powder, for suspension
Teva 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 for oral suspension 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 for oral suspension should not be used without the supervision of a physician with experience in immunosuppressive therapy.

Mycophenolate Mofetil for Oral Suspension

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

Patients should avoid inhalation or contact of the skin or mucous membranes with the powder contained in mycophenolate mofetil for 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 for oral suspension should be given as soon as possible following kidney, heart or liver transplant. It is recommended that mycophenolate mofetil for oral suspension be administered on an empty stomach. In stable transplant patients, however, mycophenolate mofetil for oral suspension 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 for oral suspension 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 gram orally twice daily (daily dose of 2 grams).

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 daily dose of 2 grams or 10 mL of the oral suspension).

2.3 Dosing for Heart Transplant Patients: Adults

The recommended dosage of mycophenolate mofetil for oral suspension for adult heart transplant patients is 1.5 grams orally administered twice daily (daily dose of 3 grams).

2.4 Dosing for Liver Transplant Patients: Adults

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

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 m2), do not administer doses of mycophenolate mofetil for oral suspension greater than 1 gram 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 for oral suspension 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].

2.6 Preparation Instructions of Oral Suspension for Pharmacists

General Preparation Instructions Before Handling the Formulations

Mycophenolate mofetil has demonstrated teratogenic effects in humans. Follow applicable special handling and disposal procedures.1 [see Warnings and Precautions (5.1), Adverse Reactions (6.2), Use in Specific Populations (8.1, 8.3), How Supplied/Storage and Handling (16.1)]

Care should be taken to avoid inhalation or direct contact with skin or mucous membranes of the dry powder or the constituted suspension because mycophenolate mofetil has demonstrated teratogenic effects in humans. Wearing disposable gloves is recommended during reconstitution and when wiping the outer surface of the bottle/cap and the table surface after reconstitution. If such contact occurs, wash hands thoroughly with soap and water; rinse eyes with water.

Alert patients that they and others should also avoid inhalation or contact of the skin or mucous membranes with the oral suspension. Advise them to wash the area thoroughly with soap and water if such contact occurs; if ocular contact occurs, rinse eyes with plain water.

Mycophenolate Mofetil for Oral Suspension

Mycophenolate mofetil for oral suspension must be reconstituted by the pharmacist prior to dispensing to the patient. Mycophenolate mofetil for oral suspension should not be mixed with any other medication. After reconstitution, the oral suspension contains 200 mg/mL mycophenolate mofetil.

Before proceeding with the reconstitution steps read the general preparation instructions above [see General Preparation Instructions Before Handling the Formulations]. The following are the steps for reconstitution:

  1. Tap the closed bottle several times to loosen the powder.
  2. Measure 94 mL of water in a graduated cylinder.
  3. Add approximately half the total amount of water for reconstitution to the bottle and shake the closed bottle well for about 1 minute.
  4. Add the remainder of water and shake the closed bottle well for about 1 minute.
  5. Remove the child-resistant cap and push bottle adapter into neck of bottle.
  6. Close bottle with child-resistant cap tightly. This will assure the proper seating of the bottle adapter in the bottle and child-resistant status of the cap.
  7. Write the date of expiration of the constituted suspension on the bottle label. (The shelf-life of the constituted suspension is 60 days.)
  8. Dispense with the “Instruction for Use” and oral dispensers. Alert patients to read the important handling information described in the instructions for use.

Store reconstituted suspension at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). Storage in a refrigerator at 2° to 8°C (36° to 46°F) is acceptable. Do not freeze. Discard any unused portion 60 days after constitution.

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