Prescription Drug Information: Mycophenolate Mofetil
MYCOPHENOLATE MOFETIL- mycophenolate mofetil injection, powder, lyophilized, for solution
Akorn
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 Specific 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 for Injection
Mycophenolate mofetil for injection is recommended for patients unable to take oral mycophenolate mofetil. Mycophenolate mofetil for injection should be administered within 24 hours following transplant. Mycophenolate mofetil for injection can be administered for up to 14 days; however, patients should be switched to oral mycophenolate mofetil as soon as they can tolerate oral medication.
Mycophenolate mofetil for injection must be reconstituted before use [see Dosage and Administration (2.6)]. Mycophenolate mofetil for injection is incompatible with other intravenous infusion solutions and should not be mixed or administered concurrently via the same infusion catheter with other intravenous drugs or infusion admixtures.
Mycophenolate mofetil for injection must not be administered as a bolus. Following reconstitution, mycophenolate mofetil for injection must be administered by slow intravenous infusion over a period of no less than 2 hours by either peripheral or central vein, as rapid infusion increases the risk of local adverse reactions such as phlebitis and thrombosis [see Adverse Reactions (6.1)].
2.2 Dosage Recommendations for Kidney Transplant Patients
Adults
The recommended dose for adult kidney transplant patients is 1 g orally or intravenously infused over no less than 2 hours, 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/m2 , administered twice daily (maximum daily dose of 2 g or 10 mL of the oral suspension). Pediatric patients with BSA ≥ 1.25 m2 may be dosed with capsules or tablets as follows:
Body Surface Area | Dosing |
1.25 m2 to < 1.5 m2 | Mycophenolate mofetil capsule 750 mg twice daily (1.5 g daily dose) |
≥ 1.5 m2 | Mycophenolate mofetil capsules or tablets 1 g twice daily (2 g daily dose) |
2.3 Dosage Recommendations for Heart Transplant Patients
Adults
The recommended dose of mycophenolate mofetil for adult heart transplant patients is 1.5 g orally or intravenously infused over no less than 2 hours administered twice daily (total daily dose of 3 g).
Pediatrics (3 months and older)
The recommended starting dosage of mycophenolate mofetil oral suspension for pediatric heart transplant patients 3 months and older is 600 mg/m2 , administered twice daily. If well tolerated, the dose can be increased to a maintenance dosage of 900 mg/m2 twice daily (maximum total daily dose of 3 g or 15 mL of the oral suspension). The dose may be individualized based on clinical assessment.
Pediatric patients with BSA ≥ 1.25 m2 may be started on therapy with capsules or tablets as follows:
*Maximum maintenance dose: 3 g total daily. | |
Body Surface Area | Starting Dosing* |
1.25 m2 to < 1.5 m2 | Mycophenolate mofetil capsule 750 mg twice daily (1.5 g daily dose) |
≥ 1.5 m2 | Mycophenolate mofetil capsules or tablets 1 g twice daily (2 g 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) or 1 g infused intravenously over no less than 2 hours, twice daily (daily dose of 2 g).
Pediatrics (3 months and older)
The recommended starting dosage of mycophenolate mofetil oral suspension for pediatric liver transplant patients 3 months of age and older is 600 mg/m2 , administered twice daily. If well tolerated, the dose can be increased to a maintenance dosage of 900 mg/m2 twice daily (maximum total daily dose of 3 g or 15 mL of the oral suspension). The dose may be individualized based on clinical assessment.
Pediatric patients with BSA ≥ 1.25 m2 may be started on therapy with capsules or tablets as follows:
*Maximum maintenance dose: 3 g total daily. | |
Body Surface Area | Starting Dosing* |
1.25 m2 to < 1.5 m2 | Mycophenolate mofetil capsule 750 mg twice daily (1.5 g daily dose) |
≥ 1.5 m2 | Mycophenolate mofetil capsules or tablets 1 g twice daily (2 g daily dose) |
2.5 Dosing Modifications: Patients with Renal Impairment, Neutropenia
Renal Impairment
No dosage modification 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 x 103 /mcL), 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)].
2.6 Preparation Instructions of Intravenous for Pharmacists
General Preparation Instructions Before Handling the Formulations
Mycophenolate mofetil (MMF) has demonstrated teratogenic effects in humans. Follow applicable special handling and disposal procedures1 [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 MMF 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 Injection
Before proceeding with the preparation steps for mycophenolate mofetil for injection read the general preparation instructions [see General Preparation Instructions Before Handling the Formulations] and note the following:
- Mycophenolate mofetil for injection does not contain an antibacterial preservative; therefore, reconstitution and dilution of the product must be performed under aseptic conditions.
- This product is sealed under vacuum and should retain a vacuum throughout its shelf life. If a lack of vacuum in the vial is noted while adding the diluent, the vial should not be used.
Mycophenolate mofetil for injection must be reconstituted and further diluted. A detailed description of the preparation is given below.
Preparation of the1 g dose |
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Preparation of the1.5 g dose |
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The administration of the infusion should be initiated within 4 hours of reconstitution and dilution of the drug product. Keep solutions at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Discard unused portion of the reconstituted solutions.
Mycophenolate mofetil for injection should not be mixed or administered concurrently via the same infusion catheter with other intravenous drugs or infusion admixtures.
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