Drug Detail:Cellcept (Mycophenolate mofetil (oral/injection) [ mye-koe-fen-oh-late-moe-fe-til ])
Generic Name: MYCOPHENOLATE MOFETIL 500mg
Dosage Form: capsules, tablets, oral suspension and injection
Drug Class: Selective immunosuppressants
Important Administration Instructions
CELLCEPT should not be used without the supervision of a physician with experience in immunosuppressive therapy.
CELLCEPT Capsules, Tablets and Oral Suspension
CELLCEPT oral dosage forms (capsules, tablets or 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 CELLCEPT oral dosage forms and mycophenolic acid delayed-release tablets are not equivalent.
CELLCEPT tablets should not be crushed and CELLCEPT capsules should not be opened or crushed. Patients should avoid inhalation or contact of the skin or mucous membranes with the powder contained in CELLCEPT capsules and 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 CELLCEPT should be given as soon as possible following kidney, heart or liver transplant. It is recommended that CELLCEPT be administered on an empty stomach. In stable transplant patients, however, CELLCEPT may be administered with food if necessary [see Clinical Pharmacology (12.3)]. Once reconstituted, CELLCEPT Oral Suspension must not be mixed with any liquids prior to dose administration. If needed, CELLCEPT 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 CELLCEPT at the usual times.
CELLCEPT Intravenous
CELLCEPT Intravenous is recommended for patients unable to take oral CELLCEPT. CELLCEPT Intravenous should be administered within 24 hours following transplant. CELLCEPT Intravenous can be administered for up to 14 days; however, patients should be switched to oral CELLCEPT as soon as they can tolerate oral medication.
CELLCEPT Intravenous must be reconstituted before use [see Dosage and Administration (2.6)]. CELLCEPT Intravenous 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.
CELLCEPT Intravenous must not be administered as a bolus. Following reconstitution, CELLCEPT Intravenous 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)].
Dosage Recommendations for Kidney Transplant Patients
Adults
The recommended dosage for adult kidney transplant patients is 1 g orally or intravenously infused over no less than 2 hours, twice daily (total daily dose of 2 g).
Pediatrics (3 months and older)
Pediatric dosing is based on body surface area (BSA). The recommended dosage of CELLCEPT oral suspension for pediatric kidney transplant patients 3 months and older is 600 mg/m2, administered twice daily (maximum total 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 | Dosage |
|---|---|
| 1.25 m2 to <1.5 m2 | CELLCEPT capsule 750 mg twice daily (1.5 g total daily dose) |
| ≥ 1.5 m2 | CELLCEPT capsules or tablets 1 g twice daily (2 g total daily dose) |
Dosage Recommendations for Heart Transplant Patients
Adults
The recommended dosage of CELLCEPT 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 CELLCEPT 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:
| Body Surface Area | Starting Dosage* |
|---|---|
|
|
| 1.25 m2 to <1.5 m2 | CELLCEPT capsule 750 mg twice daily (1.5 g total daily dose) |
| ≥ 1.5 m2 | CELLCEPT capsules or tablets 1 g twice daily (2 g total daily dose) |
Dosage Recommendations for Liver Transplant Patients
Adults
The recommended dosage of CELLCEPT 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 (total daily dose of 2 g).
Pediatrics (3 months and older)
The recommended starting dosage of CELLCEPT 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:
| Body Surface Area | Starting Dosage* |
|---|---|
|
|
| 1.25 m2 to <1.5 m2 | CELLCEPT capsule 750 mg twice daily (1.5 g total daily dose) |
| ≥ 1.5 m2 | CELLCEPT capsules or tablets 1 g twice daily (2 g total daily dose) |
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 CELLCEPT greater than 1 g twice a day. These patients should be carefully monitored [see Clinical Pharmacology (12.3)].
Preparation Instructions of Oral Suspension and 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.
CELLCEPT Oral Suspension
CELLCEPT Oral Suspension must be reconstituted by the pharmacist prior to dispensing to the patient. CELLCEPT Oral Suspension should not be mixed with any other medication. After reconstitution, the oral suspension contains 200 mg/mL MMF.
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:
- Tap the closed bottle several times to loosen the powder.
- Measure 94 mL of water in a graduated cylinder.
- Add approximately half the total amount of water for reconstitution to the bottle and shake the closed bottle well for about 1 minute.
- Add the remainder of water and shake the closed bottle well for about 1 minute.
- Remove the child-resistant cap and push bottle adapter into neck of bottle.
- 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.
- Write the date of expiration of the constituted suspension on the bottle label. (The shelf-life of the constituted suspension is 60 days.)
- 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°C to 30°C (59°F to 86°F). Storage in a refrigerator at 2°C to 8°C (36°F to 46°F) is acceptable. Do not freeze. Discard any unused portion 60 days after constitution.
CELLCEPT Intravenous
Before proceeding with the preparation steps for CELLCEPT Intravenous read the general preparation instructions [see General Preparation Instructions Before Handling the Formulations] and note the following:
- CELLCEPT Intravenous 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.
CELLCEPT Intravenous must be reconstituted and further diluted. A detailed description of the preparation is given below.
| Preparation of the 1g dose |
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| Preparation of the 1.5 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.
CELLCEPT Injection should not be mixed or administered concurrently via the same infusion catheter with other intravenous drugs or infusion admixtures.
