Renal, Cardiac, and Hepatic Transplant

CellCept is indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac or hepatic transplants. CellCept should be used concomitantly with cyclosporine and corticosteroids.

CellCept Intravenous is an alternative dosage form to CellCept capsules, tablets and oral suspension. CellCept Intravenous should be administered within 24 hours following transplantation. CellCept Intravenous can be administered for up to 14 days; patients should be switched to oral CellCept as soon as they can tolerate oral medication.

Renal Transplantation

Adults

A dose of 1 g administered orally or intravenously (over NO LESS THAN 2 HOURS) twice a day (daily dose of 2 g) is recommended for use in renal transplant patients. Although a dose of 1.5 g administered twice daily (daily dose of 3 g) was used in clinical trials and was shown to be safe and effective, no efficacy advantage could be established for renal transplant patients. Patients receiving 2 g/day of CellCept demonstrated an overall better safety profile than did patients receiving 3 g/day of CellCept.

Pediatrics (3 months to 18 years of age)

The recommended dose of CellCept oral suspension is 600 mg/m² administered twice daily (up to a maximum daily dose of 2 g/10 mL oral suspension). Patients with a body surface area of 1.25 m² to 1.5 m² may be dosed with CellCept capsules at a dose of 750 mg twice daily (1.5 g daily dose). Patients with a body surface area > 1.5 m² may be dosed with CellCept capsules or tablets at a dose of 1 g twice daily (2 g daily dose).

Cardiac Transplantation

Adults

A dose of 1.5 g bid administered intravenously (over NO LESS THAN 2 HOURS) or 1.5 g bid oral (daily dose of 3 g) is recommended for use in adult cardiac transplant patients.

Hepatic Transplantation

Adults

A dose of 1 g bid administered intravenously (over NO LESS THAN 2 HOURS) or 1.5 g bid oral (daily dose of 3 g) is recommended for use in adult hepatic transplant patients.

CellCept Capsules, Tablets, and Oral Suspension

The initial oral dose of CellCept should be given as soon as possible following renal, cardiac or hepatic transplantation. Food had no effect on MPA AUC, but has been shown to decrease MPA Cmax by 40%. Therefore, it is recommended that CellCept be administered on an empty stomach. However, in stable renal transplant patients, CellCept may be administered with food if necessary.

If required, CellCept Oral Suspension can be administered via a nasogastric tube with a minimum size of 8 French (minimum 1.7 mm interior diameter).

Patients With Hepatic Impairment

No dose adjustments are recommended for renal patients with severe hepatic parenchymal disease. However, it is not known whether dose adjustments are needed for hepatic disease with other etiologies (see CLINICAL PHARMACOLOGY: Pharmacokinetics).

No data are available for cardiac transplant patients with severe hepatic parenchymal disease.

Geriatrics

The recommended oral dose of 1 g bid for renal transplant patients, 1.5 g bid for cardiac transplant patients, and 1 g bid administered intravenously or 1.5 g bid administered orally in hepatic transplant patients is appropriate for elderly patients (see PRECAUTIONS: Geriatric Use).

Preparation of Oral Suspension

It is recommended that CellCept Oral Suspension be constituted by the pharmacist prior to dispensing to the patient.

CellCept Oral Suspension should not be mixed with any other medication.

Mycophenolate mofetil has demonstrated teratogenic effects in rats and rabbits. There are no adequate and well-controlled studies in pregnant women (see WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, and HANDLING AND DISPOSAL). Care should be taken to avoid inhalation or direct contact with skin or mucous membranes of the dry powder or the constituted suspension. If such contact occurs, wash thoroughly with soap and water; rinse eyes with water.

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 constitution 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.

Dispense with patient instruction sheet and oral dispensers. It is recommended to write the date of expiration of the constituted suspension on the bottle label. (The shelf-life of the constituted suspension is 60 days.)

After constitution the oral suspension contains 200 mg/mL mycophenolate mofetil. Store constituted suspension at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).

Storage in a refrigerator at 2° to unused portion 60 days after constitution.

CellCept Intravenous

Adults

CellCept Intravenous is an alternative dosage form to CellCept capsules, tablets and oral suspension recommended for patients unable to take oral CellCept. CellCept Intravenous should be administered within 24 hours following transplantation. CellCept Intravenous can be administered for up to 14 days; patients should be switched to oral CellCept as soon as they can tolerate oral medication.

CellCept Intravenous must be reconstituted and diluted to a concentration of 6 mg/mL using 5% Dextrose Injection USP. CellCept Intravenous is incompatible with other intravenous infusion solutions. 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.

CAUTION: CELLCEPT INTRAVENOUS SOLUTION SHOULD NEVER BE ADMINISTERED BY RAPID OR BOLUS INTRAVENOUS INJECTION (see WARNINGS).

Preparation of Infusion Solution (6 mg/mL)

Caution should be exercised in the handling and preparation of solutions of CellCept Intravenous. Avoid direct contact of the prepared solution of CellCept Intravenous with skin or mucous membranes. If such contact occurs, wash thoroughly with soap and water; rinse eyes with plain water (see WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, and HANDLING AND DISPOSAL).

CellCept Intravenous does not contain an antibacterial preservative; therefore, reconstitution and dilution of the product must be performed under aseptic conditions. Additionally, 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 diluent, the vial should not be used.

CellCept Intravenous infusion solution must be prepared in two steps: the first step is a reconstitution step with 5% Dextrose Injection USP, and the second step is a dilution step with 5% Dextrose Injection USP. A detailed description of the preparation is given below:

Step 1

1. Two (2) vials of CellCept Intravenous are used for preparing each 1 g dose, whereas three (3) vials are needed for each 1.5 g dose. Reconstitute the contents of each vial by injecting 14 mL of 5% Dextrose Injection USP.
2. Gently shake the vial to dissolve the drug.
3. Inspect the resulting slightly yellow solution for particulate matter and discoloration prior to further dilution. Discard the vials if particulate matter or discoloration is observed.

Step 2

1. To prepare a 1 g dose, further dilute the contents of the two reconstituted vials (approx. 2 x 15 mL) into 140 mL of 5% Dextrose Injection USP. To prepare a 1.5 g dose, further dilute the contents of the three reconstituted vials (approx. 3 x 15 mL) into 210 mL of 5% Dextrose Injection USP. The final concentration of both solutions is 6 mg mycophenolate mofetil per mL.
2. Inspect the infusion solution for particulate matter or discoloration. Discard the infusion solution if particulate matter or discoloration is observed.

If the infusion solution is not prepared immediately prior to administration, the commencement of administration of the infusion solution should be within 4 hours from reconstitution and dilution of the drug product. Keep solutions at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).

CellCept Intravenous should not be mixed or administered concurrently via the same infusion catheter with other intravenous drugs or infusion admixtures.

Dosage Adjustments

In renal transplant patients with severe chronic renal impairment (GFR < 25 mL/min/1.73 m²) outside the immediate posttransplant period, doses of CellCept greater than 1 g administered twice a day should be avoided. These patients should also be carefully observed. No dose adjustments are needed in renal transplant patients experiencing delayed graft function postoperatively (see CLINICAL PHARMACOLOGY: Pharmacokinetics and PRECAUTIONS: General).

No data are available for cardiac or hepatic transplant patients with severe chronic renal impairment. CellCept may be used for cardiac or hepatic transplant patients with severe chronic renal impairment if the potential benefits outweigh the potential risks.

If neutropenia develops (ANC < 1.3 x 10³/μL), dosing with CellCept should be interrupted or the dose reduced, appropriate diagnostic tests performed, and the patient managed appropriately (see WARNINGS: Neutropenia, ADVERSE REACTIONS, and PRECAUTIONS: Laboratory Tests).

HANDLING AND DISPOSAL

Mycophenolate mofetil has demonstrated teratogenic effects in rats and rabbits (see WARNINGS: Pregnancy). CellCept tablets should not be crushed and CellCept capsules should not be opened or crushed. Avoid inhalation or direct contact with skin or mucous membranes of the powder contained in CellCept capsules and CellCept Oral Suspension (before or after constitution). If such contact occurs, wash thoroughly with soap and water; rinse eyes with plain water. Should a spill occur, wipe up using paper towels wetted with water to remove spilled powder or suspension. Caution should be exercised in the handling and preparation of solutions of CellCept Intravenous. Avoid direct contact of the prepared solution of CellCept

Intravenous with skin or mucous membranes. If such contact occurs, wash thoroughly with soap and water; rinse eyes with plain water.

CellCept (mycophenolate mofetil capsules) 250 mg

Blue-brown, two-piece hard gelatin capsules, printed in black with “CellCept 250” on the blue cap and “Roche” on the brown body. Supplied in the following presentations:

Storage

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).

CellCept (mycophenolate mofetil tablets) 500 mg

Lavender-colored, caplet-shaped, film-coated tablets printed in black with “CellCept 500” on one side and “Roche” on the other. Supplied in the following presentations:

Storage and Dispensing Information

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). Dispense in lightresistant containers, such as the manufacturer's original containers.

CellCept Oral Suspension (mycophenolate mofetil for oral suspension)

Supplied as a white to off-white powder blend for constitution to a white to off-white mixed-fruit flavor suspension. Supplied in the following presentation:

Storage

Store dry powder at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). Store constituted suspension at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) for up to 60 days. Storage in a refrigerator at 2° to 8°C (36° to 46°F) is acceptable. Do not freeze.

CellCept Intravenous (mycophenolate mofetil hydrochloride for injection)

Supplied in a 20 mL, sterile vial containing the equivalent of 500 mg mycophenolate mofetil as the hydrochloride salt in cartons of 4 vials:

Storage

Store powder and reconstituted/infusion solutions at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).

Sandimmune is a registered trademark of Novartis Pharmaceuticals Corporation., ATGAM is a registered trademark of Pharmacia and Upjohn Company., Neoral is a registered trademark of Novartis Pharmaceuticals Corporation., Orthoclone OKT is a registered trademark of Ortho Biotech Inc., Maalox is a registered trademark of Novartis Consumer Health, Inc. Revised: May 2008. Distributed by Roche Pharmaceuticals, Roche Laboratories Inc.340 Kingsland Street, Nutley, New Jersey 07110 - 1199. FDA revision date: 5/9/2008

Bookmark this page: