CELLCEPT FOR I.V. INFUSION 500 MG/VIAL [SIN11328P]

Product Info

CELLCEPT FOR I.V. INFUSION 500 MG/VIAL

[SIN11328P]

2.1. Therapeutic Indication(s)
CellCept is indicated for:

• prophylaxis of acute organ rejection and treatment of refractory organ rejection in patients receiving allogeneic renal transplants.

• prophylaxis of acute organ rejection and increased graft and patient survival in patients receiving allogeneic cardiac transplants.

• prophylaxis of acute organ rejection in patients receiving allogeneic hepatic transplants.

CellCept should be used concomitantly with cyclosporin and corticosteroids.

2.2. Dosage and Administration
Please refer to full prescribing information for corticosteroids and either ciclosporin or tacrolimus, which are used in combination with CellCept.
Standard Dosage for prophylaxis of renal rejection
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 1.5g administered twice daily (daily dose of 3g) 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 2g per day of CellCept demonstrated an overall better safety profile compared to patients receiving 3g per day of CellCept.

Standard Dosage for prophylaxis of cardiac rejection
A dose of 1.5g administered orally or intravenously (over NO LESS THAN 2 HOURS) twice a day (daily dose of 3g) is recommended for use in cardiac transplant patients.

Standard Dosage for prophylaxis of hepatic rejection
A dose of 1.0g administered intravenously (over NO LESS THAN 2 HOURS) twice a day (daily dose of 2g) or 1.5g orally twice a day (daily dose of 3g) is recommended for use in hepatic transplant patients.

For Oral Administration only:
Standard dosage for treatment of refractory renal rejection
A dose of 1.5 g administered twice a day (daily dose of 3g) is recommended for management of refractory rejection.

Oral administration (see 3.2.1 Pharmacokinetic Properties, Absorption – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)
The initial dose of CellCept should be given as soon as possible following renal, cardiac or hepatic transplantation.

Intravenous administration
Caution: CellCept i.v. solution must not be administered by rapid or bolus intravenous injection.
CellCept i.v. is an alternative dosage form to CellCept capsules and tablets recommended for patients unable to take oral CellCept. CellCept i.v. should be administered within 24 hours following transplantation. CellCept i.v. can be administered for up to 14 days. Patients should be switched to oral CellCept as soon as they can tolerate oral medication.

Following reconstitution and dilution with 5% Dextrose intravenous infusion to a concentration of 6 mg/mL, CellCept i.v. must be administered by slow intravenous infusion over a period of NO LESS THAN 2 HOURS by either a peripheral or a central vein.

2.2.1. Special dosage instructions
Patients with neutropenia: If neutropenia develops (absolute neutrophil count <1.3 x 10³/microlitre), dosing with CellCept should be interrupted or the dose should be reduced and the patient carefully observed (see 2.4 Warnings and precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

For dosage instructions in special population, please refer to sections 2.5.4 Geriatric Use, 2.5.5 Renal Impairment and 2.5.6 Hepatic Impairment.

2.5. Use in Special Populations
2.5.4. Geriatric Use
The recommended oral doses of 1 g twice daily for renal transplant patients, 1.5 g twice daily for cardiac or hepatic transplant patients is appropriate for elderly patients (see 2.4 Warnings and Precautions, 2.6 Undesirable effects, and 3.2.5 Pharmacokinetics in Special Populations – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

2.5.5. Renal Impairment
Patients with severe renal impairment: In renal transplant patients with severe chronic renal impairment (glomerular filtration rate <25 mL/min/1.73m²), outside of the immediate post-transplant period or after treatment of acute of refractory rejection, doses greater than 1 g administered twice a day should be avoided. (see 2.4 Warnings and Precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

No data are available for cardiac or hepatic transplant patients with severe chronic renal impairment.

Patients with delayed renal graft function post-transplant: No dose adjustments are needed in patients experiencing delayed renal graft function post-operatively. (See 3.2 Pharmacokinetic Properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

2.5.6. Hepatic Impairment
No dose adjustments are needed for renal transplant patients with severe hepatic parenchymal disease. (see 3.2 Pharmacokinetic Properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). No data are available for cardiac transplant patients with severe hepatic parenchymal disease.

2.3. Contraindications
Allergic reactions to CellCept have been observed. Therefore, CellCept is contraindicated in patients with hypersensitivity to mycophenolate mofetil or mycophenolic acid. CellCept i.v. is contraindicated in patients who are allergic to polysorbate 80.

CellCept is contraindicated during pregnancy due to its mutagenic and teratogenic potential (see 2.5.2 Pregnancy – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

CellCept is contraindicated in women of childbearing potential not using highly effective contraceptive methods (see 2.5.1 Females and Males of Reproductive Potential – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

CellCept is contraindicated in women who are breastfeeding (see 2.5.3 Lactation – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).