TRANSTERO MYCOPHENOLATE MOFETIL CAPSULES 250MG USP [SIN16175P]

Product Info

TRANSTERO MYCOPHENOLATE MOFETIL CAPSULES 250MG USP

[SIN16175P]

2.1. Therapeutic Indication(s)

Mycophenolate 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.

Mycophenolate 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 Mycophenolate.

Standard Dosage for prophylaxis of renal rejection
A dose of 1g administered orally (over NO LESS THAN 2 HOURS) twice a day (daily dose of 2g) 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 Mycophenolate demonstrated an overall better safety profile compared to patients receiving 3g per day of Mycophenolate.

Standard Dosage for prophylaxis of cardiac rejection
A dose of 1.5g administered orally (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 1.5g 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 1.5g 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 Mycophenolate should be given as soon as possible following renal, cardiac or hepatic transplantation.

2.2.1. Special dosage instructions

Patients with neutropenia: If neutropenia develops (absolute neutrophil count <1.3 x 10³/microlitre), dosing with Mycophenolate 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 and 1.5 g twice daily for cardiac or hepatic transplant patients are 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 Mycophenolate have been observed. Therefore, Mycophenolate is contraindicated in patients with hypersensitivity to mycophenolate mofetil or mycophenolic acid. Mycophenolate i.v. is contraindicated in patients who are allergic to polysorbate 80.

Mycophenolate 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).

Mycophenolate 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).

Mycophenolate 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).