Basic Information
TRANSTERO MYCOPHENOLATE MOFETIL CAPSULES 250MG USP
CAPSULE
Regulatory Information
SIN16175P
April 30, 2021
Prescription Only
Therapeutic
ORAL
August 10, 2023
June 3, 2025
XL04AA06
Company Information
Active Ingredients
Strength: 250.000 mg
Detailed Information
Contraindications
**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_).
Indication Information
**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.