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Myfortic
mycophenolic acid
Black Box Warnings .
Appropriate Use
should only be administered by physicians experienced in immunosuppressive tx and management of organ transplant patients in adequate medical facility; physician responsible for maintenance tx should have all info needed for patient follow-up
Embryo-Fetal Toxicity
avoid use if safer tx options available; use during pregnancy associated with incr. risk of first trimester pregnancy loss and congenital malformations; patients of childbearing potential must be counseled on pregnancy prevention and planning
Malignancies
incr. risk of lymphoma and other malignancies, particularly of skin
Serious Infections
incr. risk of bacterial, viral, fungal, and protozoal infections, including opportunistic infections and hepatitis B and C viral reactivation; infections may lead to hospitalizations and fatal outcomes
Adult Dosing .
Dosage forms: DR TAB: 180 mg, 360 mg
Special Note
- [equivalency or interchangeability info]
- Info: mycophenolic acid DR products are not interchangeable with mycophenolate mofetil oral products; do not substitute on a mg to mg basis
kidney transplant rejection prophylaxis
- [720 mg PO bid]
- Info: give with cyclosporine and corticosteroids; give on empty stomach; do not cut/crush/chew tab
renal dosing
- [see below]
- renal impairment: no adjustment
- HD/PD: not defined
hepatic dosing
- [see below]
- hepatic parenchymal disease: no adjustment; other hepatic impairment: not defined
Peds Dosing .
- Dosage forms: DR TAB: 180 mg, 360 mg
Special Note
- [equivalency or interchangeability info]
- Info: mycophenolic acid DR products are not interchangeable with mycophenolate mofetil oral products; do not substitute on a mg to mg basis
kidney transplant rejection prophylaxis
- [5 yo and older, BSA <1.19 m^2]
- Info: dose cannot be accurately administered with current tab sizes
- [5 yo and older, BSA 1.19-1.58 m^2]
- Dose: 540 mg PO bid; Max: 1440 mg/day; Alt: 400 mg/m^2/dose PO bid; Info: for patients >6mo post-transplant; give with cyclosporine and corticosteroids; give on empty stomach; do not cut/crush/chew tab
- [5 yo and older, BSA >1.58 m^2]
- Dose: 720 mg PO bid; Max: 1440 mg/day; Alt: 400 mg/m^2/dose PO bid; Info: for patients >6mo post-transplant; give with cyclosporine and corticosteroids; give on empty stomach; do not cut/crush/chew tab
renal dosing
- [see below]
- renal impairment: no adjustment
- HD/PD: not defined
hepatic dosing
- [see below]
- hepatic parenchymal disease: no adjustment; other hepatic impairment: not defined