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Myfortic
mycophenolic acid
Black Box Warnings .
Appropriate Use
admin. only by physicians experienced in immunosuppress. tx and mgmt of organ transplant pts in adequate medical facility; physician responsible for maintenance tx should have all info needed for pt follow-up
Embryo-Fetal Toxicity
avoid use if safer tx options available; use during pregnancy assoc. w/ incr. risk of first trimester pregnancy loss and congenital malformations; females of reproductive 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, incl. 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
- [formulation clarification]
- Info: mycophenolic acid DR products are not interchangeable w/ mycophenolate mofetil oral products; do not substitute on a mg to mg basis
kidney transplant rejection prophylaxis
- [720 mg PO bid]
- Info: give w/ 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 dz: no adjustment; other hepatic impairment: not defined
Peds Dosing .
- Dosage forms: DR TAB: 180 mg, 360 mg
Special Note
- [formulation clarification]
- Info: mycophenolic acid DR products are not interchangeable w/ 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 admin. w/ 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 pts >6mo post-transplant; give w/ 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 pts >6mo post-transplant; give w/ 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 dz: no adjustment; other hepatic impairment: not defined