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CellCept
mycophenolate mofetil
Black Box Warnings .
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: CAP: 250 mg; TAB: 500 mg; SUSP: 200 mg per mL; INJ: various
Special Note
- [formulation clarification]
- Info: mycophenolate mofetil oral products are not interchangeable w/ mycophenolic acid DR products; do not substitute on a mg to mg basis
kidney transplant rejection prophylaxis
- [1 g PO/IV bid]
- Start: ASAP w/ in 24h post transplant; Info: for pts unable to take PO, give IV for up to 14 days and switch to PO ASAP; give on empty stomach; stable pts may take w/ food; do not open cap; do not cut/crush/chew tab
heart transplant rejection prophylaxis
- [1.5 g PO/IV bid]
- Start: ASAP w/ in 24h post transplant; Info: for pts unable to take PO, give IV for up to 14 days and switch to PO ASAP; give on empty stomach; stable pts may take w/ food; do not open cap; do not cut/crush/chew tab
liver transplant rejection prophylaxis
- [PO route]
- Dose: 1.5 g PO bid; Start: ASAP w/ in 24h post transplant; Info: give on empty stomach; stable pts may take w/ food; do not open cap; do not cut/crush/chew tab
- [IV route]
- Dose: 1 g IV bid; Start: ASAP w/ in 24h post transplant; Info: for pts unable to take PO; give for up to 14 days and switch to PO ASAP
lupus nephritis (off-label)
- [1-1.5 g PO bid]
- Info: use w/ prednisone; consider decr. dose to 0.5-1 g PO bid after 6mo of tx; do not open cap; do not cut/crush/chew tab
renal dosing
- [kidney transplant pts]
- CrCl <25: max 1 g bid
- HD: 250-500 mg bid; no supplement after dialysis; PD: max 1 g bid; no supplement
- [all other indications]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [kidney transplant pts]
- severe hepatic parenchymal dz: no adjustment; other hepatic impairment: not defined
- [all other indications]
- hepatic impairment: not defined
Peds Dosing .
- Dosage forms: CAP: 250 mg; TAB: 500 mg; SUSP: 200 mg per mL
Special Note
- [formulation clarification]
- Info: mycophenolate mofetil oral products are not interchangeable w/ mycophenolic acid DR products; do not substitute on a mg to mg basis
kidney transplant rejection prophylaxis
- [3 mo and older]
- Dose: 600 mg/m^2/dose PO bid; Start: ASAP w/in 24h post transplant; Max: 2 g/day; Alt: 750 mg PO bid for BSA 1.25-1.5 m^2; 1 g PO bid for BSA >1.5 m^2; Info: give on empty stomach; stable pts may take w/ food; do not open cap; do not cut/crush/chew tab
heart transplant rejection prophylaxis
- [3 mo and older]
- Dose: 900 mg/m^2/dose PO bid; Start: 600 mg/m^2/dose PO bid ASAP w/in 24h post transplant; Max: 3 g/day; Alt: 750 mg PO bid for BSA 1.25-1.5 m^2; 1 g PO bid for BSA >1.5 m^2; Info: give on empty stomach; stable pts may take w/ food; do not open cap; do not cut/crush/chew tab
liver transplant rejection prophylaxis
- [3 mo and older]
- Dose: 900 mg/m^2/dose PO bid; Start: 600 mg/m^2/dose PO bid ASAP w/in 24h post transplant; Max: 3 g/day; Alt: 750 mg PO bid for BSA 1.25-1.5 m^2; 1 g PO bid for BSA >1.5 m^2; Info: give on empty stomach; stable pts may take w/ food; do not open cap; do not cut/crush/chew tab
renal dosing
- [see below]
- CrCl <50: max 600 mg/m^2/day
- HD: max 600 mg/m^2/day; no supplement after dialysis; PD: max 600 mg/m^2/day; no supplement
hepatic dosing
- [kidney transplant pts]
- severe hepatic parenchymal dz: no adjustment; other hepatic impairment: not defined
- [all other indications]
- hepatic impairment: not defined