The pharmacokinetic-pharmacodynamic relationship for mycophenolate
mofetil in renal transplantation.
M2 PHARMA-March 1, 2017-Akorn wins US FDA approval for Mycophenolate
Mofetil for Injection, USP
Pharmaceutical company Endo International (Nasdaq:ENDP) (TSX:ENDP) reported on Tuesday the start of delivery of the US Food and Drug Administration approved mycophenolate
mofetil hydrochloride (HCl) for injection.
Refractory patients received a wide range of systemic agents--most commonly chloroquine (Aralen) and mycophenolate
mofetil (Cellcept), followed by quinacrine, dapsone, methotrexate, belimumab (Benlysta), azathioprine, thalidomide (Thalomid), lenalidomide (Revlimid), prednisone, and rituximab (Rituxan), Ms.
The drug is approved for use with other immunosuppressants, including basiliximab, mycophenolate
mofetil, and corticosteroids.
mofetil and rituximab are expected to join the lupus armamentarium, promising to be particularly useful for lupus nephritis, Dr.
Research is also focusing on steroid-sparing immunosuppressive agents, including mycophenolate
mofetil (MMF) has been promising as a posttransplantation immunosuppressive agent, in combination with either cyclosporin A (CsA) or tacrolimus (Tc), following renal transplantation.
The placebo-controlled study evaluates two doses of voclosporin, with all patients receiving background therapy of mycophenolate
mofetil coupled with an aggressive oral corticosteroid taper.
The required label changes affect the following drugs used to help prevent rejection of transplanted organs:--Rapamune (sirolimus) Sandimmune (cyclosporine) and cyclosporine generics--Neoral (cyclosporine modified), and generics - Cellcept (mycophenolate
mofetil) and generics--Myfortic (mycophenolic acid) The FDA is requiring the labeling changes based on its review of reported adverse events.
mofetil was safer and significantly more effective than intravenous cyclophosphamide for inducing remission of lupus nephritis in a randomized open trial.