Mycophenolate mofetil
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In immunology, mycophenolate mofetil (brand name Cellcept) is an immunosuppressive agent.
History
Cellcept brand of mycophenolate mofetil was approved for Roche Palo by the Food and Drug Administration in the United States with a New Drug Application (NDA) in 1995.[1] A generic version with a AB Therapeutic Equivalence Code was approved for Sandoz with a Abbreviated New Drug Application (ANDA) in 2008.[2]
Uses
Mycophenolate mofetil is approved by the Food and Drug Administration in the United States for:
- "prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac or hepatic transplants"
Mycophenolate mofetil has been studied for off label uses for:
- Induction therapy for lupus nephritisMeta-analysis has reported better[3] and worse[4] results with mycophenolate mofetil. A principle randomized controlled trial reported better outcomes with mycophenolate mofetil.[5]
- Maintenance therapy for lupus nephritis[6]
References
- ↑ Anonymous. Drugs@FDA for FDA Application No. 050722. U S Food and Drug Administration
- ↑ Anonymous. Drugs@FDA for FDA Application No. 065379. U S Food and Drug Administration
- ↑ Touma Z, Gladman DD, Urowitz MB, Beyene J, Uleryk EM, Shah PS (2011). "Mycophenolate mofetil for induction treatment of lupus nephritis: a systematic review and metaanalysis.". J Rheumatol 38 (1): 69-78. DOI:10.3899/jrheum.100130. PMID 20952473. Research Blogging.
- ↑ Rovin BH, Parikh SV, Hebert LA, Chan TM, Mok CC, Ginzler EM et al. (2012). "Lupus Nephritis: Induction Therapy in Severe Lupus Nephritis: Should MMF Be Considered the Drug of Choice?". Clin J Am Soc Nephrol. DOI:10.2215/CJN.03290412. PMID 22879439. Research Blogging.
- ↑ Ginzler EM, Dooley MA, Aranow C, Kim MY, Buyon J, Merrill JT et al. (2005). "Mycophenolate mofetil or intravenous cyclophosphamide for lupus nephritis.". N Engl J Med 353 (21): 2219-28. DOI:10.1056/NEJMoa043731. PMID 16306519. Research Blogging. Review in: ACP J Club. 2006 May-Jun;144(3):74
- ↑ Dooley MA, Jayne D, Ginzler EM, Isenberg D, Olsen NJ, Wofsy D et al. (2011). "Mycophenolate versus azathioprine as maintenance therapy for lupus nephritis.". N Engl J Med 365 (20): 1886-95. DOI:10.1056/NEJMoa1014460. PMID 22087680. Research Blogging.