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In [[immunology]], '''mycophenolate mofetil''' (brand name '''Cellcept''') is an [[immunosuppressive agent]]. | In [[immunology]], '''mycophenolate mofetil''' (brand name '''Cellcept''') is an [[immunosuppressive agent]]. | ||
==History== | ==History== | ||
Cellcept brand of mycophenolate mofetil was approved for Roche Palo by the [[Food and Drug Administration]] in the [[United States]] with a [http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/NewDrugApplicationNDA/ New Drug Application] (NDA) in 1995.<ref>{{FDA-Drug_Details|050722}}</ref> A generic version with a AB [[Food and Drug Administration/Catalogs/Therapeutic Equivalence Code|Therapeutic Equivalence Code]] was approved for Sandoz with a [http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/ Abbreviated New Drug Application] (ANDA) in 2008.<ref>{{FDA-Drug_Details|065379}}</ref> | Cellcept brand of mycophenolate mofetil was approved for Roche Palo by the [[Food and Drug Administration]] in the [[United States of America]] with a [http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/NewDrugApplicationNDA/ New Drug Application] (NDA) in 1995.<ref>{{FDA-Drug_Details|050722}}</ref> A generic version with a AB [[Food and Drug Administration/Catalogs/Therapeutic Equivalence Code|Therapeutic Equivalence Code]] was approved for Sandoz with a [http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/ Abbreviated New Drug Application] (ANDA) in 2008.<ref>{{FDA-Drug_Details|065379}}</ref> | ||
==Uses== | ==Uses== | ||
Mycophenolate mofetil is approved by the [[Food and Drug Administration]] in the [[United States]] for: | Mycophenolate mofetil is approved by the [[Food and Drug Administration]] in the [[United States of America]] for: | ||
* "prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac or hepatic transplants" | * "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 nephritis]]. [[Meta-analysis|Meta-analyses]] have reported better<ref name="pmid20952473">{{cite journal| author=Touma Z, Gladman DD, Urowitz MB, Beyene J, Uleryk EM, Shah PS| title=Mycophenolate mofetil for induction treatment of lupus nephritis: a systematic review and metaanalysis. | journal=J Rheumatol | year= 2011 | volume= 38 | issue= 1 | pages= 69-78 | pmid=20952473 | doi=10.3899/jrheum.100130 | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=20952473 }} </ref><ref name="pmid20616662">{{cite journal| author=Kamanamool N, McEvoy M, Attia J, Ingsathit A, Ngamjanyaporn P, Thakkinstian A| title=Efficacy and adverse events of mycophenolate mofetil versus cyclophosphamide for induction therapy of lupus nephritis: systematic review and meta-analysis. | journal=Medicine (Baltimore) | year= 2010 | volume= 89 | issue= 4 | pages= 227-35 | pmid=20616662 | doi=10.1097/MD.0b013e3181e93d00 | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=20616662 }} </ref><ref name="pmid20064907">{{cite journal| author=Lee YH, Woo JH, Choi SJ, Ji JD, Song GG| title=Induction and maintenance therapy for lupus nephritis: a systematic review and meta-analysis. | journal=Lupus | year= 2010 | volume= 19 | issue= 6 | pages= 703-10 | pmid=20064907 | doi=10.1177/0961203309357763 | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=20064907 }} </ref><ref name="pmid19494179">{{cite journal| author=Mak A, Cheak AA, Tan JY, Su HC, Ho RC, Lau CS| title=Mycophenolate mofetil is as efficacious as, but safer than, cyclophosphamide in the treatment of proliferative lupus nephritis: a meta-analysis and meta-regression. | journal=Rheumatology (Oxford) | year= 2009 | volume= 48 | issue= 8 | pages= 944-52 | pmid=19494179 | doi=10.1093/rheumatology/kep120 | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=19494179 }} </ref> and worse<ref name="pmid22879439">{{cite journal| author=Rovin BH, Parikh SV, Hebert LA, Chan TM, Mok CC, Ginzler EM et al.| title=Lupus Nephritis: Induction Therapy in Severe Lupus Nephritis: Should MMF Be Considered the Drug of Choice? | journal=Clin J Am Soc Nephrol | year= 2012 | volume= | issue= | pages= | pmid=22879439 | doi=10.2215/CJN.03290412 | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=22879439 }} </ref> results with mycophenolate mofetil. A principle [[randomized controlled trial]]s reported better<ref name="pmid16306519">{{cite journal| author=Ginzler EM, Dooley MA, Aranow C, Kim MY, Buyon J, Merrill JT et al.| title=Mycophenolate mofetil or intravenous cyclophosphamide for lupus nephritis. | journal=N Engl J Med | year= 2005 | volume= 353 | issue= 21 | pages= 2219-28 | pmid=16306519 | doi=10.1056/NEJMoa043731 | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=16306519 }} [http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=16646618 Review in: ACP J Club. 2006 May-Jun;144(3):74] </ref> and not<ref name="pmid19369404">{{cite journal| author=Appel GB, Contreras G, Dooley MA, Ginzler EM, Isenberg D, Jayne D et al.| title=Mycophenolate mofetil versus cyclophosphamide for induction treatment of lupus nephritis. | journal=J Am Soc Nephrol | year= 2009 | volume= 20 | issue= 5 | pages= 1103-12 | pmid=19369404 | doi=10.1681/ASN.2008101028 | pmc=PMC2678035 | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=19369404 }} </ref> outcomes with mycophenolate mofetil. | |||
* Maintenance therapy for [[lupus nephritis]]. [[Meta-analysis]]<ref name="pmid23113811">{{cite journal| author=Feng L, Deng J, Huo DM, Wu QY, Liao YH| title=Mycophenolate mofetil versus azathioprine as maintenance therapy for lupus nephritis: a meta-analysis. | journal=Nephrology (Carlton) | year= 2012 | volume= | issue= | pages= | pmid=23113811 | doi=10.1111/nep.12006 | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=23113811 }} </ref> and principle [[randomized controlled trial]] reported increased<ref name="pmid22087680">{{cite journal| author=Dooley MA, Jayne D, Ginzler EM, Isenberg D, Olsen NJ, Wofsy D et al.| title=Mycophenolate versus azathioprine as maintenance therapy for lupus nephritis. | journal=N Engl J Med | year= 2011 | volume= 365 | issue= 20 | pages= 1886-95 | pmid=22087680 | doi=10.1056/NEJMoa1014460 | pmc= | url=http://www.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&tool=sumsearch.org/cite&retmode=ref&cmd=prlinks&id=22087680 }} </ref> increased benefit with mycophenolate mofetil. | |||
==References== | ==References== | ||
<references/> | <references/> | ||
Latest revision as of 13:09, 2 February 2023
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 of America 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 of America 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 nephritis. Meta-analyses have reported better[3][4][5][6] and worse[7] results with mycophenolate mofetil. A principle randomized controlled trials reported better[8] and not[9] outcomes with mycophenolate mofetil.
- Maintenance therapy for lupus nephritis. Meta-analysis[10] and principle randomized controlled trial reported increased[11] increased benefit with mycophenolate mofetil.
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.
- ↑ Kamanamool N, McEvoy M, Attia J, Ingsathit A, Ngamjanyaporn P, Thakkinstian A (2010). "Efficacy and adverse events of mycophenolate mofetil versus cyclophosphamide for induction therapy of lupus nephritis: systematic review and meta-analysis.". Medicine (Baltimore) 89 (4): 227-35. DOI:10.1097/MD.0b013e3181e93d00. PMID 20616662. Research Blogging.
- ↑ Lee YH, Woo JH, Choi SJ, Ji JD, Song GG (2010). "Induction and maintenance therapy for lupus nephritis: a systematic review and meta-analysis.". Lupus 19 (6): 703-10. DOI:10.1177/0961203309357763. PMID 20064907. Research Blogging.
- ↑ Mak A, Cheak AA, Tan JY, Su HC, Ho RC, Lau CS (2009). "Mycophenolate mofetil is as efficacious as, but safer than, cyclophosphamide in the treatment of proliferative lupus nephritis: a meta-analysis and meta-regression.". Rheumatology (Oxford) 48 (8): 944-52. DOI:10.1093/rheumatology/kep120. PMID 19494179. 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
- ↑ Appel GB, Contreras G, Dooley MA, Ginzler EM, Isenberg D, Jayne D et al. (2009). "Mycophenolate mofetil versus cyclophosphamide for induction treatment of lupus nephritis.". J Am Soc Nephrol 20 (5): 1103-12. DOI:10.1681/ASN.2008101028. PMID 19369404. PMC PMC2678035. Research Blogging.
- ↑ Feng L, Deng J, Huo DM, Wu QY, Liao YH (2012). "Mycophenolate mofetil versus azathioprine as maintenance therapy for lupus nephritis: a meta-analysis.". Nephrology (Carlton). DOI:10.1111/nep.12006. PMID 23113811. Research Blogging.
- ↑ 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.