Unique Benefits
CellCept is Proven:
- Efficacy and long-term safety established in more than 10 years of clinical use
- 4 million prescriptions in the United States alone12
- Included in more than 2100 publications11
- No other MPA formulation has surpassed the GI safety profile of CellCept10
CellCept is Reliable:
- Rapidly absorbed from stomach
- Tmax is predictable and reached quickly (1 hour or less)8
-
Offers reliable MPS delivery that is minimally affected by diabetic
gastroparesis, H2 blockers and proton pump inhibitors.39
- CellCept should not be administered simultaneously with antacids containing magnesium or aluminum hydroxides.
CellCept is Flexible:
- Flexible, with approvals for use in renal, hepatic, and cardiac transplant when used in combination with cyclosporine and corticosteroids
- Available as four formulations: capsules, tablets, suspension, and IV
- Can be taken with or without food in stable renal transplant patients. However, administration on an empty stomach is recommended.
CellCept is Unique:
- Exclusive or preferred MPA on most major formularies (covering more than 170 million lives)* 16
-
Tier 2 status in a majority of employer/MCO formularies16
*Subject to plan design as of December 15, 2005.
Data in important special populations:
- Established pharmacokinetic and safety14 data in pediatric renal transplant patients. Established pediatric dosing: 600 mg/m2 bid (up to maximum of 1g bid).
- Used extensively in diabetic patients as demonstrated in an analysis of registry data15
-
Shown to provide similar absorption profiles in African American vs Caucasian
patients in a retrospective analysis† 17
†Data pooled from retrospective analysis of registration data, which were not designed or powered to provide CellCept absorption profiles.
MPA delivery in diabetic patients:
- More than half of all renal transplant patients have diabetes by year 3 posttransplant18
- Delayed gastric emptying affects up to 50% of diabetics9
- Timing of CellCept absorption is less affected by gastric emptying rates compared with EC-MPS.10,8
Safety
Information
References:
8Bullingham R, et al. Effects of food and antacid on the pharmacokinetics of single doses of mycophenolate mofetil in rheumatoid arthritis patients. Br J Clin Pharmacol. 1996;41:513-516.
9Samsom M, et al. Prevalence of delayed gastric emptying in diabetic patients and relationship to dyspeptic symptoms: a prospective study in unselected diabetic patients. Diabetes Care. 2003;26:3116-3122.
10Myfortic [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2004.
11Pub Med Inquiry. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed. PubMed search user query terms were "(mycophenolate mofetil[Title/Abstract] OR (MMF[Title/Abstract] AND transplant*[Title/Abstract]) OR cellcept[Title/Abstract]) NOT (letter[Publication Type] OR editorial[PublicationType])" yielding 2181 results on October 19, 2004.
12Data on file (Ref. 140-004), Hoffmann-La Roche, Nutley, NJ 07110.
14Höcker B, et al. Mycophenolate mofetil suspension in pediatric renal transplantation: 3-yr data from the tricontinental trial. Pediatr Transplant. 2005;9:505-511.
15David KM, et al. Mycophenolate mofetil vs azathioprine is associated with decreased acute rejection, late acute rejection, and risk for cardiac death in renal transplant patients with pre-transplant diabetes. Clin Transplant. 2005;19:279-285.
16Data on file (Ref. 140-007), Hoffmann-La Roche, Nutley, NJ 07110.
17Pescovitz MD, et al. Equivalent pharmacokinetics of mycophenolate mofetil in African-American and Caucasian male and female stable renal allograft recipients. Am J Transplant. 2003;3:1581-1586.
18U.S. Renal Data System, USRDS 2005 Annual Data Report: Atlas of End-Stage Renal Disease in the United States, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, Md, 2005. Chapter 2. Incidence & prevalence. Available at: http://www.usrds.org/2005/pdf/02_incid_prev_05..pdf. Accessed November 1, 2005.