Important Safety Information
Adverse events reported in >30% of renal, cardiac or liver transplant patients receiving CellCept® (mycophenolate mofetil), in combination with cyclosporine and corticosteroids, were pain, fever, headache, asthenia, anemia, leukopenia,* thrombocytopenia, leukocytosis, urinary tract infection, hypertension, hypotension, peripheral edema, hypercholesteremia, hypokalemia, hyperglycemia, creatinine, BUN and cough increased, hypomagnesemia, diarrhea, constipation, nausea, vomiting, respiratory infection, dyspnea, lung disorder, pleural effusion, tremor and insomnia.
Mycophenolate mofetil (MMF) can cause fetal harm when administered to a pregnant woman. Use of MMF during pregnancy is associated with an increased risk of first trimester pregnancy loss and increased risk of congenital malformation, especially external ear and other facial abnormalities including cleft lip and palate, and anomalies of the distal limbs, heart, esophagus and kidney.
Women of childbearing potential should have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 1 week prior to beginning therapy. CellCept therapy should not be initiated until a negative pregnancy test report is obtained.
Women of childbearing potential (including pubertal girls and peri-menopausal women) taking CellCept must receive contraceptive counseling and use effective contraception. The patient should begin using her two chosen methods of contraception 4 weeks prior to starting CellCept therapy, unless abstinence is the chosen method. She should continue contraceptive use during therapy and for 6 weeks after stopping CellCept. Patient should be aware that CellCept reduces blood levels of the hormones in the oral contraceptive pill and could theoretically reduce its effectiveness.
Oversuppression of the immune system can also increase susceptibility to infection, including opportunistic infections, fatal infections and sepsis.
WARNING: Immunosuppression may lead to increased susceptibility to infection and the possible development of lymphoma. Only physicians experienced in immunosuppressive therapy and management of renal, cardiac or hepatic transplant patients should use CellCept. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient.
Female users of childbearing potential must use contraception. Use of CellCept during pregnancy is associated with increased risk of pregnancy loss and congenital malformations.
*Patients should be monitored for neutropenia. Dosing should be interrupted or the dose reduced if neutropenia develops.
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References:
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.
13Data on file (Ref. 140-005) [2004 DDD data], Hoffmann-La Roche, Nutley, NJ 07110.
16Data on file (Ref. 140-007), Hoffmann-La Roche, Nutley, NJ 07110.
39Van Hest RM, et al. Explaining variability in myophenoloic acid exposure to optimize Mycophenolate Mofetil dosing: a population pharmacokinetic meta-analysis of mycophenolic acid in renal transplant recipients. J Am Soc Nephrol. 2006;17:871-880.