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These tables show (1) the proportion of patients experiencing treatment failure, (2) the proportion of patients who experienced biopsy-proven acute rejection on treatment, and (3) early termination, for any reason other than graft loss or death, without a prior biopsy-proven acute rejection episode.
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Other factors that could cause actual results to differ materially include, without limitation, uncertainty related to the current or future manufacturing of commercial quantities of CYCLOSPORINE and THYMOGLOBULIN on commercially favorable terms, adequate and continuous supply of bulk CYCLOSPORINE drug substance, market acceptance, profitability, competition and potential litigation.
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For comparison, the background rate for congenital anomalies in the United States is about 3%, and NTPR data show a rate of 4-5% among babies born to organ transplant patients using other immunosuppressive drugs.
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The dose normalized AUC in de novo liver transplant patients administered Cyclosporine Oral Solution USP MODIFIED 28 days after transplantation was 50% greater and C max was 90% greater than in those patients administered Sandimmune (Cyclosporine Oral Solution USP).
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Another example where pharmacokinetic data have shed important insights on the impact of development on drug metabolism resides with CYP3A4; the most abundant cytochrome P450 isoform in the human body which is responsible for catalyzing the biotransformation of well over 20 drugs commonly used in pediatric practice (Leeder and Kearns, 1997).
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Orally administered radiolabeled mycophenolate mofetil resulted in complete recovery of the administered dose, with 93% of the administered dose recovered in the urine and 6% recovered in feces.
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Optimal blood drug levels are influenced by type of transplant, patient response, time post-transplant, co-administration of other drugs, and drug formulation.
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Older people (who are generally too frail to undergo bone marrow transplants), and people who are unable to find a good bone marrow match, undergoing immune suppression have five-year survival rates of up to 75%.
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Cyclosporine initially was approved for humans as a vegetable-oil based preparation (Sandimmune), but variability in oral bioavailability caused marked intraindividual and interindividual variations in blood drug concentrations.
While gleaning information from various patients who had been prescribed a rather extended dose of cyclosporine, the more common cyclosporine side effects were found to be trembling of hands, headache, oily skin, increases hair growth, kidney problems, fever, vomiting, high blood pressure, increased urination habit, high blood pressure, seizures, leg cramps, enlarged gums, changes in blood chemistry, gum bleeding and nausea.
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OR EMBRYO-FETAL DEVELOPMENT IN MONKEYS, RATS, MICE, AND RABBITS AT DOSES THAT PRODUCED PLASMA LEVELS 2 TO 17 TIMES THE SERUM LEVELS ACHIEVED IN HUMANS TREATED AT THE MAXIMUM RECOMMENDED HUMAN DOSES (see PRECAUTIONS, Pregnancy).
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