Risk Evaluation and Mitigation Strategies: A Focus on the Mycophenolic Acid Preparations

Rostas, Sara E.; Kim, Min Ji; Gabardi, Steven

doi:10.7182/pit2014521

Cited by 5 publications

(4 citation statements)

References 4 publications

(4 reference statements)

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The prodrugs that liberate mycophenolic acid in vivo such as mycophenolate mofetil and mycophenolate sodium appear to be well tolerated in patients undergoing transplantation. However, numerous adverse events have been reported in transplantation patients (Rostas et al, 2014). Some of the adverse effects were related to: (a) precipitation of infections; (b) gastrointestinal distress; (c) anemia; and (d) leucopoenia.…”

Section: Introductionmentioning

confidence: 99%

“…Some of the adverse effects were related to: (a) precipitation of infections; (b) gastrointestinal distress; (c) anemia; and (d) leucopoenia. Based on the severity and frequency of such adverse events, an appropriate dose reduction strategy for mycophenolic acid may be warranted (Rostas et al, 2014). The biggest challenge of dose reduction in patients that are appropriately titrated in a drug regimen of mycophenolic acid and other agents is manifested by acute rejection of the organ transplant (Vanhove et al, 2013).…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

A comprehensive review of the published assays for the quantitation of the immunosuppressant drug mycophenolic acid and its glucuronidated metabolites in biological fluids

Syed

Srinivas²

2016

Biomedical Chromatography

View full text Add to dashboard Cite

Therapeutic use of mycophenolic acid (MPA) is steadily on the rise in combination with other immunosuppressant drugs in transplantation patients. The biotransformation of MPA resulted in the formation of glucuronide metabolites, MPAG and AcMPAG. There are a plethora of assays validated for the analysis of MPA alone or with MPAG/AcMPAG in various biological specimens including plasma/serum, urine, ultrafiltrate, saliva, PBMC, dried blood spots, tissue extract, tumor biopsies and vitreous humor. Based on the need for experimental work, a proper choice of the assay and internal standard may be made using the choices in the literature. While the chemical methods involving high-performance liquid chromatography (HPLC) or LC coupled with triple quadrupole mass spectrometry (LC-MS/MS) are popular, enzymatic assays, in spite of their higher bias, have been used for the routine drug monitoring of MPA. The objectives of the present review are: (a) to provide a focused systematic compilation of the HPLC or LC-MS/MS methods for MPA, MPAG and/or AcMPAG published in the last decade (2005 to current) to enable visual comparison of the methods; (b) to compare and contrast a few enzymatic assays with those of the chemical methods; and (c) to discuss relevant issues/limitations and perspectives on select assays under various subheadings.

show abstract

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

A comprehensive review of the published assays for the quantitation of the immunosuppressant drug mycophenolic acid and its glucuronidated metabolites in biological fluids

Syed

Srinivas²

2016

Biomedical Chromatography

View full text Add to dashboard Cite

show abstract

“…The Food and Drug Administration (FDA) approves new prescription drugs if the benefits appear to outweigh the risks. However, some new drugs have severe risks for certain populations, such as pregnant women [ 1 , 2 ], while other new drugs have risks that can be reduced with better surveillance, such as regular lab tests [ 3 , 4 ]. To ensure that these drugs can still be FDA-approved and made available for the patients who might benefit from them, Congress gave FDA the authority to require manufacturers to set up risk evaluation and mitigation strategy (REMS) programs [ 5 ].…”

Section: Introductionmentioning

confidence: 99%

Physician experiences with and perceptions of risk evaluation and mitigation strategy programs with elements to assure safe use

et al. 2023

View full text Add to dashboard Cite

Purpose The US Food and Drug Administration (FDA) Amendments Act of 2007 authorized the FDA to require risk evaluation and mitigation strategy (REMS) programs for drugs with important safety concerns. REMS can have elements to assure safe use (ETASU), such as patient registries, dispensing restrictions, and physician training and certification requirements. We aimed to understand physician experiences with and perceptions of a selection of ETASU REMS. Methods Physicians prescribing 1 of 4 ETASU REMS-covered drugs: natalizumab, riociguat, sodium oxybate, and vigabatrin. Study design Descriptive phenomenological study based on semi-structured phone interviews. Data collection/Extraction methods Qualitative content analysis to summarize physician responses to open-ended questions. Results Of 31 physicians (14 female), 6 prescribed riociguat, 6 vigabatrin, 7 sodium oxybate, and 12 natalizumab (5 for Crohn’s disease, 7 for multiple sclerosis), most demonstrated good understanding of the rationale for and requirements of the ETASU REMS but believed that the programs had limited effect on clinical practice. Some physicians reported that the ETASU REMS made them more comfortable with prescribing covered drugs due to heightened oversight, facilitated discussions about treatment, and were likely more beneficial for non-specialists. Concerns were raised about the administrative effort needed to comply with the programs and the potential misuse of patient health information transmitted to manufacturers. Conclusions Physicians are generally aware of ETASU REMS and get reassurance from the additional oversight, but the programs can be better integrated into clinical workflows and can be designed to better protect patient health information.

show abstract

“…Urine pregnancy tests are done while on MMF and patients should be appropriately counseled on fetal toxicity and teratogenicity. With evidence of increased risk of miscarriage and birth defects associated with MMF use, the FDA instituted a REMS program that contains both a medication guide and elements to assure safe use [21]. …”

Section: Introductionmentioning

confidence: 99%

An Update on Treatment and Management of Pediatric Systemic Lupus Erythematosus

Thakral

Klein‐Gitelman

2016

Rheumatol Ther

View full text Add to dashboard Cite

Systemic lupus erythematosus (SLE) is a chronic multisystem autoimmune disorder in which 20 % of patients are diagnosed in childhood. Childhood-onset SLE is associated with higher morbidity and mortality than adult-onset SLE. The aims of disease management with early immunosuppression are to decrease disease activity and improve quality of life. A multidisciplinary approach is necessary due to the complexity of lupus in pediatric patients. It is important to provide patients with high quality of care and to instill ownership of their disease process from a young age to prepare them to manage this life-long illness. This article reviews current management of SLE in children.

show abstract

Risk Evaluation and Mitigation Strategies: A Focus on the Mycophenolic Acid Preparations

Cited by 5 publications

References 4 publications

A comprehensive review of the published assays for the quantitation of the immunosuppressant drug mycophenolic acid and its glucuronidated metabolites in biological fluids

A comprehensive review of the published assays for the quantitation of the immunosuppressant drug mycophenolic acid and its glucuronidated metabolites in biological fluids

Physician experiences with and perceptions of risk evaluation and mitigation strategy programs with elements to assure safe use

An Update on Treatment and Management of Pediatric Systemic Lupus Erythematosus

Contact Info

Product

Resources

About