In 2009, the International Society for Heart and Lung Transplantation recognized the
importance and challenges surrounding generic drug immunosuppression. As experience
with generics has expanded and comfort has increased, substantial issues have arisen
since that time with other aspects of immunomodulation that have not been addressed,
such as access to medicines, alternative immunosuppression formulations, additional
generics, implications on therapeutic drug monitoring, and implications for special
populations such as pediatrics and older adults. The aim of this consensus document
is to address critically each of these concerns, expand on the challenges and barriers,
and provide therapeutic considerations for practitioners who manage patients who need
to undergo or have undergone cardiothoracic transplantation.
KEYWORDS
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References
- Generic drug immunosuppression in thoracic transplantation: an ISHLT educational advisory.J Heart Lung Transplant. 2009; 28: 655-660
- Clinical trials for immunosuppression in transplantation: the case for reform and change in direction.Transplantation. 2017; 101: 1527-1534
- Developing new immunosuppression for the next generation of transplant recipients: the path forward.Am J Transplant. 2016; 16: 1094-1101
- Lemtrada [package insert].Genzyme Corporation, Cambridge, MA2017
- Neoral [package insert].Novartis Pharmaceuticals Corporation, East Hanover, NJ2015
- Sandimmune [package insert].Novartis Pharmaceuticals Corporation, East Hanover, NJ2015
- Prograf [package insert].Astellas Pharma US, Inc, Deerfield, IL2012
- Myfortic [package insert].Novartis Pharmaceuticals Corporation, East Hanover, NJ2016
- CellCept [package insert].Genentech, Inc, South San Francisco, CA2015
- Rapamune [package insert].Pfizer Inc, Philadelphia, PA2018
- Zortress [Package insert].Novartis Pharmaceuticals Corporation, East Hanover, NJ2018
- Induction therapy in heart transplantation: where are we now?.Transpl Int. 2013; 26: 684-695
- Simulect [package insert].Novartis Pharmaceuticals Corporation, East Hanover, NJ2005
- Thymoglobulin [package insert].Genzyme Corporation, Cambridge, MA2017
- Campath [package insert].Genzyme Corporation, Cambridge, MA2014
- Report from a consensus conference on antibody-mediated rejection in heart transplantation.J Heart Lung Transplant. 2011; 30: 252-269
- Desensitization strategies in adult heart transplantation-will persistence pay off?.J Heart Lung Transplant. 2016; 35: 962-972
- Antibody-mediated rejection of the lung: a consensus report of the International Society for Heart and Lung Transplantation.J Heart Lung Transplant. 2016; 35: 397-406
- Gengraf (cyclosporine) [package insert].AbbVie Inc, North Chicago, IL2017
- Recommendations for the use of medications with continuous enteral nutrition.Am J Health Syst Pharm. 2009; 66: 1458-1467
- [package insert].Veloxis Pharmaceuticals, Inc, Edison, NJ2016
- Long-term stability of a patient-convenient 1 mg/ml suspension of tacrolimus for accurate maintenance of stable therapeutic levels.Bone Marrow Transplant. 2006; 37: 781-784
- Pharmacokinetics in stable heart transplant recipients after conversion from twice-daily to once-daily tacrolimus formulations.J Heart Lung Transplant. 2011; 30: 1003-1010
- Comparison of tacrolimus absorption in transplant patients receiving continuous versus interrupted enteral nutrition feeding.Ann Pharmacother. 1998; 32: 633-636
- Sublingual administration of tacrolimus: current trends and available evidence.Pharmacotherapy. 2014; 34: 1209-1219
- Bioavailability of mycophenolate mofetil and enteric-Coatedcoated mycophenolate sodium is differentially affected by pantoprazole in healthy volunteers.J Clin Pharmacol. 2009; 49: 1196-1201
- No relevant pharmacokinetic interaction between pantoprazole and mycophenolate in renal transplant patients: a randomized crossover study.Br J Clin Pharmacol. 2015; 80: 1086-1096
- Imuran [package insert].Prometheus Laboratories Inc, Hunt Valley, MD2011
- Stability of allopurinol and of five antineoplastics in suspension.Am J Hosp Pharm. 1983; 40: 616-618
- The registry of the International Society for Heart and Lung Transplantation: thirty-fourth adult lung and heart-lung transplantation report-2017; focus theme: allograft ischemic time.J Heart Lung Transplant. 2017; 36: 1047-1059
- Four-hour versus 24-hour intravenous infusion of FK 506 in liver transplantation.Transplant Proc. 1991; 23: 2767-2770
- Stability and sorption of FK 506 in 5% dextrose injection and 0.9% sodium chloride injection in glass, polyvinyl chloride, and polyolefin containers.Am J Hosp Pharm. 1992; 49: 119-122
- Stability of tacrolimus in an extemporaneously compounded oral liquid.Am J Health Syst Pharm. 1997; 54: 178-180
- Sublingual tacrolimus as an alternative to oral administration for solid organ transplant recipients.Am J Health Syst Pharm. 2015; 72: 277-284
Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health>NIOSH Alert: preventing occupational exposure to antineoplastic and other hazardous drugs in health care settings. Available at: https://www.cdc.gov/niosh/docs/2004-165/pdfs/2004-165.pdf?id=10.26616/NIOSHPUB2004165.
- [package insert].Astellas Pharma US, Inc, Northbrook, IL2015
- Pharmacokinetic study of conversion from tacrolimus twice-daily to tacrolimus once-daily in stable lung transplantation.Transplantation. 2014; 97: 358-362
- Cyclosporin clinical pharmacokinetics.Clin Pharmacokinet. 1993; 24: 472-495
- A new microemulsion formulation of cyclosporin: pharmacokinetic and clinical features.Clin Pharmacokinet. 1996; 30: 181-193
- Effect of assay methodology on pharmacokinetic differences between cyclosporine Neoral and Sandimmune formulations.Clin Chem. 1997; 43: 104-108
- Sandimmun and Neoral treatment: pharmacokinetics and kidney function in paediatric and adolescent renal transplant.Transplant Proc. 1998; 30: 1677
- Comparison of Sandimmune and Neoral pharmacokinetics (PK) in a stable pediatric renal transplant population.Pediatr Transplant. 1998; 2: 12-30
- Pharmacokinetics of cyclosporine in pediatric long-term liver transplant recipients converted from Sandimmune to Neoral.Transpl Int. 1997; 10: 419-425
- Successful reconversion from tacrolimus to cyclosporine A Neoral in pediatric liver recipients.Transplant Proc. 1996; 28: 2276-2278
- Study of the circadian variation of cyclosporine pharmacokinetics.Transplant Proc. 1997; 29: 2930-2931
- Cyclosporine pharmacokinetics in renal allograft recipients with diabetes mellitus with Sandimmune and Sandimmune Neoral.Transplant Proc. 1996; 28: 3140-3141
- Comparison of the pharmacokinetics of cyclosporine Sandimmune with Sandimmune Neoral in stable renal transplant patients.Transplant Proc. 1994; 26: 2961-2963
- Comparative pharmacokinetic study of Neoral vs Sandimmun in Japanese stable renal allograft recipients.Transplant Proc. 1999; 31: 3089-3092
- Randomized, trough blood cyclosporine concentration-controlled trial to compare the pharmacodynamics of Sandimmune and Neoral in de novo lung transplant recipients.Ther Drug Monit. 1999; 21: 17-26
- Safety, tolerability, and pharmacokinetics of Sandimmun Neoral: conversion study in stable renal transplant recipients.Transplant Proc. 1996; 28: 1330-1332
- Cyclosporine pharmacokinetic profiles in stable renal allograft recipients converting from Sandimmune to Neoral.Transplant Proc. 1996; 28: 1324-1326
- Pharmacokinetic of Sandimmune versus Sandimmune Neoral in heart transplant recipients.Clin Invest Med. 1996; 19: S107
- Pharmacokinetic, hemodynamic, and metabolic effects of cyclosporine Sandimmune versus the microemulsion neoral in heart transplant recipients.J Heart Lung Transplant. 1997; 16: 787-794
- Comparison of pharmacokinetics between CsA capsules and Sandimmun Neoral in pediatric patients.Transplant Proc. 1994; 26: 2973-2974
- Bioavailability of Sandimmun® versus Sandimmune Neoral®: a meta-analysis of published studies.Int J Immunopathol Pharmacol. 2010; 23: 1177-1183
U.S. Department of Health and Human Services, Food and Drug Administration, Centers for Drug Evaluation and Research (CDER)>Guidance for industry bioavailability and bioequivalence studies for orally administered drug products — general considerations. Available at: https://www.fda.gov/files/drugs/published/Guidance-for-Industry-Bioavailability-and-Bioequivalence-Studies-for-Orally-Administered-Drug-Products—General-Considerations.PDF.
- The new European Medicines Agency guideline on the investigation of bioequivalence.Basic Clin Pharmacol Toxicol. 2010; 106: 221-225
- The registry of the International Society for Heart and Lung Transplantation: thirty-fourth adult heart transplantation report-2017; focus theme: allograft ischemic time.J Heart Lung Transplant. 2017; 36: 1037-1046
- Enteric-coated mycophenolate sodium delivers bioequivalent MPA exposure compared with mycophenolate mofetil.Clin Transpl. 2005; 19: 199-206
- A prospective analysis of the effects of enteric-coated mycophenolate sodium and mycophenolate mofetil co-medicated with a proton pump inhibitor in kidney transplant recipients at a single institute in China.Transplant Proc. 2014; 46: 1362-1365
- Diminished mycophenolic acid exposure caused by omeprazole may be clinically relevant in the first week post transplantation.Ther Drug Monit. 2012; 34: 331-336
- The role of proton pump inhibitors on early mycophenolic acid exposure in kidney transplantation: evidence from the CLEAR study.Ther Drug Monit. 2011; 33: 120-123
- Proton pump inhibitor co-medication reduces active drug exposure in heart transplant recipients receiving mycophenolate mofetil.Transplant Proc. 2010; 42: 4243-4246
- Proton pump inhibitors interfere with the immunosuppressive potency of mycophenolate mofetil.Rheumatology (Oxford). 2010; 49: 2061-2067
- Proton pump inhibitors reduce mycophenolate exposure in heart transplant recipients-a prospective case-controlled study.Am J Transplant. 2009; 9: 1650-1656
- Proton pump inhibitor co-medication reduces mycophenolate acid drug exposure in heart transplant recipients.J Heart Lung Transplant. 2009; 28: 605-611
- Omeprazole impairs the absorption of mycophenolate mofetil but not of enteric-coated mycophenolate sodium in healthy volunteers.J Clin Pharmacol. 2012; 52: 1265-1272
- The proton pump inhibitor pantoprazole and its interaction with enteric-coated mycophenolate sodium in transplant recipients.J Heart Lung Transplant. 2011; 30: 565-571
- Proton pump inhibitors do not increase the risk of acute rejection.Neth J Med. 2014; 72: 86-90
- Concomitant proton pump inhibitors with mycophenolate mofetil and the risk of rejection in kidney transplant recipients.Transplantation. 2014; 97: 518-524
- Renal transplant acute rejection with lower mycophenolate mofetil dosing and proton pump inhibitors or Histamine-2 receptor antagonists.Pharmacotherapy. 2017; 37: 1507-1515
- Pediapred [package insert].Sanofi-Aventis Canada Inc, Laval, Quebec2017
- Stability of acetazolamide, allopurinol, azathioprine, clonazepam, and flucytosine in extemporaneously compounded oral liquids.Am J Health Syst Pharm. 1996; 53: 1944-1949
- The absorption site of cyclosporin in the human gastrointestinal tract.Br J Clin Pharmacol. 1992; 33: 39-43
- P-glycoprotein and drug therapy in organ transplantation.J Clin Pharmacol. 1999; 39: 995-1005
- Analysis, pharmacokinetics and therapeutic drug monitoring of mycophenolic acid.Clin Biochem. 1998; 31: 323-328
- Pharmacokinetics of intravenous and oral prednisolone.Br J Clin Pharmacol. 1980; 10: 503-508
- Assessment of tacrolimus absorption from the human intestinal tract: open-label, randomized, 4-way crossover study.Clin Ther. 2014; 36: 748-759
- Sequential group trial to determine gastrointestinal site of absorption and systemic exposure of azathioprine.Dig Dis Sci. 2000; 45: 1601-1607
Regulatory Focus>Brennan Z. Patents vs. Market Exclusivity: why does it take so long to being generics to the market? Available at:https://www.raps.org/regulatory-focus%E2%84%A2/news-articles/2016/8/patents-vs-market-exclusivity-why-does-it-take-so-long-to-bring-generics-to-market
- Narrow therapeutic index drugs: an approach to bioequivalence and interchangeability.in: Paper presented at: Meeting of the FDA Advisory Committee for Pharmaceutical Science and Clinical Pharmacology, Silver Spring, MDJuly 26, 2011
- Neoplanta as a new microemulsion formula of cyclosporine in renal transplantation: comparative study with neoral for efficacy and safety.Transplant Proc. 1998; 30: 3547-3548
- A one-year comparative study of Neoral vs Consupren in de novo renal transplant patients.Transplant Proc. 1998; 30: 3533-3534
- Conversion of stable renal allograft recipients to a bioequivalent cyclosporine formulation.Transplantation. 2002; 74: 1013-1017
- Neoral-to-Gengraf conversion in renal transplant recipients.Transplant Proc. 2003; 35: 1308-1313
- Does bioequivalence between modified cyclosporine formulations translate into equal outcomes?.Transplantation. 2005; 80: 1633-1635
- The clinical impact of 1:1 conversion from Neoral to a generic cyclosporine (Gengraf) in renal transplant recipients with stable graft function.Clin Transpl. 2006; 20: 313-317
- Comparison of generic cyclosporine microemulsion versus Neoral in de novo renal transplant recipients managed by 2-hour postdose monitoring.Transplant Proc. 2006; 38: 2051-2053
- Pharmacokinetics, efficacy, and safety of Iminoral compared with Neoral in healthy volunteers and renal transplant recipients.Transplant Proc. 2007; 39: 1214-1218
- Do we have the same clinical results with Neoral and Equoral treatment in kidney transplant recipients? A pilot study.Transpl Int. 2008; 21: 392-394
- Interchangeability of ciclosporin formulations in stable adult renal transplant recipients: comparison of Equoral and Neoral capsules in an international, multicenter, randomized, open-label trial.Kidney Int Suppl. 2010; (S12-6)
- Safety and efficacy of generic cyclosporine arpimune in Filipino low-risk primary kidney transplant recipients.Transplant Proc. 2012; 44: 101-108
- One-year multicenter double-blind randomized clinical trial on the efficacy and safety of generic cyclosporine (Iminoral) in de novo kidney transplant recipients.Exp Clin Transplant. 2015; 13: 233-238
- The impact of conversion from Prograf to generic tacrolimus in liver and kidney transplant recipients with stable graft function.Am J Transplant. 2011; 11: 1861-1867
- A multicenter experience with generic tacrolimus conversion.Transplantation. 2011; 92: 653-657
- Therapeutic equivalence and pharmacokinetics of generic tacrolimus formulation in de novo kidney transplant patients.Nephrol Dial Transplant. 2013; 28: 3110-3119
- Clinical outcomes associated with conversion from brand-name to generic tacrolimus in hospitalized kidney transplant recipients.Am J Health Syst Pharm. 2013; 70: 1507-1512
- Clinical outcomes after conversion from brand-name tacrolimus (Prograf) to a generic formulation in renal transplant recipients: a retrospective cohort study.P T. 2013; 38: 484-488
- A retrospective assessment of safety, efficacy, and pharmacoenconomics of generic azathioprine in heart-transplant recipients.J Heart Lung Transplant. 2001; 20: 372-374
- Immunosuppressive regimens containing generic mycophenolate mofetil (Myfenax) in de novo renal transplant recipients–preliminary results of 6-month observation.Ann Transplant. 2011; 16: 74-80
- Pilot study on the efficacy and safety of generic mycophenolate mofetil (Mycept) compared with CellCept among incident low-risk primary kidney transplant recipients.Transplant Proc. 2014; 46: 415-417
- Evaluation of clinical and safety outcomes associated with conversion from brand-name to generic tacrolimus in transplant recipients enrolled in an integrated health care system.Pharmacotherapy. 2012; 32: 981-987
- Safety and efficacy of the switch to generic mycophenolate mofetil and tacrolimus in heart transplant patients.Clin Transpl. 2015; 29: 619-628
- Short-term outcomes in heart transplant recipients treated with generic tacrolimus.Open J Organ Transplant Surg. 2013; 3: 19-21
- Multi-center evaluation of analytical performance of the microparticle enzyme immunoassay for sirolimus.Clin Biochem. 2006; 39: 378-386
- CEDIA sirolimus assay compared with HPLC-MS/MS and HPLC-UV in transplant recipient specimens.Ther Drug Monit. 2005; 27: 309-314
- Positive bias in mycophenolic acid concentrations determined by the CEDIA assay compared to HPLC-UV method: is CEDIA assay suitable for therapeutic drug monitoring of mycophenolic acid?.J Clin Lab Anal. 2013; 27: 77-80
- Validation of an assay for routine monitoring of sirolimus using HPLC with mass spectrometric detection.Clin Chem. 2000; 46: 1179-1183
- al. Cyclosporin whole blood immunoassays (AxSYM, CEDIA, and EMIT): a critical overview of performance characteristics and comparison with HPLC.Clin Chem. 1998; 44: 2158-2164
- Comparison of the CEDIA and MEIA assays for the measurement of sirolimus in organ transplant recipients.Clin Biochem. 2007; 40: 680-687
- al. Multi-site analytical evaluation of the Abbott ARCHITECT tacrolimus assay.Ther Drug Monit. 2009; 31: 198-204
- Multi-site analytical evaluation of a chemiluminescent magnetic microparticle immunoassay (CMIA) for sirolimus on the Abbott ARCHITECT analyzer.Clin Biochem. 2009; 42: 1543-1548
- Crossreactivity of isolated everolimus metabolites with the Innofluor Certican immunoassay for therapeutic drug monitoring of everolimus.Ther Drug Monit. 2007; 29: 743-749
- Limitations of immunoassays used for therapeutic drug monitoring of immunosuppressants.in: Oellerich M Dasgupta A Personalized immunosuppression in transplantation. Elselvier, The Netherlands2015: 29-51
- Experiences from using LC-MS/MS for analysis of immunosuppressive drugs in a TDM service.Clin Biochem. 2016; 49: 1024-1031
- Long-term evaluation of analytical methods used in sirolimus therapeutic drug monitoring.Clin Transpl. 2014; 28: 243-251
- Comparison between ultra-performance liquid chromatography with tandem mass spectrometry and a chemiluminescence immunoassay in the determination of cyclosporin A and tacrolimus levels in whole blood.Exp Ther Med. 2013; 6: 1535-1539
- High-performance liquid chromatography versus immunoassay for the measurement of sirolimus: comparison of two methods.Transplant Proc. 2006; 38: 78-80
- Comparison of everolimus QMS immunoassay on Architect ci4100 and liquid chromatography/mass spectrometry: lack of agreement in organ-transplanted patients.Ther Drug Monit. 2015; 37: 214-219
- Comparison of high-performance liquid chromatography and enzyme-multiplied immunoassay technique to monitor mycophenolic acid in paediatric renal recipients.Pediatr Nephrol. 2008; 23: 1859-1865
- Therapeutic monitoring of mycophenolate mofetil.Clin J Am Soc Nephrol. 2007; 2: 184-191
- Pharmacokinetics of mycophenolic acid and its phenolic-glucuronide and acyl glucuronide metabolites in stable thoracic transplant recipients.Ther Drug Monit. 2008; 30: 282-291
- Cyclosporine C2 levels have impact on incidence of rejection in de novo lung but not heart transplant recipients: the NOCTURNE study.J Heart Lung Transplant. 2009; 28: 919-926
- A randomized, controlled trial of C0- vs C2-guided therapeutic drug monitoring of cyclosporine in stable heart transplant patients.J Heart Lung Transplant. 2005; 24: 2137-2143
- The International Society of Heart and Lung Transplantation Guidelines for the care of heart transplant recipients.J Heart Lung Transplant. 2010; 29: 914-956
- C2 (2-h) levels are not superior to trough levels as estimates of the area under the curve in tacrolimus-treated renal-transplant patients.Nephrol Dial Transplant. 2002; 17: 1487-1490
- Clinical pharmacokinetics of tacrolimus in heart transplantation: new strategies of monitoring.Transplant Proc. 2003; 35: 1988-1991
- Tacrolimus pharmacokinetics in lung transplantation: new strategies for monitoring.J Heart Lung Transplant. 2005; 24: 1315-1319
- Pharmacokinetic study of tacrolimus in cystic fibrosis and non-cystic fibrosis lung transplant patients and design of Bayesian estimators using limited sampling strategies.Clin Pharmacokinet. 2005; 44: 1317-1328
- Does the evidence support the use of mycophenolate mofetil therapeutic drug monitoring in clinical practice? A systematic review.Transplantation. 2008; 85: 1675-1685
- Pharmacokinetic monitoring of mycophenolic acid in heart transplant patients: correlation the side-effects and rejections with pharmacokinetic parameters.Ann Transplant. 2012; 17: 68-78
- The impact of routine mycophenolate mofetil drug monitoring on the treatment of cardiac allograft rejection.Transplantation. 2000; 69: 2326-2330
- Best single time points to predict the area-under-the-curve in long-term heart transplant patients taking mycophenolate mofetil in combination with cyclosporine or tacrolimus.J Heart Lung Transplant. 2005; 24: 1614-1618
- Everolimus versus mycophenolate mofetil in heart transplantation: a randomized, multicenter trial.Am J Transplant. 2013; 13: 1203-1216
- Tacrolimus with mycophenolate mofetil or sirolimus compared with calcineurin inhibitor-free immunosuppression (sirolimus/mycophenolate mofetil) after heart transplantation: 5 year results.J Heart Lung Transplant. 2013; 32: 277-284
- Everolimus initiation with early calcineurin inhibitor withdrawal in de novo heart transplant recipients: three-year results from the randomized SCHEDULE study.Am J Transplant. 2016; 16: 1238-1247
- Everolimus versus mycophenolate mofetil de novo after lung transplantation: a prospective, randomized, open-label trial.Am J Transplant. 2016; 16: 3171-3180
- Use of sirolimus and low-dose calcineurin inhibitor in lung transplant recipients with renal impairment: results of a controlled pilot study.Kidney Int. 2005; 67: 1471-1475
- Pharmacokinetic optimization of immunosuppressive therapy in thoracic transplantation: part I.Clin Pharmacokinet. 2009; 48: 419-462
- Impact of rabbit antithymocyte globulin dose on long-term outcomes in heart transplant patients.Transplantation. 2016; 100: 685-693
- Immunosuppression in lung transplantation.J Thorac Dis. 2014; 6: 1039-1053
- Thymoglobulin induction in heart transplantation: patient selection and implications for maintenance immunosuppression.Transpl Int. 2015; 28: 259-269
- A proposal for early dosing regimens in heart transplant patients receiving thymoglobulin and calcineurin inhibition.Transplant Direct. 2016; 2: e81
- CD3 monitoring of antithymocyte globulin therapy in thoracic organ transplantation.Transplantation. 2002; 73: 1339-1341
- Induction therapy with thymoglobulin after heart transplantation: impact of therapy duration on lymphocyte depletion and recovery, rejection, and cytomegalovirus infection rates.J Heart Lung Transplant. 2008; 27: 1115-1121
- Medication nonadherence after lung transplantation in adult recipients.Ann Thorac Surg. 2017; 103: 274-280
- A review of the management of pregnancy after cardiac transplantation.Clin Transpl. 2015; 31: 151-161
- Pregnancy after heart and lung transplantation.Best Pract Res Clin Obstet Gynaecol. 2014; 28: 1146-1162
- Immunosuppressive drugs and fetal outcome.Best Pract Res Clin Obstet Gynaecol. 2014; 28: 1174-1187
- Immunosuppressant therapy in pregnant organ transplant recipients.Semin Perinatol. 2007; 31: 363-371
- Breast-feeding after transplantation.Best Pract Res Clin Obstet Gynaecol. 2014; 28: 1163-1173
- Prednisone [package insert].Roxane Laboratories, Inc, Columbus, OH2012
- Solu-Medrol [package insert].Pfizer, New York, NY2011
- Schaefer C Drugs during pregnancy and lactation treatment options and risk assessment. Academic Press, Elsevier, London2015
- BSR and BHPR guideline on prescribing drugs in pregnancy and breastfeeding-part I: standard and biologic disease modifying anti-rheumatic drugs and corticosteroids.Rheumatology (oxford). 2016; 55: 1693-1697
Health Products Regulatory Authority>CellCept (mycophenolate mofetil)—Important Safety Information from Roche Products (Ireland) Ltd. Available at:https://www.hpra.ie/homepage/medicines/safety-notices/item?t=/cellcept-(mycophenolate-mofetil)—important-safety-information-from-roche-products-(ireland)-ltd&id=f9fe0326-9782-6eee-9b55-ff00008c97d0.
- The 2016 International Society for Heart Lung Transplantation listing criteria for heart transplantation: a 10-year update.J Heart Lung Transplant. 2016; 35: 1-23
- A consensus document for the selection of lung transplant candidates: 2014–an update from the Pulmonary Transplantation Council of the International Society for Heart and Lung Transplantation.J Heart Lung Transplant. 2015; 34: 1-15
- Cardiac transplantation for older patients: characteristics and outcomes in the septuagenarian population.J Heart Lung Transplant. 2016; 35: 362-369
- Lung transplantation in elderly patients.J Thorac Dis. 2017; 9: 3346-3351
- A rationale for age-adapted immunosuppression in organ transplantation.Transplantation. 2015; 99: 2258-2268
- Age-related pharmacokinetic and pharmacodynamic changes and related risk of adverse drug reactions.Curr Med Chem. 2010; 17: 571-584
- Heart transplantation in the elderly: why cardiac transplantation does not need to be limited to younger patients but can be safely performed in patients above 65 years of age.Ann Transplant. 2010; 15: 110-119
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Published online: July 09, 2020
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