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Sandimmune® Soft Gelatin Capsules (cyclosporine capsules, USP) and Sandimmune® Oral Solution (cyclosporine oral solution, USP) have decreased bioavailability in comparison to Neoral® Soft Gelatin Capsules (cyclosporine capsules, USP) MODIFIED and Neoral® Oral Solution (cyclosporine oral solution, USP) MODIFIED.
Sandimmune® and Neoral® are not bioequivalent and cannot be used interchangeably without physician supervision.
The absorption of cyclosporine during chronic administration of Sandimmune® Soft Gelatin Capsules and Oral Solution was found to be erratic. It is recommended that patients taking the soft gelatin capsules or oral solution over a period of time be monitored at repeated intervals for cyclosporine blood levels and subsequent dose adjustments be made in order to avoid toxicity due to high levels and possible organ rejection due to low absorption of cyclosporine. This is of special importance in liver transplants. Numerous assays are being developed to measure blood levels of cyclosporine. Comparison of levels in published literature to patient levels using current assays must be done with detailed knowledge of the assay methods employed. (See Blood Level Monitoring under DOSAGE AND ADMINISTRATION.)
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SANDIMMUNE SUMMARY
Sandimmune
Cyclosporine, the active principle in Sandimmune® (cyclosporine) is a cyclic polypeptide immunosuppressant agent consisting of 11 amino acids. It is produced as a metabolite by the fungus species
Beauveria nivea.
Sandimmune® (cyclosporine) is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. It is always to be used with adrenal corticosteroids. The drug may also be used in the treatment of chronic rejection in patients previously treated with other immunosuppressive agents.
Because of the risk of anaphylaxis, Sandimmune® Injection (cyclosporine injection, USP) should be reserved for patients who are unable to take the soft gelatin capsules or oral solution.
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NEWS HIGHLIGHTSMedia Articles Related to Sandimmune (Cyclosporine)
NeuroVive: NeuroVive Doses Last Patient In Clinical Trial Of Cremophor(R)- Free Cyclosporine I.v. NeuroSTAT(R)
Source: Clinical Trials / Drug Trials News From Medical News Today [2009.11.05]
NeuroVive Pharmaceutical AB, of Lund, Sweden, announced that on November 3, 2009 it completed the clinical phase of its study investigating tolerability and pharmacokinetics of the cremophor®-free cyclosporine i.v. formula NeuroSTAT®. CEO Eskil Elmér comments that "This study in 52 healthy subjects is a direct comparison of NeuroVive's injectable cyclosporine product NeuroSTAT® with Novartis's product Sandimmune® Injection.
Published Studies Related to Sandimmune (Cyclosporine)
Impact of daclizumab, low-dose cyclosporine, mycophenolate mofetil and steroids on renal function after kidney transplantation. [2009.09.22]
BACKGROUND: Early and long-term use of cyclosporine A (CsA) leads to increased risks of renal toxicity. We hypothesized that administration of daclizumab in combination with mycophenolate mofetil (MMF) allows a relevant reduction in the dose of CsA... CONCLUSION: We demonstrate here that high-dose daclizumab in combination with lower CsA levels in adult renal transplant recipients is as or more effective than standard regimen (CsA, MMF, steroids) and may result in better outcomes at 12 months post-transplant with no increase in adverse reactions.
Contrast enhanced sonography shows superior microvascular renal allograft perfusion in patients switched from cyclosporine A to everolimus. [2009.07.27]
BACKGROUND: Real-time contrast enhanced sonography (CES) provides quantitative information on microvascular tissue perfusion in renal allografts. In contrast to calcineurin inhibitors, mammalian target of rapamycin inhibitors may have beneficial effects on renal microvascular tissue perfusion. There is no information on the microperfusion of renal allografts in patients receiving either mammalian target of rapamycin inhibitor or calcineurin inhibitor... CONCLUSION: The study demonstrates that renal microperfusion visualized by CES based on microbubble contrast agent and concomitantly kidney function, improved significantly after the switch from CsA to EVR.
Everolimus with reduced cyclosporine versus MMF with standard cyclosporine in de novo heart transplant recipients. [2009.07.15]
BACKGROUND: Pharmacokinetic modeling supports trough monitoring of everolimus, but prospective data comparing this approach versus mycophenolate mofetil (MMF) in de novo cardiac transplant recipients are currently unavailable... CONCLUSION: Concentration-controlled everolimus with reduced CsA results in similar renal function and equivalent efficacy compared with MMF with standard CsA at 12 months after cardiac transplantation.
Inhaled Cyclosporine and Pulmonary Function in Lung Transplant Recipients. [2009.07.06]
Abstract Background: Chronic rejection, manifesting as bronchiolitis obliterans, is the leading cause of death in lung transplant recipients.
Similar lipid profile but improved long-term outcomes with sirolimus after cyclosporine withdrawal compared to sirolimus with continuous cyclosporine. [2009.07]
Renal transplant recipients show an increased risk of cardiovascular disease compared with a nontransplant population. Herein we have shown an analysis of a randomized controlled trial wherein 525 patients receiving a first or second (9.7%) renal allograft from a deceased (89.1%), a living-related (7.8%), or a living-unrelated donor (3.1%) received sirolimus (SRL), cyclosporine (CsA), and steroids (ST) at the time of transplantation with randomization at 3 months after transplantation of 430 eligible patients to continue on SRL-CsA-ST or to have CsA withdrawn with increased SRL trough targets (SRL-ST group)...
Clinical Trials Related to Sandimmune (Cyclosporine)
Metabolic Pattern of Cyclosporine A and Acute Renal Failure [Completed]
Following heart transplantation many patients develop acute renal failure in the early
posttransplant phase and some are in need of renal replacement therapy for shorter or longer
time. The cause of this acute renal failure is most probably multi factorial but many reports
indicate that cyclosporine has a central role in the pathophysiology and it is generally
recommended to lower the cyclosporine load to patients developing acute renal failure in this
population.
Several in vitro studies on renal cells in culture indicate that the primary metabolites of
cyclosporine (AM1, AM9, AM4N) are less toxic to the kidney than cyclosporine itself. However,
the secondary metabolite AM19 as well as the cyclic metabolites AM1c and AM1c9 has been
associated with decreased renal function and nephrotoxicity renal transplant recipients.
The primary objective of this pilot study is to investigate if the concentrations of
secondary- and cyclic metabolites of cyclosporine (AM19, AM1c, AM1c9) is related to
development of acute renal failure in the early posttransplant phase following heart
transplantation.
Secondary objectives are to investigate associations between genotypes of P-glycoprotein and
CYP3A5 and the metabolic pattern of cyclosporine.
Will Restasis Eye Drops Increase Your Chance of Having a Successful Surgery? [Completed]
The purpose of this study is to determine whether reducing inflammation of the surface of the
eye with topical Restasis after glaucoma surgery will improve surgical outcomes and increase
patient comfort.
Maintenance Neoral Monotherapy Compared to Bitherapy in Renal Transplantation [Completed]
We have previously defined factors that predict the long term success of maintenance CsA
monotherapy (CsAm) after kidney transplantation : donor age < 40 years, serum creatinine
level at the initiation of CsAm £ 125 µmol/L, no rejection episode before CsAm initiation. We
have also shown that the 8-year graft survival in 329 selected patients enrolled in
maintenance CsA-m was 84 % (Hurault de Ligny et al, Transplantation, 2000 ; 69 : 1327-1332).
These results were obtained with an old formulation of cyclosporin, azathioprine, steroid
withdrawal over the first year and induction antibody. This prospective randomized
multicentre study was designed to clarify whether maintenance Neoral + MMF or Neoral + AZA is
better than a CsAm and wether Neoral + MMF is better than Neoral + AZA in low immunological
risk cadaveric kidney transplant recipients.
Nordic Study in Cardiac and Lung Transplantation: Outcome in Relation to Cyclosporine Microemulsion C2 Levels [Active, not recruiting]
The main purpose of this study is to identify cyclosporine C2 levels during 12 months
treatment , while cyclosporine microemulsion dosages are adjusted based on C0 cyclosporine
blood samples, and retrospectively correlate C2 levels to outcome (renal function and
incidence of acute rejections)
The Pharmacokinetics of Sirolimus When Combined With Cyclosporine or Tacrolimus in Renal Transplant Patients [Active, not recruiting]
The purpose of this study is to understand the pharmacokinetic of sirolimus in different
regimens, as well as the dose-level relationship of cyclosporine and tacrolimus, and design
the most appropriate cyclosporine/sirolimus/steroid or tacrolimus/sirolimus/steroid dose
regimen for Taiwanese.
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