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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 HIGHLIGHTS
Published Studies Related to Sandimmune (Cyclosporine)
Effect of cyclosporine-A on orthodontic tooth movement in rats. [2011.11]
CONCLUSIONS: We suggest that CsA enhanced the rate of orthodontic tooth movement. The osteopenia and the increased osteoclastic activity could be the underlying factors. (c) 2011 John Wiley & Sons A/S.
Safety and toxicology of cyclosporine in propylene glycol after 9-month aerosol exposure to beagle dogs. [2011.08]
BACKGROUND: Cyclosporine inhalation solution (CIS) delivered via nebulization is under evaluation for the prevention of chronic rejection post-lung transplant. A 300-patient randomized, controlled clinical trial (CYCLIST) is expected to be completed late in 2011. In support of this trial, a chronic inhalation toxicology study in dogs has been completed... CONCLUSION: The study supports the pulmonary and systemic safety of aerosolized CIS at expected lung dose levels/kg of up to 12 times greater than the average dose patients are receiving in the CYCLIST trial.
Prospective, randomized study of the efficacy of systemic cyclosporine in high-risk corneal transplantation. [2011.07]
PURPOSE: Immunologic rejection remains a major cause of graft failure in high-risk corneal transplantation. This study was conducted to elucidate the efficacy and safety of systemic cyclosporine (CsA) in high-risk corneal transplantation. DESIGN: Prospective, randomized, open-labeled clinical trial with a parallel-group study... CONCLUSIONS: No positive effect of systemic CsA administration for suppressing rejection in high-risk corneal transplantation was observed. With a relatively high incidence of systemic side effects, the results suggest that this protocol should not be recommended for corneal transplant recipients, especially those of advanced age. Copyright (c) 2011 Elsevier Inc. All rights reserved.
Belatacept-based regimens are associated with improved cardiovascular and metabolic risk factors compared with cyclosporine in kidney transplant recipients (BENEFIT and BENEFIT-EXT studies). [2011.05.15]
BACKGROUND: Cardiovascular disease, the most common cause of death with a functioning graft among kidney transplant recipients, can be exacerbated by immunosuppressive drugs, particularly the calcineurin inhibitors. Belatacept, a selective co-stimulation blocker, may provide a better cardiovascular/metabolic risk profile than current immunosuppressants... CONCLUSIONS: At month 12, belatacept regimens were associated with better cardiovascular and metabolic risk profiles, with lower blood pressure and serum lipids and less NODAT versus CsA. The overall profile of belatacept will continue to be assessed over the 3-year trials.
A randomized controlled study in patients with newly diagnosed severe aplastic anemia receiving antithymocyte globulin (ATG), cyclosporine, with or without G-CSF: a study of the SAA Working Party of the European Group for Blood and Marrow Transplantation. [2011.04.28]
We evaluated the role of granulocyte colony-stimulating factor (G-CSF) in patients with severe aplastic anemia (SAA) treated with antithymocyte globulin (ATG) and cyclosporine (CSA). Between January 2002 and July 2008, 192 patients with newly diagnosed SAA not eligible for transplantation were entered into this multicenter, randomized study to receive ATG/CSA with or without G-CSF...
Clinical Trials Related to Sandimmune (Cyclosporine)
Long-term Topical Cyclosporine for Atopic Keratoconjunctivitis [Recruiting]
Atopic keratoconjunctivitis (AKC) is a rare type of ocular allergy that is often associated
with eczema. Over time, the complications from this disease process lead to loss of vision
due to continual scarring of the corneal surface. The pathophysiology of AKC has not been
fully elucidated, and the triggers are still unknown.
Corticosteroids are very effective in controlling the acute symptoms of AKC. However, two
thirds of patients managed with a combination of oral antihistamine, topical mast cell
stabilizer, and intermittent topical steroid regimen eventually developed significant
keratopathy and vision loss. Additionally, there are many side effects of corticosteroids,
including local immunosuppression, cataract formation, and increased risk of glaucoma.
Cyclosporin A is an immunomodulator that specifically inhibits T lymphocytes by blocking the
expression of the interleukin-2 receptor. It also blocks the release of inflammatory
mediators from mast cells and eosinophils. Cyclosporin has no known side effects except for
burning upon instillation, and safe to use over long-term . The investigators have
demonstrated that a 0. 05% ophthalmic emulsion of cyclosporine has been shown to be effective
at improving the ocular signs and symptoms of AKC over short-term. However, the long-term
efficacy of cyclosporine A in slowing the natural history of AKC and possible steroid
sparing effects have not been assessed. The investigators hypothesize that cyclosporine A
can be used as a mainstay treatment of AKC to control signs and symptoms over a long period
of time and also prevent the progression of this disease.
Calcineurin Inhibitor (CNI) Versus Steroid Cessation in Renal Transplantation [Recruiting]
This study intends to determine whether steroid withdrawal or calcineurin inhibitor
withdrawal is superior for graft function and graft survival. Secondary endpoints for this
study are: incidence of tumors and cardiovascular events.
The primary objective: To assess if superior graft function (glomerular filtration rate
(GFR) difference of 10 ml/min) will be achieved at 1 year after transplantation in cohorts
of de novo kidney transplant patients treated with Myfortic-everolimus plus steroids
compared to Myfortic-cyclosporine.
Pilot Study of a Homeopathic Therapy in Combination With Cyclosporin (Restasis) in the Treatment of Dry Eye Disease [Recruiting]
The purpose of this study is to determine whether a homeopathic therapy in combination with
cyclosporin (Restasis) is more effective than cyclosporin (Restasis) alone in the treatment
of dry eye disease.
Cyclosporine A in Combination With Nab-Paclitaxel in Patients With Metastatic Breast Cancer [Recruiting]
The purpose of this research study is to evaluate the safety of therapy with nab-paclitaxel
and CsA and if the addition of Cyclosporine A (CsA) to nab-paclitaxel helps stop cancer
cells as well as or better than nab-paclitaxel alone.
Once-a-day Regimen With Everolimus, Low Dose Cyclosporine and Steroids in Comparison With Steroid Withdrawal or Twice a Day Regimen With Everolimus, Low Dose Cyclosporine and Steroids. [Recruiting]
This study will compare the following immunosuppressive regimens in recipients of kidney
transplantation: A) everolimus, cyclosporine and steroids given once-a-day; B) everolimus
and cyclosporine given twice a day with steroid withdrawal; C) everolimus, cyclosporine
given twice a day and continuous steroids. The purpose of this study is to evaluate regimens
A and B in comparison with the control group (group C) for efficacy, using as main endpoint
the treatment failure rate, a composite endpoint including death, graft loss, BPAR and lost
to follow-up between randomization and Month 12.
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Page last updated: 2011-12-09
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