FOR PSORIASIS PATIENTS (SEE ALSO BOXED WARNINGS ABOVE)
Psoriasis patients previously treated with PUVA and to a lesser extent, methotrexate or other immunosuppressive agents, UVB, coal tar, or radiation therapy, are at an increased risk of developing skin malignancies when taking Neoral®.
Cyclosporine, the active ingredient in Neoral®, in recommended dosages, can cause systemic hypertension and nephrotoxicity. The risk increases with increasing dose and duration of cyclosporine therapy. Renal dysfunction, including structural kidney damage, is a potential consequence of cyclosporine, and therefore, renal function must be monitored during therapy.
Neoral® is an oral formulation of cyclosporine that immediately forms a microemulsion in an aqueous environment.
Neoral® is indicated for the following:
Kidney, Liver, and Heart Transplantation: Neoral® is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Neoral® has been used in combination with azathioprine and corticosteroids.
Rheumatoid Arthritis: Neoral® is indicated for the treatment of patients with severe active, rheumatoid arthritis where the disease has not adequately responded to methotrexate. Neoral® can be used in combination with methotrexate in rheumatoid arthritis patients who do not respond adequately to methotrexate alone.
Psoriasis: Neoral® is indicated for the treatment of
patients with severe (i.e., extensive and/or disabling), recalcitrant, plaque psoriasis who have failed to respond to at least one systemic therapy (e.g., PUVA, retinoids, or methotrexate) or in patients for whom other systemic therapies are contraindicated, or cannot be tolerated.
While rebound rarely occurs, most patients will experience relapse with Neoral® as with other therapies upon cessation of treatment.
Published Studies Related to Neoral (Cyclosporine)
Efficacy of cyclosporine for chronic, refractory stomatitis in cats: A
randomized, placebo-controlled, double-blinded clinical study. 
Sixteen cats with chronic stomatitis, that had previously undergone
premolar-molar or full-mouth extractions, were randomly assigned a group to
receive 2.5 mg/kg cyclosporine or placebo orally twice daily Neither the
clinician nor the clients were aware of the group assignments... Whole-blood
cyclosporine levels > 300 ng/ml were associated with significant improvement in
oral inflammation in cats with chronic stomatitis that had previously undergone
premolar-molar or fuill-mouth extraction.
The effect of prethrombolytic cyclosporine-A injection on clinical outcome of
acute anterior ST-elevation myocardial infarction. 
(TLT)... CONCLUSION: In this study, the prethrombolytic administration of CsA was not
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.
Clinical Trials Related to Neoral (Cyclosporine)
Concentration Controlled Everolimus With Reduced Dose Neoral® Versus Mycophenolate Mofetil With Standard Dose Neoral® in de Novo Renal Transplant Adult Recipients Treated With Basiliximab and Corticosteroids [Recruiting]
This study is designed to provide efficacy and safety data for everolimus in de novo renal
transplant recipients in order to gain regulatory approval to make everolimus available for
clinical use in Japan.
This study is designed to evaluate the efficacy and safety comparing
concentration-controlled everolimus (1. 5 mg/day starting dose) with reduced dose Neoral®
(RDN) and corticosteroids versus 2 g/day mycophenolate mofetil (MMF) with standard dose
Neoral® (SDN) and corticosteroids in de novo renal transplant recipients.
Low Dose Cyclosporin A in Primary Sjï¿½gren Syndrome [Recruiting]
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.
Dasatinib and Cyclosporine in Treating Patients With Chronic Myelogenous Leukemia Refractory or Intolerant to Imatinib Mesylate [Recruiting]
This phase I trial studies the side effects and the best way to give dasatinib and
cyclosporine in treating patients with chronic myelogenous leukemia (CML) refractory or
intolerant to imatinib mesylate. Dasatinib may stop the growth of cancer cells by blocking
some of the enzymes needed for cell growth. Cyclosporine may help dasatinib work better by
making cancer cells more sensitive to the drug. Giving dasatinib together with cyclosporine
may be an effective treatment for CML
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.
Reports of Suspected Neoral (Cyclosporine) Side Effects
Renal Impairment (71),
Blood Creatinine Increased (68),
Cytomegalovirus Infection (49),
Kidney Transplant Rejection (41),
Renal Failure Acute (39), more >>
Page last updated: 2014-11-30