For Psoriasis Patients (See also BOXED WARNING 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.
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NEORAL SUMMARY
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
adult, nonimmunocompromised
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.
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NEWS HIGHLIGHTS
Published Studies Related to Neoral (Cyclosporine)
Effect of loteprednol etabonate 0.5% on initiation of dry eye treatment with
topical cyclosporine 0.05%. [2014]
randomized double-masked parallel group clinical study (NCT00407043)... CONCLUSIONS: Loteprednol etabonate induction therapy 2 weeks before the
Efficacy of cyclosporine for chronic, refractory stomatitis in cats: A
randomized, placebo-controlled, double-blinded clinical study. [2013]
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. [2013]
(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.
Clinical Trials Related to Neoral (Cyclosporine)
Gengraf Conversion Study in Stable Renal Allograft Transplant Recipients [Completed]
The purpose of this study is to establish the therapeutic equivalence of Gengraf® with the
standard treatment Neoral® for a treatment period of 6 months in stable renal allograft
transplant recipients with respect to drug levels, dosage, and acute graft rejection and
other adverse events.
Comparisone of Iminoral Versus Neoral in Prevention of Acute Rejection in Renal Transplantation [Completed]
Cyclosporine is the key drug in organ transplantation. In Iran the investigators have more
than 2500 new renal transplantation each year and because of this the government pay a huge
amount of money for subsiding the imported cyclosporine in the form of Neoral. Recently an
Iranian drug company introduced this drug in the name of Iminoral which has been approved by
different authorities in Iran and abroad, (including the Ministry of Health in Iran and also
European Directorate for the Quality of Medicines Certification Unit and FDA(Department of
Health and Human Services,Center for Drug Evaluation and Research)). The investigators
study is the first clinical trial to compare the effect of Iminoral versus Neoral in
preventing acute rejection in renal transplantation and also to compare the side effects of
these two drugs.
To Study the Effects of CD25 and Low Dose Cyclosporin in the Treatment of Active Psoriasis Vulgaris [Completed]
Concentration Controlled Everolimus With Reduced Dose Cyclosporine Versus Mycophenolate Mofetil With Standard Dose Cyclosporine in de Novo Renal Transplant Adult Recipients Treated With Basiliximab and Corticosteroids [Completed]
The 12 Month Core Study (CRAD001A1202) was designed to evaluate the efficacy and safety
comparing concentration-controlled everolimus (1. 5 mg/day starting dose) with reduced dose
cyclosporine and corticosteroids versus 2 g/day mycophenolate mofetil (MMF) with standard
dose cyclosporine and corticosteroids in de novo renal transplant recipients.
Extension Study (CRAD001A1202E1): Until 24 months after renal transplantation, the study was
designed to evaluate the long-term safety and efficacy comparing concentration-controlled
everolimus with reduced dose cyclosporine (Neoral®) and corticosteroids versus mycophenolate
mofetil with standard dose Neoral® and corticosteroids in de novo renal transplant
recipients. Beyond 24 months after renal transplantation, the study was designed to provide
everolimus treatment for patients in everolimus group until everolimus is approved and
marketed in Japan.
A Study to Evaluate the Efficiency of Intravenously Administered Cyclosporine in de Novo Liver Transplant Recipients [Completed]
The aim of this exploratory study is to evaluate the rejection rate in patients treated with
cyclosporine (CsA) preceding oral administration of cyclosporine micro emulsion in de novo
liver recipients. The blood levels of CsA and CsA micro emulsion will be monitored by C-2h
monitoring. In addition, this study will assess the safety of this treatment regimen.
Reports of Suspected Neoral (Cyclosporine) Side Effects
Pyrexia (80),
Pneumonia (74),
Death (73),
Renal Impairment (71),
Blood Creatinine Increased (68),
Cytomegalovirus Infection (49),
Diarrhoea (46),
Kidney Transplant Rejection (41),
Hypertension (41),
Renal Failure Acute (39), more >>
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Page last updated: 2015-08-10
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