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Neoral (Cyclosporine) - Summary

 
 



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 SUMMARY

Neoral

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.


See all Neoral indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Neoral (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...

more studies >>

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 Sj�gren Syndrome [Recruiting]

Double-Masked Trial of NOVA22007 (1mg/mL Ciclosporin/Cyclosporine) Versus Vehicle in Pediatric Patients With Active Severe Vernal Keratoconjunctivitis [Not yet recruiting]
The objective of this study is to compare the efficacy of two different dosing regimen of NOVA22007 (1mg/ml ciclosporin/cyclosporine) eye drops, emulsion versus placebo (vehicle of the formulation) administered four times a day in patients with severe vernal keratoconjunctivitis after 4 months of treatment.

The Insulin Independence Trial (IIT) Evaluating the Safety and Efficacy of Oral Cyclosporine and Oral Lansoprazole for Insulin Independence Among Recent Onset Type 1 Diabetes Patients [Not yet recruiting]
The purpose of this study is to determine if oral cyclosporine and oral lansoprazole are effective in rendering recent onset type 1 diabetes patients, insulin independent. This four-arm study was designed to evaluate the safety and efficacy for insulin independence by utilizing the FDA-approved oral immune tolerance agent, cyclosporine, and the FDA-approved proton-pump inhibitor, lansoprazole. Lansoprazole and other proton-pump inhibitors increase gastrin levels. Gastrin was initially shown to have the potential to increase new beta cell formation in 1955 (Zollinger RM and Ellison EH. Ann Surg. 1955;142(4):709-23).

Studies with the immune tolerance agent, cyclosporine, previously demonstrated that among recently diagnosed type 1 diabetes patients, insulin independence was achieved in as many as 67. 5% of patients within 7 weeks of therapy (Bougneres PF et al. N Engl J Med. 1988: 17;318(11):663-70). Cyclosporine protected the remaining beta cells from further autoimmune attack, but over time, there was limited beta cell regeneration, and insulin was ultimately required by all patients. Therefore, this study proposes the usage of cyclosporine with a beta regeneration agent.

Follow-up studies for up to 13 years among 285 type 1 patients utilizing cyclosporine for 20 months, did not demonstrate renal or other side effects (Assan R. et al. Diabetes Metab Res Rev. 2002;18(6):464-72). Human clinical trials with gastrin and epidermal growth factor demonstrated reductions in daily insulin requirements by much as 75% within 3 months following four weeks of therapy among existing type 1 diabetes patients (Transition Therapeutics, March 5, 2007 http://www. transitiontherapeutics. com/media/archive. php Accessed January 1, 2013). Lack of the ability to sustain these results was likely due to the ongoing autoimmune attack on the new beta cells generated by therapy. Gastrin alone has been shown to induce beta cell neogenesis from human pancreatic ductal tissue without epidermal growth factor in in-vitro studies (Suarez-Pinzon WL et al. JCEM. 2005;90(6):3401-3409).

Type 1 diabetes is an autoimmune disease. Despite evidence that many different immune tolerance agents have successfully reversed diabetes in rodent type 1 models, none have been successful in sustaining insulin independence in man (Ablamunits V et al. Ann NY Acad Sci. 2007;1103: 19-32). The distinctions and complexities of islets in man are far different than that of rodents (Levetan CS and Pierce SM. Endocr Pract. 2012 Nov 27: 1-36 Epub ahead of print). We hypothesize that in man, both an immune tolerance agent and a beta regeneration agent are required to sustain insulin independence.

Based upon proton-pump inhibitors having been shown to increase plasma gastrin levels up to 10-fold, this clinical trial utilizes the oral proton-pump inhibitor, lansoprazole. This study will determine the safety and efficacy of cyclosporine used with and without lansoprazole to determine the impact on insulin independence among recently diagnosed patients with type 1 diabetes.

Cyclosporine is utilized to protect the new beta cells formed by lansoprazole. The combination of the two therapies may render reductions in insulin requirements and have a greater impact on sustained insulin independence than previously reported with cyclosporine or gastrin alone among type 1 patients.

This 12-week study consists of four treatment arms:

- Oral Cyclosporine/Placebo

- Oral Lansoprazole/Placebo

- Oral Lansoprazole/Oral Cyclosporine

- Oral Placebo/Oral Placebo

It is hypothesized that the combination of oral cyclosporine and oral lansoprazole will safely render significantly more patients with existing type 1 diabetes, insulin independent and may serve as a novel and innovative treatment approach for recently diagnosed patients with type 1 diabetes utilizing two FDA-approved therapies.

The Insulin Independence Trial (IIT) Evaluating the Safety and Efficacy of Oral Cyclosporine and Oral Lansoprazole for Insulin Independence Among Patients With Existing Type 1 Diabetes [Not yet recruiting]
The purpose of this study is to determine if oral cyclosporine and oral lansoprazole are effective in rendering patients with existing type 1 diabetes, insulin independent. This four-arm study was designed to evaluate the safety and efficacy for insulin independence by utilizing the FDA-approved oral immune tolerance agent, cyclosporine, and the FDA-approved proton-pump inhibitor, lansoprazole. Lansoprazole and other proton-pump inhibitors increase gastrin levels. Gastrin was initially shown to have the potential to increase new beta cell formation in 1955 (Zollinger RM and Ellison EH. Ann Surg. 1955;142(4):709-23).

Studies with the immune tolerance agent, cyclosporine, previously demonstrated that among recently diagnosed type 1 diabetes patients, insulin independence was achieved in as many as 67. 5% of patients within 7 weeks of therapy (Bougneres PF et al. N Engl J Med. 1988: 17;318(11):663-70). Cyclosporine protected the remaining beta cells from further autoimmune attack, but over time, there was limited beta cell regeneration, and insulin was ultimately required by all patients. Therefore, this study proposes the usage of cyclosporine with a beta regeneration agent.

Follow-up studies for up to 13 years among 285 type 1 patients utilizing cyclosporine for 20 months, did not demonstrate renal or other side effects (Assan R. et al. Diabetes Metab Res Rev. 2002;18(6):464-72). Human clinical trials with gastrin and epidermal growth factor demonstrated reductions in daily insulin requirements by much as 75% within 3 months following four weeks of therapy among existing type 1 diabetes patients (Transition Therapeutics, March 5, 2007 http://www. transitiontherapeutics. com/media/archive. php Accessed January 1, 2013). Lack of the ability to sustain these results was likely due to the ongoing autoimmune attack on the new beta cells generated by therapy. Gastrin alone has been shown to induce beta cell neogenesis from human pancreatic ductal tissue without epidermal growth factor in in vitro studies (Suarez-Pinzon WL et al. JCEM. 2005;90(6):3401-3409).

Type 1 diabetes is an autoimmune disease. Despite evidence that many different immune tolerance agents have successfully reversed diabetes in rodent type 1 models, none have been successful in sustaining insulin independence in man (Ablamunits V et al. Ann NY Acad Sci. 2007;1103: 19-32). The distinctions and complexities of islets in man are far different than that of rodents (Levetan CS and Pierce SM. Endocr Pract. 2012 Nov 27: 1-36 Epub ahead of print). We hypothesize that in man, both an immune tolerance agent and a beta regeneration agent are required to sustain insulin independence.

Based upon proton-pump inhibitors having been shown to increase plasma gastrin levels up to 10-fold, this clinical trial utilizes the oral proton-pump inhibitor, lansoprazole. This study will determine the safety and efficacy of cyclosporine used with and without lansoprazole to determine the impact on insulin independence among patients with existing type 1 diabetes.

Cyclosporine is utilized to protect the new beta cells formed by lansoprazole. The combination of the two therapies may render reductions in insulin requirements and have a greater impact on sustained insulin independence than previously reported with cyclosporine or gastrin alone among type 1 patients.

This 12-week study consists of four treatment arms:

- Oral Cyclosporine/Placebo

- Oral Lansoprazole/Placebo

- Oral Lansoprazole/Oral Cyclosporine

- Oral Placebo/Oral Placebo

It is hypothesized that the combination of oral cyclosporine and oral lansoprazole will safely render significantly more patients with existing type 1 diabetes, insulin independent and may serve as a novel and innovative treatment approach for patients with type 1 diabetes utilizing two FDA-approved therapies.

more trials >>

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 >>


Page last updated: 2011-12-09

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