Safety

Neoral (Cyclosporine) Soft Gelatin Capsule and Neoral (Cyclosporine) Oral Solution

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – August 2012

Nephrotoxicity
Thrombotic Microangiopathy…
Hepatotoxicity-Cases of hepatotoxicity and liver injury including cholestasis, jaundice, hepatitis and liver failure have been reported in patients treated with cyclosporine…
Serious Infections-Patients receiving immunosuppressants, including Neoral, are at increased risk of developing bacterial, viral, fungal, and protozoal infections, including opportunistic infections…
Polyoma Virus Infections-Patients receiving immunosuppressants including Neoral are at increased risk for opportunistic infections, including polyoma virus infections…

A. Effect of Drugs and Other Agents on Cyclosporine Pharmacokinetics and/or Safety…

1. Drugs That Increase Cyclosporine Concentrations

2. Drugs/Dietary Supplements That Decrease Cyclosporine Concentrations

B. Effect of Cyclosporine on the Pharmacokinetics and/or Safety of Other Drugs or Agents
and, Aliskiren, Repaglinide, NSAIDs, Sirolimus, Etoposide, and other drugs. See the full prescribing information of the other drug for further information and specific recommendations...
Digoxin-If digoxin is used concurrently with cyclosporine, serum digoxin concentrations should be monitored.

Colchicine- Concomitant administration of cyclosporine and Colchicine results in significant increases in Colchicine plasma concentrations…a reduction in the dosage of Colchicine is recommended.

Aliskiren- Cyclosporine alters the pharmacokinetics of aliskiren, a substrate of P-glycoprotein and CYP3A4…
Potassium-Sparing Diuretics…
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)-Clinical status and serum creatinine should be closely monitored when cyclosporine is used with nonsteroidal anti-inflammatory agents in rheumatoid arthritis patients…
Methotrexate InteractionPreliminary data indicate that when methotrexate and cyclosporine were co-administered to rheumatoid arthritis patients (N=20), methotrexate concentrations (AUCs) were increased approximately 30% and the concentrations (AUCs) of its metabolite, 7-hydroxy methotrexate, were decreased by approximately 80%. The clinical significance of this interaction is not known. Cyclosporine concentrations do not appear to have been altered (N=6).

Sirolimus…
Nifedipine… is given concurrently with cyclosporine have been reported.
Methypredinisolone… is given concomitantly with cyclosporine…
Other Immunosuppressive Drugs and Agents…
Effect of Cyclosporine on the Efficacy of Live Vaccines-During treatment with cyclosporine, vaccination may be less effective. The use of live vaccines should be avoided.

Kidney, Liver and Heart Transplantation

Hepatotoxicity-Cases of hepatotoxicity and liver injury including cholestasis, jaundice, hepatitis and liver failure; serious and/or fatal outcomes have been reported.
Increased Risk of Infections-Cases of JC virus-associated progressive multifocal leukoencephalopathy (PML), sometimes fatal; and polyoma virus-associated nephropathy (PVAN), especially due to BK virus, resulting in graft loss, have been reported.
Headache, including Migraine-Cases of migraine have been reported. In some cases, patients have been unable to continue cyclosporine, however the final decision on treatment discontinuation should be made by the treating physician following the careful assessment of benefits versus risks.