Safety

Resources for You

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

Hepatotixicity-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 Sandimmune, are at increased risk of developing bacterial, viral, fungal, and protozoal infections, including opportunistic infections. These infections may lead to serious, including fatal, outcomes.

Polyoma Virus Infections-Patients receiving immunosuppressants, including Sandimmune are at increased risk for opportunistic infections, including polyoma virus infections…

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

St. John’s Wort…
Rifabutin…
B. Effect of Cyclosporine on the Pharmacokinetics and/or Safety of Other Drugs or Agents
… Aliskiren, Repaglinide, NSAIDs, Sirolimus, Etoposide, and other drugs…

Digoxin-If digoxin are 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.
HMG-CoA reductase inhibitors (statins)…
Repaglinide…
Aliskiren-Cyclosporine alters the pharmacokinetics of aliskiren, a substrate of P-glycoprotein and CYP3A4…
Potassium-Sparing Diuretics-Cyclosporine should not be used with potassium-sparing diuretics because hyperkalemia can occur…
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 Interaction-Preliminary data indicate that when Methotrexate and Cyclosporine were coadministered 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 -Frequent gingival hyperplasia when with nifedipine is given concurrently with cyclosporine have been reported.
Methypredisolone - Convulsions when high dose methylprednisolone is given concomitantly with cyclosporine have been reported.
Other Immunosuppressive Drugs and Agents -Psoriasis patients receiving other immunosuppressive agents or radiation therapy (including PUVA and UVB) should not receive concurrent cyclosporine because of the possibility of excessive immunosuppression.

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.