Cyclosporine Warning

[Posted 07/14/2009]

The FDA is requiring the makers of certain immunosuppressant drugs [Sirolimus (Rapamune), Cyclosporine (Sandimmune and generics), Cyclosporine modified (Neoral and generics), Mycophenolate mofetil (Cellcept and generics), Mycophenolic acid (Myfortic)] to update their labeling to reflect that immunosuppressed patients are at increased risk for opportunistic infections, such as activation of latent viral infections, including BK virus-associated nephropathy. These immunosuppressant drugs are used to protect against the rejection of certain organ transplants. The association of BK virus-associated nephropathy has previously been reported for another immunosuppressant drug, tacrolimus (Prograf). Monitoring for this serious risk and early intervention by the health care provider is critical. Adjustments in immunosuppression therapy should be considered for patients who develop BK virus-associated nephropathy.

FDA is continuing to review the safety of immunosuppressant drug products used in renal transplantation. The FDA urges both healthcare professionals and patients to report side effects from the use of immunosuppressant drug products to the FDA's MedWatch Adverse Event Reporting program. For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.


Important Warning:

Cyclosporine is available in its original form and as another product that has been modified (changed) so that the medication can be better absorbed in the body. Original cyclosporine and cyclosporine (modified) are absorbed by the body in different amounts, so they cannot be substituted for one another. Take only the type of cyclosporine that was prescribed by your doctor. When your doctor gives you a written prescription, check to be sure that he or she has specified the type of cyclosporine you should receive. Each time you have your prescription filled, look at the brand name printed on your prescription label to be sure that you have received the same type of cyclosporine. Talk to your pharmacist if the brand name is unfamiliar or you are not sure you have received the right type of cyclosporine.

Taking cyclosporine or cyclosporine (modified) may increase the risk that you will develop an infection or cancer, especially lymphoma (cancer of a part of the immune system) or skin cancer. This risk may be higher if you take cyclosporine or cyclosporine (modified) with other medications that decrease the functioning of the immune system such as azathioprine (Imuran), cancer chemotherapy, methotrexate (Rheumatrex), sirolimus (Rapamune), and tacrolimus (Prograf). Tell your doctor if you are taking any of these medications, and if you have or have ever had any type of cancer. To reduce your risk of skin cancer, plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen during your treatment. If you experience any of the following symptoms, call your doctor immediately: sore throat, fever, chills, and other signs of infection; flu-like symptoms; coughing; difficulty urinating; pain when urinating; a red, raised, or swollen area on the skin; new sores or discoloration on the skin; lumps or masses anywhere in your body; night sweats; swollen glands in the neck, armpits, or groin; trouble breathing; chest pain; weakness or tiredness that does not go away; or pain, swelling, or fullness in the stomach.

Cyclosporine and cyclosporine (modified) may cause high blood pressure and kidney damage. Tell your doctor if you have or have ever had high blood pressure or kidney disease. Also tell your doctor if you are taking any of the following medications: amphotericin B (Amphotec, Fungizone); cimetidine (Tagamet); ciprofloxacin (Cipro); colchicine; fenofibrate (Antara, Lipophen, Tricor); gemfibrozil (Lopid); gentamicin; ketoconazole (Nizoral); melphalan (Alkeran); nonsteroidal anti-inflammatory drugs such as diclofenac (Cataflam, Voltaren), naproxen (Aleve, Naprosyn), and sulindac (Clinoril); ranitidine (Zantac); tobramycin (Tobi); trimethoprim with sulfamethoxazole (Bactrim, Septra); and vancomycin (Vancocin). If you experience any of the following symptoms, call your doctor immediately: dizziness; swelling of the arms, hands, feet, ankles, or lower legs; fast, shallow breathing; nausea; or irregular heartbeat.

If you have psoriasis, tell your doctor about all the psoriasis treatments and medications you are using or have used in the past. The risk that you will develop skin cancer is greater if you have ever been treated with PUVA (psoralen and UVA; treatment for psoriasis that combines an oral or topical medication with exposure to ultraviolet A light); methotrexate (Rheumatrex) or other medications that suppress the immune system; UVB (exposure to ultraviolet B light to treat psoriasis); coal tar; or radiation therapy. You should not be treated with PUVA, UVB, or medications that suppress the immune system while you are taking cyclosporine (modified) to treat psoriasis.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to cyclosporine or cyclosporine (modified).