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USE^1,2

GENGRAF® Capsules (cyclosporine capsules, USP [MODIFIED]) and GENGRAF® Oral Solution (cyclosporine oral solution, USP [MODIFIED]) are prescription medicines used to help prevent organ rejection in people who have received a kidney, liver, or heart transplant. Cyclosporine (MODIFIED) has been used with other immunosuppressants, such as azathioprine and corticosteroids.

IMPORTANT SAFETY INFORMATION^1,2

WARNING

While you are on this treatment, it is important to be under the care of a doctor who has experience treating and monitoring organ transplant patients who are taking medicines like GENGRAF.

GENGRAF is an immunosuppressant, a drug that reduces the body’s ability to fight illness and disease. Immunosuppressant drugs may increase your chances of getting an infection and certain types of cancers. In organ transplant patients, using GENGRAF with other immunosuppressants may increase this effect.

Different formulations of cyclosporine deliver different amounts of medicine. Do not switch formulations of cyclosporine without your doctor’s permission and direction, as switching formulations may require a dosage change.

GENGRAF can cause high blood pressure and kidney problems. This risk increases the longer you take GENGRAF and with higher doses. Ongoing laboratory tests must be performed to monitor your kidney function while you are being treated with GENGRAF.

• Do not take GENGRAF if you are allergic to cyclosporine or any of the ingredients in GENGRAF.
• Occasionally patients have developed a condition that causes damage to the small blood vessels, which may result in graft failure.
• Occasionally some patients have experienced abnormally high levels of potassium in their blood.
• Cases of liver damage, including liver failure, have been reported in patients treated with cyclosporine. In some cases, fatal outcomes have been reported. Most reports included patients who also had other medical conditions. Ongoing laboratory tests must be performed to monitor your liver function while you are being treated with GENGRAF.
• Patients receiving immunosuppressants, including cyclosporine, are at an increased risk of developing lymphomas and other types of cancers, especially skin cancers. Some of these cancers may be fatal. You should avoid excess sun exposure, including tanning booths.
• Transplant patients taking cyclosporine are at an increased risk for serious infections, some of which may have fatal outcomes. Infections may include the polyoma virus, which may have a serious and sometimes fatal outcome.
• There have been reports of convulsions (uncontrolled shaking of the body) in patients taking cyclosporine and, in particular, in patients also taking high doses of corticosteroids.
• High blood pressure is a common side effect of taking cyclosporine.
• During treatment with cyclosporine, vaccination may be less effective, and the use of vaccines containing live viruses should be avoided.
• You should take GENGRAF exactly as prescribed by your physician. This includes taking your medication on the same schedule every day. You should avoid grapefruit and grapefruit juice while taking GENGRAF.
• Tell your doctor about any other medications, vitamins, nutritional supplements, or herbal products you are taking. GENGRAF and other medicines may affect each other, causing side effects. GENGRAF may affect the way other medicines work, and other medicines may affect how GENGRAF works.
• If you are or are planning to become pregnant, tell your doctor right away and follow the instructions you receive about taking GENGRAF.
• The most common side effects include kidney problems, high blood pressure, abnormal hair growth on your body or face, tremor, headache, nausea, vomiting, swollen or painful gums, low number of white blood cells, urinary tract infections, and other infections.