Everolimus is a topic covered in the Consumer DrugInfo.

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(e'' ver oh' li mus)

Brand names:

  • Afinitor®
  • Afinitor Disperz®
  • Zortress®

Other name:
  • RAD001

Important Warning

Taking everolimus may decrease your ability to fight infection from bacteria, viruses, and fungi and increase the risk that you will get a serious or life-threatening infection. If you have had hepatitis B (a type of liver disease) in the past, your infection may become active and you may develop symptoms during your treatment with everolimus. Tell your doctor if you have or have ever had hepatitis B or if you have or think you may have any type of infection now. Tell your doctor and pharmacist if you are taking other medications that suppress the immune system such as azathioprine (Imuran), cyclosporine (Gengraf, Neoral, Sandimmune), dexamethasone (Decadron, Dexpak), methotrexate (Rheumatrex, Trexall), prednisolone (Orapred, Pediapred, Prelone), prednisone (Sterapred), sirolimus (Rapamune), and tacrolimus (Prograf). If you experience any of the following symptoms, call your doctor immediately: excessive tiredness; yellowing of the skin or eyes; loss of appetite; nausea; joint pain; dark urine; pale stools; pain in the upper right part of the stomach; rash; difficult, painful, or frequent urination; ear pain or drainage; sinus pain and pressure; or sore throat, cough, fever, chills, feeling unwell or other signs of infection.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests to check your body's response to everolimus.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide [Zortress] or patient information leaflet [Afinitor, Afinitor Disperz]) when you begin treatment with everolimus and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

Talk to your doctor about the risks of taking everolimus.

For patients who are taking everolimus to prevent transplant rejection:

You must take everolimus under the supervision of a doctor who is experienced in taking care of transplant patients and giving medications that suppress the immune system.

The risk that you will develop cancer, especially lymphoma (cancer of a part of the immune system) or skin cancer is increased during your treatment with everolimus. Tell your doctor if you or anyone in your family has or has ever had skin cancer or if you have fair skin. To reduce your risk of skin cancer, plan to avoid unnecessary or prolonged exposure to sunlight or ultraviolet light (tanning beds and sunlamps) and to wear protective clothing, sunglasses, and sunscreen during your treatment. If you experience any of the following symptoms, call your doctor immediately: a red, raised, or waxy area on the skin; new sores, bumps, or discoloration on the skin; sores that do not heal; lumps or masses anywhere in your body; skin changes; night sweats; swollen glands in the neck, armpits, or groin; trouble breathing; chest pain; or weakness or tiredness that does not go away.

Taking everolimus may increase the risk that you will develop certain very rare and serious infections, including infection with the BK virus, a serious virus that may damage the kidneys and cause a transplanted kidney to fail), and progressive multifocal leukoencephalopathy (PML; a rare infection of the brain that cannot be treated, prevented, or cured and that usually causes death or severe disability). Call your doctor immediately if you experience any of the following symptoms of PML: weakness on one side of the body that worsens over time; clumsiness of the arms or legs; changes in your thinking, walking, balance, speech, eyesight, or strength that last several days; headaches; seizures; confusion; or personality changes.

Everolimus may cause a blood clot in the blood vessels of your transplanted kidney. This is most likely to happen within the first 30 days after your kidney transplant and may cause the transplant to be unsuccessful. If you experience any of the following symptoms, call your doctor immediately: pain in your groin, lower back, side, or stomach; decreased urination or no urination; blood in your urine; dark-colored urine; fever; nausea; or vomiting.

Taking everolimus in combination with cyclosporine could cause damage to your kidneys. In order to reduce this risk, your doctor will adjust the dose of cyclosporine and monitor the levels of the medications and how your kidneys are working. If you experience either of the following symptoms, call your doctor immediately: decreased urination or swelling of the arms, hands, feet, ankles, or lower legs.

In clinical studies, more people who took everolimus died during the first few months after receiving a heart transplant than people who did not take everolimus. If you have received a heart transplant, talk to your doctor about the risks of taking everolimus.

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