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Everolimus is a cancer medication that interferes with the growth of cancer cells and slows their spread in the body.
The Afinitor brand of everolimus is used to treat certain types of kidney cancer, breast cancer, or brain tumor. Afinitor is usually given after other cancer medications have been tried without successful treatment.
Afinitor is also used to treat non-cancerous (benign) kidney tumors, and certain types of advanced or progressive tumors of the pancreas.
This medication guide provides information about the Afinitor brand of everolimus. Zortress is another brand of everolimus used to prevent organ rejection after a kidney transplant.
Everolimus may also be used for purposes not listed in this medication guide.
Everolimus lowers your bodys immune system. The immune system helps your body fight infections. The immune system can also fight or "reject" a transplanted organ such as a liver or kidney. This is because the immune system treats the new organ as an invader.
The Zortress brand of everolimus is used to prevent organ rejection after a kidney or liver transplant. Zortress is used together with cyclosporine, steroids, and other medications.
This medication guide provides information about the Zortress brand of everolimus. Afinitor is another brand of everolimus used to treat certain types of cancer.
Everolimus may also be used for purposes not listed in this medication guide.
You should not use this medication if you are allergic to everolimus, sirolimus (Rapamune), tacrolimus (Prograf), or temsirolimus (Torisel).
Zortress may increase your risk of infection or certain cancer by changing the way your immune system works.
Serious and sometimes fatal infections may occur during treatment with Zortress. Stop using this medicine and call your doctor right away if you have signs of infection such as: fever, chills, body aches, or flu symptoms.
Zortress can cause a blood clot in the blood vessels of your transplanted organ, especially within 30 days after transplant. Tell your doctor right away if you have: shortness of breath, fever with nausea or vomiting, blood in your urine, dark colored urine, little or no urinating, jaundice (yellowing of your skin or eyes), or pain in your stomach, groin, lower back, or side.
You should not use this medication if you are allergic to everolimus, sirolimus (Rapamune), tacrolimus (Prograf), or temsirolimus (Torisel).
To make sure Afinitor is safe for you, tell your doctor if you have:

• a breathing disorder, such as asthma or COPD (chronic obstructive pulmonary disease);
• liver disease, or a history of hepatitis B;
• kidney disease;
• an active infection;
• diabetes or high blood sugar; or
• high cholesterol.

FDA pregnancy category D. Do not take Afinitor if you are pregnant. It could harm the unborn baby. Use effective birth control while you are taking this medication and for at least 8 weeks after your treatment ends.
Afinitor can affect fertility (your ability to have children), whether you are a man or a woman.
It is not known whether everolimus passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are taking everolimus.
You should not use this medication if you are allergic to everolimus or sirolimus (Rapamune), or if you have problems digesting lactose or galactose (sugar).
Zortress can lower blood cells that help fight infection, and may cause you to produce too much of a certain type of white blood cell. This can lead to serious conditions including cancer, severe brain infection causing disability or death, or a viral infection causing kidney transplant failure. Ask your doctor about your specific risk.
To make sure you can safely take everolimus, tell your doctor if you have any of these other conditions:

• high cholesterol or triglycerides;
• diabetes or high blood sugar;
• a breathing disorder, such as asthma or COPD (chronic obstructive pulmonary disease);
• a personal or family history of skin cancer (melanoma); or
• if you have ever had a heart transplant.

It is not known whether Zortress will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Use effective birth control while you are using this medication and for at least 8 weeks after your treatment ends.
Zortress can lower sperm count in men, which may affect fertility (your ability to have children).
It is not known whether everolimus passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are taking Zortress.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; chest pain, difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using Afinitor and call your doctor at once if you have:

• new or worsening cough, wheezing, feeling short of breath;
• fever, swollen gums, painful mouth sores, pain when swallowing, tired feeling, cold or flu symptoms;
• seizure (convulsions);
• swelling, rapid weight gain, urinating less than usual or not at all;
• pain or burning when you urinate;
• pain or fullness in your ear, hearing problems;
• pale skin, easy bruising, unusual bleeding;
• a skin wound that is swollen, red, warm, bleeding, or oozing;
• any wound that will not heal; or
• nausea, pain in your upper stomach, itching, joint pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of your skin or eyes).

Common side effects may include:

• mild skin rash;
• headache; or
• diarrhea, mild stomach pain or nausea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; chest pain, difficult breathing; swelling of your face, lips, tongue, or throat.
Serious and sometimes fatal infections may occur during treatment with Zortress. Stop using this medicine and call your doctor right away if you have signs of infection such as: fever, chills, body aches, or flu symptoms.
Zortress can cause a blood clot in the blood vessels of your transplanted organ, especially within 30 days after transplant. Tell your doctor right away if you have: shortness of breath, fever with nausea or vomiting, blood in your urine, dark colored urine, little or no urinating, jaundice (yellowing of your skin or eyes), or pain in your stomach, groin, lower back, or side.
Call your doctor at once if you have:

• pain or burning when you urinate;
• redness, warmth, swelling, oozing, or slow healing of a wound or surgical incision;
• new or worsening cough, wheezing, breathing problems;
• stabbing chest pain, cough with yellow or green mucus;
• pale skin, feeling light-headed, rapid heart rate, easy bruising, unusual bleeding (nose, mouth, vagina, or rectum);
• white patches or sores inside your mouth or on your lips;
• high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling);
• high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss); or
• dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, uneven heartbeats, seizure).

Common side effects may include:

• swelling in your legs, ankles, or feet;
• diarrhea, constipation; or
• mild stomach discomfort.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This medicine can pass into body fluids (including urine, feces, vomit, semen, vaginal fluid). Patients and caregivers should wear rubber gloves while cleaning up body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.
Body fluids should not be handled by a woman who is pregnant or who may become pregnant. Use condoms during sexual activity to avoid exposure to body fluids.
Do not receive a "live" vaccine while using Afinitor, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.
Grapefruit and grapefruit juice may interact with Afinitor and lead to unwanted side effects. Avoid the use of grapefruit products while taking Afinitor.
This medicine can pass into body fluids (including urine, feces, vomit, semen, vaginal fluid). Patients and caregivers should wear rubber gloves while cleaning up body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.
Body fluids should not be handled by a woman who is pregnant or who may become pregnant. Use condoms during sexual activity to avoid exposure to body fluids.
Do not receive a "live" vaccine while using Zortress, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.
Zortress may increase your risk of developing skin cancer. Avoid exposure to sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.
Grapefruit and grapefruit juice may interact with Zortress and lead to unwanted side effects. Avoid the use of grapefruit products while taking Zortress.
Many drugs can interact with Afinitor. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with Afinitor, especially:

• bosentan, imatinib, nefazodone, St. Johns wort;
• an antibiotic--clarithromycin, erythromycin, telithromycin; antifungal medication--itraconazole, ketoconazole, posaconazole, voriconazole; heart medication--nicardipine, quinidine;
• hepatitis C medications--boceprevir, telaprevir; HIV/AIDS medication--atazanavir, delavirdine, efavirenz, fosamprenavir, indinavir, nelfinavir, nevirapine, ritonavir, saquinavir;
• seizure medication--carbamazepine, fosphenytoin, oxcarbazepine, phenobarbital, phenytoin, primidone; tuberculosis medication--isoniazid, rifabutin, rifampin, rifapentine.

This list is not complete and many other drugs can interact with Afinitor. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.
Many drugs can interact with Zortress. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with Zortress, especially:

• aprepitant, conivaptan, cyclosporine, deferiprone, imatinib, natalizumab; or
• an antibiotic--clarithromycin, dalfopristin, erythromycin, telithromycin; an antidepressant--fluvoxamine, nefazodone; antifungal medication--fluconazole, itraconazole, ketoconazole; heart or blood pressure medication--diltiazem, verapamil; HIV/AIDS medication--atazanavir, delavirdine, fosamprenavir, indinavir, nelfinavir, ritonavir, saquinavir.

This list is not complete and many other drugs can interact with Zortress. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.