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Brand Names: Zortress

Generic Name: everolimus (Zortress) (Pronunciation: E ver OH li mus (ZOR tress))

• What is everolimus (Zortress) (Zortress)?
• What are the possible side effects of Zortress (Zortress)?
• What is the most important information I should know about Zortress (Zortress)?
• What should I discuss with my health care provider before taking Zortress (Zortress)?
• How should I take Zortress (Zortress)?
• What happens if I miss a dose (Zortress)?
• What happens if I overdose (Zortress)?
• What should I avoid while taking Zortress (Zortress)?
• What other drugs will affect Zortress (Zortress)?
• Where can I get more information?

What is everolimus (Zortress) (Zortress)?

Everolimus lowers your body's 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 transplant. Zortress is used together with cyclosporine (Gengraf, Neoral, Sandimmune), steroids, and other medications.

This medication guide provides information about the Zortress brand of everolimus. Afinitor is another brand of everolimus used to treat kidney cancer.

Everolimus may also be used for purposes not listed in this medication guide.

What are the possible side effects of Zortress (Zortress)?

Serious and sometimes fatal infections may occur during treatment with Zortress. Stop taking this medicine and call your doctor right away if you have signs of infection such as fever, chills, body aches, or flu symptoms.

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.

Call your doctor right away if you have any other serious side effects such as:

• pain in your stomach, groin, lower back or side;
• urinating less than usual or not at all;
• pain or burning when you urinate;
• blood in your urine, dark colored urine, fever with nausea or vomiting;
• redness, warmth, swelling, oozing, or slow healing of a wound or surgical incision;
• new or worsening cough, feeling short of breath;
• wheezing, trouble breathing;
• stabbing chest pain, cough with yellow or green mucus;
• pale skin, feeling light-headed, rapid heart rate, trouble concentrating;
• white patches or sores inside your mouth or on your lips;
• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
• 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, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious side effects may include:

• swelling in your legs, ankles, or feet;
• tired feeling;
• nausea, constipation, diarrhea;
• headache;
• pain in your arms and legs; or
• sleep problems (insomnia).

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.

What is the most important information I should know about Zortress (Zortress)?

This medication guide provides information about the Zortress brand of everolimus. Afinitor is another brand of everolimus used to treat kidney cancer.

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).

Taking Zortress may increase your risk of developing other types of cancer such as lymphoma or skin cancer. Ask your doctor about your individual risk.

Before taking everolimus, tell your doctor if you have liver disease, high cholesterol, a blood clotting disorder, a breathing disorder such as asthma or COPD, a history of skin cancer, or if you are pregnant.

It is not known whether Zortress will harm an unborn baby. Use effective birth control while you are using this medication and for at least 8 weeks after your treatment ends.

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.

Do not receive a "live" vaccine while taking everolimus. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), oral polio, typhoid, chickenpox (varicella), BCG (Bacillus Calmette and Guérin), and nasal flu vaccine.

To be sure this medicine is not causing harmful effects, your blood will need to be tested often. Your kidney function may also need to be tested. Visit your doctor regularly.

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