Everolimus

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 or liver transplant. Zortress is used together with cyclosporine, steroids, and other medications.

Afinitor is another brand of everolimus used to treat certain types of cancer. This medication guide provides information only about about Zortress.

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

You should not use Zortress if you are allergic to everolimus or sirolimus.

Using Zortress can increase your risk of serious infections or getting certain cancers, such as lymphoma or skin cancer. Ask your doctor about your specific risk.

Tell your doctor if you have ever had:

• problems digesting lactose or galactose (sugar);
• high cholesterol or triglycerides;
• liver disease;
• a heart transplant; or
• skin cancer in you or a family member.

Zortress may harm an unborn baby. Use effective birth control while you are using this medicine and for at least 8 weeks after your last dose. Tell your doctor if you become pregnant.

This medicine may affect fertility (ability to have children) in both men and women. However, it is important for women to use birth control because Zortress may harm the baby if a pregnancy does occur.

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.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Take Zortress at evenly spaced times with a full glass (8 ounces) of water.

Take the medicine with or without food, but the same way each time. If you also take cyclosporine or tacrolimus, take both medications at the same time.

Do not crush or chew an everolimus tablet. Swallow the pill whole.

You will need frequent medical tests.

Do not change doses or stop taking any of your medications without asking your doctor.

Store at room temperature away from moisture, heat, and light.

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Do not receive a "live" vaccine while using Zortress. The vaccine may not work as well and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), polio, 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 may interact with Zortress and lead to unwanted side effects. Avoid the use of grapefruit and grapefruit juice while taking Zortress.

Get emergency medical help if you have signs of an allergic reaction: hives, itching, skin pain; difficult breathing; swelling in your hands, 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, swollen glands, 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: fever with nausea or vomiting, blood in your urine, dark colored urine, little or no urination, or pain in your stomach, groin, lower back, or side.

Call your doctor at once if you have:

• new or worsening cough, wheezing, breathing problems;
• redness, warmth, swelling, oozing, or slow healing of a wound or surgical incision;
• easy bruising, unusual bleeding;
• high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor, headache, blurred vision; or
• low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.

Common side effects may include:

• swelling in your legs, ankles, or feet;
• anemia, infections;
• urination problems;
• high blood pressure, increased cholesterol or triglycerides;
• stomach pain, nausea, diarrhea, constipation; or
• headache.

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.

Tell your doctor about all your current medicines. Many drugs can affect Zortress, especially:

• cyclosporine or others medicine to prevent organ transplant rejection;
• St. John's wort;
• an antibiotic or antifungal medicine;
• cholesterol medication;
• heart or blood pressure medicine;
• HIV medication;
• seizure medicine; or
• tuberculosis medication.

This list is not complete and many other drugs may affect Zortress. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Your pharmacist can provide more information about everolimus (Zortress).