everolimus (Zortress)

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Pronunciation: E ver OH li mus (ZOR tress)

Brand: Zortress

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

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. Tell your doctor right away if you have: fever with nausea or vomiting, blood in your urine, dark colored urine, little or no urination, jaundice (yellowing of your skin or eyes), or pain in your stomach, groin, lower back, or side.

What is everolimus (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 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.

What should I discuss with my healthcare provider before taking Zortress?

You should not use this medicine 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 Zortress is safe for you, tell your doctor if you have:

  • high cholesterol or triglycerides;
  • liver disease;
  • a personal or family history of skin cancer (melanoma); or
  • if you have ever had a heart transplant.

Using Zortress during pregnancy could harm the unborn baby. Tell your doctor if you are pregnant or if you become pregnant while using this medicine. 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.

How should I take Zortress?

Zortress is usually taken twice daily (every 12 hours). Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

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

Do not stop taking Zortress or change your dose without first talking to your doctor.

Take this medication with a full glass (8 ounces) of water.

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

While using Zortress, you will need frequent blood and urine tests at your doctor's office.

Store at room temperature in the original container, away from moisture, heat, and light. Keep each tablet in its blister pack until you are ready to take it.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

What should I avoid while taking Zortress?

This medicine can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves while cleaning up a patient's 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.

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.

What are the possible side effects of Zortress?

Get emergency medical help if you have 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, 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, 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:

  • changes in your vision;
  • pain or burning when you urinate, red or brown colored urine;
  • redness, warmth, swelling, oozing, or slow healing of a wound or surgical incision;
  • new or worsening cough, wheezing, breathing problems;
  • muscle pain or weakness;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • rapid weight gain, especially in your face and midsection;
  • fluid build-up in the lungs --pain when you breathe, feeling short of breath while lying down, wheezing, gasping for breath, cough with foamy mucus;
  • low red blood cells (anemia) --pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or
  • high blood sugar --increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss.

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.

What other drugs will affect Zortress?

Many drugs can interact with Zortress. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any you start or stop using, 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/AIDS medication;
  • seizure medicine; or
  • tuberculosis medication.

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.

Where can I get more information?

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

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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