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About ZORTRESS1

ZORTRESS is a prescription medicine used to prevent transplant rejection (antirejection medicine) in people who have received a kidney or liver transplant. Transplant rejection happens when the body’s immune system perceives the new transplanted kidney or liver as “foreign” and attacks it.

ZORTRESS is used with other transplant medications called cyclosporine, corticosteroids, and certain other transplant medicines, to prevent rejection of your transplanted kidney. ZORTRESS is also used with other transplant medicines called tacrolimus and corticosteroids to prevent rejection of your transplanted liver.

  • It is not known if ZORTRESS is safe and effective in transplanted organs other than the kidney and liver
  • It is not known if ZORTRESS is safe and effective in children under 18 years of age

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Important Safety Information & Indication

IMPORTANT SAFETY INFORMATION

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

ZORTRESS can cause serious side effects, including:

  • Increased risk of getting certain cancers. People who take ZORTRESS have a higher chance of getting lymphoma and other cancers, especially skin cancer. Talk to your doctor about your risk of cancer
  • Increased risk of serious infections. ZORTRESS weakens the body’s immune system and affects your ability to fight infections. Serious infections can happen with ZORTRESS that may lead to death. People taking ZORTRESS have a higher chance of getting infections caused by viruses, bacteria, and fungi (yeast). Call your doctor if you have symptoms of infection including fever or chills

For kidney transplant patients only:

  • Blood clot in the blood vessels of your transplanted kidney. If this happens, it usually occurs within the first 30 days after your kidney transplant. Tell your doctor right away if you have pain in your groin, lower back, side or stomach (abdomen); make less urine or you do not pass any urine; have blood in your urine or dark-colored urine (tea-colored); have fever, nausea, or vomiting
  • Serious problems with your transplanted kidney (nephrotoxicity). You will need to start with a lower dose of cyclosporine when you take it with ZORTRESS. Your doctor should do regular blood tests to check your levels of both ZORTRESS and cyclosporine

For heart transplant patients only:

  • Increased risk of death that can be related to infection, in people who have had a heart transplant. You should not take ZORTRESS if you have had a heart transplant, without talking to your doctor

Do not take ZORTRESS if you are allergic to everolimus (ZORTRESS/AFINITOR®) or any of the ingredients in ZORTRESS or sirolimus (Rapamune®).

Before taking ZORTRESS, tell your doctor if you have liver problems; have skin cancer or it runs in your family; have high cholesterol or triglycerides (fat in your blood); have Lapp lactase deficiency or glucose-galactose malabsorption; have any other medical conditions; are pregnant or plan to become pregnant. It is not known if ZORTRESS will harm your unborn baby. Women who may become pregnant should use effective birth control (contraception) while taking ZORTRESS and for 8 weeks after stopping ZORTRESS. Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if ZORTRESS passes into your breast milk. You and your doctor should decide if you will take ZORTRESS or breastfeed. You should not do both.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. ZORTRESS may affect the way other medicines work, and other medicines may affect how ZORTRESS works. Especially tell your doctor if you take antifungal medicine, antibiotic medicine, heart medicine, high blood pressure medicine, a medicine to lower cholesterol or triglycerides, cyclosporine (Sandimmune, Gengraf, Neoral), tuberculosis (TB) medicine, HIV medicine, St. John's Wort, or seizure (anticonvulsant) medicine.

What should I avoid while taking ZORTRESS?

  • Avoid receiving any live vaccines while taking ZORTRESS
  • Do not eat grapefruit or drink grapefruit juice while you are taking ZORTRESS
  • Limit the amount of time you spend in the sunlight. Avoid using tanning beds or sunlamps. People who take ZORTRESS have a higher risk of getting skin cancer. Wear protective clothing when you are in the sun and use a sunscreen with a high protection factor (SPF 30 and above). This is especially important if you have fair skin or if you have a family history of skin cancer
  • Avoid becoming pregnant

What are possible side effects of ZORTRESS?ZORTRESS can cause serious side effects, including:

  • Swelling under your skin especially around your mouth, eyes, and in your throat (angioedema). Your chance of having swelling under your skin is higher if you take ZORTRESS along with certain other medicines. Tell your doctor right away or go to the nearest emergency room if you have any of these symptoms of angioedema: sudden swelling of your face, mouth, throat, tongue or hands; hives or welts; itchy or painful swollen skin; trouble breathing
  • Delayed wound healing. ZORTRESS can cause your incision to heal slowly or not heal well. Call your doctor right away if you have any of the following symptoms: your incision is red, warm or painful; blood, fluid, or pus in your incision; your incision opens up; swelling of your incision
  • Lung or breathing problems. Tell your doctor right away if you have new or worsening cough, shortness of breath, difficulty breathing or wheezing. In some patients lung or breathing problems have been severe, and can even lead to death. Your doctor may need to stop ZORTRESS or lower your dose
  • Increased cholesterol and triglycerides (fat in your blood). If your cholesterol and triglyceride levels are high, your doctor may want to lower them with diet, exercise and certain medicines
  • Protein in your urine (proteinuria)
  • Change in kidney function. ZORTRESS may cause kidney problems when taken along with a standard dose of cyclosporine medicine instead of a lower dose

Your doctor should do blood and urine tests to monitor your cholesterol, triglycerides, and kidney function.

  • Viral infections. Certain viruses can live in your body and cause active infections when your immune system is weak. Viral infections that can happen with ZORTRESS include BK virus-associated nephropathy. BK virus can affect how your kidney works and cause your transplanted kidney to fail
  • Blood clotting problems
  • Diabetes. Tell your doctor if you have frequent urination, increased thirst or hunger
  • Male infertility (low or no sperm count)

These common side effects have been reported in both kidney and liver transplant patients: nausea, swelling of the lower legs, ankles, and feet, and high blood pressure.

The most common side effects of ZORTRESS in people who have had a kidney transplant include constipation, low red blood cell count (anemia), urinary tract infection, and increased fat in the blood (cholesterol and triglycerides).

The most common side effects of ZORTRESS in people who have had a liver transplant include diarrhea, headache, fever, abdominal pain, and low white blood cells.

These are not all of the possible side effects of ZORTRESS. Tell your doctor about any side effect that bothers you or that does not go away.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

INDICATION

What is ZORTRESS® (everolimus) Tablets?

ZORTRESS is a prescription medicine used to prevent transplant rejection (antirejection medicine) in people who have received a kidney transplant or liver transplant.

ZORTRESS is used with other medicines called cyclosporine, corticosteroids and certain other transplant medicines to prevent rejection of your transplanted kidney. ZORTRESS is used with other medicines called tacrolimus and corticosteroids to prevent rejection of your transplanted liver.

It is not known if ZORTRESS is safe and effective in transplanted organs other than the kidney and liver.

It is not known if ZORTRESS is safe and effective in children under 18 years of age.

Please click here for Important Product Information, including Boxed WARNINGS and Medication Guide.

Reference: 1. ZORTRESS [prescribing information]. East Hanover NJ: Novartis Pharmaceuticals Corp; 2015.

Gengraf is a registered trademark of AbbVie Inc.

Rapamune is a registered trademark of Pfizer Inc.