
The US Food and Drug Administration
(FDA) has approved Zortress (everolimus) oral tablets for the prevention of rejection of kidney transplants in adult patients at low-to-moderate immunologic risk.
Zortress is to be given in combination with reduced doses of the calcineurin inhibitor (CNI) cyclosporine, as well as basiliximab and corticosteroids.
Zortress Medication Guide
Read this Medication Guide before you start using Zortress and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or treatment.
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 for 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).
o Call your doctor if you have symptoms of infection including fever or chills.
• Serious problems with your transplanted kidney (nephrotoxicity). You will need to start with a lower dose of cyclosporine.
• 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:
o have pain in your groin, lower back, side or stomach (abdomen)
o make less urine or you do not pass any urine
o have blood in your urine or dark colored urine (tea-colored)
o have fever, nausea, or vomiting