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U.S. Department of Health and Human Services

Safety

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Zortress (Everolimus) Tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) –

February 2013

Summary View

 

WARNINGS AND PRECAUTIONS

Hepatic Artery Thrombosis
  • Mammalian target of rapamycin (mTOR) inhibitors are associated with an increase in hepatic artery thrombosis (HAT). Reported cases mostly have occurred within the first 30 days post-transplant and most also lead to graft loss or death. Therefore, Zortress should not be administered earlier than 30 days after liver transplant.

 

October 2012

Summary View

 

ADVERSE REACTIONS

Post Marketing Experience
  • pulmonary embolism

 

April 2012

Summary View

 

BOXED WARNING:

  • MALIGNANCIES AND SERIOUS INFECTIONS, KIDNEY GRAFT THROMBOSIS; NEPHROTOXICITY; AND MORTALITY IN HEART TRANSPLANTATION
Malignancies and Serious Infections
  • Increased susceptibility to infection and the possible development of malignancies such as lymphoma and skin cancer may result from immunosuppression
Kidney Graft Thrombosis
  • An increased risk of kidney arterial and venous thrombosis, resulting in graft loss, was reported, mostly within the first 30 days post-transplantation.
 

WARNINGS AND PRECAUTIONS

Heart Transplantation
  • In a clinical trial of de novo heart transplant patients, Zortress in an immunosuppressive regimen with or without induction therapy, resulted in an increased mortality often associated with serious infections within the first three months post-transplantation compared to the control regimen. Use of Zortress in heart transplantation is not recommended.
Polyoma Virus Infections
  • Polyoma virus infections in transplant patients may have serious, and sometimes fatal, outcomes. These include polyoma virus-associated nephropathy (PVAN), mostly due to BK virus infection, and JC virus associated progressive multiple leukoencephalopathy (PML)… PVAN or PML. Physicians should also consider the risk that reduced immunosuppression represents to the functioning allograft.
 

MEDICATION GUIDE

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