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Zortress (Everolimus) - Summary

 
 



WARNING IMMUNOSUPPRESSION, RENAL FUNCTION, AND GRAFT THROMBOSIS

Increased susceptibility to infection and the possible development of malignancies such as lymphomaand skin cancer may result from immunosuppression.[ See Warnings and Precautions (5. 2 ) ]

• Only physicians experienced in immunosuppressive therapy and management of transplant patients should prescribe Zortress. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient. [ See Warnings and Precautions (5.1) ]

• Increased nephrotoxicity can occur with use of standard doses of cyclosporine in combination with everolimus. Therefore reduced doses of cyclosporine should be used in combination with everolimus in order to reduce renal dysfunction. It is important to monitor the cyclosporine and everolimus whole blood trough concentrations.[ See Dosage and Administration (2.2 and 2.3) and Warnings and Precautions (5.8) and Clinical Pharmacology (12.5 and 12.6) ]

• An increased risk of kidney arterial and venous thrombosis, resulting in graft loss, was reported, mostly within the first 30 days post-transplantation. [ See Warnings and Precautions (5.5) ]

 

ZORTRESS SUMMARY

Zortress (everolimus) is a macrolide immunosuppressant.

Zortress (EVEROLIMUS) is indicated for the following:

- Prophylaxis of organ rejection in adult patients at low-moderate immunologic risk receiving a kidney transplant.

- Use in combination with basiliximab and concurrently with reduced doses of cyclosporine and corticosteroids. (1.1)

- Use in patients at high immunologic risk is not established.

- Use for prophylaxis in organs other than kidney is not established.

- Safety and efficacy in pediatric patients (<18 years) has not been established.
See all Zortress indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Zortress (Everolimus)

FDA OKs New Kids' Dose of Cancer Drug
Source: MedPage Today Product Alert [2012.08.30]
WASHINGTON -- The FDA has approved a pediatric dosage of the cancer drug everolimus (Afinitor Disperz) for the treatment of a rare brain tumor.

Innovative kidney transplant technique developed by Henry Ford Hospital
Source: Transplants / Organ Donations News From Medical News Today [2014.04.09]
An innovative kidney transplant technique developed by Henry Ford Hospital is credited as the first in the world to use a new set of patient safety standards coordinated by the University of Oxford...

more news >>

Published Studies Related to Zortress (Everolimus)

Efficacy and safety of everolimus for subependymal giant cell astrocytomas associated with tuberous sclerosis complex (EXIST-1): a multicentre, randomised, placebo-controlled phase 3 trial. [2013]
subependymal giant cell astrocytomas associated with tuberous sclerosis complex... INTERPRETATION: These results support the use of everolimus for subependymal

Everolimus for advanced pancreatic neuroendocrine tumours: a subgroup analysis evaluating Japanese patients in the RADIANT-3 trial. [2012]
enrolled in the RADIANT-3 study... CONCLUSIONS: These results support the use of everolimus as a valuable treatment

Long-term response with everolimus for metastatic renal cell carcinoma refractory to sunitinib. [2011.12]
A 70-year-old man with metastatic renal cell carcinoma developed progressive liver metastases after 8 weeks of treatment with the multitargeted tyrosine kinase inhibitor (TKI) sunitinib... This case illustrates the potential for patients with metastatic renal cell carcinoma, a malignancy with historically poor prognosis, to derive long-term benefit from everolimus when used in a manner consistent with its approved indication (after TKI therapy with sunitinib or sorafenib).

Impact of Lesion Length and Vessel Size on Clinical Outcomes After Percutaneous Coronary Intervention With Everolimus- Versus Paclitaxel-Eluting Stents Pooled Analysis From the SPIRIT (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) and COMPARE (Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice) Randomized Trials. [2011.11]
OBJECTIVES: The aim of this study was to investigate the impact of reference vessel diameter (RVD) and lesion length (LL) on the relative safety and efficacy of everolimus-eluting stents (EES) and paclitaxel-eluting stents (PES). BACKGROUND: Lesion length and RVD are well-known predictors of adverse events after percutaneous coronary intervention... CONCLUSIONS: Patients with short lesions in large vessels have low rates of MACE at 2 years after treatment with either EES or PES. In higher-risk patients with long lesions and/or small vessels, EES results in significant improvements in both clinical safety and efficacy outcomes. (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions; NCT00180310; SPIRIT III: A Clinical Evaluation of the Investigational Device XIENCE V Everolimus Eluting Coronary Stent System [EECSS] in the Treatment of Subjects With de Novo Native Coronary Artery Lesions; NCT00180479; SPIRIT IV Clinical Trial: Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions; NCT00307047; A Randomized Controlled Trial of Everolimus-eluting Stents and Paclitaxel-eluting Stents for Coronary Revascularization in Daily Practice: The COMPARE Trial; NCT01016041). Copyright (c) 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Biodegradable polymer versus permanent polymer drug-eluting stents and everolimus- versus sirolimus-eluting stents in patients with coronary artery disease: 3-year outcomes from a randomized clinical trial. [2011.09.20]
OBJECTIVES: The aim of this study was to compare the 3-year efficacy and safety of biodegradable polymer with permanent polymer stents and of everolimus-eluting stents (EES) with sirolimus-eluting stents (SES). BACKGROUND: Biodegradable polymer drug-eluting stents (DES) offer potential for enhanced late outcomes in comparison with permanent polymer stents. In addition, there is increasing interest in the comparison of EES (Xience, Abbott Vascular, Abbott Park, Illinois) versus SES (Cypher, Cordis Corporation, Miami Lakes, Florida)... CONCLUSIONS: Biodegradable polymer and permanent polymer DES are associated with similar clinical outcomes at 3 years. In addition, EES are comparable to SES in terms of overall clinical efficacy and safety. (Intracoronary Stenting and Angiographic Results: Test Efficacy of 3 Limus-Eluting STents [ISAR-TEST 4]: Prospective, Randomized Trial of 3-limus Agent-eluting Stents With Different Polymer Coatings; NCT00598676). Copyright (c) 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

more studies >>

Clinical Trials Related to Zortress (Everolimus)

A Safety Study of LBH589 (Panobinostat) and RAD001 (Everolimus) to Stabilize Kidney Cancer [Recruiting]
This study will see how these two commonly used treatments (Everolimus and Panobinostat) work together in treating kidney cancer. These two drugs have already progressed through the earliest types of research trials, such as a dose finding trial. We will combine these drugs at doses that were found to be safe when given alone, and will watch participants carefully to determine how well this drug combination is working to control your kidney cancer.

A Pilot Study Evaluating the Use of mTor Inhibitor Sirolimus in Children and Young Adults With Desmoid-Type Fibromatosis [Recruiting]
Desmoid-type fibromatosis (or desmoid tumor) represents an intermediate grade neoplasm with a striking predilection for locally invasive growth and recurrence following resection. It occurs in children as well as young adults. As a typically localized disease, the historical standard of care for treatment has been surgical resection, with or without ionizing radiation. In some cases where surgical resection or radiation is not feasible, chemotherapy has been used. Two clinical trials conducted in the Pediatric Oncology Group (POG) and the Children's Oncology Group (COG) evaluated the role for either low intensity or non-cytotoxic chemotherapy for children with desmoid tumor that is not amenable to standard therapy. These were largely empirical treatment strategies or based on somewhat anecdotal observations. By better understanding desmoid tumor biology, even more effective therapy targeting a particular protein that is central to the disease can be developed.

Desmoid tumor is well-known to be associated with deregulation of the Adematous Polyposis Cell/beta-catenin (APC/β-catenin pathway). This is true of familial cases associated with Gardner's Syndrome and also in sporadic desmoid tumor, nearly all of which display histological or molecular evidence of Adematous Polyposis Cell/beta-catenin (APC β-catenin) pathway activation (Alman et al., 1997; Lips et al., 2009). Several new pieces of evidence support the concept that deregulation of the mammalian target of rapamycin (mTOR) cell proliferation/survival pathway may play an important role in tumor biology when the APC/β-catenin pathway is disrupted. Sirolimus, a drug that inhibits mammalian target of rapamycin (mTOR), is currently being evaluated as an anti-cancer agent in a variety of tumor types, but it has not been previously studied in desmoid tumor.

The investigators are conducting this pilot study to begin to explore whether mTOR inhibition may be beneficial for children and young adults with desmoid tumor.

A Study of Temsirolimus Plus Capecitabine in Patients With Advanced Cancer [Recruiting]
This study is for people with advanced cancer for which no curative treatment exists.

The purpose of this study is to test the safety and effectiveness of the combination of the drugs Temsirolimus and Capecitabine and see what effects it has on cancer.

Temsirolimus is a drug that is given by vein that targets a protein important for the growth of cancer cells known as mTOR. By inhibiting this protein, Temsirolimus can inhibit cancer cell growth and even lead to their death.

Capecitabine is a more traditional chemotherapy. It is an oral pill that gets converted in the body to the very common chemotherapy known as 5-fluorouracil.

This research is being done because it is not known if the combination of Temsirolimus and Capecitabine will work better than Capecitabine or Temsirolimus alone.

Torisel in Addition to Standard Chemotherapy With Radiation for Advanced Head and Neck Cancer [Recruiting]
Patients with advanced head and neck cancer is at high risk of recurrence at the primary site or in the neck. Part of normal treatment is to treat such patients with chemotherapy and radiation. The chemotherapy can include Erbitux. The purpose of this study is to treat such patients with an additional agent, Torisel. This study tests the doses of Torisel that can be safely administered together with radiation and chemotherapy.

Trial to Evaluate Paclitaxel Plus RAD001 in Urothelial Carcinoma [Recruiting]
This is a single arm open- label phase II- trial evaluating safety and efficacy of paclitaxel and RAD001 in patients with metastatic urothelial bladder cancer who failed prior platin-based systemic therapy.

more trials >>

Reports of Suspected Zortress (Everolimus) Side Effects

Liver Transplant Rejection (13)Pancytopenia (9)Abdominal Pain (8)Liver Function Test Abnormal (8)Pyrexia (7)Anaemia (7)Transaminases Increased (6)Thrombocytopenia (6)Hepatic Enzyme Increased (6)Hepatitis C (5)more >>


Page last updated: 2014-04-09

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