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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 lymphoma and 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.

Success of kidney transplants may be predicted by genetic marker
Source: Transplants / Organ Donations News From Medical News Today [2014.12.04]
Kidneys donated by people born with a small variation in the code of a key gene may be more likely, once in the transplant recipient, to accumulate scar tissue that contributes to kidney failure...

New U.S. Kidney Transplant Rules Take Effect
Source: MedicineNet Kidney Failure Specialty [2014.12.04]
Title: New U.S. Kidney Transplant Rules Take Effect
Category: Health News
Created: 12/4/2014 12:00:00 AM
Last Editorial Review: 12/4/2014 12:00:00 AM

Administration of antibiotic following kidney transplantation does not prevent virus infection
Source: Transplants / Organ Donations News From Medical News Today [2014.11.17]
Among kidney transplant recipients, a 3-month course of the antibiotic levofloxacin following transplantation did not prevent the major complication known as BK virus from appearing in the urine.

Gene Test May Spot Which Kidney Transplants More Likely to Fail
Source: MedicineNet Kidney Failure Specialty [2014.11.12]
Title: Gene Test May Spot Which Kidney Transplants More Likely to Fail
Category: Health News
Created: 11/11/2014 12:00:00 AM
Last Editorial Review: 11/12/2014 12:00:00 AM

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 plus exemestane in postmenopausal patients with HR(+) breast cancer: BOLERO-2 final progression-free survival analysis. [2013]
this patient population... CONCLUSION: The addition of everolimus to exemestane markedly prolonged PFS in

Everolimus for previously treated advanced gastric cancer: results of the randomized, double-blind, phase III GRANITE-1 study. [2013]
gastric cancer... CONCLUSION: Compared with BSC, everolimus did not significantly improve overall

Health-related quality of life of patients with advanced breast cancer treated with everolimus plus exemestane versus placebo plus exemestane in the phase 3, randomized, controlled, BOLERO-2 trial. [2013]
(HRQOL)... CONCLUSIONS: In patients with advanced breast cancer who develop disease

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

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 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.

Dose Escalation Study of RAD001 in Combination w/Chemotherapy & Radiation in Patients With NSCLC [Recruiting]
The purpose of this study is to understand the effects (good and/or bad) of the addition of RAD001 to standard radiation and chemotherapy (cisplatin and pemetrexed) for patients with non-small cell lung cancer.

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: 2014-12-04

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