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Zortress

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Zortress

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Zortress (everolimus)

WARNING

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]
  • Only physicians experienced in immunosuppressive therapy and management of transplant patients should prescribe Zortress (everolimus) . 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]
  • 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 and WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY]
  • 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]

DRUG DESCRIPTION

Zortress (everolimus) is a macrolide immunosuppressant.

The chemical name of everolimus is

(1R, 9S, 12S, 15R, 16E, 18R, 19R, 21R, 23S, 24E, 26E, 28E, 30S, 32S, 35R)-1, 18-dihydroxy-12 -{(1R)- 2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15, 17, 21, 23, 29, 35-hexamethyl-11, 36-dioxa-4-aza-tricyclo[30.3.1.04,9] hexatriaconta-16,24,26,28-tetraene-2, 3,10,14,20-pentaone.

The molecular formula is C53H83NO14 and the molecular weight is 958.25. The structural formula is

Zortress (everolimus) Structural Formula Illustration

Everolimus is supplied as tablets for oral administration containing 0.25 mg, 0.5 mg and 0.75 mg of everolimus together with butylated hydroxytoluene, magnesium stearate, lactose monohydrate, hypromellose, crospovidone and lactose anhydrous as inactive ingredients.

What are the precautions when taking everolimus (Zortress)?

Before taking everolimus, tell your doctor or pharmacist if you are allergic to it; or to sirolimus or temsirolimus; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: high cholesterol/triglyceride levels, any recent/current infections, diabetes, liver disease, certain hereditary enzyme problems (galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption).

Everolimus can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact...

Read All Potential Precautions of Zortress »

Last reviewed on RxList: 5/6/2010
This monograph has been modified to include the generic and brand name in many instances.

Zortress - User Reviews

Zortress User Reviews

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