Recommended Topic Related To:

Zortress

"The U.S. Food and Drug Administration today approved Liposorber LA-15 System to treat pediatric patients with primary focal segmental glomerulosclerosis (FSGS) either before transplant, or after renal (kidney) transplantation in which there is re"...

Zortress

ZORTRESS
(everolimus) Tablets

WARNING

MALIGNANCIES AND SERIOUS INFECTIONS, KIDNEY GRAFT THROMBOSIS; NEPHROTOXICITY; AND MORTALITY IN HEART TRANSPLANTATION

Malignancies and Serious Infections

  • 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]
  • Increased susceptibility to infection and the possible development of malignancies such as lymphoma and skin cancer may result from immunosuppression. [See WARNINGS AND PRECAUTIONS]

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. [See WARNINGS AND PRECAUTIONS]

Nephrotoxicity

  • Increased nephrotoxicity can occur with use of standard doses of cyclosporine in combination with Zortress. Therefore reduced doses of cyclosporine should be used in combination with Zortress 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]

Mortality in Heart Transplantation

  • Increased mortality, often associated with serious infections, within the first three months post-transplantation was observed in a clinical trial of de novo heart transplant patients receiving immunosuppressive regimens with or without induction therapy. Use in heart transplantation is not recommended. [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, 36dioxa-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

Zortress 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 possible side effects of Zortress (Zortress)?

Serious and sometimes fatal infections may occur during treatment with Zortress. Stop taking this medicine and call your doctor right away if you have signs of infection such as fever, chills, body aches, or flu symptoms.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; chest pain, difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor right away if you have any other serious side effects such as:

  • pain in your stomach, groin, lower back or side;
  • urinating less than usual or not at...

Read All Potential Side Effects and See Pictures of Zortress »

What are the precautions when taking everolimus (Zortress)?

See also Warning section.

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...

Read All Potential Precautions of Zortress »

Last reviewed on RxList: 3/6/2013
This monograph has been modified to include the generic and brand name in many instances.

A A A

Zortress - User Reviews

Zortress User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Zortress sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Women's Health

Find out what women really need.