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Zortress Warnings and Precautions

People who have diabetes or high cholesterol may not be able to safely take Zortress. Other warnings and precautions involve possible complications this drug may cause, such as lung problems or an increased risk for skin cancer. In addition, you may not be able to safely take this medicine if you are using certain other medications or if you have certain allergies.

What Should I Tell My Healthcare Provider?

You should talk with your healthcare provider prior to taking Zortress® (everolimus) if you have:
 
  • Liver disease, such as hepatitis, cirrhosis, or liver failure
  • Kidney disease, such as kidney failure (renal failure)
  • Had a heart transplant 
  • Diabetes
  • High cholesterol or high triglycerides
  • Skin cancer or a family member who has had skin cancer
  • Genetic problems digesting the sugar galactose, such as glucose-galactose malabsorption or Lapp lactase deficiency
  • An infection of any kind
  • Plans to receive a vaccine
  • A blood clotting disorder
  • Anemia or other blood cell problems
  • Any allergies, including to foods, dyes, or preservatives.
 
Also, let your healthcare provider know if you are:
 
  • Pregnant or thinking of becoming pregnant
  • Breastfeeding.
 
You should also tell your healthcare provider about all other medications you are taking, including prescription and nonprescription medicines, vitamins, and herbal supplements.
 

Specific Precautions and Warnings With Zortress

Some warnings and precautions to be aware of prior to taking this medication include the following:
 
  • You must take this medicine under the direction of a healthcare provider who has experience prescribing medications that suppress the immune system, and in treating people who have had an organ transplant.
 
  • This medication increases your risk for developing skin cancer and lymphoma (cancer of the lymph nodes, part of the body's immune system). Because sun exposure also increases your risk for skin cancer, you should limit sun exposure during treatment. When you are out in the sun, wear sunscreen with a sun protective factor (SPF) of at least 30 and protective clothing, such as hats, long pants, and long sleeves.

Contact your healthcare provider if you notice any skin changes or develop lumps in your neck, underarms, or groin area.

  • People who took this medication after having a heart transplant had an increased risk for death due to serious infections. Therefore, Zortress is not recommended to prevent transplant rejection after a heart transplant.

  

  • Zortress weakens the immune system, which could make you more likely to get infections, including potentially serious or life-threatening bacterial, viral, or fungal infections. You may become infected with the BK virus, which is a virus that can damage your kidneys and cause your new kidney to fail. Contact your healthcare provider right away if you develop symptoms of an infection, such as fever, body aches, or chills, or if you think you might have an infection.
 
  • Zortress may cause a potentially serious reaction known as angioedema. This condition causes swelling beneath the skin, usually around the mouth, eyes, and throat. Your risk for angioedema is higher if you take Zortress with an angiotensin-converting enzyme (ACE) inhibitor (see Zortress Drug Interactions). Seek immediate medical attention if you develop:

 

    • Hives or welts
    • Swelling of the face, tongue, mouth, or throat
    • Problems breathing.
 
  • You may develop a blood clot in the blood vessels of your new kidney, which could cause your transplant to be unsuccessful. This problem is most likely to occur in the first 30 days after your transplant surgery. Contact your healthcare provider right away if you:
 
    • Experience pain in your lower back, side, abdomen (stomach), or groin
    • Cannot urinate or urinate less often
    • Have blood in your urine or dark-colored urine
    • Develop fever, nausea, or vomiting.
 
  • Zortress can delay wound healing and increase the risk for wound problems, such as infections. Contact your healthcare provider if your surgical cut (incision site):

 

    • Does not seem to be healing
    • Becomes red, swollen, or painful
    • Fills with pus, fluid, or blood
    • Opens up.
 
  • People who take Zortress may develop high cholesterol (increased lipids in the blood). Your healthcare provider will need to monitor your blood cholesterol during treatment with a simple blood test, and may recommend certain exercise, diet changes, or medication if you develop high cholesterol.
 
  • Zortress is always taken in combination with cyclosporine. However, this combination of medicines can cause kidney problems. You will need to take lower doses of cyclosporine to reduce your risk of kidney damage. Your healthcare provider will monitor how well your kidneys are working, as well as your cyclosporine and Zortress blood levels, and adjust your dose of either medicine if necessary.
 
  • The combination of Zortress and cyclosporine can also lead to problems with blood clots and low blood cell counts (low platelets and red blood cells). The blood clots could damage your kidneys and blood vessels. Your healthcare provider will periodically monitor you with blood tests for these problems. Contact your healthcare provider if you develop unusual bruising or bleeding, or red or purple spots on the skin.
 
  • Zortress can cause serious and potentially life-threatening lung problems. Contact your healthcare provider right away if you develop any breathing problems, such as wheezing, shortness of breath, a new or worsening cough, or chest pain. Your healthcare provider may temporarily stop Zortress treatment or lower your dose.
 
  • People taking this medication may have an increased risk for developing diabetes. Contact your healthcare provider if you experience any signs of diabetes, such as:
 
    • Frequent urination
    • Increased thirst or hunger
    • Weight loss
    • Blurry vision.
 
  • This medication can cause a condition known as proteinuria, which occurs when there is an abnormal amount of protein in the urine. Proteinuria is a sign of kidney disease. Contact your healthcare provider if you notice foamy urine or swelling of the arms, hands, feet, legs, or other areas of the body.
 
  • You should know that Zortress can decrease sperm count in men, which could cause infertility.
 
  • Zortress can increase the risk of a blood clot in the artery that supplies blood to the liver (this is known as hepatic artery thrombosis). Most cases have occurred within 30 days after a liver transplant. For this reason, Zortress should be started no sooner than 30 days after a liver transplantation.
 
  • People with a rare genetic condition that causes galactose intolerance should not take this medication. Doing so could cause diarrhea and problems absorbing certain nutrients from food.
 
  • People taking Zortress should not receive certain vaccinations or immunizations (see Zortress Drug Interactions). Check with your healthcare provider before getting any vaccine while taking this medication.
 
 
  • Zortress is a pregnancy Category C medication. This means it may not be safe for use during pregnancy. Talk to your healthcare provider about the risks and benefits of using this medicine during pregnancy (see Zortress and Pregnancy).
 
  • It is unknown if Zortress passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to taking the drug (see Zortress and Breastfeeding).
 
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