Precautions and Warnings With Everolimus

Specific Everolimus Warnings and Precautions

Some warnings and precautions to be aware of prior to taking this medication include the following:
 
  • People who took this medication after having a heart transplant had an increased risk for death due to serious infections. Therefore, everolimus is not recommended to prevent transplant rejection after a heart transplant.

  

  • Everolimus 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 everolimus treatment or lower your dose.
 
  • Everolimus weakens the immune system, which could increase your risk for 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 after a kidney transplant. Also, if you have had hepatitis B in the past, everolimus may reactivate your hepatitis B infection. Contact your healthcare provider right away if you develop signs of an infection, such as fever, body aches, or chills.
 
  • Everolimus can delay wound healing and increase the risk for wound problems, such as infections. Contact your healthcare provider if you have wounds or sores that do not heal, or if you had a kidney transplant and your surgical cut (incision site):
 
    • Does not seem to be healing
    • Becomes red, swollen, or painful
    • Fills with pus, fluid, or blood
    • Opens up.
 
  • Everolimus can cause mouth sores and ulcers. Tell your healthcare provider about any pain, sores, or swelling in your mouth. Do not use any mouthwashes that contain alcohol or peroxide, as they can worsen the problem.
 
  • Everolimus 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, everolimus should be started no sooner than 30 days after a liver transplantation.
 
  • 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.

 

  • Your healthcare provider will test your blood periodically during treatment to monitor you for high cholesterol, diabetes, low blood cell counts, kidney problems, and other everolimus side effects. He or she may also want to check your everolimus blood levels. Therefore, it is important to keep all of your healthcare appointments.
 
  • 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.
 
  • If you are taking everolimus after a kidney transplant, you must take it under the direction of a healthcare provider who has experience prescribing medicines that suppress the immune system and treating people who have had an organ transplant.
 
  • Everolimus 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 everolimus with an angiotensin-converting enzyme (ACE) inhibitor (see Drug Interactions With Everolimus). Seek immediate medical attention if you develop:
 
    • Hives or welts
    • Swelling of the face, tongue, mouth, or throat
    • Problems breathing.
 
  • People taking everolimus should not receive certain vaccinations or immunizations (see Drug Interactions With Everolimus). Check with your healthcare provider before getting any vaccination while taking this medication, or if you will be in close contact with someone who will be receiving a vaccination.
 
  • If you are taking everolimus after a kidney transplant, you may develop a blood clot in the blood vessels of your new kidney, which could cause your transplant to be unsuccessful. Although this problem is most likely to occur in the first 30 days after your surgery, it can happen at any time. 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.
 
  • You should know that everolimus can decrease sperm count in men, which could lead to infertility.
 
  • Talk to your healthcare provider prior to treatment if you have a galactose intolerance. You may not be able to take this medicine.
 
 
  • It is unknown if everolimus 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 Everolimus and Breastfeeding).
 
  • Everolimus is a pregnancy Category C or D medication (depending on the particular everolimus product), which means it may not be safe for use during pregnancy. If you are pregnant or thinking about becoming pregnant, talk to your healthcare provider prior to taking this medicine (see Everolimus and Pregnancy).
 
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Everolimus Drug Information

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