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Everolimus (By mouth)

Everolimus (e-ver-OH-li-mus)

Treats cancer, including cancer of the kidneys, pancreas, breasts, and brain. Used with other medicines to keep your body from rejecting a transplanted kidney or liver.

Brand Name(s):

Afinitor, Afinitor Disperz, Zortress

There may be other brand names for this medicine.

When This Medicine Should Not Be Used:

This medicine is not right for everyone. Do not use it if you had an allergic reaction to everolimus or similar medicines, or if you are pregnant.

How to Use This Medicine:

Tablet, Tablet for Suspension

  • Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
  • Take this medicine the same way every day. This means take it at the same time, and always take it with food or always without food.
  • Swallow the regular tablet whole with a glass of water. Do not crush, break, or chew it.
  • Do not swallow the tablet for suspension. It must be dissolved in water before you take it. Once dissolved, the mixture must be used within 60 minutes. If it is not, throw that dose away and prepare another. If you are preparing the oral suspension for another person, wear disposable gloves. There are 2 ways to prepare the suspension:
    • Small glass: Put the tablet in a cup that contains 25 mL (milliliters) water. Do not break or crush the tablet. Wait 3 minutes, and then gently stir the mixture to break up the tablet. Drink the mixture right away. Refill the glass with the same amount of water and drink it right away so you get all the medicine.
    • Oral syringe: Follow the directions that came with your medicine. Dissolve the tablet inside a 10 mL syringe, using 5 mL water and 4 mL of air. The tablet will take 3 minutes to dissolve. Slowly turn the syringe up and down 5 times. Place the syringe in the mouth and slowly give the dose. Fill the syringe with water and air again, and give this to the patient to make sure all of the medicine is taken. Use a new syringe for each dose.
  • Do not use the regular tablet and the tablet for suspension together. Use only one form of this medicine.
  • If you have a kidney or liver transplant, you may have to take this medicine for the rest of your life to prevent rejection of the organ. Do not change your dose or stop taking this medicine without talking to your doctor. Take all other medicines that are part of your transplant treatment, especially ones that you need to take at the same time as everolimus.
  • Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
  • Missed dose:
    • If you miss a dose of Zortress®, take it as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
    • If you miss a dose of Afinitor® or Afinitor® Disperz and it is less than 6 hours from the time you normally take it, you may still take the dose. If it is more than 6 hours, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
  • Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep your medicine in the original package until you are ready to use it.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

  • Some foods and medicines can affect how everolimus works. Tell your doctor if you are using amprenavir, aprepitant, atazanavir, carbamazepine, clarithromycin, cyclosporine, dexamethasone, digoxin, diltiazem, erythromycin, fluconazole, fosamprenavir, indinavir, itraconazole, ketoconazole, midazolam, nefazodone, nelfinavir, octreotide, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, ritonavir, saquinavir, St John's wort, telithromycin, verapamil, or voriconazole.
  • Tell your doctor if you are taking a corticosteroid (such as prednisone, prednisolone, dexamethasone) or another medicine that may weaken your immune system. This may increase your risk for developing a serious infection.
  • Do not eat grapefruit or drink grapefruit juice while you are using this medicine.
  • This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines.

Warnings While Using This Medicine:

  • It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. Use an effective form of birth control during treatment and for at least 8 weeks after you stop treatment.
  • This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
  • Tell your doctor if you are breastfeeding, or if you have kidney problems, liver problems, any type of infection (such as hepatitis B), diabetes, high cholesterol, or a history of skin cancer or lymphoma. Tell your doctor if you are lactose intolerant or have Lapp lactase deficiency or glucose-galactose malabsorption.
  • This medicine may cause the following problems:
    • Noninfectious pneumonitis
    • Slow wound healing
    • Kidney failure
    • Increased risk of skin cancer and lymphoma
    • Increased risk of blood clots in the new kidney or liver (transplant patients)
  • This medicine may weaken your immune system and increase your risk for infections. Tell your doctor right away if you notice any changes in your health.
  • Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
  • This medicine may make your skin more sensitive to sunlight. Wear sunscreen. Do not use sunlamps or tanning beds.
  • Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
  • Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

  • Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
  • Chest pain, trouble breathing, fast, slow, uneven, or pounding heartbeat
  • Decrease in how much or how often you urinate, painful urination, cloudy or bloody urine
  • Dry mouth, increased thirst or hunger, muscle cramps, shakiness
  • Fever, chills, cough, stuffy or runny nose, sore throat, and body aches
  • Sores, ulcers, or white patches on your lips, mouth, or throat
  • Swollen glands in your neck, armpits, or groin, pain in your groin, lower back, or side
  • Unexplained weight gain, swelling in your hands, ankles, or feet
  • Unusual bleeding, bruising, or weakness
  • Yellow skin or eyes

If you notice these less serious side effects, talk with your doctor:

  • Acne, rash, dry skin
  • Change in taste
  • Diarrhea, constipation, nausea, vomiting, loss of appetite, stomach pain
  • Headache
  • Joint or muscle pain

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088


Last Updated: 11/4/2014


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