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Everolimus (By mouth)

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

Treats advanced kidney cancer. Also treats some types of pancreatic cancer, breast cancer, and brain cancer. 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:

Do not use this medicine if you have had an allergic reaction to everolimus or similar medicines, such as sirolimus (Rapamune®) or temsirolimus (Torisel®). Do not use this medicine if you are pregnant.

How to Use This Medicine:

Tablet, Tablet for Suspension

  • 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.
  • 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. If you are preparing the oral suspension for another person, wear disposable gloves. There are 2 ways to prepare the suspension:
    • Small glass: Use a medicine cup to measure 25 milliliters (mL) of water. Pour the water into a small glass. Put the tablet in the water without breaking or crushing it. Wait 3 minutes, then gently stir the mixture to break up the tablet. Drink the mixture right away. After drinking, refill the glass with the same amount of water. Drink the water right away so you get all the medicine.
    • Oral syringe: Use a 10 mL syringe. Pull out the plunger and put the tablet in the barrel of the syringe. Replace the plunger and push it until it touches the tablet. Fill a small glass with 30 mL (2 tablespoons) of water. Place the syringe tip in the water and draw up enough water to cover the tablet and fill half of the syringe. Hold the syringe with the tip up and draw in 4 mL of air. Place the syringe in an empty glass with the tip up and wait 3 minutes. Slowly turn the syringe up and down 5 times. Do not shake it. Hold the syringe with the tip up and push the plunger to remove most of the air. Place the syringe in the mouth and slowly give the dose. Fill the syringe with 5 mL of water from the small glass. Hold the tip up and add 4 mL of air. Swirl the water in the syringe to rinse any extra medicine from the sides. Hold the syringe with the tip up and push the plunger to remove most of the air. Place the syringe in the mouth and slowly give the liquid. Use a new syringe for each dose.
  • 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 first checking with your doctor.
  • If you have a kidney transplant, this medicine will be given together with another medicine called cyclosporine. Take both medicines at the same time.
  • If you have a liver transplant, this medicine will be given together with another medicine called tacrolimus. Take both medicines at the same time.
  • This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.

If a dose is missed:

  • Take a dose 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.

How to Store and Dispose of This Medicine:

  • 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.
  • The tablet for oral suspension must be given within 60 minutes after it is dissolved in water. If it is not used during this time, throw it away and prepare another dose.
  • Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any leftover medicine after you have finished your treatment. You will also need to throw away old medicine after the expiration date has passed.
  • Keep all medicine out of the reach of children. Never share your medicine with anyone.

Drugs and Foods to Avoid:

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

  • Make sure your doctor knows if you use St John's wort, medicine to treat an infection (such as clarithromycin, erythromycin, fluconazole, itraconazole, ketoconazole, rifabutin, rifampin, rifapentine, telithromycin, voriconazole, Diflucan®, Nizoral®), medicine to treat hepatitis C (such as boceprevir, telaprevir, Incivek®, Victrelis®), or medicine for a heart condition or high blood pressure (such as captopril, diltiazem, enalapril, fosinopril, nicardipine, quinapril, ramipril, verapamil, Accupril®, Calan®, Capoten®, Cardene®, Cardizem®, Isoptin®, Monopril®, Verelan®).
  • Tell your doctor if you also use aprepitant (Emend®), cyclosporine (Gengraf®, Neoral®, Sandimmune®), dexamethasone (Decadron®, DexPak®), digoxin (Lanoxin®), midazolam (Versed®), nefazodone (Serzone®), octreotide (Sandostatin®), tacrolimus (Prograf®), medicine to lower cholesterol (such as gemfibrozil, lovastatin, simvastatin, Tricor®, Zocor®), medicine for seizures (such as carbamazepine, phenobarbital, phenytoin, Dilantin®, Tegretol®), or medicine for HIV or AIDS (such as amprenavir, atazanavir, delavirdine, efavirenz, fosamprenavir, indinavir, nelfinavir, nevirapine, ritonavir, saquinavir, Crixivan®, Lexiva®, Norvir®, Rescriptor®, Reyataz®).
  • 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:

  • You can harm your unborn baby if you use this medicine while you are pregnant. Use an effective form of birth control during treatment and for at least 8 weeks after you stop treatment. Tell your doctor right away if you think you have become pregnant.
  • Talk with your doctor before you use this medicine if you are a man and plan to have children. Some men who have used this medicine have become infertile (not able to have children).
  • Make sure your doctor knows 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. Tell your doctor if you have had a heart transplant.
  • Check with your doctor right away if you have chest pain, chills, a cough, a fever, or trouble breathing.
  • This medicine may weaken your immune system and you may get infections more easily. Call your doctor right away if you have symptoms of an infection, such as a fever, chills, cloudy urine, or a cough that does not go away.
  • Check with your doctor right away if you have swelling, unusual tiredness, or less urine than normal. These may be symptoms of kidney failure.
  • This medicine may increase your risk for certain types of cancer, such as lymphoma and skin cancer. This medicine may make your skin more sensitive to sunlight. Wear sunscreen. Do not use sunlamps or tanning beds.
  • If you have a kidney transplant, this medicine may increase your risk for blood clots in the new kidney. This usually occurs within the first 30 days after the transplant. Check with your doctor right away if you have dark urine, a fever, nausea or vomiting, or pain in your groin, lower back, side, or stomach.
  • Call your doctor right away if you see blood, fluid, or pus in your wound or incision, or if it is red, warm, painful, or swollen. Also contact your doctor if your incision opens up.
  • This medicine may increase blood sugar levels. Tell your doctor if you have increased hunger or thirst, changes in how much you urinate, or unusual weight loss.
  • Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

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
  • Decrease in how much or how often you urinate, painful urination, cloudy or bloody urine
  • Dry mouth, increased thirst or hunger, muscle cramps, shakiness, nausea, vomiting
  • Fast, slow, uneven, or pounding heartbeat
  • Fever, chills, cough, stuffy or runny nose, sore throat, and body aches
  • Lightheadedness, dizziness, or fainting
  • Lumps in your neck, armpits, or groin
  • Pain in your groin, lower back, or side
  • Sores, ulcers, or white patches on your lips, mouth, or throat
  • 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 or a rash
  • Diarrhea, constipation, loss of appetite, stomach pain
  • Earache, 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: 7/4/2014

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