Everolimus (By mouth)


Everolimus (e-ver-OH-li-mus)
Treats advanced (late-stage) kidney cancer. Also used with other medicines to keep your body from rejecting a transplanted kidney. Also used to treat a brain tumor called subependymal giant cell astrocytoma (SEGA).

Brand Name(s)

There may be other brand names for this medicine.

Zortress, Afinitor

When This Medicine Should Not Be Used

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

How to Use This Medicine

  • 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.
  • Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
  • You may take this medicine with or without food. However, you should take it the same way (with or without food) each time.
  • This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
  • Swallow the tablet whole with a glass of water. Do not break, crush, or chew it. If you accidentally break or crush the tablet, wash your hands with water right away.
  • If you cannot swallow the tablets, you may dissolve the tablets in a glass (30 mL) of water. Gently stir it before drinking the medicine. Rinse the glass with the same amount of water and swallow it immediately.
  • If you have a kidney transplant, you might have to take this medicine for the rest of your life to prevent rejection of the kidney. 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. It should be taken at the same time with the cyclosporine capsules.
If a dose is missed:
  • If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose. If you miss a dose of this medicine, you may still take it up to 6 hours after the time you normally take it. However, 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. Protect the medicine from direct light. Keep your medicine in the original package until you are ready to use it.
  • 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 away from children and 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 are using a medicine to treat an infection or tuberculosis (such as clarithromycin, erythromycin, fluconazole, itraconazole, ketoconazole, rifabutin, rifampin, rifapentine, telithromycin, voriconazole, Biaxin®, Diflucan®, Ery-Tab®, Ketek®, Mycobutin®, Nizoral®, Priftin®, Rifadin®, Rimactane®, Sporanox®, or Vfend®), medicine to lower cholesterol (such as lovastatin, simvastatin, Altocor®, Mevacor®, or Zocor®), or medicine for a heart condition or high blood pressure (such as diltiazem, nicardipine, verapamil, Cardene®, Cardizem®, Calan®, Isoptin®, or Verelan®).
  • Tell your doctor if you are using a medicine for HIV or AIDS (such as amprenavir, atazanavir, delavirdine, efavirenz, fosamprenavir, indinavir, nelfinavir, nevirapine, ritonavir, saquinavir, Agenerase®, Crixivan®, Fortovase®, Invirase®, Lexiva®, Norvir®, Rescriptor®, Reyataz®, Sustiva®, Viracept®, or Viramune®).
  • Make sure your doctor knows if you are also using a medicine for seizures or convulsions (such as carbamazepine, phenobarbital, phenytoin, Dilantin®, or Tegretol®), or aprepitant (Emend®), dexamethasone (Decadron®, DexPak®), nefazodone (Serzone®), or St. John's Wort.
  • Do not eat grapefruit or drink grapefruit juice while you are using this medicine.
  • Talk to your doctor before getting flu shots or other vaccines while you are receiving this medicine. Vaccines may not work as well, or they could make you ill while you are using this medicine.

Warnings While Using This Medicine

  • Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control while using this medicine and for at least 8 weeks after stopping treatment. If you think you have become pregnant while using the medicine, tell your doctor right away.
  • If you are male and plan to have children, talk with your doctor before using this medicine. Some men using this medicine have become infertile (unable to have children).
  • Make sure your doctor knows if you are breastfeeding, or if you have liver problems, any type of infection (such as hepatitis B infection), blood clotting problems, lung or breathing problems, diabetes, high cholesterol or fats in the blood, or a history of skin cancer or lymphoma (cancer of the lymph glands). Tell your doctor if you have lactose intolerance, Lapp lactase deficiency (a rare genetic disorder), or glucose-galactose malabsorption (a rare genetic disorder).
  • This medicine may cause mouth ulcers and sores in some patients. Tell your doctor right away if you have pain, discomfort, or open sores in your mouth while you are using this medicine. You may use a special mouthwash or mouth gel to treat these ulcers. Ask your doctor what type of products to use.
  • This medicine may cause a serious lung problem called noninfectious pneumonitis. Stop using this medicine and check with your doctor right away if you have chest pain, chills, a cough, a fever, shortness of breath, or troubled breathing.
  • This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.
  • Using this medicine may increase your risk for getting skin cancer. When you begin taking this medicine, stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible. Wear protective clothing, including a hat, and sunglasses. Apply a sunblock product that has a skin protection factor (SPF) of at least 15, or higher if you have a fair complexion. Apply a sunblock lipstick that has an SPF of at least 15 to protect your lips. Do not use sunlamps, tanning beds, or tanning booths. If you have any questions about this, check with your doctor.
  • This medicine may cause a serious type of allergic reaction called angioedema. This may occur more often when it is used with certain heart and blood pressure medicines called ACE inhibitors (such as captopril [Capoten®], enalapril [Vasotec®], fosinopril [Monopril®], quinapril [Accupril®], or ramipril [Altace®]). Stop taking this medicine and tell your doctor right away if you have a rash; itching; a large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs; trouble with breathing; or chest tightness while you are using this medicine.
  • If you have a kidney transplant, this medicine may increase your risk for having a blood clot in the new kidney. This usually occurs within the first 30 days after the kidney transplant. Check with your doctor right away if you are making less urine, or if you have pain in your groin, lower back, side, or stomach; dark-colored urine; a fever; or nausea or vomiting.
  • If you are taking this medicine after a kidney transplant, it may increase your risk for developing a rare and serious virus infection called BK virus-associated nephropathy (BKVAN). The BK virus may affect how your kidneys work and cause a transplanted kidney to fail. Check with your doctor right away if you are having more than one of these symptoms: bloody urine; a decreased frequency or amount of urine; increased thirst; loss of appetite; lower back or side pain; nausea; swelling of the face, fingers, or lower legs; trouble with breathing; unusual tiredness or weakness; vomiting; or weight gain.
  • Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments.
  • Your doctor will need to check your blood or urine at regular visits while you are using this medicine. Be sure to keep all appointments.
  • This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor.

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.
  • Change in how much or how often you urinate, painful urination, or cloudy or bloody urine.
  • Chest pain, shortness of breath, troubled breathing, or wheezing.
  • Confusion, weakness, uneven heartbeat, or numbness or tingling in your hands, feet, or lips.
  • Dry mouth, increased thirst, muscle cramps, nausea or vomiting.
  • Fever, chills, cough, stuffy or runny nose, sore throat, and body aches.
  • Increased thirst or hunger.
  • Lightheadedness, dizziness, or fainting.
  • Lumps in your neck, armpits, or groin.
  • Nosebleeds.
  • Pain in your arms or legs.
  • Rapid weight gain.
  • Sores or ulcers in your mouth.
  • Swelling in your hands, ankles, or feet.
  • Tremors or seizures.
  • Unusual bleeding, bruising, or weakness.
  • Yellowing of your skin or the whites of your eyes.
If you notice these less serious side effects, talk with your doctor:
  • Acne or pimples.
  • Back pain.
  • Change or loss of taste.
  • Diarrhea, constipation, loss of appetite, or stomach pain.
  • Earache.
  • Feeling weak or tired.
  • Headache.
  • Lack or loss of strength.
  • Rash, dry skin, or itching skin.
  • Trouble with sleeping.

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
Review Date: 2011-02-04 Reviewed By: Keywords: ,
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