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

Treats cancer, including breast cancer, kidney cancer, neuroendocrine tumors of the pancreas, stomach or bowels, or lungs, and renal angiomyolipoma, subependymal giant cell astrocytoma (SEGA), and seizures with tuberous sclerosis complex (TSC). Also used to prevent your body from rejecting a kidney or liver after transplant.

Brand Name(s):

Afinitor, Afinitor Disperz, Torpenz, Zortress

When This Medicine Should Not Be Used:

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 with food or always without food.
• Regular tablet: Swallow whole with a glass of water. Do not crush, break, or chew it.
• Tablet for suspension: Wear disposable gloves if you are mixing the medicine for another person. Dissolve the tablet in water before you take it. Do not swallow the tablet whole. After the tablet dissolves, drink the mixture within 60 minutes. If you are not able to drink it within 60 minutes, throw that dose away and prepare another one. There are 2 ways to prepare the suspension:
  • Oral syringe: Follow the directions that came with your medicine. Dissolve the tablet inside a 10 milliliter (mL) syringe, using 5 mL of water and 4 mL of air. The tablet will take 3 minutes to dissolve. Slowly turn the syringe upside 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.
  • Small cup: Put the tablet in a cup with 25 mL water. Do not break or crush the tablet. Wait 3 minutes, and then gently stir the mixture. 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.
• Do not use the regular tablet and the tablet for suspension together. Use only 1 form of this medicine.
• You may be given a mouthwash (including dexamethasone alcohol-free mouthwash) when starting Afinitor® or Afinitor® Disperz to prevent mouth sores or ulcers. Do not drink or eat food for at least 1 hour after swishing and spitting the mouthwash.
• Kidney or liver transplant patients: 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 medicines that are part of your treatment as prescribed, especially the ones you need to take at the same time as everolimus.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose:
  • Afinitor® or Afinitor® Disperz: If it is less than 6 hours from the time you normally take the dose, you may still take it. If it is more than 6 hours, skip the missed dose and go back to your regular dosing schedule. Do not take extra medicine to make up for a missed dose.
  • Zortress®: Take the 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.
• 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. Also, keep Zortress® tablets dry.

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 any of the following:
  • Amprenavir, aprepitant, atazanavir, boceprevir, cannabidiol, carbamazepine, clarithromycin, cyclosporine, digoxin, diltiazem, efavirenz, erythromycin, fluconazole, fosamprenavir, indinavir, itraconazole, ketoconazole, midazolam, nefazodone, nelfinavir, nevirapine, nicardipine, octreotide, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, ritonavir, saquinavir, St John's wort, telaprevir, telithromycin, verapamil, voriconazole
  • Blood pressure medicine
  • Medicine to lower cholesterol (including atorvastatin, lovastatin, pravastatin, simvastatin)
  • Steroid medicine
• 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:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. Use an effective form of birth control during treatment with this medicine and for at least 8 weeks after your last dose. Male patients with female partners should use an effective form of birth control during treatment with Afinitor® or Afinitor® Disperz and for 4 weeks after the last dose.
• Do not breastfeed during treatment with Afinitor® or Afinitor® Disperz and for 2 weeks after your last dose.
• Tell your doctor if you have kidney disease, liver disease, lung or breathing problems, any type of infection (including hepatitis B), diabetes, high cholesterol, or a history of skin cancer or lymphoma. Tell your doctor if you have a lactose intolerance, Lapp lactase deficiency, or a glucose-galactose malabsorption. Also, tell your doctor if you have had a heart transplant, if you are having a surgery or other procedures, or if you had or are planning to receive a radiation treatment.
• This medicine may cause the following problems:
  • Increased risk of cancer (including skin cancer, lymphoma)
  • Increased risk of serious infections
  • Interstitial lung disease or non-infectious pneumonitis (inflammation of the lungs)
  • Angioedema (severe swelling, when used with an ACE inhibitor)
  • Kidney problems
  • Slow wound healing
  • Diabetes
  • High cholesterol in the blood
  • Liver problems
  • Increased risk of blood clots in the transplanted kidney or liver
  • Worsening side effects from radiation treatment
  • Thrombotic microangiopathy (damage in the smallest blood vessels), hemolytic uremic syndrome, and thrombotic thrombocytopenic purpura
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
• 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
• Blurred vision, increased hunger, thirst, or urination, unexplained weight loss
• Chest pain, trouble breathing, cough, fast, slow, uneven, or pounding heartbeat
• Dark urine or pale stools, loss of appetite, nausea, vomiting, stomach pain, yellow skin or eyes
• Decrease in how much or how often you urinate, painful urination, cloudy bloody urine
• Fever, chills, stuffy or runny nose, sore throat, body aches
• Rapid weight gain, swelling in your hands, ankles, or feet
• 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
• Unusual bleeding, bruising, or weakness

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

• Diarrhea
• Dry mouth, muscle cramps, shakiness
• Headache

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