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.
• 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 away that dose and prepare another one. There are 2 ways to prepare the suspension:
  
  • Small cup: Put the tablet in a cup with 25 milliliters (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.
  • Oral syringe: Follow the directions that came with your medicine. Dissolve the tablet inside a 10 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.
• Do not use the regular tablet and the tablet for suspension together. Use only 1 form of this medicine.
• 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 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:
  
  • 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.
  • 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.
• 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 any of the following:
  
  • Amprenavir, aprepitant, atazanavir, boceprevir, carbamazepine, clarithromycin, cyclosporine, digoxin, diltiazem, erythromycin, fluconazole, fosamprenavir, indinavir, itraconazole, ketoconazole, midazolam, nefazodone, nelfinavir, octreotide, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, ritonavir, saquinavir, St John's wort, telaprevir, telithromycin, verapamil, or voriconazole
  • ACE inhibitor blood pressure medicine
  • Steroid medicine (including dexamethasone, prednisolone, prednisone)
• 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.
• Do not breastfeed during treatment and for 2 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 have kidney problems, liver disease, 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
  • Angioedema (when used with an ACE inhibitor blood pressure medicine)
  • 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.
• Because this medicine increases your risk for skin cancer, wear sunscreen when you are outside. Do not use sunlamps or tanning beds. Tell your doctor if you notice any growths or changes on your skin.
• 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, cough, fast, slow, uneven, or pounding heartbeat
• Decrease in how much or how often you urinate, painful urination, cloudy or 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
• Yellow skin or eyes

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

• Diarrhea, nausea, vomiting, loss of appetite, stomach pain
• Dry mouth, increased thirst or hunger, 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