Proper Use

Drug information provided by: Merative, Micromedex®

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

If you have a kidney or liver transplant, you might 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 checking first with your doctor.

This medicine comes with a Medication Guide and patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Take this medicine the same way every day. Take it at the same time and consistently either with or without food.

Swallow the regular tablet whole with a glass of water. Do not crush, break, or chew it. If you accidentally break or crush the tablet, wash your hands with water right away.

Do not swallow the tablet for suspension. It must be dissolved in water before you take the medicine. If you are preparing the oral suspension for another person, wear disposable gloves.

  • To dissolve the tablet for suspension in an oral syringe:
    • Use a syringe that measures 10 milliliters (mL). 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 to 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 but 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.
  • To dissolve the tablet for suspension in a small glass:
    • Use a medicine cup to measure 25 milliliters (mL) of water.
    • Pour the water into a small glass and put the tablet in the water without breaking or crushing it.
    • Wait 3 minutes then gently stir the mixture to break up the tablets. Drink the mixture right away. After drinking, rinse the glass with the same amount of water and drink the liquid.

Do not use the regular tablet and the tablet for suspension together. Use only one dosage form of this medicine.

You may be given a mouthwash (eg, dexamethasone alcohol-free mouthwash) when starting the medicine to prevent mouth sores or ulcers. Do not drink or eat food for at least 1 hour after swishing and spitting the mouthwash.

You should not eat grapefruit or drink grapefruit juice while you are taking this medicine. Grapefruit and grapefruit juice may cause higher levels of everolimus in the body. This could result in more unwanted effects.

If you have a kidney transplant, everolimus will be given together with another medicine called cyclosporine. Take both medicines at the same time.

If you have a liver transplant, everolimus will be given together with another medicine called tacrolimus. Take both medicines at the same time.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For advanced breast cancer:
      • Adults—10 milligrams (mg) once a day. Your doctor may adjust your dose as needed.
      • Children—Use and dose must be determined by your doctor.
    • For advanced neuroendocrine tumors:
      • Adults—10 milligrams (mg) once a day. Your doctor may adjust your dose as needed.
      • Children—Use and dose must be determined by your doctor.
    • For angiomyolipomas:
      • Adults—10 milligrams (mg) once a day. Your doctor may adjust your dose as needed.
      • Children—Use and dose must be determined by your doctor.
    • For brain tumors (SEGA):
      • Adults and children 1 year of age and older—Dose is based on body size and must be determined by your doctor. The starting dose is 4.5 milligrams (mg) per square meter (m(2)) of body size once a day. Your doctor may adjust your dose as needed.
      • Children younger than 1 year of age—Use is not recommended.
    • For kidney cancer:
      • Adults—10 milligrams (mg) once a day. Your doctor may adjust your dose as needed.
      • Children—Use and dose must be determined by your doctor.
    • For kidney transplant rejection:
      • Adults—At first, 0.75 milligram (mg) 2 times a day taken every 12 hours. Your doctor may adjust your dose as needed.
      • Children—Use and dose must be determined by your doctor.
    • For liver transplant rejection:
      • Adults—At first, 1 milligram (mg) 2 times a day taken every 12 hours. Your doctor may adjust your dose as needed.
      • Children—Use and dose must be determined by your doctor.
  • For oral dosage form (tablets for suspension):
    • For brain tumors (SEGA):
      • Adults and children 1 year of age and older—Dose is based on body size and must be determined by your doctor. The starting dose is 4.5 milligrams (mg) per square meter (m(2)) of body size once a day. Your doctor may adjust your dose as needed.
      • Children younger than 1 year of age—Use is not recommended.
    • For partial-onset seizures:
      • Adults and children 2 years of age and older—Dose is based on body size and must be determined by your doctor. The starting dose is 5 milligrams (mg) per square meter (m(2)) of body size once a day. Your doctor may adjust your dose as needed.
      • Children younger than 2 years of age—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose of Afinitor® or Afinitor® Disperz, you may still take it up to 6 hours after the time you normally take the dose. But if more than 6 hours have passed, skip the missed dose and go back to your regular dosing schedule.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep the medicine in its original package until you are ready to use it. The oral suspension must be used within 60 minutes after mixing. If it is not used during this time, throw it away and prepare another dose.

Keep Zortress® tablets dry.