Everolimus Oral suspension

What is this medicine?

EVEROLIMUS (eve ROE li mus) decreases the activity of your immune system. Afinitor is used to treat certain types of cancer.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• diabetes

• heart disease

• high cholesterol

• immune system problems

• infection (especially a virus infection such as chickenpox, cold sores, or herpes)

• kidney disease

• liver disease

• low blood counts, like low white cell, platelet, or red cell counts

• rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption

• an unusual or allergic reaction to everolimus, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth. You may take it with or without food. Do not take with grapefruit juice. Follow the directions on the prescription label. Leave the tablets in the blister package until you are ready to make the suspension. Do not push the tablets through the blister pack; use scissors to open. Do not chew or swallow whole tablets. You must add the dose to water as directed and wait about 3 minutes for the suspension to form. Stir the suspension with a spoon. Drink all of the liquid in the glass. Add more water to the empty glass, stir again, and drink. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on the advice of your doctor or health care professional.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

This medicine may interact with the following medications:

• antiviral medicines for HIV or AIDS

• aprepitant

• carbamazepine

• certain medicines for cholesterol like simvastatin

• clarithromycin

• cyclosporine

• dexamethasone

• diltiazem

• erythromycin

• fluconazole

• grapefruit juice

• itraconazole

• ketoconazole

• live vaccines

• nefazodone

• nicardipine

• phenobarbital

• phenytoin

• rifabutin

• rifampin

• telithromycin

• verapamil

• voriconazole

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

This drug may make you feel generally unwell. This is not uncommon, as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your doctor tells you to stop. Visit your doctor or health care professional for regular check-ups. You may need regular tests to monitor possible side effects of the drug.

This medicine may affect blood sugar levels. If you have diabetes, check with your doctor or health care professional before you change your diet or the dose of your diabetic medicine.

Do not become pregnant while taking this medicine or for 8 weeks after stopping it. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine or for 2 weeks after stopping it.

This medicine has caused ovarian failure in some women. This medicine may interfere with the ability to have a child. You should talk with your doctor or health care professional if you are concerned about your fertility.

This medicine has caused reduced sperm counts in some men. This may interfere with the ability to father a child. You should talk to your doctor or health care professional if you are concerned about your fertility.

Call your doctor or health care professional for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This drug decreases your body's ability to fight infections. Try to avoid being around people who are sick.

This medicine may increase your risk to bruise or bleed. Call your doctor or health care professional if you notice any unusual bleeding.

If you have had a recent surgery, immediately tell your doctor if your incision site is red, warm, or painful. Also, tell your doctor if your incision site opens up or swells or if contains blood, fluid, or pus.

Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• chest pain

• cough

• dark urine

• fever or chills, sore throat

• increased hunger or thirst

• increased urination

• nausea, vomiting

• stomach pain

• swelling of ankles, feet, hands

• trouble passing urine or change in the amount of urine

• unusual bleeding or bruising

• unusually weak or tired

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

• constipation

• diarrhea

• dizziness

• dry mouth or mouth sores

• headache

• nausea, vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Keep this medicine in the original blister pack until the tablets are ready for suspension. Discard any prepared suspension that is not used immediately within 60 minutes of preparation. Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Everolimus Oral tablet

What is this medicine?

EVEROLIMUS (eve ROE li mus) decreases the activity of your immune system. Afinitor is used to treat certain types of cancer. Zortress is used for kidney and liver transplant rejection prophylaxis.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• diabetes

• heart disease

• high cholesterol

• immune system problems

• infection (especially a virus infection such as chickenpox, cold sores, or herpes)

• kidney disease

• liver disease

• low blood counts, like low white cell, platelet, or red cell counts

• rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption

• an unusual or allergic reaction to everolimus, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a full glass of water. Follow the directions on the prescription label. You can take this medicine with or without food, but always take Zortress the same way. Do not cut, crush, or chew this medicine. Do not take with grapefruit juice. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

This medicine may interact with the following medications:

• antiviral medicines for HIV or AIDS

• aprepitant

• carbamazepine

• certain medicines for cholesterol like simvastatin

• clarithromycin

• cyclosporine

• dexamethasone

• diltiazem

• erythromycin

• fluconazole

• grapefruit juice

• itraconazole

• ketoconazole

• live vaccines

• nefazodone

• nicardipine

• phenobarbital

• phenytoin

• rifabutin

• rifampin

• telithromycin

• verapamil

• voriconazole

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

This drug may make you feel generally unwell. This is not uncommon, as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your doctor tells you to stop. Visit your doctor or health care professional for regular check-ups. You may need regular tests to monitor possible side effects of the drug.

This medicine may affect blood sugar levels. If you have diabetes, check with your doctor or health care professional before you change your diet or the dose of your diabetic medicine.

Do not become pregnant while taking this medicine or for 8 weeks after stopping it. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine or for 2 weeks after stopping it.

This medicine has caused ovarian failure in some women. This medicine may interfere with the ability to have a child. You should talk with your doctor or health care professional if you are concerned about your fertility.

This medicine has caused reduced sperm counts in some men. This may interfere with the ability to father a child. You should talk to your doctor or health care professional if you are concerned about your fertility.

Call your doctor or health care professional for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This drug decreases your body's ability to fight infections. Try to avoid being around people who are sick.

This medicine may increase your risk to bruise or bleed. Call your doctor or health care professional if you notice any unusual bleeding.

If you have had a kidney transplant, immediately tell your doctor if your incision site is red, warm, or painful. Also, tell your doctor if your incision site opens up or swells or if contains blood, fluid, or pus.

Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• chest pain

• cough

• dark urine

• fever or chills, sore throat

• increased hunger or thirst

• increased urination

• nausea, vomiting

• stomach pain

• swelling of ankles, feet, hands

• trouble passing urine or change in the amount of urine

• unusual bleeding or bruising

• unusually weak or tired

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

• constipation

• diarrhea

• dizziness

• dry mouth or mouth sores

• headache

• nausea, vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.