Everolimus dispersible tablets for suspension

What is this medication?

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.

COMMON BRAND NAME(S): Afinitor DISPERZ

What should I tell my care team before I take this medication?

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
• recent or ongoing radiation
• 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 medication?

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. While this drug may be prescribed for children as young as 1 year for selected conditions, precautions do apply.

Overdosage: If you think you have 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 medication?

Do not take this medicine with any of the following medications:

• live virus vaccines

This medicine may interact with the following medications:

• antiviral medicines for HIV or AIDS
• aprepitant
• certain antibiotics like clarithromycin, erythromycin, or telithromycin
• certain medicines for blood pressure, heart disease, irregular heart beat like diltiazem, nicardipine, or verapamil
• certain medicines for cholesterol like simvastatin
• certain medicines for fungal infections like fluconazole, itraconazole, ketoconazole, or voriconazole
• certain medicines for seizures like carbamazepine, phenobarbital, phenytoin
• cyclosporine
• dexamethasone
• grapefruit juice
• nefazodone
• rifabutin
• rifampin

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 medication?

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 increase blood sugar. Ask your healthcare provider if changes in diet or medicines are needed if you have diabetes.

Before having surgery, talk to your health care provider to make sure it is ok. This drug can increase the risk of poor healing of your surgical site or wound. You will need to stop this drug for 1 week before surgery. After surgery, wait at least 2 weeks before restarting this drug. Make sure the surgical site or wound is healed enough before restarting this drug. Talk to your health care provider if questions.

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. Men should not father a child while taking this medicine and for 4 weeks after stopping it. 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 and reduced sperm counts in some men. 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 medication?

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
• nausea, vomiting
• signs and symptoms of high blood sugar such as being more thirsty or hungry or having to urinate more than normal. You may also feel very tired or have blurry vision.
• stomach pain
• swelling of ankles, feet, hands
• trouble passing urine
• unusual bleeding or bruising
• unusually weak

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

• constipation
• diarrhea
• dizziness
• dry mouth or mouth sores
• headache

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 medication?

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.