Everolimus is used to treat a certain type of benign (non-cancerous) brain tumor in people with a certain genetic disorder (tuberous sclerosis complex). It works by slowing or stopping the growth of tumor cells. Everolimus is also used with other medications to treat certain types of seizures in people with tuberous sclerosis complex. Everolimus may reduce the number of seizures you have.

Read the Patient Information Leaflet if available from your pharmacist before you start taking everolimus and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Do not change dosage forms of this medication without checking with your doctor or pharmacist.

Take this medication by mouth as directed by your doctor, usually once daily. You may take this medication with or without food, but it is important to choose one way and take this medication the same way with every dose.

Do not swallow the tablet whole. This medication must be dispersed in water before swallowing. If another person is helping you prepare this medication, he/she should wear gloves while preparing each dose to avoid possible contact with everolimus.

Do not disperse more than 10 milligrams total at a time. You may use an oral syringe or a drinking glass (see instructions in the package). If you are using an oral syringe, place the medication into a 10-milliliter syringe. Do not break or crush the tablet(s). Draw 1 teaspoon (5 milliliters) of water into the syringe. Place the filled syringe into a container (tip up) for 3 minutes to allow the tablet(s) to disperse. Gently swirl the syringe 5 times before taking the medication. To make sure you have taken the whole dose, draw another teaspoon (5 milliliters) of water into the syringe, swirl, and take the rest of the mixture.

If you are using a drinking glass, place the medication in a glass with about 5 teaspoons (25 milliliters) of water. Do not use other liquids. Do not break or crush the tablet(s). After 3 minutes, stir the mixture gently with a spoon, then drink all of the mixture right away. To make sure you have taken the whole dose, add another 5 teaspoons (25 milliliters) of water to the glass to rinse it, and drink all the rinse water.

Take this medication within 60 minutes of mixing.

The dosage is based on your medical condition, body size, response to treatment, lab tests, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of serious side effects will increase.

Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

Diarrhea, nausea/vomiting, decreased appetite, weight loss, changes in taste, nosebleeds, dry skin, dizziness, and headache may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Pain or sores in the mouth and throat may occur. To reduce the risk of getting mouth sores when you start everolimus treatment, your doctor may prescribe a mouthwash that contains a corticosteroid medication. Brush your teeth carefully/gently and avoid using mouthwash that contains alcohol, iodine, peroxide, or thyme. Rinse your mouth often with cool water mixed with baking soda or salt. It may also be best to eat soft, moist foods.

Temporary hair loss may occur. Normal hair growth should return after treatment has ended.

People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including:

• swelling hands/ankles/feet
• missed/heavy/painful periods
• easy bruising/bleeding
• unusual tiredness
• mental/mood changes (such as anxiety, aggression)
• wound problems (such as slowed wound healing)

Everolimus has rarely caused very serious (possibly fatal) kidney problems. Tell your doctor right away if you develop signs of kidney problems, such as a change in the amount of urine.

This medication may rarely make your blood sugar rise, which can cause or worsen diabetes. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. If you already have diabetes, check your blood sugar regularly as directed and share the results with your doctor. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

This medication may cause your cholesterol/triglycerides to increase. You may need to have your cholesterol/triglycerides checked periodically and/or take another medication to control your cholesterol/triglycerides.

This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as sore throat that doesn't go away, fever, chills, cough).

This medication may make side effects from radiation treatment worse. These side effects can sometimes be severe. Tell your doctor if you have had or are planning to have radiation treatment.

This medication has caused very serious (rarely fatal) lung problems. Get medical help right away if you have symptoms of lung problems, such as shortness of breath, chest pain.

Everolimus may rarely cause serious (possibly fatal) liver disease in people who have hepatitis B virus. Get medical help right away if you have any symptoms of liver damage, including:

• nausea/vomiting that doesn't stop
• loss of appetite
• dark urine
• stomach/abdominal pain
• yellow eyes/skin

This medication may increase your risk of getting a rare but very serious (sometimes fatal) brain infection (progressive multifocal leukoencephalopathy-PML). Get medical help right away if any of these rare but very serious side effects occur:

• clumsiness
• loss of coordination
• weakness
• sudden change in your thinking (such as confusion, difficulty concentrating)
• difficulty moving your muscles
• problems with speech
• new/worsening seizures
• vision changes

Everolimus can commonly cause a mild rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe allergic reaction. Get medical help right away if you develop any rash.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking everolimus, tell your doctor or pharmacist if you are allergic to it; or to sirolimus or temsirolimus; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• liver disease
• any recent/current infections
• diabetes
• high cholesterol/triglyceride levels
• radiation treatment

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Everolimus can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

Tell your health care professional that you are using everolimus before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Your doctor or dentist may tell you to stop taking everolimus at least 1 week before surgery. This medication may cause wounds to heal more slowly. Follow all instructions about when to stop or restart this medication.

Older adults may be more sensitive to the side effects of this drug.

This medication can affect fertility in both males and females. Ask your doctor for more details.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using everolimus. Everolimus may harm an unborn baby. Women using this medication should ask about reliable forms of birth control during treatment and for 8 weeks after the last dose. Men using this medication should ask about reliable forms of birth control during treatment and for 4 weeks after the last dose. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this medication and for 2 weeks after the last dose. Consult your doctor before breastfeeding.

See also How to Use section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• other drugs that weaken the immune system/increase the risk of infection (such as natalizumab, rituximab)
• ACE inhibitors (such as captopril, lisinopril)

Other medications can affect the removal of everolimus from your body, which may affect how everolimus works. Examples include azole antifungals (such as itraconazole, ketoconazole), cobicistat, macrolide antibiotics (such as clarithromycin, erythromycin), nefazodone, HIV protease inhibitors (such as atazanavir, indinavir), ritonavir, St. John's wort, telithromycin, among others.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as blood sugar, cholesterol/triglyceride levels, complete blood count, kidney function, everolimus trough levels) will be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, take it as soon as you remember. If it is more than 6 hours after the missed dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store in the original container at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).