everolimus (antineoplastic)

Everolimus is used to treat various types of cancer (such as kidney, breast, pancreas, lung, stomach/intestinal cancers). Everolimus is also used in people with a certain genetic disorder (tuberous sclerosis complex) to treat certain types of benign tumors in the brain or kidney. It works by slowing or stopping the growth of cancer or tumor cells.

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. Swallow this medication whole with a glass of water. Do not crush or chew the tablets.

The dosage is based on your medical condition, response to treatment, laboratory 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). If you are taking this medication to treat a certain type of benign brain tumor, the dosage is also based on body size.

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 persist or worsen, 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 frequently 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, your doctor has prescribed this drug because he or she 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, 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.

Everolimus 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 fever, chills, persistent sore throat, cough).

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: dark urine, persistent nausea/vomiting/loss of appetite, 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, seizure, 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. Therefore, 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.

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 worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. 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. Female patients should ask about reliable forms of birth control while using this medication and for 8 weeks after stopping treatment. Male patients with female partners should ask about reliable forms of birth control while using this medication and for 4 weeks after stopping treatment. If you or your partner become 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, breast-feeding while using this drug and for 2 weeks after stopping treatment is not recommended. Consult your doctor before breast-feeding.

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.

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 and HCV 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 their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

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

Do not share this medication with others.

Laboratory and/or medical tests (such as blood sugar, cholesterol/triglyceride levels, complete blood count, kidney function, everolimus trough levels) should be performed before you start treatment, periodically to monitor your progress, or to check for side effects. Consult your doctor for more details.