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Drugs & Medications

Afinitor

EVEROLIMUS

GENERIC NAME(S): EVEROLIMUS

Uses

Everolimus is used to treat kidney cancer and certain types of breast and pancreas cancers. Everolimus is also used to treat certain types of benign tumors in brain or kidney in people with a certain genetic disorder (tuberous sclerosis complex). It works by slowing or stopping the growth of cancer cells.

How to use Afinitor

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.

Side Effects

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. 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.

Many people using this medication 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 disease. Tell your doctor right away if you develop symptoms of kidney disease, such as a change in the amount of urine.

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

This medication may infrequently make your blood sugar level rise, which can cause or worsen diabetes. Tell your doctor immediately if you develop symptoms of high blood sugar, such as increased thirst and urination. If you already have diabetes, be sure to check your blood sugars regularly. 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).

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.

This medication can decrease sperm production, an effect that may lower male fertility. Consult your doctor for more details.

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.

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

Precautions

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. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

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).

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

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Consult your doctor for more details and to discuss the use of reliable forms of birth control while taking this medication and for 8 weeks after stopping treatment. If you become pregnant or think you may be pregnant, tell your doctor immediately.

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 is not recommended. Consult your doctor before breast-feeding.

Interactions

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).

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), macrolide antibiotics (such as clarithromycin, erythromycin), nefazodone, HIV protease inhibitors (such as atazanavir, indinavir), St. John's wort, telithromycin, among others.

Overdose

If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

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.

Missed Dose

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 and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store 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.

MEDICAL ALERT: 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).

Information last revised May 2013. Copyright(c) 2013 First Databank, Inc.

Images

AFINITOR 2.5 MG TABLET
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LCL, NVR
AFINITOR 5 MG TABLET
AFINITOR 5 MG TABLET
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oblong
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5, NVR
AFINITOR 7.5 MG TABLET
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7P5, NVR
AFINITOR 10 MG TABLET
AFINITOR 10 MG TABLET
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white
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UHE, NVR
AFINITOR 2.5 MG TABLET

Identification

color
white
shape
oblong
imprint
LCL, NVR
This medicine is a white, oblong tablet imprinted with "LCL" and "NVR".
AFINITOR 5 MG TABLET
AFINITOR 5 MG TABLET

Identification

color
white
shape
oblong
imprint
5, NVR
This medicine is a white, oblong tablet imprinted with "5" and "NVR".
AFINITOR 7.5 MG TABLET

Identification

color
white
shape
oblong
imprint
7P5, NVR
This medicine is a white, oblong tablet imprinted with "7P5" and "NVR".
AFINITOR 10 MG TABLET
AFINITOR 10 MG TABLET

Identification

color
white
shape
oblong
imprint
UHE, NVR
This medicine is a white, oblong tablet imprinted with "UHE" and "NVR".

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, expect as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

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