Everolimus | Side Effects, Dosage, Uses & More
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Generic Name:

everolimus, Oral tablet

Generic Name:
Afinitor,Zortress

everolimus, Oral tablet

All Brands

  • Afinitor
  • Zortress
SECTION 1 of 5

Highlights for everolimus

Oral tablet
1

Everolimus is an oral drug used to treat certain types of breast cancer, kidney cancer, and brain tumors. It’s also used to treat tumors of the pancreas and noncancerous kidney tumors.

2

Everolimus comes as a tablet you take by mouth. It also comes as a tablet you mix into a liquid suspension that you take by mouth.

3

The tablet is available as the brand-name drug Afinitor. The tablet for suspension is available as the brand-name Afinitor Disperz. Neither form is available as a generic drug.

IMPORTANT INFORMATION

Risk of infections

This drug raises your risk of bacterial, fungal, or viral infections. These infections may be severe and possibly fatal (causing death). If you’ve had hepatitis B in the past, you’re at higher risk of the infection becoming active again. Tell your doctor right away if you have symptoms of an infection, such as fever or chills.

Allergic reaction

Everolimus raises your risk of a severe allergic reaction if you also take an angiotensin-converting enzyme (ACE) inhibitor drug. Call your doctor right away if you have swelling of your tongue, mouth, or throat or trouble breathing during your treatment with everolimus.

What is everolimus?

Everolimus is a prescription drug. It comes as a tablet, or as a tablet for suspension. Both forms are taken by mouth.

Everolimus oral tablet is available as the brand-name drug Affinitor. The oral tablet for suspension is available as the brand-name drug Affinitor Disperz. Everolimus isn’t available as a generic drug.

The oral tablet is used as part of a combination therapy when it’s used to treat advanced breast cancer (hormone receptor-positive, HER2-negative breast cancer). That means you need to take it with other drugs.

Why it's used

Everolimus oral tablet is used to treat:

  • Advanced breast cancer. It’s used to treat hormone receptor-positive, HER2-negative breast cancer in postmenopausal women.
  • Advanced pancreatic neuroendocrine tumors (PNET)
  • Renal cell carcinoma (advanced kidney cancer)
  • Kidney tumors in adults with a genetic condition called tuberous sclerosis complex (TSC)

Everolimus oral tablet and tablet for oral suspension are both used to treat:

  • Brain tumors called subependymal giant cell astrocytomas (SEGAs) in adults and children with tuberous sclerosis complex (TSC)

Everolimus is used when these conditions haven’t responded to other treatments, or when tumors can’t be surgically removed.

How it works

Everolimus belongs to a class of drugs called mammalian target of rapamycin (mTOR) kinase inhibitors. A class of drugs refers to medications that work in a similar way. These drugs are often used to treat similar conditions.

Everolimus works by interfering with the action of certain enzymes in your body called mTOR kinases. These enzymes help both healthy cells and cancer cells to grow and multiply. When kinases don’t act normally, they make cancers and tumors grow out of control. Everolimus inhibits mTOR kinases and stops the tumor or cancer from growing. This prevents the spread of the cancer or tumor in your body.

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SECTION 2 of 5

everolimus Side Effects

Oral tablet

More common side effects

  • The more common side effects of everolimus in people with breast cancer, pancreatic tumors, and kidney cancer include:

    • mouth sores
    • infections
    • weakness or tiredness
    • cough
    • shortness of breath
    • diarrhea
    • constipation
    • skin rash or dry, itchy skin
    • nausea
    • vomiting
    • fever
    • loss of appetite
    • weight loss
    • swelling of your arms, hands, feet, ankles, face, or other parts of your body
    • metallic taste in your mouth
    • dry mouth
    • inflammation of the lining of your digestive system
    • headache
    • nosebleeds
    • pain in your arms, legs, mouth, throat, back, or joints
    • high blood sugar levels
    • high blood pressure
    • trouble sleeping
    • hair loss
    • muscle spasms
    • dizziness
    • nail disorders
  • The more common side effects of everolimus in people with subependymal giant cell astrocytoma (SEGA) brain tumors or kidney tumors include:

    • mouth sores
    • infections
    • nausea
    • vomiting
    • diarrhea
    • constipation
    • swelling of your hands, arms, legs, and feet
    • joint pain
    • cough
    • skin problems, such as rash, acne, or dry skin
    • fever
    • tiredness
    • anxiety, aggression, and other abnormal behavior
    • missed menstrual periods
    • low levels of red blood cells, white blood cells, or platelets
    • high cholesterol levels
    • high blood sugar levels
    • low blood phosphate levels

If these effects are mild, they may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk to your doctor or pharmacist.

Serious Side Effects

Call your doctor right away if you have serious side effects. Call 9-1-1 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:

  • Lung or breathing problems. Symptoms can include:

    • cough that’s new gets worse
    • shortness of breath
    • chest pain
    • wheezing or trouble breathing
  • Infections. Symptoms can include:

    • fever greater than 100.5°F
    • chills
    • skin rash
    • joint pain and swelling
    • tiredness
    • loss of appetite
    • nausea
    • pale stools
    • dark urine
    • yellowing of your skin
    • pain in the upper right side of your abdomen
  • Kidney failure. Symptoms can include:

    • fever
    • weakness
    • tiredness
    • producing little to no urine
    • swelling of parts of your body
  • Wounds that heal slowly or don’t heal well. Symptoms can include:

    • wound that’s red, warm, or painful
    • blood, fluid, or pus in the wound
    • open wounds
    • swelling of the wound
Pharmacist's Advice
Healthline Pharmacist Editorial Team

Everolimus may cause drowsiness.

This drug can cause mouth sores. Tell your doctor if you have pain, discomfort, or open sores in your mouth. Your doctor may tell you to use a special mouthwash or mouth gel that doesn’t contain alcohol, peroxide, iodine, or thyme.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this information includes all possible side effects. This information is not a substitute for medical advice. Always discuss possible side effects with a healthcare provider who knows your medical history.
SECTION 3 of 5

everolimus May Interact with Other Medications

Oral tablet

Everolimus can interact with other medications, vitamins, or herbs you may be taking. An interaction is when a substance changes the way a drug works. This can be harmful or prevent the drug from working well.

To help avoid interactions, your doctor should manage all of your medications carefully. Be sure to tell your doctor about all medications, vitamins, or herbs you’re taking. To find out how this drug might interact with something else you’re taking, talk to your doctor or pharmacist.

Food interactions

You shouldn’t drink grapefruit juice or eat grapefruit while you’re taking everolimus. Grapefruit may increase the amount of everolimus in your blood to a harmful level.

Alcohol interaction

Everolimus can make you feel tired. Drinking alcohol may also cause drowsiness or dizziness. You should limit the amount of alcohol you drink while taking this medication. Don’t drive, use machinery, or perform similar tasks that require alertness if you drink alcohol while taking everolimus.

Medications that might interact with this drug

Antifungal drugs

These drugs may increase the amount of everolimus in your body. Examples of these drugs include:

  • fluconazole
  • itraconazole
  • ketoconazole
  • posaconazole

Antibiotics

These drugs may decrease the amount of everolimus in your body. Examples of these drugs include:

  • rifampin
  • rifabutin
  • rifapentine
  • rifaximin

These drugs may decrease the amount of everolimus in your body. Examples of these drugs may include:

  • clarithromycin
  • erythromycin
  • telithromycin

High blood pressure or heart drugs

These drugs may increase the amount of everolimus in your body. Examples of these drugs include:

  • verapamil
  • diltiazem

Drugs called angiotensin-converting enzyme (ACE) inhibitors raise your risk of a severe allergic reaction when taken with everolimus. Examples of these drugs include:

  • benazepril
  • captopril
  • enalapril
  • fosinopril
  • lisinopril
  • moexipril
  • perindopril
  • quinapril
  • ramipril
  • trandolapril

Antidepressants

This drug may increase the amount of everolimus in your body:

  • nefazodone

HIV drugs

These drugs may increase the amount of everolimus in your body. Examples of these drugs include:

  • atazanavir
  • indinavir
  • lopinavir/ritonavir
  • nelfinavir
  • ritonavir
  • saquinavir

Herbal supplement

This drug may decrease the amount of everolimus in your body:

  • St. John's wort

Seizure drugs

These drugs may decrease the amount of everolimus in your body. Get medical help right away if you have trouble breathing or develop swelling of your tongue, mouth, or throat during treatment with everolimus and any of these drugs. Examples of these drugs include:

  • carbamazepine
  • phenobarbital
  • phenytoin

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs interact differently in each person, we cannot guarantee that this information includes all possible interactions. This information is not a substitute for medical advice. Always speak with your healthcare provider about possible interactions with all prescription drugs, vitamins, herbs and supplements, and over-the-counter drugs that you are taking.
Everolimus warnings
kidney disease
People with kidney disease

Everolimus may cause kidney failure. Your doctor should do tests to check your kidney function before and during your treatment to make sure this drug isn’t harming your kidneys.

liver disease
People with liver disease

If you have liver disease, your body may not process everolimus correctly. More of the drug may stay in your body, putting you at risk for side effects. Your dose of everolimus may need to be decreased.

weakened immune system
People with weakened immune systems

Everolimus can lower the ability of your immune system to fight infections. In some people, these infections may be severe and can even be fatal. Tell your doctor right away if you don’t feel well, or have a temperature of 100.5˚F or above, or chills.

hepatitis B infection
People who have had hepatitis B virus infection

Everolimus may reactivate a hepatitis B virus infection that you had in the past. You should be tested for the hepatitis B virus before you start everolimus.

diabetes
People with diabetes

Everolimus may increase your blood sugar levels. You and your doctor may need to check your blood sugar levels more often while you’re taking this drug.

high blood pressure
People with high blood pressure

Everolimus may increase your blood pressure. You and your doctor may need to monitor your blood pressure more closely while you’re taking this drug.

pregnant women
Pregnant women

Everolimus is a category D pregnancy drug.

That means two things:

  1. Research in humans has shown adverse effects to the fetus when the mother takes the drug.
  2. This drug should only be used during pregnancy in serious cases where it's needed to treat a dangerous condition in the mother.

Ask your doctor to tell you about the specific harm that may be done to the fetus. Use effective birth control while you’re on this medication and for 8 weeks after stopping treatment. Talk to your doctor about birth control options while taking everolimus.

Tell your doctor if you’re pregnant or plan to become pregnant. Everolimus should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

breastfeeding
Women who are breast-feeding

It isn’t known if this drug goes into breast milk. If it does, it may cause serious effects in a breastfeeding child.

You shouldn’t breastfeed while taking this drug. You and your doctor may need to decide if you’ll take everolimus or breastfeed.

for seniors
For seniors

Your organs liver or kidneys may not work as well. More of the drug may stay in your body and you may be more sensitive to its effects. Your doctor will monitor you closely and may adjust your dose if you have any reactions.

for children
For children

Everolimus is only used in certain children. It is recommended only for use in people aged 1 year or older who have a genetic condition called tuberous sclerosis (TSC). In these children it is used for the treatment of a brain tumor (subependymal giant cell astrocytoma, or SEGA) that can’t be removed by surgery.

Everolimus isn’t approved for use in children with any other condition.

drug transfer
Contact with drug

Everolimus can transfer to others. You should wear protective gloves to avoid contact with everolimus when preparing everolimus tablets for oral suspension for another person.

When possible, the suspension should be prepared by an adult who isn’t pregnant or planning to become pregnant. Everolimus can harm the fetus.

call the doctor
When to call the doctor

Call your doctor right away if you become pregnant while taking this drug.

allergies
Allergies

Everolimus can cause a severe allergic reaction. Symptoms may include:

  • trouble breathing
  • swelling of your throat or tongue
  • hives

Don’t take this drug again if you’ve ever had an allergic reaction to it. Taking it again could be fatal.

Everolimus may increase your risk for a severe allergic reaction (angioedema) if you take it with an angiotensin-converting enzyme (ACE) inhibitor. Tell your healthcare provider before taking everolimus if you’re currently taking an ACE inhibitor medicine. Get medical help right away if you have trouble breathing or develop swelling of your tongue, mouth, or throat during treatment with these drugs.

SECTION 4 of 5

How to Take everolimus (Dosage)

Oral tablet

All possible dosages and forms may not be included here. Your dose, form, and how often you take it will depend on:

  • your age
  • the condition being treated
  • how severe your condition is
  • other medical conditions you have
  • how you react to the first dose

What are you taking this medication for?

Certain cancers and noncancerous tumors

Brand: Afinitor

Form: Oral tablet
Strengths: 0.25 mg, 0.50 mg, 0.75 mg, 2.5 mg, 5 mg, 7.5 mg, and 10 mg

Brand: Afinitor Disperz

Form: Tablet for oral suspension
Strengths: 2 mg, 3 mg, and 5 mg
Adult dosage (ages 18–64 years)

For treating breast cancer, pancreatic neuroendocrine tumors (PNET), kidney cancer (renal cell carcinoma), and kidney tumors (angiomyolipoma) with tuberous sclerosis complex (TSC):

  • Oral tablet:
    • 10 mg taken by mouth once per day with or without food

For treating a brain tumor (subependymal giant cell astrocytoma, SEGA) with tuberous sclerosis complex (TSC)::

  • Oral tablet:
    • Your doctor will decide your dosage is determined using your body surface area. This is calculated by your height and weight, and it’s measured in squared meters (m2).
    • The typical dose is 4.5 mg/m² taken by mouth once per day. Your doctor will adjust your dosage depending on your blood levels of everolimus as needed.
  • Tablet for oral suspension:
    • Your dose is determined using your body surface area. This is calculated by your height and weight, and it’s measured in squared meters (m2).
    • The typical dose is 4.5 mg/m² taken by mouth once per day. Your doctor will adjust your dosage as needed depending on your blood levels of everolimus.
Child dosage (ages 1–17 years)

For treating a brain tumor (subependymal giant cell astrocytoma, SEGA) with tuberous sclerosis complex (TSC):

  • Oral tablet:
    • Your doctor will decide your child’s dosage using your child’s body surface area. This is calculated by their height and weight, and it’s measured in squared meters (m2).
    • The typical dose is 4.5 mg/m² taken by mouth once per day. Your child’s doctor will adjust your child’s dosage as needed.
  • Tablet for oral suspension:
    • Your doctor will decide your child’s dosage using your child’s body surface area. This is calculated by their height and weight, and it’s measured in squared meters (m2).
    • The typical dose is 4.5 mg/m² taken by mouth once per day. Your child’s doctor will adjust your child’s dosage as needed.
Child dosage (ages 0–11 months)

This drug should not be used in children younger than 1 year of age.

Senior dosage (ages 65 years and older)

The kidneys of older adults may not work as well as they used to. This can cause your body to process drugs more slowly. As a result, more of a drug stays in your body for a longer time. This raises your risk of side effects.

Your doctor may start you on a lowered dose or a different dosing schedule. This can help keep levels of this drug from building up too much in your body.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this list includes all possible dosages. This information is not a substitute for medical advice. Always to speak with your doctor or pharmacist about dosages that are right for you.
Pharmacist's Advice
Healthline Pharmacist Editorial Team

Everolimus comes with serious risks if you don't take it as prescribed.

If you stop taking the drug suddenly or don't take it at all

Your cancer or tumors may get worse.

If you miss doses or don’t take the drug on schedule

Your medication may not work as well or may stop working completely. For this drug to work well, a certain amount needs to be in your body at all times.

If you take too much

You’re at a higher risk of having common side effects. If you think you’ve taken too much of this drug, call your doctor or local poison control center. If your symptoms are severe, call 9-1-1 or go to the nearest emergency room right away. Take the pack of everolimus with you to show the doctor.

What to do if you miss a dose

You may still take the dose up to 6 hours after the time you normally take it. If it’s more than 6 hours after you normally take everolimus, skip the dose for that day. The next day, take everolimus at your usual time. Never try to catch up by taking two doses at once. This could result in dangerous side effects. If you’re not sure what to do, call your healthcare provider.

How to tell if the drug is working

Your advanced breast cancer, kidney cancer, or pancreatic cancer may stop spreading. Your kidney tumors or brain tumors may get smaller. Your doctor will do tests to tell if this drug is working.

Everolimus is a long-term drug treatment.

Important considerations for taking this drug

You can take everolimus with or without food

Be sure to take it the same way each time, either with food or without it.

Store this drug carefully

  • Store everolimus at room temperature between 59°F and 86°F (15°C and 30°C).
  • Keep this drug in the pack it comes in.
  • Store this drug away from light.
  • Don’t store this medication in moist or damp areas, such as bathrooms.

A prescription for this medication is refillable

You should not need a new prescription for this medication to be refilled. Your doctor will write the number of refills authorized on your prescription.

Travel

When traveling with your medication:

  • Always carry your medication with you. When flying, never put it into a checked bag, Keep it in your carry-on bag.
  • Don’t worry about airport x-ray machines. They can’t hurt your medication.
  • You may need to show airport staff the pharmacy label for your medication. Always carry the original prescription-labeled box with you.
  • Don’t put this medication in your car’s glove compartment or leave it in the car. Be sure to avoid doing this when the weather is very hot or very cold.

Self-management

Training is required when using the tablets for oral suspension. You’ll need to learn how to mix the suspension. Your healthcare provider can tell you how. Here are the basic steps:

  • Put on protective gloves.
  • Mix the tablets with water. Do not mix them with other liquids.
  • Drink all of the liquid right after mixing it.
  • Throw the suspension away if you don’t take it within 60 minutes of mixing it.

Clinical monitoring

Your doctor may do blood tests before and during your treatment with everolimus. These tests may check your:

  • Blood cell levels
  • Kidney function 
  • Liver function
  • Cholesterol levels
  • Blood sugar levels
  • Levels of everolimus. This check may be done if you’re taking this drug to treat a brain tumor. This will help your doctor decide how much everolimus you should take.

Hidden costs

To prepare the everolimus tablets for oral suspension, you may need to purchase:

  • oral syringes
  • 30-mL dose cups
  • disposable gloves

The cost of these items depends on where you buy them.

Insurance

Many insurance companies require a prior authorization for this drug. This means your doctor may need to get approval from your insurance company before your insurance company will pay for the prescription.

Are there any alternatives?

There are other drugs available to treat your condition. Some may be better suited for you than others. Talk to your doctor about other drug options that may work for you.

SECTION 5 of 5

How Much Does everolimus Cost?

Oral tablet

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Lowest price for everolimus

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These prices represent the lowest priced national pharmacies for everolimus on GoodRx. They may be lower than your insurance.

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Content developed in collaboration with University of Illinois-Chicago, Drug Information Group

Medically reviewed by Creighton University, Center for Drug Information and Evidence-Based Practice on August 18, 2015

Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.
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