Everolimus | Side Effects, Dosage, Uses & More

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, or brain tumors. It’s also used to treat noncancerous kidney tumors and pancreas tumors. 

2

Your doctor will decide your dose. It depends on your diagnosis, liver function, what other medications you’re taking, and your response to the drug.

3

You should take everolimus once per day at the same time each day, consistently with food or without food. The tablets should be swallowed whole with a glass of water. The tablets for suspension must be dissolved in water first. Don’t break or crush any of the everolimus tablets.

4

Common side effects include mouth sores, infections, weakness or tiredness, cough, diarrhea, constipation, skin rash, dry, itchy skin, swelling of parts of the body, abnormal taste, swelling in your digestive system, nosebleeds, pain in your arms or legs, and headache.

5

Before you start everolimus, tell your doctor about all medications you’re taking and your current and past medical conditions, such as: kidney problems, liver problems, diabetes, high cholesterol, infections, including hepatitis B virus infection. Also tell your doctor if you’re pregnant, plan to become pregnant, are breastfeeding, or plan to receive any vaccinations.

IMPORTANT INFORMATION

Risk of infections

Taking everolimus may increase your chance of developing a bacterial, fungal, or viral infection. Viral infections may include hepatitis B virus infection in people who’ve had hepatitis B in the past (reactivation). In some people, these infections may be severe and possibly fatal. Tell your doctor right away if you don’t feel well or have symptoms of an infection, such as a fever or chills.

Allergic reaction

Everolimus may increase your risk for a severe allergic reaction if you also take an Angiotensin-Converting Enzyme (ACE) inhibitor drug with everolimus. Seek medical help right away if you have trouble breathing or swelling of your tongue, mouth, or throat during treatment with everolimus.

Drug interactions

Tell your doctor about all prescription and over-the-counter medicines, herbs, and supplements that you’re taking. Some medications may increase or decrease the amount of everolimus in your blood. Your doctor may need to adjust your dose of everolimus.

Lung disease and pneumonia

This drug may cause interstitial lung disease and pneumonia. This can lead to pulmonary hypertension (a type of high blood pressure that affects your lungs). In rare cases, this can be fatal.

Drug features

Everolimus is a prescription drug. It’s available in these forms: oral tablet and tablet for oral suspension. 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 types of breast cancer, kidney cancer, pancreatic tumors, kidney tumors (non-cancerous), and brain tumors (non-cancerous). It’s used when these conditions can’t be surgically removed or haven’t responded to other treatments.

More Details

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 similarly. They have a similar chemical structure and are often used to treat similar conditions.

More Details

Why it's used

Everolimus oral tablet is used to treat advanced types of breast cancer, kidney cancer, pancreatic tumors, kidney tumors (non-cancerous), and brain tumors (non-cancerous). It’s used when these conditions can’t be surgically removed or haven’t responded to other treatments.

Everolimus is used to treat:

  • Advanced breast cancer (hormone receptor-positive, HER2-negative breast cancer) in postmenopausal women who have already received medicines to treat their cancer.
  • Advanced pancreatic neuroendocrine tumors (PNET) that have progressed and can’t be removed by surgery. Everolimus can’t be used in people with carcinoid tumors that actively produce hormones.
  • Advanced kidney cancer (renal cell carcinoma) when other medicines haven’t worked.
  • Kidney tumors (angiomyolipoma) in adults with the genetic condition tuberous sclerosis complex (TSC) that don’t need surgery right away.
  • Brain tumor (subependymal giant cell astrocytoma, SEGA) in adults and children with the genetic condition tuberous sclerosis complex (TSC). It’s used when the tumor can’t be fully removed by surgery.

Everolimus tablet for oral suspension is used to treat the genetic condition tuberous sclerosis complex (TSC) in adults and children with a brain tumor called subependymal giant cell astrocytoma (SEGA). It’s given when the tumor cannot be fully removed by surgery.

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 similarly. They have a similar chemical structure and are often used to treat similar conditions.

The mTOR is a kinase, which is a type of protein or enzyme in the body. Kinases help all cells, both healthy and cancerous cells, 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.

By interfering with the growth of cancer and tumor cells, everolimus prevents the spread of the cancer or tumor in your body.

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SECTION 2 of 5

everolimus Side Effects

Oral tablet

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

    • mouth ulcers and sores. Tell your doctor if you have pain, discomfort, or open sores in your mouth. They may tell you to use a special mouthwash or mouth gel that doesn’t contain alcohol, peroxide, iodine, or thyme.
    • infections
    • weakness or tiredness
    • cough
    • shortness of breath
    • diarrhea
    • constipation
    • skin rash or dry or itchy skin
    • nausea
    • vomiting
    • fever
    • loss of appetite
    • weight loss
    • swelling of your arms, hands, feet, ankles, face, or other parts of the body
    • metallic  taste in your mouth
    • dry mouth
    • inflammation of lining of the digestive system
    • headache
    • nosebleeds
    • pain in your arms, legs, mouth, throat, back or joints
    • high blood sugar
    • high blood pressure
    • trouble sleeping
    • hair loss
    • muscle spasms
    • dizziness
    • nail disorders
  • Common side effects of everolimus in people with subependymal giant cell astrocytoma (SEGA) brain tumors or kidney tumors include:

    • mouth ulcers and sores. Tell your doctor if you have pain, discomfort, or open sores in your mouth. They may tell you to use a special mouthwash or mouth gel that doesn’t contain alcohol, peroxide, iodine, or thyme.
    • 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. You may miss 1 or more menstrual periods. Tell your healthcare provider if this happens.
    • low 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

If you experience any of these serious side effects, call your doctor right away. If your symptoms are potentially life threatening, or if you think you’re experiencing a medical emergency, call 9-1-1.

  • Lung or breathing problems. Symptoms include:

    • new or worsening cough
    • shortness of breath
    • chest pain
    • wheezing or trouble breathing
  • Infections. Symptoms include:

    • fever of 100.5°F or above
    • chills
    • viral infections may include active hepatitis B virus infection in people who have had hepatitis B in the past (reactivation). Symptoms include:
      • fever
      • chills
      • skin rash
      • joint pain and swelling
      • tiredness
      • loss of appetite
      • nausea
      • pale-colored stools
      • dark-colored urine
      • yellowing of your skin
      • pain in the upper right side of your stomach
  • Severe allergic reaction. Everolimus may increase the risk for a severe allergic reaction if you take an Angiotensin-Converting Enzyme (ACE) inhibitor medicine with everolimus. Symptoms include:

    • trouble breathing
    • swelling of your tongue, mouth, or throat
  • Kidney failure

    • fever
    • weakness
    • fatigue
    • no urine output
    • swelling of parts of your body
  • Wounds or cuts that heal slowly or don’t heal well. Symptoms include:

    • wound or incision that’s red, warm, or painful
    • blood, fluid, or pus in your incision
    • your incision opens up
    • swelling at the incision or wound site
Pharmacist's Advice
Healthline Pharmacist Editorial Team

Everolimus may cause drowsiness. It may make you feel tired.

Mouth ulcers and mouth sores are common side effects. They occur in most people who take everolimus.

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 may interact with other medications, herbs, or vitamins you might be taking. That’s why your doctor should manage all of your medications carefully. If you’re curious about how this drug might interact with something else you’re taking, talk to your doctor or pharmacist.

Note: You can reduce your chances of drug interactions by having all of your prescriptions filled at the same pharmacy. That way, a pharmacist can check for possible drug interactions.

Food interactions

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

Alcohol interaction

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

Medications that might interact with this drug

Antifungal drugs
  • fluconazole
  • itraconazole
  • ketoconazole
  • posaconazole

These drugs may increase the amount of everolimus in your body.

Antibiotics
  • rifampin (Rifadin)
  • rifabutin (Mycobutin)
  • rifapentine (Priftin)
  • rifaximin (Xifaxan)

These drugs may decrease the amount of everolimus in your body.

  • clarithromycin
  • erythromycin
  • telithromycin

These drugs may increase the amount of everolimus in your body.

High blood pressure or heart drugs
  • verapamil
  • diltiazem

These drugs may increase the amount of everolimus in your body.

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

Everolimus can independently increase your risk for a severe allergic reaction (angioedema) and this risk is increased with other medications that can cause angioedema, such as these drugs.

Antidepressants
  • nefazodone 

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

Human immunodeficiency virus (HIV) drugs
  • atazanavir
  • indinavir
  • lopinavir/ritonavir
  • nelfinavir
  • ritonavir
  • saquinavir

These drugs may increase the amount of everolimus in your body.

Herbal supplement
  • St. John's wort

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

Seizures drugs
  • carbamazepine (Tegretol)
  • phenobarbital
  • phenytoin (Dilantin)

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 these drugs.

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.

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.

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.

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.

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.

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.

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

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.

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

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

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.

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.

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)

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
    • Take everolimus at the same time every day. Take it either consistently with food or consistently without food.
    • Swallow the tablets whole with a full glass of water.

Brain tumor (subependymal giant cell astrocytoma, SEGA) with tuberous sclerosis complex (TSC):

  • Oral tablet:
    • 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 recommended dose is 4.5 mg/m² taken by mouth once per day. Your doctor will adjust your dose depending on your blood levels of everolimus.
    • Take everolimus at the same time every day. Take it either consistently with food or consistently without food.
    • Swallow the tablets whole with a full glass of water.
  • 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 recommended dose is 4.5 mg/m² taken by mouth once per day. Your doctor will adjust your dose depending on your blood levels of everolimus.
    • Take everolimus at the same time every day. Take it either consistently with food or consistently without food.
Child dosage (ages 1–17 years)

Brain tumor (subependymal giant cell astrocytoma, SEGA) with tuberous sclerosis complex (TSC):

  • Oral tablet:
    • 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 recommended dose is 4.5 mg/m² taken by mouth once per day. Your doctor will adjust your dose depending on your blood levels of everolimus.
    • Take everolimus at the same time every day. Take it either consistently with food or consistently without food.
    • Swallow the tablets whole with a full glass of water.
  • 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 recommended dose is 4.5 mg/m² taken by mouth once per day. Your doctor will adjust your dose depending on your blood levels of everolimus.
    • Take everolimus at the same time every day. Take it either consistently with food or consistently without food.
Senior dosage (ages 65 years and older)

Older adults may process drugs more slowly. There is no dosage adjustment needed when you first start everolimus. However, your doctor will watch you closely and may adjust your dose if you have any reactions to this drug.

Warnings

You may experience side effects such as inflammation of the lungs, inflammation of the stomach, high blood sugar, high cholesterol levels, or infections. If these symptoms happen and are severe enough, your doctor will decrease your dose, temporarily stop or permanently discontinue everolimus.

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 don't take it at all

If you don’t take your everolimus, your cancer or tumors may not decrease in size or go away.

If you take too much

If you take too much, you’re at a higher risk of experiencing common side effects. If you think that you’ve taken too much everolimus, call your healthcare provider or go to the emergency room right away. Take the pack of everolimus with you.

What to do if you miss a dose

If you miss a dose of everolimus, you may still take it 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.

Don’t take two doses to make up for a missed dose. If you’re not sure what to do, call your healthcare provider.

How to tell if the drug is working

If you’re using everolimus oral tablets to treat advanced breast cancer, kidney cancer, or pancreatic cancer, the medication may slow the spread of your cancer. If you’re using everolimus to treat kidney tumors or brain tumors, your tumor may get smaller. Your doctor will do tests to tell if this drug is working.

If you’re using everolimus tablets for oral suspension to treat a brain tumor called subependymal giant cell astrocytoma (SEGA), you may be able to tell if this drug is working if your brain tumor gets smaller. Your doctor will do tests to tell if this drug is working.

Everolimus is a long-term drug treatment.

Important considerations for taking everolimus
can take with food You can take everolimus with or without food See Details
timing Take it at the same time every day
do not crush or cut or chew Don’t crush, cut, or chew the tablets. Don’t take tablets that are crushed or broken.
storage Store everolimus at room temperature See Details
refillable Prescription is refillable
travel Travel See Details
self management Self-management See Details
clinical monitoring Clinical monitoring See Details
not usually stocked Not every pharmacy stocks this drug, so call ahead
hidden costs Hidden costs See Details
prior authorization Insurance See Details

You can take everolimus with or without food

Take it the same way each day, either always with food or always without food.

Store everolimus at room temperature

Keep it from 59–86°F (15–30°C).

Keep it in the pack it comes in.

Keep it dry and away from light.

Keep your drugs away from areas where they could get wet, such as bathrooms. Store this drug away from moisture and damp locations.

Keep everolimus and all drugs out of the reach of children.

Travel

When traveling with your medication:

  • Always carry your medication with you or in your carry-on bag.
  • Don’t worry about airport X-ray machines. They can’t hurt this medication.
  • You may need to show your pharmacy’s label to clearly identify the medication. Keep the original prescription label with you when traveling with your medication.
  • Don’t leave this medicine in the car, especially when the temperature is hot or freezing.

Self-management

Training required when using tablets for oral suspension. You’ll need to learn how to mix this suspension. Everolimus tablets for suspension are first mixed with water. Then the liquid it is taken by mouth immediately afterwards. Throw it away if you don’t take it within 60 minutes after mixing.

Don’t chew, crush, or swallow everolimus tablets for suspension whole. Prepare suspension in water only.  Be sure to wear protective gloves when preparing the dose.

Clinical monitoring

Your doctor may do blood tests. These may be done before starting and during treatment with everolimus. These include tests to check your:

  • blood cell counts (white blood cells, red blood cells, platelets)
  • kidney function  (such as creatinine clearance and blood urea nitrogen)
  • liver function
  • cholesterol
  • blood sugar levels
  • levels of everolimus in your blood if you’re taking this drug to treat the brain tumor subependymal giant cell astrocytoma (SEGA). 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

Insurance

Many insurance companies will require a prior authorization before they approve the prescription and pay for everolimus.

Are there any alternatives?

There are other drugs available to treat your condition. Some may be more suitable for you than others. Talk to your doctor about possible alternatives.

SECTION 5 of 5

How Much Does everolimus Cost?

Oral tablet

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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 December 22, 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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