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Everolimus

Generic name: everolimus
Brand names: Afinitor, Afinitor Disperz, Zortress
Dosage form: oral tablet, tablet for oral suspension
Drug classes: MTOR inhibitors, Selective immunosuppressants

Medically reviewed by Philip Thornton, DipPharm. Last updated on Jun 2, 2023.

What is everolimus?

Everolimus (Afinitor, Afinitor Disperz, Zortress) belongs to a class of drugs called kinase inhibitors. It is used to prevent organ transplant rejection and treat certain benign (noncancerous) and cancerous tumors.

Different brandnames and tablet strengths of everolimus are used for different conditions:

Everolimus is an inhibitor of a kinase called mammalian target of rapamycin (mTOR), which plays an important role in a pathway that regulates things such as how cells in your body multiply, form new blood vessels and use nutrients.

In people with tumors, everolimus works by reducing the blood flow to the tumor, which slows down the growth of tumors. Everolimus does this my binding to a protein called FKBP-12 and forming a complex, which blocks the activity of mTOR.

In people with a transplanted liver or kidney, everolimus acts as an immunosuppressant to prevent your body from attacking or rejecting the transplanted organ. Everolimus works by stopping a type of white blood cell called lymphocytes from activating and multiplying. These cells usually help our bodies fight off invading organisms, but after an organ transplant you don't want your immune system cells attacking or rejecting the new organ. Everolimus inhibits both antigenic and interleukin (IL-2 and IL-15) stimulation of lymphocytes.

Everolimus was approved by the US Food and Drug Administration (FDA) in 2009.

What is everolimus used for?

The Afinitor brand of everolimus is a prescription medicine used to treat:

The Afinitor Disperz brand of everolimus is a prescription medicine used to treat:

The Zortress brand of everolimus is a prescription medicine used to:

It is not known if everolimus:

Important information

Important information you should know if you are taking everolimus to treat a tumor

This medication can cause serious side effects, including:

1. You may develop lung or breathing problems. In some people lung or breathing problems may be severe and can lead to death. Tell your healthcare provider right away if you have any of these symptoms:

2. You may be more likely to develop an infection, such as pneumonia, or a bacterial, fungal or viral infection. Viral infections may include active hepatitis B in people who have had hepatitis B in the past (reactivation). In some people (including adults and children) these infections may be severe and can lead to death. You may need to be treated as soon as possible.

Tell your healthcare provider right away if you have a temperature of 100.5˚F or above, chills, or do not feel well.

Symptoms of hepatitis B or infection may include the following:

3. Severe allergic reactions. Call your healthcare provider or get medical help right away if you get signs and symptoms of a severe allergic reaction, including: rash, itching, hives, flushing, trouble breathing or swallowing, chest pain or dizziness.

4. Possible increased risk for a type of allergic reaction called angioedema, in people who take an Angiotensin-Converting Enzyme (ACE) inhibitor medicine during treatment with everolimus. Talk with your healthcare provider before taking this medication if you are not sure if you take 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 this medications.

5. Mouth ulcers and sores. Mouth ulcers and sores are common during treatment with everolimus but can also be severe. When you start treatment with one of this medication, your healthcare provider may tell you to also start a prescription mouthwash to reduce the likelihood of getting mouth ulcers or sores and to reduce their severity. Follow your healthcare provider’s instructions on how to use this prescription mouthwash. If you develop pain, discomfort, or open sores in your mouth, tell your healthcare provider. Your healthcare provider may tell you to restart this mouthwash or to use a special mouthwash or mouth gel that does not contain alcohol, peroxide, iodine, or thyme.

6. You may develop kidney failure. In some people this may be severe and can lead to death. Your healthcare provider should do tests to check your kidney function before and during your treatment.

If you have any of the serious side effects listed above, you may need to stop taking everolimus for a while or use a lower dose. Follow your healthcare provider’s instructions.

Important information you should know if you are taking everolimus to prevent transplant rejection

This medication can cause serious side effects, including:

See the section below “What are the side effects of everolimus?” for information about other serious side effects.

Who should not take everolimus?

Do not take everolimus if you have had a severe allergic reaction to everolimus.

Do not take everolimus if you are allergic to any of the ingredients in it. See below for a complete list of ingredients.

Talk to your healthcare provider before taking this medicine if you are allergic to:

Ask your healthcare provider if you do not know.

What should I tell my doctor before taking everolimus?

Before taking everolimus, tell your healthcare provider about all of your medical conditions, including if you:

How should I take everolimus?

Enhertu, Verzenio, tacrolimus, azathioprine, cyclosporine, Keytruda, mycophenolate mofetil, Arimidex, pembrolizumab, fluorouracil

What happens if I miss a dose?

If you are taking everolimus to treat a tumor and you miss a dose, you may take it if it is less than 6 hours after the time you normally take it. If it is more than 6 hours after you normally take your everolimus, skip the dose for that day. The next day, take everolimus at your usual time. Do not take 2 doses to make up for a missed dose. If you are not sure about what to do, call your healthcare provider.

What happens if I overdose?

If you are taking everolimus to treat a tumor and you take too much, contact your healthcare provider or go to the nearest hospital emergency room right away. Take the pack of everolimus with you.

If you are taking everolimus to prevent transplant rejection, call your doctor or go to the nearest hospital emergency room right away.

What should I avoid while taking everolimus?

What are the side effects of everolimus?

If you are taking everolimus to treat a tumour:

Everolimus can cause serious side effects, including:

The most common side effects of everolimus in people with advanced hormone receptor-positive, HER2-negative breast cancer, advanced neuroendocrine tumors of the pancreas, stomach and intestine (gastrointestinal) or lung, and advanced kidney cancer include:

The most common side effects of everolimus in people who have SEGA, renal angiomyolipoma, or certain types of seizures with TSC include respiratory tract infections.

Other side effects that may occur with everolimus:

If you are taking everolimus to prevent transplant rejection:

Everolimus may cause serious side effects, including:

The most common side effects of everolimus in people who have had a kidney or liver transplant include:

These common side effects have been reported in both kidney and liver transplant patients:

The most common side effects of everolimu in people who have had a kidney transplant include:

The most common side effects of everolimus in people who have had a liver transplant include:

Tell your healthcare provider if you have any side effect that bothers you or does not go away.

These are not all the possible side effects of everolimus. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Interactions

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Everolimus may affect the way other medicines work, and other medicines can affect how everolimus works. Taking everolimus with other medicines can cause serious side effects.

Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine. Especially tell your healthcare provider if you take:

Ask your healthcare provider or pharmacist if you are not sure if your medicine is one of those taken for the conditions listed above. If you are taking any medicines for the conditions listed above, your healthcare provider might need to prescribe a different medicine or your dose of everolimus may need to be changed. You should also tell your healthcare provider before you start taking any new medicine.

Does everolimus interact with my other drugs?

Enter medications to view a detailed interaction report using our Drug Interaction Checker.

Pregnancy and breastfeeding

Tell your doctor if you are pregnant, can become pregnant, or have a partner who can become pregnant. Everolimus can cause harm to your unborn baby.

Females who are able to become pregnant:

Males with a female partner, you should use effective birth control during treatment and for 4 weeks after your last dose of everolimus.

Talk to your healthcare provider about birth control methods that may be right for you during this time. If you become pregnant or think you are pregnant, tell your healthcare provider right away.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if everolimus passes into your breast milk. Do not breastfeed during treatment and for 2 weeks after your last dose of everolimus.

Storage

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

What are the ingredients in everolimus?

Active ingredient: everolimus.

Inactive ingredients:

Afinitor tablets: anhydrous lactose, butylated hydroxytoluene, crospovidone, hypromellose, lactose monohydrate, and magnesium stearate.

Afinitor Disperz tablets: butylated hydroxytoluene, colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, mannitol, and microcrystalline cellulose.

Zortress tablets: butylated hydroxytoluene, magnesium stearate, lactose monohydrate, hypromellose, crospovidone and lactose anhydrous.

Generic versions of Afinitor, Afinitor Disperz and Zortress are available. Inactive ingredients in generic versions of these tablets may vary from those listed in the branded versions of everolimus listed above. Check the product label for the version of everolimus you take to find out all the ingredients in that particular version.

Everolimus is distributed under the brandname Afinitor, Afinitor Disperz and Zortress by Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936. Other companies also manufacture generic versions of these tablets.

Frequently asked questions

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.