Everolimus (Afinitor)

The basics

Everolimus (brand name- Afinitor) is an FDA-approved treatment for cancers of the kidneys, breast, pancreas, stomach, intestine, lungs, and brain that have spread to different body parts and cannot be treated with surgery. It is also used to treat kidney tumors in people with Tuberous Sclerosis Complex (TSC; a genetic condition that causes tumors to grow in many organs).

Everolimus (Afinitor Disperz) is also used with other medications to treat certain types of seizures in adults and children two years of age and older who have TSC. Everolimus (Zortress) is used with other medications to prevent transplant rejection (attack of the transplanted organ by the immune system of the person who received the organ) in certain adults who have received kidney transplants.

It is in a class of medications called kinase inhibitors. Everolimus treats cancer by stopping cancer cells from reproducing and by decreasing the blood supply to the cancer cells. Everolimus prevents transplant rejection by decreasing the activity of the immune system.

Let us walk you through the key things you need to know about Everolimus

Make sure you go through the IMPORTANT WARNING section at the end of this article

How should I take everolimus (Afinitor)?

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Everolimus comes as a tablet to take by mouth and as a tablet to suspend in water and take by mouth. Everolimus should either always be taken with food or always without food. Take everolimus at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand.

Take everolimus exactly as directed. Do not take more or less of it or more often than your doctor prescribes. You should take either everolimus tablets or everolimus tablets for oral suspension. Do not take a combination of both of these products. Swallow the tablets whole with a full glass of water; do not split, chew, or crush them.

Do not stop taking everolimus without talking to your doctor. You can help them by tracking your side effects in Ankr.

What are the side effects of everolimus ?

Common side effects

Serious side effects

  • difficulty breathing or swallowing
  • wheezing
  • flushing
  • chest pain
  • extreme thirst or hunger
  • unusual bleeding or bruising
  • fast or irregular heartbeat
  • dizziness
  • seizures
  • heavy menstrual bleeding
  • difficulty getting or keeping an erection
  • anxiety
  • aggression or other changes in behavior

Everolimus may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication. If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online or by phone (1-800-332-1088).

Use the free Ankr platform or Ankr app to track your symptoms.

What special precautions should I follow?

Before taking everolimus (Afinitor)

  • tell your doctor about your allergies
  • tell your doctor about other intakes
  • tell your doctor if you have or have ever had any other disease, symptom, or treatment
  • tell your doctor if you or your partner are pregnant or plan to become pregnant.Talk to your doctor about methods of birth control that will work for you.

While you are on everolimus (Afinitor)

  • If you or your partner become pregnant while taking everolimus, call your doctor. Everolimus may harm the fetus.
  • Tell your doctor if you are breastfeeding. Do not breastfeed during your treatment and for two weeks after your final dose.
  • If you are having surgery, including dental surgery, tell the doctor or dentist that you are taking everolimus.
  • Do not have any vaccinations without talking to your doctor.

I forgot a dose. What should I do?

If you remember the missed dose within 6 hours of the time you were scheduled to take it, take the missed dose right away. However, if more than 6 hours have passed since the scheduled time, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

In case of an emergency/overdose

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can’t be awakened, immediately call emergency services at 911.

How should I safely store and dispose of everolimus (Afinitor)?

Keep this medication in the blister pack it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light and excess heat and moisture (not in the bathroom). Keep the blister packs and tablets dry.

You should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA’s Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What special dietary instructions should I follow?

Do not eat grapefruit or drink grapefruit juice while taking this medication.

Brand names

  • Afinitor®
  • Afinitor Disperz®
  • Zortress®

Other names

  • RAD001

Last Revised -06/13/2023, FDA updated- 06/15/2018, SG

Taking everolimus may decrease your ability to fight infection from bacteria, viruses, and fungi and increase the risk that you will get a serious or life-threatening infection. If you have had hepatitis B (a type of liver disease) in the past, your infection may become active and you may develop symptoms during your treatment with everolimus. Tell your doctor if you have or have ever had hepatitis B or if you have or think you may have any type of infection now.

Side effects

If you experience any of the following symptoms, call your doctor immediately: excessive tiredness; yellowing of the skin or eyes; loss of appetite; nausea; joint pain; dark urine; pale stools; pain in the upper right part of the stomach; rash; difficult, painful, or frequent urination; ear pain or drainage; sinus pain and pressure; or sore throat, cough, fever, chills, feeling unwell or other signs of infection.

The risk that you will develop cancer, especially lymphoma (cancer of a part of the immune system) or skin cancer, is increased during your treatment with everolimus. Tell your doctor if you or anyone in your family has or has ever had skin cancer or if you have fair skin. To reduce your risk of skin cancer, plan to avoid unnecessary or prolonged exposure to sunlight or ultraviolet light (tanning beds and sunlamps) and to wear protective clothing, sunglasses, and sunscreen during your treatment. If you experience any of the following symptoms, call your doctor immediately: a red, raised, or waxy area on the skin; new sores, bumps, or discoloration on the skin; sores that do not heal; lumps or masses anywhere in your body; skin changes; night sweats; swollen glands in the neck, armpits, or groin; trouble breathing; chest pain; or weakness or tiredness that does not go away.

Other complications

Taking everolimus may increase the risk that you will develop certain very rare and serious infections, including infection with the BK virus, a serious virus that may damage the kidneys and cause a transplanted kidney to fail), and progressive multifocal leukoencephalopathy (PML; a rare infection of the brain that cannot be treated, prevented, or cured and that usually causes death or severe disability). Call your doctor immediately if you experience any of the following symptoms of PML: weakness on one side of the body that worsens over time; clumsiness of the arms or legs; changes in your thinking, walking, balance, speech, eyesight, or strength that last several days; headaches; seizures; confusion; or personality changes.

Everolimus may cause a blood clot in the blood vessels of your transplanted kidney. This is most likely to happen within the first 30 days after your kidney transplant and may cause the transplant to be unsuccessful. If you experience any of the following symptoms, call your doctor immediately: pain in your groin, lower back, side, or stomach; decreased urination or no urination; blood in your urine; dark-colored urine; fever; nausea; or vomiting.

Taking everolimus in combination with cyclosporine could cause damage to your kidneys. In order to reduce this risk, your doctor will adjust the dose of cyclosporine and monitor the levels of the medications and how your kidneys are working. If you experience either of the following symptoms, call your doctor immediately: decreased urination or swelling of the arms, hands, feet, ankles, or lower legs.

In clinical studies, more people who took everolimus died during the first few months after receiving a heart transplant than people who did not take everolimus. If you have received a heart transplant, talk to your doctor about the risks of taking everolimus.

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DISCLAIMER: No part of this content constitutes medical advice, opinion, or should be used for medical decision making without consultation with a licenced medical practitioner and under a patient-provider relationship. All information on the website is provided without any claims of accuracy. For full terms and conditions, visit this link. Content curated by the Ankr team.

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