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Drugs reference index «everolimus»

everolimus (Oral route)

e-ver-OH-li-mus

Commonly used brand name(s):

In the U.S.

  • Afinitor

Available Dosage Forms:

  • Tablet

Therapeutic Class: Antineoplastic Agent

Uses For everolimus

Everolimus is used to treat advanced (late-stage) kidney cancer in patients who have already been treated with other medicines that did not work well.

Everolimus belongs to the group of medicines known as antineoplastics or cancer medicines. It works by interfering with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by everolimus, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects may not be serious but may cause concern.

Before you begin treatment with everolimus, you and your doctor should talk about the good everolimus will do as well as the risks of using it.

everolimus is available only with your doctor's prescription.

Before Using everolimus

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For everolimus, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to everolimus or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of everolimus in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of everolimus in the elderly.

Pregnancy

Pregnancy CategoryExplanation
All TrimestersDStudies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Using everolimus with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Amprenavir
  • Aprepitant
  • Atazanavir
  • Clarithromycin
  • Delavirdine
  • Diltiazem
  • Erythromycin
  • Fluconazole
  • Fosamprenavir
  • Indinavir
  • Itraconazole
  • Ketoconazole
  • Nefazodone
  • Nelfinavir
  • Posaconazole
  • Ritonavir
  • Saquinavir
  • Telithromycin
  • Verapamil
  • Voriconazole

Using everolimus with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Carbamazepine
  • Dexamethasone
  • Phenobarbital
  • Phenytoin
  • Rifabutin
  • Rifampin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using everolimus with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use everolimus, or give you special instructions about the use of food, alcohol, or tobacco.

  • Grapefruit Juice

Other Medical Problems

The presence of other medical problems may affect the use of everolimus. Make sure you tell your doctor if you have any other medical problems, especially:

  • Diabetes or
  • Hyperglycemia (high sugar in the blood) or
  • Hyperlipidemia (high cholesterol in the blood) or
  • Hypertriglyceridemia (high fat in the blood) or
  • Hypoxia (low oxygen in the blood) or
  • Lung or breathing problems—Use with caution. May make these conditions worse.
  • Infection—Everolimus decreases your body's ability to fight infection.
  • Liver disease—Effects may be increased because of slower removal from the body.
  • Liver disease, severe—Should not be used in patients with this condition.

Proper Use of everolimus

Take everolimus exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

everolimus usually comes with a patient information leaflet. Read the leaflet carefully and make sure you understand it before taking everolimus. If you have any questions, talk to your doctor.

Everolimus works best when there is a constant amount in the blood. You can keep the amount constant by taking the dose at the same time each day.

You may take everolimus with or without food. However, you should take it the same way each time.

Swallow the tablet whole with a glass of water. Do not break, crush, or chew it. If you accidentally break or crush the tablet, wash your hands with water right away.

Dosing

The dose of everolimus will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of everolimus. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For advanced kidney cancer:
      • Adults—10 milligrams (mg) once a day. Your doctor may adjust your dose if needed.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of everolimus, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose of everolimus, you may still take it up to 6 hours after the time you normally take it. However, if it is more than 6 hours, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using everolimus

It is very important that your doctor check your progress at regular visits to make sure that everolimus is working properly. Blood tests may be needed to check for unwanted effects.

Using everolimus while you are pregnant can harm your unborn baby. Use an effective form of birth control while being treated with everolimus and for at least 8 weeks after stopping treatment. If you think you have become pregnant while using the medicine, tell your doctor right away.

If you plan to have children, talk with your doctor before using everolimus. everolimus may decrease fertility in men and women.

everolimus may cause a serious lung problem called noninfectious pneumonitis. Stop using everolimus and check with your doctor right away if you have chest pain, chills, a cough, fever, shortness of breath, or troubled breathing.

While you are being treated with everolimus, and after you stop treatment with it, it is important to talk to your doctor about the immunizations (vaccinations) you should receive. Do not get any immunizations without your doctor's approval. Everolimus may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not take oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid other persons who have taken the oral polio vaccine. Do not get close to them, and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.

Everolimus can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

  • If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
  • Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in urine or stools; or pinpoint red spots on your skin.
  • Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
  • Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
  • Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
  • Avoid contact sports or other situations where bruising or injury could occur.

Everolimus may cause mouth ulcers and sores in some patients. Tell your doctor right away if you have pain, discomfort, or open sores in your mouth while you are using everolimus. You may use a special mouthwash or mouth gel to treat these ulcers. Ask your doctor what type of products to use.

everolimus may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor.

everolimus may increase your cholesterol and fats in the blood. If this condition occurs, your doctor may give you some medicines that can lower the amount of cholesterol and fats in the blood.

Grapefruits and grapefruit juice may increase the effects of everolimus by increasing the amount of everolimus in your body. You should not eat grapefruit or drink grapefruit juice while you are taking everolimus.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (e.g., St. John's wort) or vitamin supplements.

everolimus Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
  • Bloating or swelling of the face, arms, hands, lower legs, or feet
  • bloody nose
  • chest pain
  • cough or hoarseness
  • cracked lips
  • decreased weight
  • diarrhea
  • difficult or labored breathing
  • difficulty with swallowing
  • fever or chills
  • general feeling of discomfort or illness
  • lower back or side pain
  • painful or difficult urination
  • rapid weight gain
  • shortness of breath
  • sores, ulcers, or white spots on the lips, tongue, or inside the mouth
  • swelling or inflammation of the mouth
  • thickening of bronchial secretions
  • tightness in the chest
  • tingling of the hands or feet
  • troubled with breathing
  • unusual weight gain or loss
  • wheezing
Less common
  • Bleeding after defecation
  • bleeding gums
  • bloody urine
  • blurred vision
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • coughing up blood
  • decreased frequency or amount of urine
  • decreased urine output
  • dilated neck veins
  • dry mouth
  • extreme fatigue
  • fast, pounding, or irregular heartbeat or pulse
  • flushed, dry skin
  • fruit-like breath odor
  • headache
  • increased blood pressure
  • increased hunger
  • increased menstrual flow or vaginal bleeding
  • increased thirst
  • increased urination
  • irregular breathing
  • irregular heartbeat
  • loss of appetite
  • loss of consciousness
  • nausea
  • nervousness
  • nosebleeds
  • paralysis
  • pounding in the ears
  • prolonged bleeding from cuts
  • red or black, tarry stools
  • red or dark brown urine
  • runny nose
  • slow heartbeat
  • sore throat
  • stomachache
  • sweating
  • uncomfortable swelling around the anus
  • unexplained weight loss
  • unusual tiredness or weakness
  • vomiting
  • weight gain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Abdominal or stomach pain
  • change in taste
  • dizziness
  • dry skin
  • itching skin
  • lack or loss of strength
  • loss of taste
  • pain in the arms or legs
  • rash
  • sleeplessness
  • trouble with sleeping
  • unable to sleep
Less common
  • Back pain
  • blistering, peeling, redness, or swelling of the palms, hands, or bottoms of the feet
  • bumps on the skin
  • burning, dry, or itching eyes
  • discharge or excessive tearing
  • discoloration of the fingernails or toenails
  • excess air or gas in the stomach or intestines
  • flushing or redness of the skin
  • full feeling
  • jaw pain
  • numbness, pain, tingling, or unusual sensations in the palms of the hands or bottoms of the feet
  • passing gas
  • redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
  • sleepiness or unusual drowsiness
  • unusually warm skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

The information contained in the Thomson Healthcare (Micromedex) products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Healthcare does not assume any responsibility or risk for your use of the Thomson Healthcare products.

  • Everolimus Professional Patient Advice (Wolters Kluwer)
  • Everolimus MedFacts Consumer Leaflet (Wolters Kluwer)
  • Afinitor Prescribing Information (FDA)
  • Afinitor Consumer Overview

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