Description and Brand Names
Drug information provided by: Merative, Micromedex®
US Brand Name
- Afinitor
- Afinitor Disperz
- Zortress
Descriptions
Everolimus is used to treat advanced (late-stage) cancers or noncancerous tumors, such as kidney and breast cancer, subependymal giant cell astrocytoma (SEGA, a brain tumor), renal angiomyolipoma (kidney tumor), and partial-onset seizures (epilepsy) with tuberous sclerosis complex (TSC), and neuroendocrine tumors of the pancreas, stomach or bowels, and lungs. It is used for patients who have already received other medicines that did not work well or those who will not be treated with surgery.
Everolimus works by interfering with the growth of cancer cells, which are eventually destroyed by the body. Since the growth of normal body cells may also be affected, other unwanted effects will also occur. It belongs to the group of medicines known as antineoplastics (cancer medicines).
Everolimus is also used together with other medicines to prevent the body from rejecting a transplanted organ (eg, kidney or liver) in patients who have received kidney or liver transplant. This medicine may be used with cyclosporine, steroids, basiliximab, or tacrolimus. When a patient receives an organ transplant, the body's white blood cells may try to get rid of (reject) the transplanted organ. Everolimus works to suppress the immune system and prevents the white blood cells from getting rid of the transplanted organ.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet
- Tablet for Suspension
Before Using
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 this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of everolimus in children 1 year of age and older to treat SEGA brain tumors and in children 2 years of age and older to treat partial-onset seizures. However, use is not recommended in children younger than 1 year of age to treat SEGA brain tumors and in children younger than 2 years of age to treat partial-onset seizures.
Appropriate studies have not been performed on the relationship of age to the effects of everolimus when used for kidney cancer, neuroendocrine tumors, and kidney or liver transplants in children. 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. However, elderly patients are more likely to have unwanted side effects, which may require caution and an adjustment in the dose for patients receiving everolimus.
Breastfeeding
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.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
-
Levoketoconazole
-
Ritonavir
Using this medicine 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.
-
Abrocitinib
-
Adagrasib
-
Adenovirus Vaccine, Live
-
Apalutamide
-
Asciminib
-
Avacopan
-
Bacillus of Calmette and Guerin Vaccine, Live
-
Belumosudil
-
Belzutifan
-
Benazepril
-
Berotralstat
-
Boceprevir
-
Cannabidiol
-
Capmatinib
-
Captopril
-
Carbamazepine
-
Ceritinib
-
Cholera Vaccine, Live
-
Cimetidine
-
Clarithromycin
-
Cobicistat
-
Conivaptan
-
Crizotinib
-
Curcumin
-
Cyclosporine
-
Dabrafenib
-
Danicopan
-
Daridorexant
-
Darunavir
-
Dengue Tetravalent Vaccine, Live
-
Diltiazem
-
Dronedarone
-
Duvelisib
-
Ebola Zaire Vaccine, Live
-
Elacestrant
-
Enalapril
-
Enalaprilat
-
Enasidenib
-
Enzalutamide
-
Erdafitinib
-
Erythromycin
-
Fedratinib
-
Fexinidazole
-
Fluconazole
-
Fluvoxamine
-
Fosinopril
-
Fosnetupitant
-
Fosphenytoin
-
Gilteritinib
-
Givinostat
-
Idelalisib
-
Indinavir
-
Influenza Virus Vaccine, Live
-
Isavuconazonium Sulfate
-
Itraconazole
-
Ivacaftor
-
Ivosidenib
-
Ketoconazole
-
Lanreotide
-
Larotrectinib
-
Lasmiditan
-
Lefamulin
-
Lenacapavir
-
Lisinopril
-
Lonafarnib
-
Lorlatinib
-
Lumacaftor
-
Mavacamten
-
Mavorixafor
-
Measles Virus Vaccine, Live
-
Mifepristone
-
Mitapivat
-
Mitotane
-
Mobocertinib
-
Moexipril
-
Mumps Virus Vaccine, Live
-
Nefazodone
-
Nelfinavir
-
Neratinib
-
Netupitant
-
Nirmatrelvir
-
Nirogacestat
-
Octreotide
-
Olutasidenib
-
Omaveloxolone
-
Pacritinib
-
Palbociclib
-
Perindopril
-
Phenobarbital
-
Phenytoin
-
Pirtobrutinib
-
Poliovirus Vaccine, Live
-
Posaconazole
-
Primidone
-
Quinapril
-
Ramipril
-
Remdesivir
-
Repotrectinib
-
Ribociclib
-
Rifampin
-
Rifapentine
-
Ritlecitinib
-
Rotavirus Vaccine, Live
-
Rubella Virus Vaccine, Live
-
Saquinavir
-
Selpercatinib
-
Smallpox Monkeypox Vaccine, Live Non-Replicating
-
Smallpox Vaccine
-
Sotorasib
-
Sparsentan
-
St John's Wort
-
Taurursodiol
-
Telaprevir
-
Telithromycin
-
Tepotinib
-
Tocilizumab
-
Tovorafenib
-
Trandolapril
-
Trofinetide
-
Troleandomycin
-
Tucatinib
-
Turmeric
-
Typhoid Vaccine, Live
-
Varicella Virus Vaccine, Live
-
Venetoclax
-
Verapamil
-
Vilazodone
-
Voclosporin
-
Vonoprazan
-
Voriconazole
-
Voxelotor
-
Yellow Fever Vaccine
-
Zofenopril
-
Zoster Vaccine, Live
Other Interactions
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 this medicine 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 this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
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Blood clotting problems or
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Diabetes or
-
Hepatitis B infection, history of or
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Hyperglycemia (high sugar in the blood) or
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Hyperlipidemia (high cholesterol in the blood) or
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Hypertriglyceridemia (high fat in the blood) or
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Hypoxia (low oxygen in the blood) or
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Infection (eg, bacteria, fungus, virus) or
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Lung or breathing problems or
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Lymphoma (cancer of the lymph glands) or
-
Proteinuria (protein in the urine) or
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Skin cancer—Use with caution. May make these conditions worse.
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Heart transplant—Use is not recommended for patients receiving Zortress®.
-
Lapp lactase deficiency or glucose-galactose malabsorption—Zortress® should not be used in patients with these conditions.
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Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
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Radiation treatment, or history of—Use with caution. May cause side effects to become worse.
Proper Use
Take this medicine 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.
If you have a kidney or liver transplant, you might have to take this medicine for the rest of your life to prevent rejection of the organ. Do not change your dose or stop taking this medicine without checking first with your doctor.
This medicine comes with a Medication Guide and patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Take this medicine the same way every day. Take it at the same time and consistently either with or without food.
Swallow the regular tablet whole with a glass of water. Do not crush, break, or chew it. If you accidentally break or crush the tablet, wash your hands with water right away.
Do not swallow the tablet for suspension. It must be dissolved in water before you take the medicine. If you are preparing the oral suspension for another person, wear disposable gloves.
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To dissolve the tablet for suspension in an oral syringe:
-
Use a syringe that measures 10 milliliters (mL). Pull out the plunger and put the tablet in the barrel of the syringe. Replace the plunger and push it until it touches the tablet.
-
Fill a small glass with 30 mL (2 tablespoons) of water. Place the syringe tip in the water and draw up enough water to cover the tablet and to fill half of the syringe. Hold the syringe with the tip up and draw in 4 mL of air. Place the syringe in an empty glass with the tip up and wait 3 minutes.
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Slowly turn the syringe up and down 5 times but do not shake it. Hold the syringe with the tip up and push the plunger to remove most of the air. Place the syringe in the mouth and slowly give the dose.
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Fill the syringe with 5 mL of water from the small glass. Hold the tip up and add 4 mL of air. Swirl the water in the syringe to rinse any extra medicine from the sides. Hold the syringe with the tip up and push the plunger to remove most of the air.
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Place the syringe in the mouth and slowly give the liquid. Use a new syringe for each dose.
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To dissolve the tablet for suspension in a small glass:
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Use a medicine cup to measure 25 milliliters (mL) of water.
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Pour the water into a small glass and put the tablet in the water without breaking or crushing it.
-
Wait 3 minutes then gently stir the mixture to break up the tablets. Drink the mixture right away. After drinking, rinse the glass with the same amount of water and drink the liquid.
Do not use the regular tablet and the tablet for suspension together. Use only one dosage form of this medicine.
You may be given a mouthwash (eg, dexamethasone alcohol-free mouthwash) when starting the medicine to prevent mouth sores or ulcers. Do not drink or eat food for at least 1 hour after swishing and spitting the mouthwash.
You should not eat grapefruit or drink grapefruit juice while you are taking this medicine. Grapefruit and grapefruit juice may cause higher levels of everolimus in the body. This could result in more unwanted effects.
If you have a kidney transplant, everolimus will be given together with another medicine called cyclosporine. Take both medicines at the same time.
If you have a liver transplant, everolimus will be given together with another medicine called tacrolimus. Take both medicines at the same time.
Dosing
The dose of this medicine 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 this medicine. 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 breast cancer:
-
Adults—10 milligrams (mg) once a day. Your doctor may adjust your dose as needed.
-
Children—Use and dose must be determined by your doctor.
-
For advanced neuroendocrine tumors:
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Adults—10 milligrams (mg) once a day. Your doctor may adjust your dose as needed.
-
Children—Use and dose must be determined by your doctor.
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For angiomyolipomas:
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Adults—10 milligrams (mg) once a day. Your doctor may adjust your dose as needed.
-
Children—Use and dose must be determined by your doctor.
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For brain tumors (SEGA):
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Adults and children 1 year of age and older—Dose is based on body size and must be determined by your doctor. The starting dose is 4.5 milligrams (mg) per square meter (m(2)) of body size once a day. Your doctor may adjust your dose as needed.
-
Children younger than 1 year of age—Use is not recommended.
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For kidney cancer:
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Adults—10 milligrams (mg) once a day. Your doctor may adjust your dose as needed.
-
Children—Use and dose must be determined by your doctor.
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For kidney transplant rejection:
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Adults—At first, 0.75 milligram (mg) 2 times a day taken every 12 hours. Your doctor may adjust your dose as needed.
-
Children—Use and dose must be determined by your doctor.
-
For liver transplant rejection:
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Adults—At first, 1 milligram (mg) 2 times a day taken every 12 hours. Your doctor may adjust your dose as needed.
-
Children—Use and dose must be determined by your doctor.
-
For oral dosage form (tablets for suspension):
-
For brain tumors (SEGA):
-
Adults and children 1 year of age and older—Dose is based on body size and must be determined by your doctor. The starting dose is 4.5 milligrams (mg) per square meter (m(2)) of body size once a day. Your doctor may adjust your dose as needed.
-
Children younger than 1 year of age—Use is not recommended.
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For partial-onset seizures:
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Adults and children 2 years of age and older—Dose is based on body size and must be determined by your doctor. The starting dose is 5 milligrams (mg) per square meter (m(2)) of body size once a day. Your doctor may adjust your dose as needed.
-
Children younger than 2 years of age—Use is not recommended.
Missed Dose
If you miss a dose of this medicine, 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 Afinitor® or Afinitor® Disperz, you may still take it up to 6 hours after the time you normally take the dose. But if more than 6 hours have passed, skip the missed dose and go back to your regular dosing schedule.
Storage
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.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep the medicine in its original package until you are ready to use it. The oral suspension must be used within 60 minutes after mixing. If it is not used during this time, throw it away and prepare another dose.
Keep Zortress® tablets dry.
Precautions
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. It may also cause birth defects if the father is using it when his sexual partner becomes pregnant. Female patients should use an effective form of birth control during treatment with this medicine and for at least 8 weeks after the last dose. Male patients who have female partners should use effective birth control during treatment with Afinitor® or Afinitor® Disperz and for 4 weeks after the last dose. If you think you have become pregnant while using the medicine, tell your doctor right away.
If you are planning to have children, talk with your doctor before using this medicine. Some men and women using this medicine have become infertile (unable to have children).
This medicine may cause a serious lung problem called interstitial lung disease or non-infectious pneumonitis. Check with your doctor right away if you have chest pain, chills, cough, fever, or trouble breathing.
Check with your doctor right away if you have bloody urine, a decrease in frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain. These may be symptoms of a serious kidney problem.
While you are being treated with everolimus, and after you stop treatment with it, do not have any immunizations (vaccines) without your doctor's approval. Everolimus may lower your body's resistance and the vaccine may not work as well or you might get the infection the vaccine is meant to prevent. In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you. Some examples of live virus vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.
Everolimus can temporarily lower the number of white blood cells in your blood, which increases 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:
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If you can, avoid people with infections. Check with your doctor right away 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.
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Check with your doctor right away if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
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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.
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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.
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Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
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Avoid contact sports or other situations where bruising or injury could occur.
This medicine may increase your risk for getting skin cancer. When you begin taking this medicine:
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Stay out of direct sunlight, especially between the hours of 10:00 AM and 3:00 PM, if possible.
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Wear protective clothing, including a hat and sunglasses.
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Apply a sunblock product that has a sun protection factor (SPF) of at least 15 or higher if you have a fair complexion.
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Apply a sunblock lipstick that has an SPF of at least 15 to protect your lips.
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Do not use sunlamps, tanning beds, or tanning booths.
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If you have any questions about this, check with your doctor.
This medicine may cause a serious allergic reaction called anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after using this medicine.
Everolimus may cause a serious allergic reaction called angioedema, which can be life-threatening and requires immediate medical attention. This may occur more often when it is used with certain heart and blood pressure medicines called ACE inhibitors (eg, captopril [Capoten®], enalapril [Vasotec®], fosinopril [Monopril®], quinapril [Accupril®], ramipril [Altace®]). Check with your doctor right away if you have a rash, itching, a large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals, trouble breathing, or chest tightness while you are using this medicine.
If you have a kidney or liver transplant, this medicine may increase your risk for having a blood clot in the new kidney. This usually occurs within the first 30 days after the kidney transplant. Check with your doctor right away if you are making less urine, or if you have pain in your groin, lower back, side, or stomach, dark urine, fever, nausea, or vomiting.
This medicine may also prevent you from healing correctly after an injury. Do not take this medicine at least 1 week before surgery and at least 2 weeks after a surgery. Call your doctor right away if you have blood, fluid, or pus in your incision, your incision opens up, or if it is red, warm, painful, or swollen.
This medicine may also increase your risk of bleeding and cause delay in wound healing. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers. Check with your doctor immediately if you or your child notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
This medicine may increase your cholesterol and fats in the blood. If this condition occurs, your doctor may give you or your child some medicines that can lower the amount of cholesterol and fats in the blood.
Make sure any doctor who treats you knows that you are using this medicine. This medicine may worsen the side effects from radiation treatment.
If you are taking this medicine after a kidney transplant, it may increase your risk for developing rare and serious virus infections, including polyoma virus-associated nephropathy (PVAN), progressive multiple leukoencephalopathy (PML), and BK virus-associated nephropathy (BKVAN). The BK virus may affect how your kidneys work and cause a transplanted kidney to fail. Check with your doctor right away if you have bloody urine, a decreased frequency or amount of urine, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain.
This medicine may cause thrombotic microangiopathy (damage in the smallest blood vessels), hemolytic uremic syndrome, and thrombotic thrombocytopenic purpura. Tell your doctor right away if you have a change in mental status, dark or bloody urine, decreased urine output, difficulty speaking, fever, pale color of the skin, pinpoint red spots on the skin, seizures, severe chest pain, sudden weakness in the arms or legs, unusual bleeding or bruising, or yellow eyes or skin.
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 this medicine. You may use a special mouthwash (eg, dexamethasone alcohol-free oral solution) or mouth gel to treat these ulcers. Ask your doctor what type of products to use.
This medicine may affect blood sugar levels. If you have diabetes, check with your doctor if you notice a change in your blood or urine sugar tests.
Tell your doctor if you are taking a corticosteroid or another medicine that may weaken your immune system. This may increase your risk for developing a serious infection.
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 (eg, cannabidiol, St. John's Wort) or vitamin supplements.
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
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Bloating or swelling of the face, arms, hands, lower legs, or feet
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bloody nose
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chest pain or tightness
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chills
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cough
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decreased weight
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diarrhea
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difficult or labored breathing
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difficulty with swallowing
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fever
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general feeling of discomfort or illness
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hoarseness
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lower back or side pain
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painful or difficult urination
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rapid weight gain
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sores, ulcers, or white spots on the lips, tongue, or inside the mouth
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tingling of the hands or feet
Less common
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Black, tarry stools
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bladder pain
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bleeding gums
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bloody urine
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blurred vision
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body aches or pain
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burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
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coughing up blood
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difficult, burning, or painful urination
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ear congestion
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fast, pounding, or irregular heartbeat or pulse
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frequent urge to urinate
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headache
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increased fat deposits on the face, neck, and trunk
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increased thirst or urination
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irregular breathing
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loss of appetite
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loss of voice
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nausea
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nervousness
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nosebleeds
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pain, redness, or swelling in the arm or leg
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pale skin
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pinpoint red spots on the skin
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prolonged bleeding from cuts
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red or black, tarry stools
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red or dark brown urine
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sneezing
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sore throat
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slow heartbeat
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stomach ache
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stuffy or runny nose
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sweating
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unusual bleeding or bruising
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unusual tiredness or weakness
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vomiting
Rare
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Bloating
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change in mental status
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chest discomfort
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constipation
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dark or bloody urine
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difficulty speaking
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increased or decreased urination
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indigestion
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large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
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pains in the stomach, side, or abdomen, possibly radiating to the back
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seizures
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sudden weakness in the arms or legs
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swelling of the face, fingers, feet, or lower legs
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yellow eyes or skin
Incidence not known
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Agitation
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confusion
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decreased awareness or responsiveness
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depression
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dizziness
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hostility
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irritability
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muscle twitching
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severe sleepiness
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unusual drowsiness, dullness, or feeling of sluggishness
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
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Change in taste
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dry skin
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itching skin or rash
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lack or loss of strength
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loss of taste
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pain in the arms or legs
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trouble sleeping
Less common
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Back pain
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blistering, peeling, redness, or swelling of the palms, hands, or bottoms of the feet
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bumps on the skin
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burning, dry, or itching eyes
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difficulty in moving
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discoloration of the fingernails or toenails
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feeling of fullness
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flushing or redness of the skin
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jaw pain
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joint pain
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muscle cramps, spasms, or stiffness
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muscle or bone pain
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numbness, pain, tingling, or unusual sensations in the palms of the hands or bottoms of the feet
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passing of gas
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redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
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.
Portions of this document last updated: Aug. 01, 2024
Original article: https://www.mayoclinic.org/es/drugs-supplements/everolimus-oral-route/side-effects/drg-20072842