everolimus
Everolimus (Afinitor) is an oral medication used to treat different types of cancer, including certain types of breast cancer and kidney cancers. It's taken by mouth, typically just once daily. But depending on the type of cancer you're being treated for, your provider might ask you to do regular blood draws to figure out a dose that's safe for you. Keep in mind that everolimus (Afinitor) comes in 3 different formulations and they don't all treat the same conditions. Some common side effects everolimus (Afinitor) can cause include mouth sores and skin rashes.
What is Everolimus (Afinitor)?
What is Everolimus (Afinitor) used for?
- Breast cancer (hormone receptor-positive, HER2-negative)
- Neuroendocrine tumors (NET)
- Kidney cancer (renal cell cancer or RCC)
- Tuberous sclerosis complex (TSC)-associated kidney tumor
- Tuberous sclerosis complex (TSC)-associated brain tumor (people age 1 years and older)
- Tuberous sclerosis complex (TSC)-associated seizures (people age 2 years and older)
How Everolimus (Afinitor) works
Everolimus (Afinitor) is kinase inhibitor. It blocks a specific type of protein that's involved in cell growth and spread. This protein can be more active in cancer cells, leading to tumor growth. When everolimus (Afinitor) blocks this protein, cancer cells can’t grow and spread as well.
Drug facts
Side effects of Everolimus (Afinitor)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Abnormal blood cell counts (up to 92%)
- Higher cholesterol and lipid levels (up to 86%)
- Mouth ulcers or inflammation (up to 78%)
- Higher blood sugar levels (up to 75%)
- Abnormal liver labs (up to 74%)
- Rash (up to 59%)
- Diarrhea (up to 50%)
- Abnormal kidney lab values (up to 50%)
- Infections (up to 58%)
- Extreme tiredness (up to 45%)
- Fluid buildup in the arms or legs (up to 39%)
- Stomach pain (36%)
- Nausea (up to 32%)
- Fever (up to 31%)
- Appetite loss (up to 30%)
- Headache (up to 30%)
- Cough (up to 30%)
- Weight loss (up to 28%)
Please note: The frequency of certain side effects depends on what condition you’re being treated for.
Less Common Side Effects
- Vomiting
- Constipation
- Dry mouth
- Weakness
- Change in taste
- Dizziness
- Difficulty breathing
- High blood sugar
- Joint pain
- Back pain
- Difficulty sleeping
- Nail changes
- Anxiety
Everolimus (Afinitor) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Serious infections: repeated fevers, chills, cough, trouble breathing, severe diarrhea, vomiting, painful or frequent urination
- Serious bleeds: bleeding or bruising that doesn’t stop or go away, large amount of bleeding, throwing up blood, bloody or black and tarry stool
- Lung problems: new or worsening cough, chest pain, difficulty breathing
- Serious allergic reactions: throat tightness, trouble breathing, flushing, swelling, chest pain
- Angioedema: Swelling of the face, lips, throat
The following Everolimus (Afinitor) side effects have also been reported
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 or tightness
chills
decreased weight
difficult or labored breathing
difficulty with swallowing
general feeling of discomfort or illness
hoarseness
lower back or side pain
painful or difficult urination
rapid weight gain
sores, ulcers, or white spots on the lips, tongue, or inside the mouth
tingling of the hands or feet
Less common
Bleeding gums
bloody urine
blurred vision
burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
coughing up blood
extreme tiredness or weakness
fast, pounding, or irregular heartbeat or pulse
increased thirst or urination
irregular breathing
loss of appetite
nervousness
nosebleeds
prolonged bleeding from cuts
red or black, tarry stools
red or dark brown urine
slow heartbeat
stomach ache
sweating
unusual tiredness or weakness
vomiting
Incidence not known
Agitation
confusion
decreased awareness or responsiveness
dizziness
hostility
irritability
muscle twitching
seizures
severe sleepiness
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
Change in taste
itching skin or rash
lack or loss of strength
loss of taste
pain in the arms or legs
stomach pain
trouble sleeping
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
discoloration of the fingernails or toenails
feeling of fullness
flushing or redness of the skin
jaw pain
numbness, pain, tingling, or unusual sensations in the palms of the hands or bottoms of the feet
passing of gas
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.
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Pros and cons of Everolimus (Afinitor)
Pros
- Oral pill, taken once daily
- Available as a lower-cost generic
- Can be taken with or without food
- Can be taken by children (only for TSC-associated brain tumors or seizures)
Cons
- Can raise blood sugar levels
- Can cause painful sores in the mouth
- Might make it difficult for you to have children in the future
- Raises the risk of infection
- Higher risk of serious side effects in older adults
Pharmacist tips for Everolimus (Afinitor)
- Take everolimus (Afinitor) at the same time each day. It can be taken either with or without food, but try to keep it consistent. Swallow Afinitor and generic everolimus tablets whole with a glass of water. Don’t break or crush the tablets.
- Afinitor or Afinitor Disperz aren’t interchangeable and one can’t be substituted for the other. Make sure to take the right form of medication that’s appropriate for your condition. Don’t mix the two together. Ask your provider or pharmacist if you have questions about which form of everolimus you’re supposed to take.
- If you miss a dose, take it as soon as you remember if it’s within 6 hours from the time you normally take it. If it’s been more than 6 hours, then skip your dose for that day. The next day, take your dose at the normal time.
- If you’re taking angiotensin-converting enzyme (ACE) inhibitors, such as lisinopril (Zestril), to lower blood pressure, let your provider know. Taking everolimus (Afinitor) with ACE inhibitors raises your risk for serious swelling of the tongue and face (angioedema). If you do experience angioedema, your provider will likely ask you to stop taking everolimus (Afinitor).
- Everolimus (Afinitor) can make it harder for your body to heal itself. This can be a problem when your body is recovering from surgery. Make sure to tell your provider if you have a planned surgery coming up. Your provider might ask you to stop taking everolimus (Afinitor) for a week or two before and after the surgery. They’ll also monitor your healing progress to let you know when it’s safe to start taking everolimus (Afinitor) again.
- If you’re taking everolimus (Afinitor) for TSC-associated brain tumors or seizures, you’ll need to have your blood work checked to monitor the levels of the medication in your body. Your provider might adjust your dose based on your lab results. Make sure to follow the lab work schedule you’re given.
Tips for Afinitor Disperz:
- If you’re taking Afinitor Disperz, you need to dissolve the tablet in water to prepare a suspension. Make sure to wear gloves while preparing the suspension.
- You can prepare the Afinitor Disperz in a small drinking glass. Place your dose (up to 10 mg of Afinitor Disperz) in a glass that contains about 25 mL of water. It’ll take about 3 minutes for the tablet to dissolve. Stir the suspension gently, then drink. After drinking the suspension, add another 25 mL of water to the cup. Then stir and drink again.
- If you or your child aren’t able to drink the Afinitor Disperz suspension from a cup, you can also prepare the medication for an oral syringe.
- If you’re taking a dose that’s higher than 10 mg of Afinitor Disperz, then you’ll need to prepare additional drinking glasses or oral syringes. Once the suspension is made, make sure to drink the suspension immediately. Don’t take the suspension if it has been sitting out for 60 minutes or longer.
Common questions about Everolimus (Afinitor)
Yes, taking everolimus (Afinitor) weakens your immune system and makes it more likely for you to get an infection. Infections can become a serious problem because your body will also have a harder time fighting them off. You can lower your risk of getting an infection by washing your hands often, and avoiding crowded places, and minimizing contact with people who are sick. To prevent getting ill from foods, you’re recommended to wash raw fruits and vegetables before eating, and cook foods thoroughly. If you do get sick while taking everolimus (Afinitor), your provider might ask you to stop the medication until they can treat your infection. Let your provider know right away if you think you might be sick or experience symptoms such as fever, body aches, or cough.
Before you receive a vaccine, make sure your provider knows that you’re taking everolimus (Afinitor). Because this medication weakens your immune system and makes it more difficult for you to fight off infections, you’re recommended to avoid live vaccines while taking everolimus (Afinitor). Live vaccines are made with weakened forms of viruses that typically won’t cause a person with a healthy immune system to become sick. But they can cause people with a weakened immune system to become ill. Examples of live vaccines include measles, mumps, and rubella virus vaccine (MMR) and the chickenpox vaccine (Varivax). The childhood vaccination series should be completed before starting everolimus (Afinitor). Speak to your provider before getting any vaccines and make sure they know you're taking everolimus (Afinitor).
Let your provider know if you have problems with your liver, because you’ll need to be monitored more closely. If you’ve liver problems, your body might have a harder time getting rid of this medication. This causes higher levels of everolimus (Afinitor) in your body and can raise your risk for more side effects, such as lung problems, infections. Depending on how severe your liver problems are, you might need to take the medication at a lower dose, or you might not be able to receive everolimus (Afinitor) entirely.
Based on animal studies, everolimus (Afinitor) can cause harm to your unborn baby. This medication isn't typically recommended during pregnancy, unless the provider thinks the benefit is greater than the risk for both you and your unborn baby. Let your provider know right away if you or your partner becomes pregnant while receiving everolimus (Afinitor).
There haven’t been any studies in humans about how everolimus (Afinitor) can affect breast milk and your breastfed baby. However, everolimus (Afinitor) was found in the milk of rats in animal studies, so it's likely that this medication can be passed along in human milk and cause serious harm to nursing infants. Because of this risk, you shouldn’t breastfeed during everolimus (Afinitor) treatment and for 2 weeks after your last dose. Talk with your provider if you have any questions about breastfeeding while taking everolimus (Afinitor).
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Risks and warnings for Everolimus (Afinitor)
Everolimus (Afinitor) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Lung problem
Let your provider know right away if you experience coughing or trouble breathing while taking everolimus (Afinitor) because this medication can cause your lungs to become inflamed. If you develop these symptoms, your provider will need to examine you to figure out they’re caused by everolimus (Afinitor) or an infection, and treat you accordingly. If your symptoms aren’t too severe, your provider will likely ask you to continue taking everolimus (Afinitor), while giving you a corticosteroid to ease the inflammation in your lungs. But if they’re severe, your provider might ask you to stop this medication.
Low blood cell counts and serious infections
Risk factors: Taking other medications that weakens your immune system
Everolimus (Afinitor) can cause your white blood cell (WBCs), red blood cell (RBCs), and platelet counts to drop. Your provider will closely monitor your blood cell counts through lab work before you start everolimus (Afinitor) and every 6 months while you’re receiving treatment. If your blood counts are low, your dose might need to be lowered or you might stop taking the medication altogether.
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Lower RBC and platelet counts can raise your risk for anemia, bleeding, and bruising. Let your provider know as soon as possible if you experience tiredness, bleeding, or bruising that doesn’t stop or go away, because you might need to stop this medication.
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Lower WBC counts weakens your ability to fight off infections. This means you’re at higher risk for developing serious infections, including bacterial, viral, and fungal infections. The risk of serious infections is higher for children under 6 years old. Sometimes, these infections can lead to sepsis, which can be life-threatening. Before you start everolimus (Afinitor), your provider will check for and treat any infections you might have. Let your provider know if you have any symptoms of an infection, such as fever, tiredness, body aches, or cough.
Severe allergic reactions
- Risk factors: Taking angiotensin-converting enzyme (ACE) inhibitors
Everolimus (Afinitor) can cause allergic reactions, including anaphylaxis. In addition, people who take ACE inhibitors such as lisinopril (Prinivil, Zestril) are at higher risk for swelling in the face and tongue (angioedema). Contact your provider or get medical help right away if you experience any throat tightness, trouble breathing, flushing, chest pain, or swelling of the face, airways, or tongue (angioedema).
Mouth sores
Everolimus (Afinitor) can cause painful mouth ulcers or sores. People typically experience this within the first 2 months after starting treatment. If you have mouth sores, let your provider know. They might be able to recommend mouthwashes and other options, such as sucking on ice chips, to help with these symptoms.
Kidney problems
Some people developed kidney problems, including kidney failure, after starting everolimus (Afinitor) can harm your kidneys. Your provider will order labs to check your kidney health before you start this medication, then at least yearly during treatment. Reach out to your provider right away if you experience blood in the urine, pain or problems urinating, or changes in the color or cloudiness of the urine. These can be signs of a serious kidney problem.
Higher blood sugar and lipids levels (cholesterol and triglycerides)
- Risk factors: Diabetes
Everolimus (Afinitor) can raise your blood sugar, cholesterol, and triglyceride (a type of fat) levels. Because of this, your provider will work with you to make sure your blood sugar and lipid levels are within a healthy range before you start everolimus (Afinitor). They’ll also order lab work to check your sugar and lipid levels yearly while you’re receiving treatment. If you have diabetes, your provider will check your blood sugar levels more often. If your blood sugar or lipid levels aren’t within a healthy range and are difficult to control with medications, diet, and exercise, then your provider might recommend that you stop taking this medication.
Inflammation and sensitivity with radiation therapy
- Risk factors: Previous, current, or subsequent radiation therapy
Everolimus (Afinitor) can cause inflammation around the areas of radiation you receive, both on your skin or inside your body. This medication can also make you more sensitive to the effects of radiation and cause more side effects. This can happen if you receive radiation therapy before, during, or after treatment with everolimus (Afinitor).
Harm to unborn baby and effects on fertility
Based on animal studies, everolimus (Afinitor) can harm an unborn baby. Because of this risk, regardless of your sex, you should use birth control during treatment with everolimus (Afinitor) to prevent pregnancy. After treatment, continue to use birth control for another 8 weeks (for females) or 4 weeks (for males). Let your provider know right away if you or your partner becomes pregnant during this time.
Everolimus (Afinitor) can also affect your ability to have a baby. If you or your partner are thinking about having a child in the future, talk to your provider about your different options before starting everolimus (Afinitor), such as sperm banking or egg freezing.
Everolimus (Afinitor) dosage
Typical dosage for Everolimus (Afinitor)
Breast cancer, neuroendocrine tumors, kidney cancer, or TSC-associated kidney tumor
- Afinitor and generic everolimus tablet only: The typical dose is 10 mg by mouth once daily.
TSC-associated brain tumor
- Afinitor, Afinitor Disperz, and generic everolimus tablet: Your provider will determine your dose base on your body surface area (BSA, in units of m2), which takes into account your body weight and height. The typical starting dose is 4.5 mg/m2 by mouth once daily.
TSC-associated seizures
- Afinitor Disperz only: Your provider will determine your dose base on your body surface area (BSA, in units of m2), which takes into account your body weight and height. The typical starting dose is 5 mg/m2 by mouth once daily.
Interactions between Everolimus (Afinitor) and other drugs
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.
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.
- Adenovirus Vaccine Type 4, Live
- Adenovirus Vaccine Type 7, Live
- Bacillus of Calmette and Guerin Vaccine, Live
- Benazepril
- Boceprevir
- Capmatinib
- Captopril
- Carbamazepine
- Ceritinib
- Cholera Vaccine, Live
- Clarithromycin
- Cobicistat
- Conivaptan
- Curcumin
- Dengue Tetravalent Vaccine, Live
- Dronedarone
- Duvelisib
- Enalapril
- Enalaprilat
- Enzalutamide
- Fosinopril
- Fosnetupitant
- Fosphenytoin
- Idelalisib
- Indinavir
- Influenza Virus Vaccine, Live
- Itraconazole
- Ivosidenib
- Ketoconazole
- Larotrectinib
- Lasmiditan
- Lefamulin
- Lisinopril
- Lopinavir
- Lorlatinib
- Lumacaftor
- Measles Virus Vaccine, Live
- Mitotane
- Moexipril
- Mumps Virus Vaccine, Live
- Nefazodone
- Nelfinavir
- Netupitant
- Perindopril
- Phenytoin
- Poliovirus Vaccine, Live
- Posaconazole
- Quinapril
- Ramipril
- Ribociclib
- Rifampin
- Rotavirus Vaccine, Live
- Rubella Virus Vaccine, Live
- Saquinavir
- Smallpox Vaccine
- St John's Wort
- Telaprevir
- Telithromycin
- Tofacitinib
- Trandolapril
- Typhoid Vaccine, Live
- Varicella Virus Vaccine, Live
- Venetoclax
- Verapamil
- Voriconazole
- Yellow Fever Vaccine
- Zofenopril
- Zoster Vaccine, Live
How much does Everolimus (Afinitor) cost?
Everolimus (Afinitor) contraindications
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Everolimus (Afinitor) will not be safe for you to take.
- Allergy to everolimus (Afinitor) or other rapamycins, including sirolimus (Rapamune) and temsirolimus (Torisel)
What are alternatives to Everolimus (Afinitor)?
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