everolimus
Everolimus, also known by the brand name Zortress, is an FDA approved immunosuppressant used in adults to prevent rejection after a kidney or liver transplant. The tablet is typically taken by mouth twice a day along with other anti-rejection medications. Your transplant provider will adjust your dose based on the levels of the medication in your body. Common side effects include swelling in the arms and legs, nausea, and high blood pressure.
What is Everolimus (Zortress)?
What is Everolimus (Zortress) used for?
- Prevent kidney transplant rejection
- Prevent liver transplant rejection
How Everolimus (Zortress) works
Everolimus (Zortress) is an immunosuppressant. It works by weakening your immune system to help prevent organ rejection after a transplant. This makes it easier for your body to accept the new organ and lowers the risk of rejection.
Drug facts
Side effects of Everolimus (Zortress)
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
Kidney transplant:
- Swelling in the arms and legs (45%)
- Constipation (38%)
- High blood pressure (30%)
- Nausea (29%)
- Low red blood count, anemia (26%)
- Urinary tract infection (UTI) (22%)
- High cholesterol (21%)
Note: These side effects were reported in people taking everolimus (Zortress) and cyclosporine.
Liver transplant:
- Diarrhea (19-24%)
- Headache (19-22%)
- High blood pressure (17-21%)
- Swelling in the arms and legs (18-20%)
Note: These side effects were reported in people taking everolimus (Zortress) and tacrolimus.
Less Common Side Effects
Kidney transplant:
- Diarrhea
- Vomiting
- Stomach pain
- Fever
- Fatigue
- Upper respiratory tract infection
- Muscle pain
- Back pain
- Headache
- Trouble sleeping
Liver transplant:
- Nausea
- Stomach pain
- Fever
- Fatigue
- Tremor
- Trouble sleeping
Everolimus (Zortress) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Serious infection: fever, chills, fatigue, muscle aches, cough, sore throat, runny or stuffy nose
- Cancers:
- Severe allergic reaction: trouble breathing, swelling of the face, tightening of the throat, rash, hives, welts, itchy or painful skin
- Serious lung problems: cough, shortness of breath, trouble breathing, wheezing
- Kidney damage (for kidney transplant): feeling sick or weak, dehydrated, urinating less than usual, confusion, blood in urine, swelling in the legs, ankles, or feet
The following Everolimus (Zortress) 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 (Zortress)
Pros
- Can be taken with or without food
- Available as a tablet that's taken by mouth
- Comes in different strengths to allow for dose adjustments
Cons
- Raises the risk of infections
- Commonly causes swelling in the arms and legs
- Must be taken with other anti-rejection medications
Pharmacist tips for Everolimus (Zortress)
- Take everolimus (Zortress) at the same time as your other transplant medication (either cyclosporine (Sandimmune) or tacrolimus (Prograf)). You can take these with or without food, but stay consistent — always take them the same way.
- Take everolimus (Zortress) twice a day, about 12 hours apart to keep a steady level of medication in your body.
- Swallow the everolimus (Zortress) tablet whole with a glass of water. Don't crush or chew the tablet since this can affect how well it works.
- You'll need to have regular lab tests done while you're taking everolimus (Zortress). These tests help make sure the medication is working properly and that you aren’t having serious side effects. Follow your prescriber’s instructions and don’t skip any lab tests.
- Taking everolimus (Zortress) can weaken your immune system, raising your risk of infections. Watch for signs like fever, chills, cough, or feeling unusually tired. If you notice any symptoms of infection, contact your care team right away.
- Taking everolimus (Zortress) can raise your risk of developing certain cancers, especially skin cancer. To help protect yourself, limit your time in the sun and avoid ultraviolet light. When outdoors, wear protective clothing and use sunscreen.
- Everolimus (Zortress) interacts with many medications. Always check with your transplant provider before starting any new medication or supplement.
- Avoid grapefruit, pomelo, pomegranate, and Seville oranges while taking everolimus (Zortress). These citrus fruits and their juices can raise the level of the medication in your body, which can be very dangerous.
- While taking everolimus (Zortress), vaccines might not work as well, so you won't get full protection. Avoid live vaccines since they can raise your risk of infection. Talk to your prescriber before getting any vaccines while taking this medication.
- Talk to your transplant team about family planning. Everolimus (Zortress) can affect fertility and harm an unborn baby. People who can become pregnant should use birth control while taking everolimus (Zortress) and for 8 weeks after stopping the medication.
Common questions about Everolimus (Zortress)
Weight gain wasn't reported as a side effect in clinical studies of everolimus (Zortress). But this medication can cause your body to hold onto fluid, leading to swelling in the arms and legs, which might cause weight gain. Contact your transplant provider if your weight changes very quickly. They'll want to check your labs to see if you have too much fluid build up.
Even though everolimus (Zortress) can stay in your body for about 5 to 6 days after a dose (time frame is based on its half-life), it's very important to take it every day. This medication has a narrow safety window, meaning that missing one dose can cause its level to drop and raise your risk for organ rejection. If you miss a dose, let your transplant team know right away.
No, everolimus (Zortress) is only approved to prevent kidney or liver transplant rejection. You might be thinking of everolimus (Afinitor), which is used for certain cancers. Although everolimus (Zortress) and everolimus (Afinitor) have the same active ingredient, everolimus (Afinitor) is usually taken once a day at a higher dose for cancer treatment. Speak to your prescriber if you have questions comparing both medications.
Hair loss can happen with everolimus (Zortress), but it isn't common. In clinical trials, less than 10% of people experienced hair loss while taking this medication. If you notice hair loss, talk with your transplant provider. They can help figure out the cause and discuss possible solutions.
Yes, everolimus (Zortress) is an immunosuppressant. It works by weakening your immune system to help prevent organ rejection after a transplant.
Keep taking everolimus (Zortress) and your anti-rejection medications until your transplant provider tells you to stop. This usually only happens if you have a serious side effect and need to switch to a different medication. If you're ever unsure about how to take your medications, contact your transplant team.
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Risks and warnings for Everolimus (Zortress)
Everolimus (Zortress) 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.
Cancer
- Risk factors: Long-term use
Long-term use of everolimus (Zortress) raises your risk of developing lymphoma and other cancers, especially skin cancer. To protect your skin, limit sun exposure by wearing protective clothing and using sunscreen whenever you go outside. Talk to your prescriber if you have concerns about your cancer risk while taking this medication.
Serious infections
- Risk factors: Taking other immunosuppressants
Immunosuppressants like everolimus (Zortress) can raise your risk of bacterial, fungal, and viral infections. Some infections can be serious or even life-threatening. Your transplant provider might prescribe medications to help prevent certain types of infections to lower your risk of serious illness. If you develop symptoms of fever, chills, fatigue, muscle aches, cough, sore throat, runny or stuffy nose, tell your care team right away.
Kidney or liver blood clot
- Risk factors: Recent kidney or liver transplant (within 30 days)
Everolimus (Zortress) can raise your risk of developing a blood clot in the vessels of your transplanted kidney or liver, which could put your transplanted organ in danger. It's most likely to happen within the first 30 days after your transplant. Your transplant provider might order blood tests and scans to check for any signs of a clot.
Kidney damage
- Risk factors: Taking cyclosporine (Sandimmune) or tacrolimus (Prograf) | Taking other medications that can damage your kidneys
Taking everolimus (Zortress) with other anti-rejection medications like cyclosporine and tacrolimus can harm your kidneys. Since these medications must be used together, your transplant provider will adjust the doses to help protect your kidney function. Your care team will check your lab tests regularly to monitor your kidney health and make sure your medication levels stay safe.
Allergic reaction
- Risk factors: Taking ACE inhibitors
Everolimus (Zortress) has been linked to angioedema, a serious swelling that can affect your face, lips, or throat. Taking everolimus (Zortress) with certain blood pressure medications, like angiotensin-converting enzyme (ACE) inhibitors, can raise your risk of developing this side effect. Let your care team know if you notice any unusual swelling, especially if it makes it hard to breathe or swallow.
Slower wound healing and fluid build up
Everolimus (Zortress) can slow down wound healing and raise the risk of problems like infections and your incision opening up. Some of these issues might require additional surgery.
You might also have fluid buildup in different parts of your body, causing swelling in your arms and legs, or fluid around your heart, lungs, or stomach. Let your care team know if you notice unusual swelling, fluid retention, or any changes in how you feel.
Lung problems
Everolimus (Zortress) is linked to a lung condition called interstitial lung disease (ILD), which causes inflammation or scarring in the lungs. Let your prescriber know if you have symptoms like shortness of breath, cough, chest pain, or wheezing. Most people recover once they stop taking everolimus (Zortress), with or without additional treatment. But in rare cases, it can be very serious or even life-threatening.
High cholesterol and triglyceride
- Risk factors: High everolimus (Zortress) levels | History of high cholesterol
Taking everolimus (Zortress) can raise your cholesterol and triglyceride levels, especially if your everolimus (Zortress) levels in the blood are too high. Your prescriber will check your labs for any changes in your cholesterol levels. They might also recommend diet changes, exercise, or cholesterol-lowering medications. If you already have high cholesterol, your transplant provider will weigh the risks and benefits before starting or continuing this medication.
Diabetes after transplant
Everolimus (Zortress) can raise your risk of developing diabetes after a transplant. Your transplant provider will check your blood sugar levels closely while you're taking this medication. Let your care team know if you notice signs of high blood sugar, such as unusual thirst or hunger, frequent urination, blurred vision, or unusual tiredness.
Harm to unborn baby and fertility concerns
Everolimus (Zortress) can cause harm to an unborn baby if taken during pregnancy. If you can get pregnant, use birth control while taking this medication and keep taking it for 8 weeks after stopping treatment to prevent pregnancy. If you're pregnant or planning to become pregnant, talk to your prescriber about the risks.
Everolimus (Zortress) can lower sperm count, which can affect a person's ability to have children. This happens because the medication affects fast-growing cells, including those involved in sperm production. If you're planning to have children, discuss any fertility concerns with your prescriber before starting this medication.
Vaccines
Transplant medications like everolimus (Zortress) can change the way your immune system responds to vaccines. Avoid live vaccines while taking this medication because they can raise your risk of infection. If you need a vaccine while taking this medication, talk to your prescriber or pharmacist first to make sure it is safe for you.
Everolimus (Zortress) dosage
Tablet| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 0.25mg | 180 tablets | $137.90 | $0.77 |
| 0.5mg | 60 tablets | $99.54 | $1.66 |
| 0.75mg | 60 tablets | $139.99 | $2.33 |
Typical dosage for Everolimus (Zortress)
- Kidney transplant: The typical starting dose is 0.75 mg by mouth twice a day, starting as soon as possible after your transplant.
- Liver transplant: The typical starting dose is 1 mg by mouth two times a day, starting at least 30 days after your transplant.
Interactions between Everolimus (Zortress) 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 (Zortress) cost?
Everolimus (Zortress) 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 (Zortress) will not be safe for you to take.
- Allergy to sirolimus
What are alternatives to Everolimus (Zortress)?
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