everolimus (immunosuppressive) 0.25 mg tablet

Generic name:
Everolimus (transplant) - oral

Pronunciation
(/E-ver-OH-li-mus)

Brand name(s)
Zortress

Everolimus can increase your risk for developing certain types of cancers (including skin cancer, lymphoma). Tell your doctor right away if you notice unusual skin changes, change in the appearance/size of moles, unusual growths/lumps, swollen glands, night sweats, or loss of appetite/weight loss.

This medication lowers your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as sore throat that doesn't go away, fever, chills, cough).

Using this medication may increase your risk for developing a blood clot in your kidney transplant, usually within the first 30 days after surgery. Tell your doctor right away if you have nausea/vomiting, pain in your groin/lower back/abdomen, blood in your urine, or unusual decrease in the amount of urine.

This medication may increase the risk of death from infection in people who have had a heart transplant. Before using this medication, tell your doctor if you have had a heart transplant.

Everolimus is used with other medications (such as cyclosporine) to prevent rejection of a kidney transplant. Everolimus is also used with other medications (such as tacrolimus) to prevent rejection of a liver transplant. This medication belongs to a class of drugs known as immunosuppressants. It works by weakening your body's defense system (immune system) to help your body accept the new organ as if it were your own.

This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This drug may also be used for certain types of cancers and benign tumors.

Read the Medication Guide provided by your pharmacist before you start taking everolimus and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth as directed by your doctor, usually every 12 hours with your cyclosporine dose, beginning immediately after a kidney transplant. Everolimus is usually started 30 days after a liver transplant and is usually taken every 12 hours with your tacrolimus dose. You may take this medication with or without food, but it is important to choose one way and take this medication the same way with every dose. Swallow this medication whole with a glass of water. Do not crush, chew, or break the tablets.

The dosage is based on your medical condition, response to treatment, lab tests, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.

Do not increase your dose or use this medication more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

See also Warning section.

Constipation, headache, nausea, and sores in the mouth/throat may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including:

• swelling hands/ankles/feet
• wound problems (such as infection, slow wound healing, opening of wound)
• decreased sexual ability (in men)
• chest pain/pressure
• shortness of breath
• unusual bruising/bleeding

This medication may make side effects from radiation treatment worse. These side effects can sometimes be severe. Tell your doctor if you have had or are planning to have radiation treatment.

This medication has caused very serious (rarely fatal) lung problems. Get medical help right away if you have symptoms of lung problems, such as shortness of breath, chest pain.

This medication may increase your risk of getting a rare but very serious (sometimes fatal) brain infection (progressive multifocal leukoencephalopathy-PML). Get medical help right away if any of these rare but very serious side effects occur:

• clumsiness
• loss of coordination
• weakness
• sudden change in your thinking (such as confusion, difficulty concentrating)
• difficulty moving your muscles
• problems with speech
• seizure
• vision changes

Everolimus may cause your cholesterol/triglycerides or blood sugar to increase. You may be required to have your cholesterol/triglycerides or blood sugar checked periodically. You may need medication to control your cholesterol/triglycerides or blood sugar. Tell your doctor or pharmacist if you experience symptoms of high blood sugar, including increased thirst/hunger, frequent urination.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

See also Warning section.

Before taking everolimus, tell your doctor or pharmacist if you are allergic to it; or to sirolimus or temsirolimus; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• high cholesterol/triglyceride levels
• any recent/current infections
• diabetes
• liver disease
• radiation treatment
• certain hereditary enzyme problems (galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption)

Everolimus can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

Tell your health care professional that you are using everolimus before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Since this medication may increase your risk of developing skin cancer, limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication can affect fertility in both males and females. Ask your doctor for more details.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using everolimus. Everolimus may harm an unborn baby. Women using this medication should ask about reliable forms of birth control during treatment and for 8 weeks after the last dose. Men using this medication should ask about reliable forms of birth control during treatment and for 4 weeks after the last dose. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this medication and for 2 weeks after the last dose. Consult your doctor before breastfeeding.

See also How to Use section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• other drugs that weaken the immune system/increase the risk of infection (such as natalizumab, rituximab)
• ACE inhibitors (such as captopril, lisinopril)

Other medications can affect the removal of everolimus from your body, which may affect how everolimus works. Examples include azole antifungals (such as itraconazole, ketoconazole), cobicistat, macrolide antibiotics (such as clarithromycin, erythromycin), HIV protease inhibitors (such as atazanavir), rifamycins (such as rifabutin, rifampin), ritonavir, St. John's wort, telithromycin, among others.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as everolimus/cyclosporine/tacrolimus blood levels, cholesterol/triglyceride levels, kidney function, urine protein, complete blood count, blood sugar) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.