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Drugs & Medications

Zortress

EVEROLIMUS (TRANSPLANT)

GENERIC NAME(S): EVEROLIMUS

WARNINGS:

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 fever, chills, persistent sore throat, 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.

Who should not take Zortress?
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Uses

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.

OTHER USES: 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.

Everolimus has been used to treat certain types of cancers and benign tumors.

How to use Zortress

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, laboratory 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.

Side Effects

See also Warning section.

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

Many people using this medication have serious side effects. However, your doctor has prescribed this drug because he or she 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 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.

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

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.

This medication can decrease sperm production, an effect that may lower male fertility. Consult your doctor for more details.

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.

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

Precautions

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, certain hereditary enzyme problems (galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption).

Everolimus can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. 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 skin cancer, avoid prolonged sun exposure, tanning booths, and sunlamps. Use a 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 is not recommended for use during pregnancy. It may harm an unborn baby. Consult your doctor for more details and to discuss the use of reliable forms of birth control while taking this medication and for 8 weeks after stopping treatment. If you become pregnant or think you may be pregnant, tell your doctor immediately.

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, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Interactions

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).

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), boceprevir, macrolide antibiotics (such as clarithromycin, erythromycin), HIV protease inhibitors (such as atazanavir, ritonavir), rifamycins (such as rifabutin, rifampin), St. John's wort, telaprevir, telithromycin, among others.

Overdose

If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Laboratory 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 performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Missed Dose

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 and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

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.

MEDICAL ALERT: 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).

Information last revised June 2013. Copyright(c) 2013 First Databank, Inc.

Images

ZORTRESS 0.25 MG TABLET
ZORTRESS 0.25 MG TABLET
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ZORTRESS 0.5 MG TABLET
ZORTRESS 0.5 MG TABLET
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ZORTRESS 0.75 MG TABLET
ZORTRESS 0.75 MG TABLET
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imprint
CL, NVR
ZORTRESS 0.25 MG TABLET
ZORTRESS 0.25 MG TABLET

Identification

color
white
shape
round
imprint
C, NVR
This medicine is a white, round tablet imprinted with "C" and "NVR".
ZORTRESS 0.5 MG TABLET
ZORTRESS 0.5 MG TABLET

Identification

color
white
shape
round
imprint
CH, NVR
This medicine is a white, round tablet imprinted with "CH" and "NVR".
ZORTRESS 0.75 MG TABLET
ZORTRESS 0.75 MG TABLET

Identification

color
white
shape
round
imprint
CL, NVR
This medicine is a white, round tablet imprinted with "CL" and "NVR".

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, expect as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

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