EVEROLIMUS (TRANSPLANT) - ORAL

EVEROLIMUS (TRANSPLANT) - ORAL

PHONETIC PRONUNCIATION: (/E-ver-OH-li-mus)

COMMON BRAND NAME(S): Zortress

GENERIC NAME(S): everolimus

Uses

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.


How to use EVEROLIMUS (TRANSPLANT) - ORAL

HOW TO USE: 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

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. People using this medication may 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 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. This medication may affect male and female 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 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.

Precautions

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 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). 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. Female patients should ask about reliable forms of birth control while using this medication and for 8 weeks after stopping treatment. Male patients with female partners should ask about reliable forms of birth control while using this medication and for 4 weeks after stopping treatment. If you or your partner become 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, breast-feeding while using this drug and for 2 weeks after stopping treatment is not recommended. Consult your doctor before breast-feeding.

Interactions

DRUG 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), 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 and HCV protease inhibitors (such as atazanavir, boceprevir, ritonavir, telaprevir), rifamycins (such as rifabutin, rifampin), St. John's wort, telithromycin, among others.

Overdose

OVERDOSE: 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 their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

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ZORTRESS 0.5 MG TABLET

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ZORTRESS 0.75 MG TABLET

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ZORTRESS 0.25 MG TABLET

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Faq for EVEROLIMUS (TRANSPLANT) - ORAL

Everolimus is prescribed to prevent rejection of organ transplants, such as kidney or liver transplants.

Everolimus belongs to a group of medications called immunosuppressants. It works by suppressing the immune system's ability to reject the transplanted organ, allowing the body to accept and adapt to the new organ.

Common side effects of Everolimus may include mouth ulcers, diarrhea, nausea, vomiting, fatigue, headache, and joint pain.

Everolimus is usually taken orally once a day, at the same time each day. It is important to take it exactly as prescribed by your doctor, and do not stop taking it without their guidance.

It is generally recommended to avoid alcohol while taking Everolimus, as mixing the two may increase the risk of liver damage.

Everolimus may harm an unborn baby, so it is important to discuss the potential risks and benefits with your doctor if you are pregnant or planning to become pregnant. It is also not recommended to breastfeed while taking Everolimus, as it may pass into breast milk.

If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.

Certain medications, particularly strong inducers or inhibitors of certain enzymes, may interact with Everolimus and affect its effectiveness or increase the risk of side effects. It is important to inform your doctor and pharmacist about all the medications and supplements you are taking.

The duration of Everolimus treatment may vary depending on individual circumstances and the specific transplant. Your doctor will determine the appropriate length of treatment for you.


Warning

WARNING: 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.


Disclaimer

IMPORTANT: 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.