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everolimus (Zortress)

Pronunciation: E ver OH li mus (ZOR tress)

Brand: Zortress

What is the most important information I should know about Zortress?

This medication guide provides information about the Zortress brand of everolimus. Afinitor is another brand of everolimus used to treat kidney cancer.

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You should not use this medication if you are allergic to everolimus or sirolimus (Rapamune), or if you have problems digesting lactose or galactose (sugar).

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Taking Zortress may increase your risk of developing other types of cancer such as lymphoma or skin cancer. Ask your doctor about your individual risk.

Before taking everolimus, tell your doctor if you have liver disease, high cholesterol, a blood clotting disorder, a breathing disorder such as asthma or COPD, a history of skin cancer, or if you are pregnant.

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It is not known whether Zortress will harm an unborn baby. Use effective birth control while you are using this medication and for at least 8 weeks after your treatment ends.

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Serious and sometimes fatal infections may occur during treatment with Zortress. Stop using this medicine and call your doctor right away if you have signs of infection such as fever, chills, body aches, or flu symptoms.

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Do not receive a "live" vaccine while taking everolimus. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), oral polio, typhoid, chickenpox (varicella), BCG (Bacillus Calmette and Guérin), and nasal flu vaccine.

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There are many other drugs that can interact with everolimus. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

To be sure this medicine is not causing harmful effects, your blood will need to be tested often. Your kidney function may also need to be tested. Visit your doctor regularly.

What is everolimus (Zortress)?

Everolimus lowers your body's immune system. The immune system helps your body fight infections. The immune system can also fight or "reject" a transplanted organ such as a liver or kidney. This is because the immune system treats the new organ as an invader.

The Zortress brand of everolimus is used to prevent organ rejection after a kidney transplant. Zortress is used together with cyclosporine (Gengraf, Neoral, Sandimmune), steroids, and other medications.

This medication guide provides information about the Zortress brand of everolimus. Afinitor is another brand of everolimus used to treat kidney cancer.

Everolimus may also be used for purposes not listed in this medication guide.

What should I discuss with my health care provider before taking Zortress?

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You should not use this medication if you are allergic to everolimus or sirolimus (Rapamune), or if you have problems digesting lactose or galactose (sugar).

To make sure you can safely take everolimus, tell your doctor if you have any of these other conditions:

  • liver disease;
  • high cholesterol or triglycerides;
  • an active infection;
  • diabetes or high blood sugar;
  • a blood clotting disorder;
  • a breathing disorder, such as asthma or COPD (chronic obstructive pulmonary disease);
  • a personal or family history of skin cancer (melanoma); or
  • if you are pregnant or may become pregnant.
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Taking Zortress may increase your risk of developing other types of cancer such as lymphoma or skin cancer. Ask your doctor about your individual risk.

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FDA pregnancy category C. It is not known whether Zortress will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Use effective birth control while you are using this medication and for at least 8 weeks after your treatment ends.

Zortress can lower sperm count in men, which may affect fertility (your ability to have children).

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It is not known whether everolimus passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are taking Zortress.

How should I take Zortress?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results.

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Do not stop taking Zortress or change your dose without first talking to your doctor.

Zortress is usually taken twice daily (every 12 hours). You may take the medicine with or without food, but take it the same way each time. If you also take cyclosporine, take both medications at the same time.

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Take this medication with a full glass (8 ounces) of water.

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Do not crush or chew an everolimus tablet. Swallow the pill whole.

Everolimus can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Your blood will need to be tested often. Your kidney function will also need to be tested. Visit your doctor regularly.

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Store at room temperature in the original container, away from moisture, heat, and light. Keep each tablet in its blister pack until you are ready to take it.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Zortress?

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Do not receive a "live" vaccine while taking Zortress. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), oral polio, typhoid, chickenpox (varicella), BCG (Bacillus Calmette and Guérin), and nasal flu vaccine.

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Zortress may increase your risk of developing skin cancer. Avoid exposure to sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Grapefruit and grapefruit juice may interact with Zortress and lead to potentially dangerous effects. Avoid using these products while you are taking Zortress.

What are the possible side effects of Zortress?

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Serious and sometimes fatal infections may occur during treatment with Zortress. Stop taking this medicine and call your doctor right away if you have signs of infection such as fever, chills, body aches, or flu symptoms.

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Get emergency medical help if you have any of these signs of an allergic reaction: hives; chest pain, difficult breathing; swelling of your face, lips, tongue, or throat.

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Call your doctor right away if you have any other serious side effects such as:

  • pain in your stomach, groin, lower back or side;
  • urinating less than usual or not at all;
  • pain or burning when you urinate;
  • blood in your urine, dark colored urine, fever with nausea or vomiting;
  • redness, warmth, swelling, oozing, or slow healing of a wound or surgical incision;
  • new or worsening cough, feeling short of breath;
  • wheezing, trouble breathing;
  • stabbing chest pain, cough with yellow or green mucus;
  • pale skin, feeling light-headed, rapid heart rate, trouble concentrating;
  • white patches or sores inside your mouth or on your lips;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling);
  • high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss); or
  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious side effects may include:

  • swelling in your legs, ankles, or feet;
  • tired feeling;
  • nausea, constipation, diarrhea;
  • headache;
  • pain in your arms and legs; or
  • sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Zortress?

Many drugs can interact with Zortress. Below is just a partial list. Tell your doctor if you are using:

  • aprepitant (Emend);
  • dexamethasone (Decadron, Hexadrol);
  • isoniazid (for treating tuberculosis);
  • rifabutin (Mycobutin), rifampin (Rifadin, Rifater, Rifamate), or rifapentine (Priftin);
  • St. John's wort;
  • an antidepressant such as nefazodone;
  • other drugs that weaken your immune system;
  • an antibiotic such as clarithromycin (Biaxin), dalfopristin/quinupristin (Synercid), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), rifabutin (Mycobutin), rifampin (Rifadin, Rifater, Rifamate), rifapentine (Priftin), or telithromycin (Ketek);
  • an antifungal medication such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), or voriconazole (Vfend);
  • a barbiturate such as butabarbital (Butisol), secobarbital (Seconal), or phenobarbital (Solfoton);
  • cholesterol-lowering medicines such as atorvastatin (Lipitor, Caduet), lovastatin (Mevacor, Altoprev, Advicor), pravastatin (Pravachol), or simvastatin (Zocor, Simcor, Vytorin);
  • heart or blood pressure medication such as amiodarone (Cordarone, Pacerone), diltiazem (Cartia, Cardizem), felodipine (Plendil), nifedipine (Nifedical, Procardia), quinidine (Quin-G), verapamil (Calan, Covera, Isoptin, Verelan), and others;
  • HIV medication such as delavirdine (Rescriptor), efavirenz (Atripla, Sustiva), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Kaletra, Norvir), or saquinavir (Invirase); or
  • seizure medication such as carbamazepine (Carbatrol, Tegretol), felbamate (Felbatol), oxcarbazepine (Trileptal), phenytoin (Dilantin), or primidone (Mysoline).
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This list is not complete and there are many other drugs that can interact with everolimus. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

Where can I get more information?

Your pharmacist can provide more information about everolimus (Zortress).


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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