Zortress (Everolimus)

Zortress is marketed as Afinitor in Canada

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Certican 0.25mg

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Certican 0.25mg
Product of Australia
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Certican 0.5mg

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Certican 0.5mg
Product of Australia
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Certican 0.75mg

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Certican 0.75mg
Product of Australia
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Zortress 0.25mg

Product of Turkey
Manufactured by: Novartis
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Zortress is also marketed as Certican
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Zortress 0.25mg
Product of Turkey
Manufactured by Novartis
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Zortress 0.75mg

Product of Turkey
Manufactured by: Novartis
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Zortress is also marketed as Certican
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Zortress 0.75mg
Product of Turkey
Manufactured by Novartis
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Zortress (Everolimus) Dosage and Side Effects

ZORTRESS is a cancer medicine that interferes with the growth of cancer cells and slows their spread in the body.

Warnings and Precautions

ZORTRESS can cause serious and sometimes fatal side effects. Call your doctor right away if you have symptoms such as: fever, chills, joint pain, cough, chest pain, wheezing, trouble breathing, swelling, little or no urinating, loss of appetite, dark urine, yellowing of your skin or eyes, or upper stomach pain.

ZORTRESS may increase your risk of infection or certain cancer by changing the way your immune system works.

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.

ZORTRESS can cause a blood clot in the blood vessels of your transplanted organ, especially within 30 days after transplant. Tell your doctor right away if you have: shortness of breath, fever with nausea or vomiting, blood in your urine, dark colored urine, little or no urinating, jaundice (yellowing of your skin or eyes), or pain in your stomach, groin, lower back, or side.

You should not use this medicine if you are allergic to ZORTRESS, sirolimus (Rapamune), tacrolimus (Prograf), or temsirolimus (Torisel).

To make sure ZORTRESS is safe for you, tell your doctor if you have:

  • an active infection, or history of chronic infections;
  • liver disease, or a history of hepatitis B;
  • kidney disease;
  • diabetes or high blood sugar;
  • high cholesterol;
  • if you are scheduled to receive any vaccine; or
  • if you also take an "ACE inhibitor" heart or blood pressure medication, such as benazepril, captopril, enalapril, fosinopril, lisinopril, moexipril, perindopril, quinapril, ramipril, or trandolapril.

Do not take ZORTRESS if you are pregnant. It could harm the unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 8 weeks after your treatment ends.

ZORTRESS can affect fertility (your ability to have children), whether you are a man or a woman.

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

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

ZORTRESS can lower blood cells that help fight infection, and may cause you to produce too much of a certain type of white blood cell. This can lead to serious conditions including cancer, severe brain infection causing disability or death, or a viral infection causing kidney transplant failure. Ask your doctor about your specific risk.

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

  • high cholesterol or triglycerides;
  • diabetes or high blood sugar;
  • a breathing disorder, such as asthma or COPD (chronic obstructive pulmonary disease);
  • a personal or family history of skin cancer (melanoma); or
  • if you have ever had a heart transplant.

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).

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

Side Effects

Get emergency medical help if you have signs of an allergic reaction: hives; chest pain, difficult breathing; swelling of your face, lips, tongue, or throat. You may be more likely to have some of these symptoms if you also take an "ACE inhibitor" heart or blood pressure medication.

Stop using ZORTRESS and call your doctor at once if you have:

  • new or worsening cough, chest pain, wheezing, feeling short of breath;
  • signs of infection--fever, chills, joint pain, red or swollen gums, painful mouth sores, skin sores, rapid heart rate, pale skin, easy bruising, unusual bleeding, feeling light-headed;
  • kidney problems--little or no urination; painful or difficult urination; swelling in your feet or ankles; feeling tired or short of breath;
  • liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • any wound that will not heal; or
  • a surgical incision that is red, warm, swollen, painful, bleeding, or oozing pus.

Common side effects may include:

  • infections, cough, nosebleeds;
  • mouth sores, taste problems, dry mouth;
  • nausea, vomiting, diarrhea, constipation;
  • weight loss, feeling weak or tired;
  • pain or swelling anywhere in your body;
  • dry skin, rash, acne;
  • missed menstrual periods;
  • unusual changes in mood or behavior;
  • sleep problems (insomnia);
  • dizziness, headache; or
  • high blood sugar--increased thirst or urination, hunger, fruity breath odor, blurred vision.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

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

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.

ZORTRESS can cause a blood clot in the blood vessels of your transplanted organ, especially within 30 days after transplant. Tell your doctor right away if you have: shortness of breath, fever with nausea or vomiting, blood in your urine, dark colored urine, little or no urinating, jaundice (yellowing of your skin or eyes), or pain in your stomach, groin, lower back, or side.

Call your doctor at once if you have:

  • pain or burning when you urinate;
  • redness, warmth, swelling, oozing, or slow healing of a wound or surgical incision;
  • new or worsening cough, wheezing, breathing problems;
  • stabbing chest pain, cough with yellow or green mucus;
  • pale skin, feeling light-headed, rapid heart rate, easy bruising, unusual bleeding (nose, mouth, vagina, or rectum);
  • white patches or sores inside your mouth or on your lips;
  • 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, uneven heartbeats, seizure).

Common side effects may include:

  • swelling in your legs, ankles, or feet;
  • diarrhea, constipation; or
  • mild stomach discomfort.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Interactions with this medication

If you develop mouth sores or ulcers, avoid using mouthwashes or applying medicines that contain alcohol, peroxide, iodine, or thyme.

Do not receive a "live" vaccine while using ZORTRESS, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

This medicine can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Grapefruit and grapefruit juice may interact with ZORTRESS and lead to unwanted side effects. Avoid the use of grapefruit products while taking ZORTRESS.

This medicine can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Do not receive a "live" vaccine while using ZORTRESS, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

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 unwanted side effects. Avoid the use of grapefruit products while taking ZORTRESS.

Many drugs can interact with ZORTRESS. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any you start or stop using, especially:

  • an antibiotic;
  • antifungal medicine;
  • heart or blood pressure medication;
  • medicine to treat hepatitis C, or HIV/AIDS;
  • seizure medicine;
  • St. John's wort;
  • tuberculosis medication; or
  • drugs that weaken the immune system, such as cancer medicine, steroids, and medicines to prevent organ transplant rejection.

This list is not complete and many other drugs can interact with ZORTRESS. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

Many drugs can interact with ZORTRESS. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with ZORTRESS, especially:

  • aprepitant, conivaptan, cyclosporine, deferiprone, imatinib, natalizumab; or
  • an antibiotic--clarithromycin, dalfopristin, erythromycin, telithromycin; an antidepressant--fluvoxamine, nefazodone; antifungal medication--fluconazole, itraconazole, ketoconazole; heart or blood pressure medication--diltiazem, verapamil; HIV/AIDS medication--atazanavir, delavirdine, fosamprenavir, indinavir, nelfinavir, ritonavir, saquinavir.

This list is not complete and many other drugs can interact with ZORTRESS. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

Proper Use of this medication

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

ZORTRESS should be taken at the same time each day. You may take ZORTRESS with or without food, but take it the same way each time.

Do not take a ZORTRESS regular tablet together with an ZORTRESS dispersible tablet. Use only one form of this medicine.

Take the ZORTRESS regular tablet with a full glass of water. Do not crush, chew, or break the tablet. Swallow the pill whole.

Do not swallow the dispersible tablet (Afinitor Disperz) whole. Place it into about 2 tablespoons of water and allow the tablet to disperse in the liquid for at least 3 minutes. Stir gently and drink this mixture right away. The dispersed tablet may also be taken with an oral syringe. Wear latex gloves while handling the ZORTRESS Disperz tablet.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

ZORTRESS can lower blood cells that help your body fight infections and help your blood to clot. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Your blood may need to be tested often.

If you have ever had hepatitis B, ZORTRESS can cause this condition to come back or get worse. You will need frequent blood tests to check your liver function during treatment and for several months after you stop using this medicine.

If you need surgery, tell the surgeon ahead of time that you are using ZORTRESS. Your surgical incisions or other wounds may take longer to heal while you are taking this medicine.

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.

ZORTRESS is usually taken twice daily (every 12 hours). Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take the medicine with or without food, but take it the same way each time. If you also take cyclosporine or tacrolimus, take both medications at the same time.

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

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

Do not crush or chew a ZORTRESS tablet. Swallow the pill whole.

While using ZORTRESS, you will need frequent blood and urine tests at your doctor's office.

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.

Take the missed dose as soon as you remember. If you are more than 6 hours late, skip the missed dose. Do not take extra medicine to make up the missed 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.

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The above information is an educational aid only. It is not intended as medical advice for individual conditions or treatments. Talk to your doctor, nurse or pharmacist before following any medical regimen to see if it is safe and effective for you.

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