Generic Name: everolimus (E-ver-OH-li-mus)
Brand Name: Zortress
Zortress decreases the action of the immune system. This may increase your risk of developing infection or certain types of cancer (eg, lymphoma, skin cancer). Tell your doctor right away if you notice signs of infection (eg, persistent sore throat, chills, fever, painful or frequent urination). Tell your doctor right away if you notice a change in the appearance or size of a mole, unusual itching, fever, night sweats, unexplained weight loss, swollen lymph nodes, or unusual growths or lumps.
Zortress is usually taken with cyclosporine (another medicine to suppress the immune system). The risk of kidney damage may be increased when Zortress is used along with certain doses of cyclosporine. You may need lab tests to check the amount of these medicines in your blood.
Zortress may increase the risk of developing a blood clot that may cause you to lose the transplanted kidney. If this occurs, it usually happens within the first 30 days after the transplant. Discuss any questions or concerns with your doctor. Tell your doctor right away if you have pain in your groin, lower back, side, or stomach; decreased urination; dark or bloody urine; fever; nausea; or vomiting.
The risk of death may be increased in people who take Zortress after a heart transplant. This is often associated with serious infections. Use of Zortress following a heart transplant is not recommended. Talk with your doctor for more information.
Zortress is used for:
Preventing organ rejection after a kidney or liver transplant in certain patients. It is used with other medicines. It may also be used for other conditions as determined by your doctor.
Zortress is an immunosuppressant. It works by blocking the action of certain blood cells in the immune system that may cause the body to reject the transplanted organ.
Do NOT use Zortress if:
- you are allergic to any ingredient in Zortress or to other similar medications (eg, sirolimus, temsirolimus)
- you have had a heart transplant or certain hereditary problems (eg, galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption)
- you are taking delavirdine
Contact your doctor or health care provider right away if any of these apply to you.
Before using Zortress:
Some medical conditions may interact with Zortress. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are able to become pregnant
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have diabetes or high blood sugar, high cholesterol or triglycerides, bone marrow problems, certain blood problems (eg, low white blood cell or platelet levels), a weakened immune system, a history of lung or breathing problems, or any type of infection
- if you have a history of liver problems or skin cancer, or if a member of your family has had skin cancer
- if you have recently received or will be receiving a live vaccine (eg, measles, mumps), or if you will be in close contact with anyone who has received a live vaccine
- if you are taking other medicines to suppress your immune system
Some MEDICINES MAY INTERACT with Zortress. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Angiotensin-converting enzyme (ACE) inhibitors (eg, lisinopril) because it may increase the risk of a serious side effect that may cause swelling of the hands, face, lips, eyes, throat, or tongue; difficulty swallowing or breathing; or hoarseness
- Fibrates (eg, fenofibrate, gemfibrozil) or HMG-CoA reductase inhibitors (statins) (eg, atorvastatin, lovastatin, simvastatin) because the risk of severe muscle problems may be increased
- Medicines that may harm the kidney (eg, aminoglycoside antibiotics [eg, gentamicin], amphotericin B, cyclosporine, nonsteroidal anti-inflammatory drugs [NSAIDs] [eg, ibuprofen], tacrolimus, vancomycin) because the risk of kidney side effects may be increased. Ask your doctor if you are unsure if any of your medicines might harm the kidney
- Aprepitant, azole antifungals (eg, itraconazole, ketoconazole, voriconazole), delavirdine , digoxin, diltiazem, macrolide antibiotics (eg, clarithromycin, erythromycin), nefazodone, nicardipine, protease inhibitors (eg, boceprevir, ritonavir), telithromycin, or verapamil because they may increase the risk of Zortress's side effects
- Carbamazepine, dexamethasone, efavirenz, hydantoins (eg, phenytoin), nevirapine, phenobarbital, primidone, rifamycins (eg, rifabutin, rifampin), or St. John's wort because they may decrease Zortress's effectiveness
This may not be a complete list of all interactions that may occur. Ask your health care provider if Zortress may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Zortress:
Use Zortress as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Zortress comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Zortress refilled.
- Take Zortress by mouth with or without food. It is important to take it consistently with regard to food. If you take it with food, try to always take it with food. If you prefer to take it on an empty stomach, then always try to take it on an empty stomach.
- Swallow Zortress whole. Do not break, crush, or chew before swallowing.
- Take Zortress with a full glass of water (8 oz [240 mL]).
- Do not eat grapefruit or drink grapefruit juice while you use Zortress.
- Zortress is usually taken with certain other medicines (eg, cyclosporine, tacrolimus). Take them at the same time as Zortress. Do not switch the brand or dose form (eg, capsules, solution), change your dose, or stop taking any of these medicines without checking with your doctor. Discuss any questions or concerns with your doctor.
- Take your doses of Zortress about 12 hours apart. Taking Zortress at the same time each day will help you to remember.
- If you miss a dose of Zortress, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule the next day. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Zortress.
Important safety information:
- Zortress may cause dizziness or drowsiness. This effect may be worse if you take it with alcohol or certain medicines. Use Zortress with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Tell your doctor or dentist that you take Zortress before you receive any medical or dental care, emergency care, or surgery.
- If vomiting or diarrhea occurs, you will need to take care not to become dehydrated. Contact your doctor for instructions.
- Zortress can cause your surgery site to heal slowly or not heal well. Contact your doctor if your surgery site is red, warm, painful, or swollen; if your surgery site opens up; or if you have blood or fluid at your surgery site. Contact your doctor if you have a wound that does not heal properly while you are using Zortress.
- Zortress may lower the ability of your body to fight infection. This may increase your risk of developing a serious infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
- Some people treated with Zortress have developed severe and sometimes fatal viral infections, such as JC virus or BK virus infection. JC virus infection may lead to a serious effect called progressive multifocal leukoencephalopathy (PML). BK virus may cause kidney problems or loss of a transplanted kidney in kidney transplant patients. Tell your doctor right away if you notice symptoms of PML (eg, confusion; disorientation; depression; changes in thinking, strength, or vision; one-sided weakness; trouble walking or talking; loss of balance or coordination) or kidney problems (eg, change in the amount of urine produced, difficult or painful urination, blood in the urine).
- Do not receive a live vaccine (eg, measles, mumps) while you are taking Zortress. Avoid close contact with anyone who has recently received a live vaccine. Talk with your doctor before you receive any vaccine.
- Patients who take Zortress after an organ transplant may have an increased risk of developing high blood sugar or diabetes. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.
- Diabetes patients - Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- Noninfectious pneumonitis is a severe and possibly fatal reaction that may occur with the use of Zortress. Tell your doctor right away if you develop fever, shortness of breath, cough, wheezing, or any other new or worsening breathing problems.
- Zortress may increase your risk of developing skin cancer or certain other types of cancer (eg, lymphoma). Avoid the sun, sunlamps, or tanning booths. Use a sunscreen or wear protective clothing if you must be outside for more than a short time. Tell your doctor right away if you notice a change in the appearance or size of a mole, unusual itching, fever, night sweats, unexplained weight loss, swollen lymph nodes, or unusual growths or lumps.
- If you may become pregnant, you must use an effective form of birth control while you use Zortress and for 8 weeks after you stop using it. If you have questions about effective birth control, talk with your doctor.
- Decreased sperm production has occurred in some men taking Zortress. Discuss any questions or concerns with your doctor.
- Lab tests, including kidney function, blood medicine levels, blood cholesterol levels, blood glucose levels, urine protein tests, and complete blood cell counts, may be performed while you use Zortress. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Zortress should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: It is not known if Zortress can cause harm to the fetus. Do not become pregnant while you are using it and for 8 weeks after you stop Zortress. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Zortress while you are pregnant. It is not known if this medicine is found in breast milk. Do not breast-feed while taking Zortress.
Possible side effects of Zortress:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Back, arm, or leg pain; constipation; decreased sexual ability in men; diarrhea; dizziness; drowsiness; headache; loss of appetite; nausea; stomach pain or upset; tiredness or weakness; trouble sleeping; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; flushing, tightness in the chest; swelling of the mouth, eyes, face, lips, throat, or tongue; unusual hoarseness); bloody stools; calf or leg pain, swelling, redness, or tenderness; change in the appearance or size of a mole; chest pain; confusion; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; hallucination; mental or mood changes (eg, agitation, anxiety, depression); muscle pain or weakness; new or worsening cough; numbness or tingling; pale stools; severe or persistent constipation, diarrhea, nausea, stomach pain, or vomiting; severe or persistent dizziness or headache; severe or persistent tiredness or weakness; shortness of breath or other breathing problems; sores in the mouth or on the tongue; stomach swelling; swelling of the arms, hands, feet, or ankles; swollen lymph nodes; symptoms of high blood sugar (eg, increased hunger, thirst, or urination; confusion; unusual drowsiness); symptoms of kidney or urinary problems (eg, change in the amount of urine produced; difficult or painful urination; dark or bloody urine; pain in the groin, side, or lower back); tremor; unusual bruising or bleeding; vision changes; white patches in the mouth; yellowing of the eyes or skin.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of Zortress:
Store Zortress at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Zortress out of the reach of children and away from pets.
- If you have any questions about Zortress, please talk with your doctor, pharmacist, or other health care provider.
- Zortress is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Zortress or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Zortress. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Zortress. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Zortress.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.