Afinitor; Afinitor Disperz; Zortress
- This drug may raise the chance of very bad and sometimes deadly infections. Tell your doctor if you get signs of infection like a fever of 100.4°F (38°C) or higher, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, wound that will not heal, or anal itching or pain.
- This drug may raise the chance of getting cancer like lymphoma or skin cancer. Call your doctor right away if you have a change in color or size of a mole, a skin lump or growth, a big weight loss, night sweats, or swollen glands.
- In people who have had a kidney transplant, the risk of a blood clot in your kidney transplant may be raised. This may lead to loss of the kidney. Most of the time, this has happened within the first 30 days after the kidney transplant. Call your doctor right away if you have back, groin, or belly pain; are not able to pass urine; have blood in your urine, dark urine, a fever, or an upset stomach; or you are throwing up.
- If you are taking this drug with cyclosporine, you will need a lower dose of cyclosporine. Talk with your doctor.
- This drug is not to be used if you have had a heart transplant. More deaths were seen in people taking this drug after a heart transplant. Talk with your doctor.
- It is used to treat cancer.
- It is used to treat certain kinds of kidney cysts.
- It is used to keep the body from harming the organ after an organ transplant.
- It may be given to you for other reasons. Talk with the doctor.
- If you have an allergy to everolimus, temsirolimus, sirolimus, or any other part of this drug.
- If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
- If you have an infection.
- If you take any drugs (prescription or OTC, natural products, vitamins) that must not be taken with this drug, like certain drugs that are used for HIV, infections, or depression. There are many drugs that must not be taken with this drug. Your doctor or pharmacist can tell you if you are taking a drug that must not be taken with this drug.
- If you are taking another drug that has the same drug in it.
- Do not take St John’s wort with this drug. This drug may not work as well.
- If you have a rare hereditary problem of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
- Tell dentists, surgeons, and other doctors that you use this drug.
- You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
- This drug may raise the chance of very bad and sometimes deadly infections. Talk with the doctor.
- If you have high blood sugar (diabetes), you will need to watch your blood sugar closely. Tell your doctor if you get signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
- Have blood work checked as you have been told by the doctor. Talk with the doctor.
- Avoid grapefruit and grapefruit juice.
- Talk with your doctor before getting any vaccines. Use with this drug may either raise the chance of an infection or make the vaccine not work as well.
- If you have mouth irritation or mouth sores, do not use mouth rinses that have alcohol, peroxide, iodine, or thyme in them. Talk with your doctor.
- This drug may affect how wounds heal. Sometimes, people with wound healing problems have needed surgery. Call your doctor right away if you have a wound that is red, warm, painful, or swollen. Call your doctor right away if your wound opens up or if there is blood, fluid, or pus in a wound.
- This drug may cause harm to the unborn baby if you take it while you are pregnant.
- Use birth control that you can trust during care and for 2 months after care ends.
- Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this drug while you are pregnant.
- Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
- There is a chance of skin cancer. Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.
- In people who have had a liver transplant, the risk of a blood clot in the liver transplant may be raised. This may lead to loss of the liver or death. Most of the time, this has happened within the first 30 days after the liver transplant. Talk with the doctor.
- Some people treated with this drug have had very bad kidney problems caused by a certain viral infection (BK virus). In people who have had a kidney transplant, BK virus infection may cause loss of the kidney. Call your doctor right away if you have signs of kidney problems like change in the amount of urine passed, difficulty or pain when passing urine, or blood in the urine.
- This drug may affect sperm in men. This may affect being able to father a child. Talk with the doctor.
All other products:
- Avoid being near anyone who has had a recent live vaccine. There are many types of live vaccines. Ask your doctor or pharmacist if you are not sure.
- This drug may cause fertility problems. This may affect being able to have children. Talk with the doctor.
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
- Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
- Redness or irritation of the palms of hands or soles of feet.
- A burning, numbness, or tingling feeling that is not normal.
- Chest pain.
- Any bruising or bleeding.
- A fast heartbeat.
- A heartbeat that does not feel normal.
- Very bad dizziness or passing out.
- Muscle pain or weakness.
- Period (menstrual) changes. These may include a missed period.
- Mood changes.
- Change in the way you act.
- Very bad and sometimes deadly lung problems have happened with this drug. Call your doctor right away if you have lung or breathing problems like trouble breathing, shortness of breath, or a cough that is new or worse.
- Very bad and sometimes deadly kidney problems have happened with this drug. Call your doctor right away if you are unable to pass urine or if you have blood in the urine or a change in the amount of urine passed.
- A very bad brain problem called progressive multifocal leukoencephalopathy (PML) may happen with this drug. It may cause disability or death. Tell your doctor right away if you have signs like confusion, memory problems, low mood (depression), change in the way you act, change in strength on 1 side is greater than the other, trouble speaking or thinking, change in balance, or change in eyesight.
- Pimples (acne).
- Feeling tired or weak.
- Not able to sleep.
- Upset stomach or throwing up.
- Loose stools (diarrhea).
- Hard stools (constipation).
- Mouth irritation or mouth sores.
- Change in taste.
- Not hungry.
- Weight loss.
- Dry mouth.
- Dry skin.
- Change in nails.
- Hair loss.
- Joint pain.
- Back pain.
- Pain in arms or legs.
- Muscle spasm.
- Belly pain.
- To gain the most benefit, do not miss doses.
- Take as you have been told, even if you feel well.
- Take this drug at the same time of day.
- Take with or without food. Always take with food or always take on an empty stomach.
- Take with a full glass of water.
- Swallow whole. Do not chew, break, or crush.
- If you take cyclosporine or tacrolimus, take them at the same time as this drug.
- Take as a liquid only. Do not swallow tablets whole.
- Wear gloves when touching this drug.
- Mix with water as you have been told before drinking.
- Drink right after mixing. Throw away any part not used after 1 hour.
- If possible, do not mix this drug if you are pregnant or plan to get pregnant. Talk with the doctor.
- Take a missed dose as soon as you think about it.
- If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
All other products:
- Take a missed dose as soon as you think about it.
- If it has been 6 hours or more since the missed dose, skip the missed dose and go back to your normal time.
- Do not take 2 doses at the same time or extra doses.
- Store in the original container at room temperature.
- Protect from light.
- Store in a dry place. Do not store in a bathroom.
- Keep all drugs out of the reach of children and pets.
- Check with your pharmacist about how to throw out unused drugs.
- If your symptoms or health problems do not get better or if they become worse, call your doctor.
- Do not share your drugs with others and do not take anyone else’s drugs.
- Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
- Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
- Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, pharmacist, or other health care provider.
- If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
If you have any questions or concerns, talk with a member of your healthcare team. You can reach them Monday through Friday from 9:00 am to 5:00 pm at ____________________. After 5:00 pm, during the weekend, and on holidays, please call____________________. If there’s no number listed, or you’re not sure, call 212-639-2000.