- This drug may raise the chance of very bad and sometimes deadly infections. Talk with the doctor.
- This drug may raise the chance of getting cancer like lymphoma or skin cancer. Talk with the doctor.
- This drug is not for use in people who have had liver or lung transplants. Very bad and sometimes deadly problems have happened in these people. Talk with the doctor.
- It is used to keep the body from turning down the kidney after a kidney transplant.
- It may be given to you for other reasons. Talk with the doctor.
- If you have an allergy to 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 are taking any of these drugs: Clarithromycin, erythromycin, itraconazole, ketoconazole, rifabutin, rifampin, telithromycin, or voriconazole.
- Tell dentists, surgeons, and other doctors that you use this drug.
- Do not switch between different forms of this drug without first talking with the doctor.
- Have your blood pressure checked often. Talk with your doctor.
- Have blood work checked as you have been told by the doctor. Talk with the doctor.
- Have your urine checked. Talk with your 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.
- You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
- You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
- 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.
- 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.
- Avoid grapefruit and grapefruit juice.
- This drug may affect how wounds heal. If you need to have surgery, you may need to stop this drug before surgery. Start taking it again after surgery as you have been told by your doctor. Talk with your 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.
- A very bad and sometimes deadly blood problem called thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS) has happened with this drug in some people. Call your doctor right away if you have any bruising or bleeding; feel very tired or weak; have dark urine or yellow skin or eyes; pale skin; change in the amount of urine passed; change in eyesight; change in strength on 1 side is greater than the other, trouble speaking or thinking, or change in balance; or fever.
- Use birth control that you can trust before care begins, during care, and for 3 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.
- 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 low potassium levels like muscle pain or weakness, muscle cramps, or a heartbeat that does not feel normal.
- Swelling, warmth, numbness, change of color, or pain in a leg or arm.
- Chest pain or pressure.
- Coughing up blood.
- Very bad dizziness or passing out.
- A fast heartbeat.
- Night sweats.
- Very bad headache.
- A skin lump or growth.
- Change in color or size of a mole.
- Feeling very tired or weak.
- Skin wound that will not heal.
- Any bruising or bleeding.
- For females, menstrual changes. These include lots of bleeding, spotting, or bleeding between cycles
- 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.
- 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.
- Belly pain.
- Hard stools (constipation).
- Loose stools (diarrhea).
- Upset stomach.
- Joint pain.
- To gain the most benefit, do not miss doses.
- Take as you have been told, even if you feel well.
- Take with or without food. Always take with food or always take on an empty stomach.
- Do not take cyclosporine capsules (Neoral®, Gengraf®) or oral solution (Neoral®) within 4 hours of this drug.
- Put 1/4 cup of water or orange juice into a cup.
- Measure this drug in the oral dose syringe. Empty drug from syringe into cup. Mix well and drink.
- Fill container again with 1/2 cup of water or orange juice. Mix well and drink.
- Throw syringe away after use. Do not use more than one time.
- If you get this drug on the skin, wash it off right away with soap and water.
- If this drug gets in the eyes, rinse with cool water.
- Swallow whole. Do not chew, break, or crush.
- Wash your hands after use.
- 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.
- Do not take 2 doses at the same time or extra doses.
- Store at room temperature.
- Store in a dry place. Do not store in a bathroom.
- Do not remove the tablet from the tablet pack until you are ready to take this drug. Take the tablet right away after opening the blister pack. Do not store the removed tablet for future use.
- Store liquid (solution) at room temperature or in a refrigerator. Throw away any part not used after 15 days if stored at room temperature. Throw away any part not used after 1 month if refrigerated.
- Liquid (solution) may look hazy when refrigerated. Bring to room temperature and shake gently until haze goes away.
- Liquid (solution) in a syringe may be stored at room temperature or in a refrigerator for up to 24 hours.
- Protect from light.
- 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.