Sirolimus Oral Solution

• It is used to keep the body from turning down the kidney after a kidney transplant.
• It is used to treat a lung disease called lymphangioleiomyomatosis (LAM).
• 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 sirolimus oral solution.
• 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.
• If you are breast-feeding or plan to breast-feed.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take sirolimus oral solution with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Do not switch between different forms of sirolimus oral solution without first talking with the doctor.
• High blood pressure has happened with this medicine. Have your blood pressure checked as you have been told by your doctor.
• This medicine may cause high cholesterol and triglyceride levels. Talk with the doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Have your urine checked as you have been told by 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 sirolimus oral solution may either raise the chance of an infection or make the vaccine not work as well.
• Avoid grapefruit and grapefruit juice.
• This medicine 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.
• Some people treated with this medicine 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.
• Very bad and sometimes deadly blood problems like thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS) have happened with sirolimus oral solution in some people. Call your doctor right away if you feel very tired or weak or have any bruising or bleeding; 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.
• If you get pregnant while taking this medicine or within 3 months after your last dose, call your doctor right away.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• 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 high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• 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 or a fast heartbeat.
• Coughing up blood.
• Feeling very tired or weak.
• Skin wound that will not heal.
• Swelling in the arms or legs.
• Any unexplained bruising or bleeding.
• Period (menstrual) changes.
• Very bad and sometimes deadly lung problems have happened with sirolimus oral solution. 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) has happened with this medicine. It may cause disability or can be deadly. 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.
• Very bad and sometimes deadly liver problems have happened with sirolimus oral solution. Call your doctor right away if you have 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.

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.

• Store in a refrigerator. Do not freeze.
• After opening, throw away any part not used after 1 month.
• This medicine may also be stored at room temperature. If stored at room temperature, throw away any part not used after 15 days.
• 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 in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Do not take this medicine with any of the following medications:

• certain antibiotics like clarithromycin, erythromycin, telithromycin
• grapefruit juice
• medicines for fungal infections like itraconazole, ketoconazole, posaconazole, and voriconazole
• mifepristone, RU-486
• rifabutin, rifampin

This medicine may also interact with the following medications:

• boceprevir
• bromocriptine
• carbamazepine
• cimetidine
• cisapride
• clotrimazole
• cyclosporine
• danazol
• diltiazem
• fluconazole
• indinavir
• metoclopramide
• nicardipine
• phenobarbital
• phenytoin
• rifapentine
• ritonavir
• St. John's wort
• telaprevir
• troleandomycin
• vaccines
• verapamil