Sirolimus Oral Solution (SIROLIMUS SOLUTION - ORAL)

Instructions

Mix the dose with 60 mL (2 oz.) of water or orange juice. Stir for 1 minute then drink the mixture quickly. Add another 120 mL (4 oz.) to the cup, stir and drink.

Measure the dose of liquid medicine carefully. Use the measuring device that comes with the medicine. If you do not have one, please ask your pharmacist for help.

Only use glass or plastic cups when mixing medicine.

Do not use any other juices or liquids to mix the medicine.

Drink the medicine immediately after mixing.

This medicine may be taken with or without food, but it is important to take it the same way each time.

If you are also taking cyclosporine, take this medicine 4 hours after the cyclosporine.

This medicine will work best if you take it at about the same time every day.

Keep the medicine in the refrigerator. Do not freeze.

Store in original bottle, tightly closed and upright.

Discard any unused medicine 30 days after opening.

Any medicine stored in the syringe should be used within 24 hours.

Avoid grapefruit and grapefruit juice while on this medicine.

This medicine can make you sensitive to the sun. Use sunscreen or protective clothing when in sun.

It is important that you keep taking each dose of this medicine on time even if you are feeling well.

If you forget to take a dose on time, take it as soon as you remember. If it is almost time for the next dose, do not take the missed dose. Return to your normal schedule. Do not take 2 doses at one time.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

This medicine may cause higher blood sugar levels or diabetes. Please follow your doctor's instructions and check your blood sugar level regularly while on this medicine.

Keep all appointments for medical exams and tests while on this medicine.

Cautions

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

Some patients on this medicine have developed severe, life-threatening infections. Please speak with your doctor about the risks and benefits of using this medicine.

This medicine may increase the risk of cancer. Ask your doctor about the benefits and risks.

It is very important that you carefully measure the amount of medicine you take. Your healthcare provider or pharmacist should show you the correct way to measure this medicine.

Do not use the medication any more than instructed.

This medicine may reduce your body's ability to fight infections. Avoid contact with people with colds, flu or other infections. Contact your doctor if you develop fever, cough, sore throat, or chills.

Speak with your health care provider before receiving any vaccinations.

Do not breastfeed while on this medicine. This medicine can pass through breast milk to the baby.

This medicine can hurt a new baby in the womb. If you become pregnant while on this medicine, tell your doctor immediately. Your doctor may switch you to a different medicine.

Women must use reliable forms of birth control while taking this medicine and for 3 months after stopping to prevent pregnancy.

This medicine may reduce sperm count.

Do not share this medicine with anyone who has not been prescribed this medicine.

Some patients have serious side effects from this medicine. Ask your pharmacist to show you the information from the Food and Drug Administration (FDA) and discuss it with you.

Always refill this medicine before it runs out.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

• acne
• agitated feeling or trouble sleeping
• diarrhea
• high blood sugar
• pain in the joints
• shakiness

Call your doctor or get medical help right away if you notice any of these more serious side effects:

• increased appetite
• bleeding or bruising
• bone pain
• chest pain
• changes in memory, mood, or thinking
• difficulty concentrating
• confusion
• feeling of swelling of the body
• swelling of the legs, feet, and hands
• fainting
• fever
• flu-like symptoms
• severe or persistent headache
• hearing loss
• fast, irregular, or slow heartbeat
• muscle pain or weakness
• unusual growth or lump on the neck
• ringing in the ears
• seizures
• shortness of breath
• skin changes - a darker area with uneven edges or coloring
• change in the size or color of a skin mole
• sore throat
• stomach pain
• sweating at night
• persistent or unusual thirst
• unusual or unexplained tiredness or weakness
• increased urinary frequency
• dark urine
• blurring or changes of vision
• severe or persistent vomiting
• weight loss
• yellowing of eyes or skin

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.