Sirolimus oral solution
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What is sirolimus oral solution?
SIROLIMUS (Rapamune®) is a medication used to decrease the immune system's response to a transplanted organ, which the body would otherwise see as foreign. Sirolimus helps to reduce immune responses and prevent organ rejection in patients who have received a kidney or other organ transplant. Generic sirolimus solution is not yet available.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
• heart disease, heart failure, or heart rhythm problems (fast or slow heartbeat)
• high cholesterol or triglycerides
• an active infection
• liver disease
• an unusual or allergic reaction to sirolimus, soy products, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding
How should I take this medicine?
Take sirolimus solution by mouth once daily. Follow the directions on the prescription label. You may take sirolimus with or without food, but make sure to take it the same way all the time. Do not take your medicine more often than directed. If you are also taking cyclosporine, make sure to take sirolimus at least 4 hours after taking your dose of cyclosporine.
To use the bottle of sirolimus, first insert the adapter unit (a plastic tube with stopper) into the bottle; push it in until the unit is even with the top of the bottle. Do not remove the adapter unit from the bottle once it has been placed. To withdraw your dose, insert one amber oral dosage syringe, with the plunger pushed down, into the opening of the adapter. Gently pull out the plunger of the syringe until the black line of the plunger is even with the correct dose on the syringe. Always keep the bottle in an upright position. If bubbles form in the syringe, empty the syringe into the bottle and try again to withdraw the dose. If you need to take your medicine with you to take later, place a cap tightly on the end of the syringe. The cap should snap in place. When opening the pouches, squeeze the pouch from the top to push the contents to the bottom. Then fold the top of the pouch along the marked line. Carefully open the pouch by cutting with a scissors along the marked line near the top of the pouch.
Empty the oral syringe or pouch into a glass or plastic container holding at least 2 ounces (¼ cup or 60 ml) of water or orange juice. Do not mix with apple juice, grapefruit juice, or other liquids. Stir vigorously and drink at once. Refill the container with 4 ounces (½ cup or 120 ml) of water or orange juice, stir vigorously, and drink at once. Use only glass or plastic cups to dilute sirolimus. The oral syringe and cap should be thrown away after using once.
Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.
What drug(s) may interact with sirolimus?
• amiodarone
• bosentan
• carbamazepine
• cimetidine
• cisapride
• clarithromycin
• cyclosporine
• diltiazem
• erythromycin
• fluoxetine
• fluvoxamine
• grapefruit juice
• imatinib
• medicines for fungal infections (antifungal medicines applied to the skin should not interact)
• medicines for HIV infection including protease inhibitors, delavirdine, efavirenz, and nevirapine
• metoclopramide
• micafungin
• mifepristone
• nefazodone
• nicardipine
• oxcarbazepine
• phenobarbital
• phenytoin
• rifabutin
• rifampin
• rifapentine
• St. John's wort
• telithromycin
• vaccines
• verapamil
Talk to your prescriber or health care professional before taking any of these medicines:
• aspirin
• acetaminophen
• ibuprofen
• ketoprofen
• naproxen
Tell your prescriber or health care professional about all other medicines that you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.
What should I watch for while taking sirolimus?
Sirolimus increases your cholesterol or lipid levels. This may require additional treatment in some cases. Your prescriber will check your blood levels on a regular basis while you are taking sirolimus to check for this effect. You will need to visit your prescriber or health care professional for regular checks on your progress.
Sirolimus will decrease your body's ability to fight infections. Call your prescriber or health care professional if you have a fever, chills, sore throat or other symptoms of a cold or flu. Do not treat these symptoms yourself. Try to avoid being around people who are sick. Sirolimus may increase your risk to bruise or bleed. Call your prescriber or health care professional if you notice any unusual bruising or bleeding.
After you stop taking this medication, side effects can continue. Some side effects may not occur until years after the medicine was taken. These effects can include the development of certain types of cancer. Discuss this possibility with your prescriber or health care professional.
Avoid taking aspirin, acetaminophen (Tylenol®), ibuprofen (Advil®), ketoprofen (Orudis KT®), or naproxen (Aleve®) products as these may mask a fever, unless instructed to by your prescriber or health care professional.
Patients who may still have children should use effective birth control methods before, during, and for 12 weeks following sirolimus therapy.
What side effects may I notice from taking sirolimus?
Contact your prescriber or health care professional about any unusual effects. Side effects that you should report to your prescriber or health care professional as soon as possible:
• difficulty breathing
• rapid heart beat or chest pain
• signs of infection - fever or chills, cough, sore throat, pain or difficulty passing urine
• signs of decreased platelets or bleeding - bruising, pinpoint red spots on the skin, black, tarry stools, and blood in the urine
• signs of decreased red blood cells - unusual weakness or tiredness, fainting spells, lightheadedness
• skin rash or hives
Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):
• acne
• aches
• diarrhea
• difficulty sleeping
• headache
• nausea, vomiting
Where can I keep my medicine?
Keep out of the reach of children.
Store sirolimus oral solution bottles or pouches in the refrigerator. Once a bottle is opened, it should be used within one month. If necessary, the bottles and pouches may be stored at room temperature for a short period of time (i.e., up to 24 hours for the pouches and not more than 15 days for the bottles). Once in the oral syringe, the oral solution may be kept for one day only at room temperature or under refrigeration. The syringe should be discarded after one use. After mixing with juice or water, the solution should be used immediately.
Sirolimus bottles may develop a slight haze when refrigerated. If this occurs, allow the bottles to stand at room temperature and shake gently until the haze disappears. The presence of a haze does not affect the quality of the product.
Important Disclaimer: The drug information provided here is for educational purposes only. It is intended to supplement, not substitute for, the diagnosis, treatment and advice of a medical professional. This drug information does not cover all possible uses, precautions, side effects and interactions. It should not be construed to indicate that this or any drug is safe for you. Consult your medical professional for guidance before using any prescription or over the counter drugs.
