What is sirolimus?
Sirolimus lowers your body's immune system. The immune system helps your body fight
infections. The immune system can also fight or "reject" a transplanted organ such as a liver or kidney.
This is because the immune system treats the new organ as an invader.
Sirolimus is used to prevent your body from rejecting a transplanted kidney. Sirolimus is
sometimes used in a combination treatment with cyclosporine (Neoral, Sandimmune) and a steroid
medicine such as prednisone.
Sirolimus may also be used for other purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking sirolimus?
Sirolimus may increase your risk of developing lymphoma or other forms of cancer. Talk with
your doctor about your specific cancer risk.
You should not use this medication if you are allergic to sirolimus.
If you have certain conditions, you may need a dose adjustment or special tests to safely use
this medication. Before you take sirolimus, tell your doctor if you are allergic to any drugs, or if you
have:
FDA pregnancy category C. It is not known whether sirolimus is
harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to
become pregnant during treatment. Use an effective form of birth control while you are using this
medication and for at least 12 weeks after your treatment ends.
It is not known whether sirolimus passes into breast milk or if it could harm a nursing baby.
Do not use this medication without telling your doctor if you are breast-feeding a baby.
This medicine should not be given to a child younger than 13 years old.
How should I take sirolimus?
Take this medication exactly as it was prescribed for you. Do not take the medication in larger
amounts, or take it for longer than recommended by your doctor. Your doctor may occasionally
change your dose to make sure you get the best results from this medication. Follow your doctor's
dosing instructions carefully.
Take the sirolimus tablet with a full glass of water.
Do not crush, chew, or break a sirolimus
tablet
. Tell your doctor if you
have trouble swallowing the tablet whole.
You may take sirolimus with or without food, but take it the same way every time.
The oral
liquid
(solution) comes with patient instructions for safe and effective
use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.
The oral liquid must be mixed with at least 2 ounces (1/4 cup) of water or orange juice. Do not
use any other liquids to mix this medicine.
Stir the mixture and drink all of it right away. Then add at least 4 ounces (1/2 cup) more water
or orange juice to the same glass, stir again and drink right away.
Sirolimus is usually taken once a day. If you also take cyclosporine, wait at least 4 hours after
your cyclosporine dose before you take sirolimus.
Sirolimus can lower the blood cells that help your body fight infections. This can make it easier
for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood
cells do not get too low, your blood will need to be tested on a regular basis. Your kidney function
may also need to be tested. Do not miss any scheduled visits to your doctor.
Avoid getting sirolimus liquid on your skin or around your nose. If it does get onto any of
these areas, wash with soap and water. If this medicine gets into your eyes, rinse them with plain
water.
Store sirolimus
tablets
at room temperature, away from heat, moisture,
and light.
Store sirolimus
oral liquid
in the refrigerator. Do not freeze. You may
notice a slight haze to the liquid after it has been refrigerated. This haze will not affect the medication,
and should disappear when the medicine reaches room temperature.
If you are taking Rapamune oral liquid with a disposable syringe, you may store a loaded
syringe in the carrying case provided. Keep the case at room temperature and use the medicine within
24 hours. Use a disposable syringe only once and then throw it away.
What happens if I miss a dose of sirolimus?
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the
missed dose and take the medicine at the next regularly scheduled time.
Do not
take
extra medicine to make up the missed dose.
Where can I get more information about sirolimus?
Your pharmacist has information about sirolimus written for health professionals that you may read.
What are the possible side effects of sirolimus?
Get emergency medical help if you have any of these
signs of an allergic
reaction:
hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
-
fast heart rate;
-
pain when you breathe, feeling short of breath;
-
chest pain, feeling weak or tired;
-
coughing up blood or mucus;
-
feeling like you might pass out;
-
pale skin, easy bruising or bleeding, weakness;
-
fever, chills, body aches, flu symptoms;
-
night sweats, weight loss;
-
swelling in your face, stomach, hands or feet;
-
rapid weight gain;
-
pain or burning when you urinate; or
-
slow healing of a wound.
Less serious side effects may include:
-
joint pain;
-
nausea, vomiting, diarrhea, constipation, stomach pain;
-
headache; or
-
acne or skin rash.
This is not a complete list of side effects and others may occur. Call your
doctor for medical advice about side effects. You may report side effects to FDA at
1-800-FDA-1088.
What is the most important information I should know about sirolimus?
This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or
plan to become pregnant. Use an effective form of birth control while you are using this medication and
for at least 12 weeks after your treatment ends.
The oral liquid form of sirolimus must be mixed with water or orange juice only. Do not use any
other liquids to mix this medicine.
Do not mix this medicine with grapefruit juice or potentially dangerous effects may result. Avoid
eating grapefruit or drinking grapefruit juice while you are taking sirolimus.
If you also take cyclosporine, take the sirolimus at least 4 hours after taking cyclosporine.
You may take sirolimus with or without food, but take it the same way every time.
Sirolimus can lower the blood cells that help your body fight infections. Avoid contact with
people who have colds, the flu, or other contagious illnesses. Do not receive any vaccines without your
doctor's advice. Contact your doctor immediately if you develop signs of infection.
Avoid getting this medication on your skin, or around your nose and mouth. If it does get
onto any of these areas, wash with soap and water. If this medicine gets into your eyes, rinse them with
plain water.
Sirolimus may increase your risk of developing lymphoma or other forms of cancer. Talk with
your doctor about your specific cancer risk.
Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Sirolimus may
increase your risk of skin cancer. Use a sunscreen (minimum SPF 15) and wear protective clothing if
you must be out in the sun.
What should I avoid while taking sirolimus?
Grapefruit and grapefruit juice may interact with sirolimus and could lead to potentially
dangerous effects. Do not mix this medicine with grapefruit juice. Avoid eating grapefruit or drinking
grapefruit juice while you are taking sirolimus.
Avoid contact with people who have colds, the flu, or other contagious illnesses. Contact your
doctor immediately if you develop signs of infection.
Do not receive a vaccine while you are being treated with sirolimus. The vaccine may not
work as well during this time, and may not fully protect you from disease.
Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Sirolimus may
increase your risk of skin cancer. Use a sunscreen (minimum SPF 15) and wear protective clothing if
you must be out in the sun.
What other drugs will affect sirolimus?
Tell your doctor if you are using any of the following drugs:
-
amphotericin B (Fungizone, AmBisome, Amphotec, Abelcet);
-
bromocriptine (Parlodel);
-
cimetidine (Tagamet);
-
cisapride (Propulsid);
-
danazol (Danocrine);
-
metoclopramide (Reglan );
-
rifampin (Rifater, Rifadin, Rimactane), rifabutin
(Mycobutin), rifapentine (Priftin);
-
St. John's wort;
-
tacrolimus (Prograf);
-
an ACE inhibitor such as benazepril (Lotensin), captopril
(Capoten), fosinopril (Monopril), enalapril (Vasotec), lisinopril (Prinivil, Zestril), moexipril
(Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), or trandolapril (Mavik);
-
an antibiotic such clarithromycin (Biaxin), erythromycin
(E-Mycin, Ery-Tab, Erythrocin, E.E.S), telithromycin (Ketek), capreomycin (Capastat), or
troleandomycin (Tao);
-
an antifungal medication such as clotrimazole (Mycelex
Troche), fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), or
voriconazole (Vfend);
-
a calcium channel blocker such as diltiazem (Tiazac,
Cardizem), nicardipine (Cardene), or verapamil (Calan, Covera, Verelan);
-
HIV medicines such as indinavir (Crixivan) or ritonavir
(Norvir); or
-
seizure medicine such as carbamazepine (Tegretol),
phenytoin (Dilantin), phenobarbital (Luminal).
This list is not complete and there may be other drugs that can interact with
sirolimus. Tell your doctor about all the prescription and over-the-counter medications you use. This
includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using
a new medication without telling your doctor.
What happens if I have an overdose of sirolimus?
