Rapamune
/ sirolimus
rapamycin
Some commonly used brand names
are:
In the U.S.—
Sirolimus
(( sir-OH-li-mus)) belongs to a group of medicines known as immunosuppressive
agents. It is used to lower the body's natural immunity in patients who receive
kidney transplants.
When
a patient receives an organ transplant, the body's white blood cells will try
to get rid of (reject) the transplanted organ. Sirolimus works by preventing
the white blood cells from getting rid of the transplanted organ.
Sirolimus
is a very strong medicine. It can cause side effects that can be very serious,
such as kidney problems. It may also reduce the body's ability to fight infections.
You and your doctor should talk about the good this medicine will do as well as
the risks of using it.
Sirolimus
is available only with your doctor's prescription, in the following dosage
forms:
In
deciding to use a medicine, the risks of taking the medicine must be weighed
against the good it will do. This is a decision you and your doctor will make.
For sirolimus, the following should be considered:
Allergies— Tell your doctor if you have ever had
any unusual or allergic reaction to sirolimus. Also tell your health care
professional if you are allergic to any other substances, such as foods,
preservatives, or dyes.
Pregnancy— Sirolimus has not been studied in
pregnant women. However, studies in animals have shown that sirolimus causes
problems in the fetus. It is very important that an effective form of birth
control be used before starting sirolimus therapy, during sirolimus therapy,
and for 12 weeks after sirolimus therapy has stopped.
Breast-feeding—It is not known whether sirolimus passes
into human breast milk. However, because this medicine may cause serious side
effects, breast-feeding may not be recommended while you are receiving it.
Discuss with your doctor whether or not you should breast-feed while you are
receiving sirolimus.
Other
medicines—Although
certain medicines should not be used together at all, in other cases two
different medicines may be used together even if an interaction might occur. In
these cases, your doctor may want to change the dose, or other precautions may
be necessary. When you are taking sirolimus, it is especially important that
your health care professional knows if you are taking any of the following:
Other
medical problems—The
presence of other medical problems may affect the use of sirolimus. Make sure
you tell your doctor if you have any other medical problems, especially:
This
medicine usually comes with patient information or directions. Read them
carefully and make sure you understand them before taking this medicine. If you have any questions, ask your
health care professional.
Take
this medicine only as directed by your doctor. Do not use more or less of it, and do
not use it more often than your doctor ordered. The exact amount of medicine
you need has been carefully worked out. Using too much will increase the risk
of side effects, while using too little may lead to rejection of your
transplanted kidney.
To
help you remember to take your medicine, try to get into the habit of taking it
at the same time each day. This will help sirolimus work better by keeping a
constant amount in the blood.
Absorption
of this medicine may be changed if you change your diet. This medicine should
be taken consistently with respect to meals. You should not change the type or
amount of food you eat unless you discus it with your health care professional.
Do
not stop taking this medicine without first checking with your doctor. You may have to take this medicine for
the rest of your life to prevent your body from rejecting the transplant.
Sirolimus
usually is used along with a corticosteroid (cortisone-like medicine) and
cyclosporine (another immunosuppressive agent). Sirolimus should be taken 4
hours after cyclosporine modified oral solution (Neoral , SangCya
) or cyclosporine modified capsules (Neoral ). If you have any questions
about this, ask your health care professional.
Mix
sirolimus oral solution with at least 2 ounces (1/4 cup, 60 milliliters [mL])
of water or orange juice in a glass or plastic container. Stir the mixture well
and drink it immediately. Then, rinse the container with at least 4 ounces (1/2
cup, 120 mL) of additional water or orange juice, stir it well, and drink it to
make sure that all of the medicine is taken.
Dosing—The dose of sirolimus will be different
for different patients. Follow your doctor's orders or the directions on the
label. The following information includes only the average doses of
sirolimus. If your dose is different, do not change it unless your doctor
tells you to do so. If you have any questions about the proper dose of
sirolimus, ask your doctor.
Missed
dose—If you miss a dose
of sirolimus and remember it within 12 hours, take the missed dose as soon as
you remember. However, if it is almost time for the next dose, skip the missed
dose, go back to your regular dosing schedule, and check with your doctor. Do
not double doses.
Storage—To store this medicine:
It
is very important that your doctor check your progress at regular visits to make sure that this medicine is
working properly and to check for unwanted effects.
While
you are taking sirolimus, it is important to maintain good dental hygiene and
see a dentist regularly for teeth cleaning.
Raw
oysters or other shellfish may contain bacteria that can cause serious illness
and possibly death. This is more likely to be a problem if these foods are
eaten by patients with certain medical conditions. Even eating oysters from “clean” water
or good restaurants does not guarantee that the oysters do not contain the
bacteria. Eating raw shellfish is not a problem for most healthy people;
however, patients with the following conditions may be at greater risk: cancer,
immune disorders, organ transplantation, long-term corticosteroid use (as for
asthma, arthritis, or organ transplantation), liver disease (including viral
hepatitis), excess alcohol intake (2 to 3 drinks or more per day), diabetes,
stomach problems (including stomach surgery and low stomach acid), and
hemochromatosis (an iron disorder). Do not eat raw oysters or other
shellfish while you are taking sirolimus. Be sure oysters and shellfish are
fully cooked.
While
you are being treated with sirolimus, and after you stop treatment with it, it
is important to see your doctor about the immunizations (vaccinations) you
should receive. Do not get any immunizations without your doctor's approval.
Sirolimus may lower your body's resistance and there is a chance you might get
the infection the immunization is meant to prevent. In addition, other persons
living in your household should not take or have recently taken oral polio
vaccine since there is a chance they could pass the polio virus on to you.
Also, avoid other persons who have taken the oral polio vaccine. Do not get
close to them, and do not stay in the same room with them for very long. If you
cannot take these precautions, you should consider wearing a protective face
mask that covers the nose and mouth.
Treatment
with sirolimus may also increase the chance of getting other infections. If you
can, avoid people with colds or other infections. If you think you are getting
a cold or other infection, check with your doctor.
Grapefruits
and grapefruit juice may increase the effects of sirolimus by increasing the
amount of this medicine in your body. You should not eat grapefruit or drink
grapefruit juice while you taking this medicine.
Along
with its needed effects, a medicine may cause some unwanted effects. Although
not all of these side effects may occur, if they do occur they may need medical
attention.
Also,
because of the way sirolimus acts on the body, there is a chance that it may
cause effects that may not occur until years after the medicine is used. These
delayed effects may include certain types of cancer, such as lymphoma.
Check
with your doctor or nurse immediately
if any of the following side effects occur:
More
common
Chest pain
black,
tarry stools; general feeling of illness; shortness of breath; swollen glands;
weight loss, unusual; yellow skin and eyes
Check with
your doctor as soon as possible if any of the following side effects occur:
More
common
Abdominal
pain; anxiousness, unexplained; bloody or cloudy urine; bone pain; chills;
confusion; convulsions (seizures); cough; decreased urge to urinate; fast,
slow, or irregular heartbeat; fever; frequent urge to urinate; increased
thirst; loss of appetite; lower back or side pain; mood changes; muscle pain or
cramps; nausea or vomiting; numbness or tingling around lips, hands, or feet;
painful or difficult urination; rash; sore throat; sores or white spots on lips
or in mouth; swelling of hands, ankles, feet, or lower legs; swollen glands;
trouble breathing; unusual bleeding or bruising; unusual tiredness or weakness;
weakness or heaviness of legs
Less
common
Skin ulcer or sores
Rare
Weight gain, unusual
Other side
effects may occur that usually do not need medical attention. These side
effects may go away during treatment as your body adjusts to the medicine.
However, check with your doctor if any of the following side effects continue
or are bothersome:
More
common
Acne;
constipation; diarrhea; difficulty in moving; headache; loss of energy or
weakness; muscle pain or stiffness; pain; shaking or trembling; trouble in
sleeping
Less
common
Nosebleed;
swelling of the face
Other side
effects not listed above may also occur in some patients. If you notice any
other effects, check with your doctor.
Developed:
04/20/00
Revised: 03/21/01
Note: The information
contained herein has been devised without reference to cultural, dietary,
societal, language, prescribing or dispensing conditions (including those
imposed by law), other than those of the United States, which might affect the
information provided. Information is for your personal use only and may not be
sold or redistributed.
Copyright
® 2001 Micromedex, Inc. All rights reserved. USPDI® and Advice for the Patient?
are registered trademarks USP used under license to Micromedex, Inc. Patient
Education Leaflets is a trademark of Micromedex, Inc.