Prograf / tacrolimus
Some commonly used brand names
are:
In the U.S.—
In
Canada—
Tacrolimus
(ta-KROE-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
organ (for example, kidney, liver, pancreas, lung, and heart) transplants.
When
a patient receives an organ transplant, the body's white blood cells will try to
get rid of (reject) the transplanted organ. Tacrolimus works by preventing the
white blood cells from getting rid of the transplanted organ.
Tacrolimus
may also be used for other indications, as determined by your doctor.
Tacrolimus
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.
Tacrolimus
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 tacrolimus, the following should be considered:
Allergies—Tell your health care professional if you
have ever had any unusual or allergic reaction to tacrolimus. Also, if you will
be receiving this medicine by injection, tell your health care professional if
you are allergic to any other substances, such as castor oil.
Pregnancy—Some women have become pregnant and had
babies while receiving tacrolimus after an organ transplantation. Some of the
newborn babies had temporary kidney problems after birth. Some babies were born
prematurely.
Breast-feeding—Tacrolimus passes into breast milk. There
is a chance that it causes the same side effects in the baby that it does in
the mother. It may be necessary for you to stop breast-feeding during
treatment.
Children—This medicine does not cause different
types of side effects or problems in children than it does in adults, although
some side effects may occur more or less often than they do in adult patients.
Older
adults—There is no
specific information comparing the use of tacrolimus in the elderly with the
use in other age groups. Tacrolimus is not expected to cause different side
effects or problems in older people than it does in younger adults. However,
older patients may need lower doses of tacrolimus.
Dental—The effects of tacrolimus may cause
increased infections and delayed healing. Dental work, whenever possible,
should be completed prior to beginning this medicine.
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 tacrolimus, 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 tacrolimus. Make sure
you tell your doctor if you have any other medical problems, especially:
Take
this medicine only as directed by your doctor . Do not take more or less of it and do not take it more
often than your doctor ordered. The exact amount of medicine you need has been
carefully worked out. Taking too much may increase the chance of side effects,
while taking too little may lead to rejection of your transplanted organ.
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 also help tacrolimus 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 discuss it with your health care
professional.
Do
not stop taking this medicine without first checking with your doctor . You may have to take medicine for the
rest of your life to prevent your body from rejecting the transplant.
Dosing—The dose of tacrolimus 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
tacrolimus. If your dose is different, do not change it unless your
doctor tells you to do so.
The
number of capsules that you take depends on the strength of the medicine in the
capsule and the dose prescribed by your doctor. Also, the number of doses
you take each day, the time allowed between doses, and the length of time you
take the medicine depend on the medical problem for which you are taking
tacrolimus .
Missed
dose—If you miss a dose
of tacrolimus 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 . Your doctor will want to do laboratory
tests to make sure that tacrolimus is working properly and to check for
unwanted effects.
While
you are taking tacrolimus, 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. Symptoms of this infection include sudden chills, fever, nausea,
vomiting, blood poisoning, and sometimes death. 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 previous stomach surgery and low stomach acid), and hemochromatosis
(an iron disorder). Do not eat raw oysters or other shellfish while you are
taking tacrolimus. Be sure oysters and shellfish are fully cooked .
While
you are being treated with tacrolimus, 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
. Tacrolimus lowers your body's resistance. For some immunizations, there is a
chance you might get the infection the immunization is meant to prevent. For
other immunizations, it may be especially important to receive the immunization
to prevent a disease. In addition, other persons living in your house should
not take oral poliovirus vaccine since there is a chance they could pass the
poliovirus on to you. Also, avoid persons who have recently taken oral
poliovirus 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 tacrolimus 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.
Tacrolimus
is not available in all countries. If you are traveling to another country,
be sure you will have a supply of your medicine .
Grapefruits
and grapefruit juice may increase the effects of tacrolimus by increasing the
amount of this medicine in the body. You should not eat grapefruit or drink
grapefruit juice while you are taking this medicine .
Along
with its needed effects, a medicine may cause some unwanted effects. Some side
effects will have signs or symptoms that you can see or feel. Your doctor will
watch for others by doing certain tests.
Also,
because of the way tacrolimus 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 lymphomas or skin
cancers.
Check
with your doctor or nurse immediately
if any of the following side effects occur:
More
common
Abdominal
pain; abnormal dreams; agitation; anxiety; chills; confusion; convulsions
(seizures); diarrhea; dizziness; fever and sore throat; flu-like symptoms;
frequent urination; hallucinations (seeing or hearing things that are not
there); headache; infection; itching; loss of appetite; loss of energy or
weakness; mental depression; muscle trembling or twitching; nausea;
nervousness; pale skin; shortness of breath; skin rash; swelling of feet or
lower legs; tingling; trembling and shaking of hands; trouble in sleeping;
unusual bleeding or bruising; unusual tiredness or weakness; vomiting
Less
common
Blurred
vision; chest pain; increased sensitivity to pain; muscle cramps; numbness or
pain in legs; ringing in ears; sweating
Rare
Flushing of
face or neck; general feeling of discomfort or illness; weight loss; wheezing
This
medicine may also cause the following side effects that your doctor will watch
for:
More
common
Hyperkalemia
(too much potassium in the blood); hypomagnesemia (not enough magnesium in the
blood); kidney problems
Less
common
Hyperlipidemia
(high cholesterol); hypertension (high blood pressure)
Other
side effects not listed above may also occur in some patients. If you notice
any other effects, check with your doctor.
Once
a medicine has been approved for marketing for a certain use, experience may
show that it is also useful for other medical problems. Although not
specifically included in the product labeling, tacrolimus is used in certain
patients with the following medical conditions:
For
patients receiving bone marrow transplantation, tacrolimus may work by
preventing the cells from the transplanted bone marrow from attacking the cells
of the patient. The dose of tacrolimus for patients receiving bone marrow
transplantation is based on body weight. The usual dose is 0.12 to 0.3 mg per
kg (0.05 to 0.14 mg per pound) of body weight a day for patients taking
tacrolimus by mouth, and 0.04 to 0.1 mg per kg (0.018 to 0.045 mg per pound) of
body weight a day for patients receiving tacrolimus by injection.
The
dose of tacrolimus for patients with severe, refractory uveitis is based on
body weight. For severe, refractory uveitis, the usual dose is 0.1 to 0.15 mg
per kg (0.045 to 0.068 mg per pound) of body weight a day.
Other
than the above information, there is no additional information relating to
proper use, precautions, or side effects for these uses.
Developed:
08/14/97
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
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