|
Please
note: This article does not adequately emphasize that the different
formulations of cyclosporine are not equivalent in the dosage required to
maintain the same blood levels. Never substitute one variety
for a different medicine without the knowledge and guidance of your
physician. If
a pharmacy tries to substitute one version for different type of
cyclosporine, do not assume that the doctor ordered this. Neoral and Gengraf
are theoretically bioequivalent but many physicians prefer one specific drug to
the other. Make sure that you receive exactly what the doctor prescribed. |
Some commonly used brand names
are:
In the U.S.—
In
Canada—
Some
other commonly used names are ciclosporin and cyclosporin A .
Cyclosporine
(SYE-kloe-spor-een) belongs to the group of medicines known as
immunosuppressive agents. It is used to reduce the body's natural immunity in
patients who receive organ (for example, kidney, liver, 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. Cyclosporine works by preventing
the white blood cells from doing this.
Cyclosporine
also is used to treat severe cases of psoriasis and rheumatoid arthritis.
Cyclosporine
may also be used for other conditions, as determined by your doctor.
Cyclosporine
is a very strong medicine. It may cause side effects that could be very
serious, such as high blood pressure and kidney and liver 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.
Cyclosporine
is available only with your doctor's prescription, in the following dosage
forms:
Oral
Parenteral
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 cyclosporine, the following should be considered:
Allergies—Tell your doctor if you have ever had any
unusual or allergic reaction to cyclosporine.
Pregnancy—Studies have not been done in humans.
However, some women who received cyclosporine during pregnancy delivered their
babies prematurely, and some babies were smaller than average when they were
born. Additionally, some babies had birth defects. It is not certain that these
birth defects occurred because of the use of cyclosporine by the mothers.
Studies
in rats and rabbits have shown that cyclosporine at toxic doses (2 to 5 times
the human dose) causes birth defects or death of the fetus.
Breast-feeding—Cyclosporine passes into breast milk.
There is a chance that it could cause the same side effects in the baby that it
does in people taking it. It may be necessary for you to stop breast-feeding
during treatment. Be sure you have discussed the risks and benefits of the
medicine with your doctor.
Children—This medicine has been tested in children
and, in effective doses, has not been shown to cause different side effects or
problems than it does in adults.
Older
adults—Older people are
more likely to experience some side effects (e.g., high blood pressure and
kidney problems) than are younger adults.
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 cyclosporine, 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 cyclosporine. 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 not improve your condition.
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 cyclosporine 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. If this medicine upsets your stomach, your doctor may recommend
that you take it with meals. However, check with your doctor before you decide
to do this on your own.
Grapefruit
and grapefruit juice may increase the effects of cyclosporine 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 .
This
medicine is to be taken by mouth even if it comes in a dropper bottle. The
amount you should take is to be measured only with the specially marked dropper
provided with your prescription. The dropper should be wiped with a clean towel
after it is used, and stored in its container.
To
make Sandimmune[reg ] taste better, mix it in a glass container with
milk, chocolate milk, or orange juice (preferably at room temperature). To make
Neoral[reg ] taste better, mix it in a glass container with apple juice
or orange juice (preferably at room temperature). Do not use a wax-lined or
plastic disposable container. Stir it well, then drink it immediately. After
drinking all the liquid containing the medicine, rinse the glass with a little
more liquid and drink that also, to make sure you get all the medicine. Dry the
dropper used to measure the cyclosporine, but do not rinse it with water.
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 cyclosporine 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 cyclosporine. If your dose is different, do not change it
unless your doctor tells you to do so.
The
number of capsules or teaspoonfuls of oral solution that you take depends on
the strength of the medicine. 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 cyclosporine .
Missed
dose—If you miss a dose
of cyclosporine 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 cyclosporine is working properly and to check for
unwanted effects.
While
you are being treated with cyclosporine, and after you stop treatment with it, it
is important to see your doctor about the immunizations (vaccinations) you
should receive. Do not have any immunizations without your doctor's approval
. Cyclosporine lowers your body's resistance and there is a chance you might
get the infection the immunization is meant to prevent. However, it may be
especially important to receive certain immunizations to prevent a disease. In
addition, other persons living in your house should not take oral polio vaccine
since there is a chance they could pass the polio virus on to you. Also, avoid
persons who have recently taken 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.
In
some patients (usually younger patients), tenderness, swelling, or bleeding of
the gums may appear soon after treatment with cyclosporine is started. Brushing
and flossing your teeth, carefully and regularly, and massaging your gums may
help prevent this. See your dentist regularly to have your teeth cleaned.
Check with your medical doctor or dentist if you have any questions about how
to take care of your teeth and gums, or if you notice any tenderness, swelling,
or bleeding of your gums .
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 that cyclosporine 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. You and your doctor should discuss the good this medicine will do
as well as the risks of using it.
Check
with your doctor or nurse immediately
if any of the following side effects occur:
Rare
Blood in
urine; flushing of face and neck (for injection only); wheezing or shortness of
breath (for injection only)
Check with
your doctor as soon as possible if any of the following side effects occur:
More
common
Bleeding,
tender, or enlarged gums
Less
common
Convulsions
(seizures); fever or chills; frequent urge to urinate; vomiting
Rare
Confusion;
general feeling of discomfort and illness; irregular heartbeat; numbness or
tingling in hands, feet, or lips; shortness of breath or difficult breathing;
stomach pain (severe) with nausea and vomiting; unexplained nervousness;
unusual tiredness or weakness; weakness or heaviness of legs; weight loss
This
medicine may also cause the following side effects that your doctor will watch
for:
More
common
High blood
pressure; kidney problems
Less
common
Liver
problems; changes in blood chemistry
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
Increase in
hair growth; trembling and shaking of hands
Less
common
Acne or oily
skin; headache; leg cramps; nausea
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, cyclosporine is used in certain
patients with the following medical conditions:
For
patients receiving bone marrow transplantation, cyclosporine may work by
preventing the cells from the transplanted bone marrow from attacking the cells
of the patient's own body.
The
doses of cyclosporine for patients receiving bone marrow transplantation and
for patients with nephrotic syndrome are based on the patients' body weight.
The usual starting dose for patients receiving bone marrow transplantation is
12.5 milligrams (mg) per kilogram (kg) (5.7 mg per pound) of body weight a day.
The dose of cyclosporine for patients with nephrotic syndrome is 3.5 to 5 mg
per kg (1.6 to 2.3 mg per pound) of body weight a day.
The
side effects that patients experience when they receive cyclosporine for bone
marrow transplantation or nephrotic syndrome are similar to those side effects
experienced by patients receiving cyclosporine for organ transplantation.
Other
than the above information, there is no additional information relating to
proper use, precautions, or side effects for these uses.
Revised:
07/23/98
Interim revision: 10/20/98, 02/26/99
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.