Q ue s tions & A ns w e r s
about your treatment with
TRISENOX® (arsenic trioxide) injection
1
Why has my physician recommended
treatment with TRISENOX® ?
TRISENOX® (Try'-sen-ocks) is an anti-cancer
drug that is effective against certain
cancers of the blood. Research has proven
that TRISENOX® may benefit patients with
certain cancers, and your doctor believes
that TRISENOX® can be helpful to you.
2
Isn't TRISENOX® arsenic? How can arsenic
help my cancer?
Yes, TRISENOX® is a form of arsenic known
as "arsenic trioxide." It is prepared with
the highest quality standards and has been
Q ue s tions & A ns w e r s
found to be safe and effective when
about your treatment with
®
used appropriately by doctors and nurses
TRISENOX (arsenic trioxide) injection
experienced in the treatment of cancer.
Like other cancer medicines, arsenic kills
cancer cells, and the federal government
approved TRISENOX® as a cancer medicine
because clinical trials conducted at cancer
centers proved that it is safe and effective
when used correctly.
Please see accompanying
Although some people may automatically
full prescribing information.
think of arsenic as a toxic chemical, it is
actually a naturally occurring substance that
has been used in medicine for over 2,000
years. For example, arsenic was used to
fight the plague in the middle ages, and it
was one of the first drugs used to treat a
certain type of leukemia back in the 1800's.
Doctors in Asia have used arsenic
for hundreds of years for many different
medical problems.
Q U E S T I O N S & A N S W E R S
As with all medicines, the dose of arsenic
4
How dose TRISENOX® work?
is important. Many cancer drugs would
How TRISENOX® works is not completely
be hazardous if used in the wrong amounts
understood, but it appears to cause cancer
or in the wrong way, and arsenic is no
®
cells to self-destruct. This process is called
different. The dose of arsenic in TRISENOX
"programmed cell death" or apoptosis,
is very small, and it is given over time
a natural mechanism of self-destruction.
at a carefully measured rate. When used at
TRISENOX® also may prevent cancer cells
the right dose and given in the right way,
®
from multiplying and may keep cancer
TRISENOX is a safe and effective cancer
cells from being supplied with important
treatment.
nutrients that feed their growth.
3
What can I expect TRISENOX® to do for me?
5
How will my treatment with TRISENOX®
In general, the goal of treatment with
occur?
TRISENOX® is to eliminate or reduce
Each TRISENOX® treatment is given
the number of cancer cells in the body.
directly into a vein (infusion), usually over
Some patients treated with TRISENOX®
1-2 hours. If you experience certain side
have no evidence of cancer cells after
effects (described below), the infusion may
treatment, indicating a complete response.
be slowed down, and it may take as long
Other patients may have a reduction in
as 4 hours to complete the infusion.
the number of cancer cells, or reduced
symptoms of their cancer. Some patients
Your doctor or nurse will describe how
will have no response to this treatment.
often and for how long you will receive
TRISENOX.® In many cases, TRISENOX® works
While TRISENOX® has been effective
gradually, so it may take several weeks
in many patients in clinical trials, no one
before your doctor can tell if TRISENOX® is
can predict how you will respond to
helping you.
treatment. Your doctor can give you more
information about the likelihood that
If your cancer responds to the initial
TRISENOX® will be beneficial to you based
treatment with TRISENOX®, you may receive
on your individual situation. Your doctor
additional doses to maintain that response.
can also tell you what tests will be done to
Your doctor will determine what schedule of
determine if TRISENOX® is working for you.
treatment is right for you.
Q U E S T I O N S & A N S W E R S
6
What possible side effects should I be
these symptoms. You will be asked to weigh
aware of ? How will my medical team watch
yourself every day during the first few
for side effects and prevent them from
weeks of TRISENOX® therapy, and to report
becoming serious?
any increases in weight right away.
In general, side effects with TRISENOX®
You might experience changes in your heart
stop when you stop treatment. Your doctor
rhythm. In particular, some patients
or nurse will carefully monitor your
experience QT interval prolongation, which
condition during your treatments. This will
means that the time it takes the heart to
allow them to manage any side effect you
relax in between beats is longer than usual.
might experience. The three most common
If extreme, QT prolongation can cause
potentially serious side effects that have
fainting or other more serious effects. Your
been reported are described below:
medical team will perform tests called
electrocardiograms (ECGs) during treatment
Your body may begin to make more white
to monitor any changes in heart rhythm.
blood cells (the cells that fight infection)
Your doctor will also check your blood
than usual in the first few weeks after you
frequently and may prescribe daily doses of
start TRISENOX® therapy. This is called
magnesium or potassium if your blood
hyperleukocytosis. It does not generally
shows that you have low levels of these
cause any significant problems, and it does
electrolytes. Maintaining the right levels of
not require the treatment to be stopped
these important electrolytes helps prevent
or interrupted. Your doctor will monitor
changes in heart rhythm. You may have
your blood counts for hyperleukocytosis
to stop TRISENOX® therapy for a short time
during therapy.
if your blood levels of magnesium or
potassium are too low or if you develop
You might experience symptoms related
QT prolongation.
to changes in the development of your
blood cells, called differentiation syndrome.
In general, side effects associated with
These symptoms include fever, sudden
TRISENOX® cease after treatment is
weight gain, and bone or joint pain. Also,
stopped, and toxicities are manageable if
fluid can build up around the heart, or
properly monitored and treated when
in the lungs, and chest, causing shortness
necessary. In addition to QT interval prolon-
of breath or difficulty breathing. This
gation, the most common drug-related
syndrome is treated immediately with high
side effects in the U.S. clinical studies of
doses of corticosteroids and diuretics
arsenic trioxide in patients with relapsed
(fluid pills). Your medical team will monitor
acute promyelocytic leukemia (APL)
for these signs or symptoms, but it is also
included leukocytosis, gastrointestinal
important for you to tell your doctor or
(nausea, vomiting, diarrhea and abdominal
nurse promptly if you experience any of
pain), fatique, swelling, hyperglycemia
Q U E S T I O N S & A N S W E R S
(an abnormal increased content of sugar in
store can be used if you have diarrhea.
the blood), shortness of breath, cough,
You should drink plenty of fluids if you do
rash or itching, headaches, and dizziness.
develop diarrhea. Tell your doctor or nurse
if you develop diarrhea, since he or she
Remember, your medical team will
may want to take a culture just to make
perform frequent laboratory tests to be
sure there is no infection.
certain that TRISENOX® can be continued
safely, to look for side effects, and to
You may develop a rash during TRISENOX®
monitor the effects that cancer is having
treatment. Rashes can develop anywhere
on your body.
on the body, but most frequently occur on
the back, chest, or abdomen. Rashes are
®
usually not severe, although they may itch.
7
Will TRISENOX treatment have any serious
You should tell your doctor if you develop a
impact on my daily life?
rash, and if the rash is itchy or bothersome,
TRISENOX® may be less likely to have an
your doctor may prescribe a topical
impact on your daily life than other cancer
medication for you to put on your skin.
medications you may have taken in the
Rashes may get better on their own during
past. For example, few patients receiving
treatment, but if not, they will disappear
TRISENOX® have had hair loss or pain and
after all the courses of TRISENOX® are
inflammation of mucus membranes, such
complete. It is a good idea to avoid oil-
as mouth sores.
based or perfumed skin products that can
irritate the skin during treatment. Water-
You may have some mild nausea, stomach
based soaps and lotions are a better choice
upset, or, less commonly, vomiting,
to prevent skin irritation, and if a rash
during or shortly after administration of
does occur, these products make it less
TRISENOX.® These side effects are usually
likely that a skin infection will develop.
not severe enough to require treatment
with anti-nausea drugs. Of course, anti-
nausea drugs can be used if you need them.
8
Will TRISENOX® interfere with other
To reduce the chance of developing nausea
medications that I am taking?
or an upset stomach, it is a good idea to
Studies of TRISENOX® in combination with
have something to eat before going to the
other medications have not been done, but
clinic for treatment with TRISENOX.®
some information is available. You should
Antacids can also provide some relief from
tell your doctor all of the medications
stomach discomfort.
you are taking, both prescription and over-
You may develop diarrhea while receiving
the-counter, and including any vitamins or
courses of TRISENOX.® Ask your doctor
herbal supplements. Your doctor will
whether over-the-counter (OTC) medicines
monitor your condition very closely, espe-
that you can buy in the drugstore or grocery
cially if you are taking any drugs that affect
G L O S S A R Y
Q U E S T I O N S & A N S W E R S
Apoptosis (a-pop-toe´ -sis)
your heart. For example, some anti-nausea
The self-destruction, or suicide, of cancer
drugs, antidepressants, and antibiotics can
cells. Apoptosis is one of the likely mechanisms
cause QT interval prolongation, the same
for how TRISENOX® works.
heart rhythm change that can happen with
TRISENOX.®
Corticosteroids (kor-ti-koe-stair´ -oyds)
Also called "steroids," corticosteroids are
9
What about vitamins, herbs, or
powerful anti-inflammatory agents
natural remedies? Will TRISENOX®
used to treat many diseases and conditions.
interact with them?
They are similar to a protein called cortisol
Because very little information is available
that is made in the adrenal glands. Some
about the possible side effects and
corticosteroids that you may have heard of
interactions of natural remedies, such as
are prednisone and dexamethasone.
Ginkgo Biloba or St. John's Wort, your
doctor may suggest you stop taking them
Differentiation Syndrome (diff-er-en-
during therapy. For example, some
sheeay´ -shun sin´ -drome) A group of related
herbs can affect electrolyte levels or cause
symptoms that can occur during treatment
diarrhea, and potentially increase the
with TRISENOX® because of changes in the
chances of side effects with TRISENOX.®
development and death of blood cells.
Symptoms of differentiation syndrome include
You may be able to continue to take your
fever, weight gain, joint or muscle aches, and
vitamins, but you should discuss this with
difficulty breathing. This syndrome is treated
your doctor to be sure.
with corticosteroids.
Diuretics (dye-´ yur-et-iks) Medications
1 0
Will I need someone to accompany me
that reduce the amount of fluid, or water, in
when I go for treatment?
the body.
If you are being treated as an outpatient,
you can drive yourself to treatment.
Electrocardiogram (ee-lek´ -troe-kardeeo
If you have a particularly long drive, however,
gram) Also called an ECG, is a non-invasive test
you might find that you are tired after
to evaluate heart rhythms. Electrodes are
treatment. As a precaution, it is a good idea
placed on the body, and an electrical reading
to let your family or friends know that
of the heart's contractions is produced.
you might need their help to get to and
From this reading, doctors can tell if there are
from the treatment center.
any abnormal changes in the heart's rhythm.
G L O S S A R Y
N O T E S
Electrolytes (ee-lek´ -troe-lites)
Questions to ask my doctor:
Chemical nutrients that help the body function.
Some of the electrolytes needed to help the
heart work properly include sodium, potassium,
and magnesium. Doctors can measure the
amount of electrolytes in the blood to
determine if supplements are needed during
TRISENOX® treatment.
Hyperleukocytosis (high-per-loo´ -ko-sy-toe-
sis) An increase in the white blood cell count
to above-normal levels. Some patients receiving
TRISENOX® develop hyperleukocytosis.
QT Interval Prolongation A change in the
heart's rhythm that is characterized by an
increase in the time it takes the heart to relax
in between beats.
N O T E S
P A T I E N T R E S O U R C E S
American Cancer Society
www.cancer.org
1-800-ACS-2345
Aplastic Anemia and International
MDS Foundation
www.aplastic.org/contacts.html
1-800-747-2820
International Myeloma Foundation
14 www.myeloma.org
1-800-452-CURE (2873) in the U.S. and Canada;
elsewhere please call 1-818-487-7455
The Leukemia and Lymphoma Society
www.leukemia-lymphoma.org
1-800-955-4572
Lymphoma Research Foundation
www.lymphoma.org
1-800-500-9976
Multiple Myeloma Research Foundation
www.multiplemyeloma.org
203-972-1250
The Myelodysplastic Syndromes Foundation
www.mds-foundation.org
U.S. and Canada: 1-800-MDS-0839
Outside the U.S. only: 609-298-6746
National Organization for Rare Disorders
www.rarediseases.org
203-744-0100
1-800-999-6673 (voicemail only)
This booklet has been
prepared by
Cell Therapeutics, Inc. (CTI),
a company committed to
developing oncology products
aimed at making cancer
more treatable. For more
information about TRISENOX,®
visit our website:
w w w . c tic s e a ttle . c om
Cell Therapeutics, Inc. 501Elliott Ave., West Suite 400 Seattle, WA 98119
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