Frequently asked questions about TRISENOX
If you are considering therapy with TRISENOX
® (arsenic trioxide)
injection, you may have the following questions:
- What is TRISENOX?
- Why has my physician recommended treatment with TRISENOX?
- Isn't TRISENOX a form of arsenic?
- What makes TRISENOX different than naturally occurring arsenic?
- How can TRISENOX help treat my cancer?
- What can I expect TRISENOX to do for me?
- How is TRISENOX given?
- What side effects are possible with the use of TRISENOX?
- Will my doctor and nurse monitor my treatment for any side effects?
- Will TRISENOX interfere with my other medications?
- What about vitamins, herbs, or natural remedies? Will TRISENOX interact
with them?
- Will I need someone to accompany me when I go for treatment?
- Is TRISENOX covered by my insurance?
Answers to Frequently Asked Questions about TRISENOX:
1. What is TRISENOX?
TRISENOX (TRI'-sen-ahks) is an anticancer drug that is effective against relapsed
or refractory acute promyelocytic leukemia (APL).
- TRISENOX is considered the standard of care and is indicated in patients with APL
who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy
- TRISENOX has been found to be safe and effective when used appropriately by doctors
and nurses experienced in the treatment of cancer1
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2. Why has my physician recommended treatment
with TRISENOX?
- In clinical trials, TRISENOX was found to be highly effective in the treatment of
relapsed or refractory APL
- Your doctor believes that TRISENOX can be helpful to you
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3. Isn't TRISENOX a form of arsenic?
- TRISENOX is a form of arsenic known as "arsenic trioxide"
- Arsenic is a naturally occurring substance that has been used in medicine for more
than 2,000 years
- The U.S. Food and Drug Administration (FDA) approved TRISENOX as a cancer medicine
because clinical trials conducted at cancer centers proved that it is safe and effective
in patients with relapsed or refractory APL
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4. What makes TRISENOX different than naturally
occurring arsenic?
- The arsenic trioxide in TRISENOX is manufactured under controlled conditions
- When used at the right dose and given in the right maner, TRISENOX is a safe and effective treatment for relapsed or refractory APL
- TRISENOX is given over time at a carefully measured rate
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5. How can TRISENOX help treat my cancer?
TRISENOX seems to work against cancer in different ways:
- TRISENOX can cause cancer cells to die
- TRISENOX can keep cancer cells from multiplying and growing
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6. What can I expect TRISENOX to do for me?
The goal of treatment with TRISENOX is to eliminate or reduce the number of cancer
cells in the body.
- Some patients treated with TRISENOX have no evidence of cancer cells after treatment,
indicating a complete response
- Other patients may have a reduction in the number of cancer cells or reduced symptoms
of cancer
- Some patients will have no response to this treatment
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7. How is TRISENOX given?
You will receive TRISENOX as an outpatient; your doctor or nurse will administer
it by infusion.
- Each TRISENOX treatment is usually infused over 1 to 2 hours
- If you experience certain side effects, the infusion may be slowed down
- If this occurs, the infusion can take as long as 4 hours to complete
- Your doctor or nurse will tell you how often and for how long you will receive TRISENOX
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8. What side effects are possible with the
use of TRISENOX?
Three potentially serious side effects have occurred in patients using TRISENOX,
although they rarely required therapy to be stopped:
APL differentiation syndrome: Symptoms include fever, sudden weight gain,
labored breathing, and accumulation of fluid in the lungs, heart, and chest. This
syndrome is managed by immediate treatment with high-dose corticosteroids and diuretics.
Hyperleukocytosis: An unusual increase in the number of white blood cells
(disease-fighting cells) in the blood. Your physician will continue to monitor you
should you develop this condition.
QT interval prolongation: An increase in the time it takes the heart to relax
between beats. If extreme, this prolongation has the potential to cause fainting
or more serious side effects.
Other serious adverse events that have been observed are atrial dysrhythmia and
hyperglycemia. In general, side effects associated with TRISENOX cease after treatment
is stopped, and toxicities are manageable if properly monitored and treated when
necessary. In addition to QT interval prolongation, the most common drug-related
side effects included leukocytosis, gastrointestinal events (nausea, vomiting, diarrhea,
and abdominal pain), fatigue, swelling, hyperglycemia (an abnormal increased content
of sugar in the blood), shortness of breath, cough, rash or itching, headaches,
and dizziness. Have your healthcare practitioner review the side effects for this
product.
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9. Will my doctor and nurse monitor my treatment
for any side effects?
Your team of nurses and physicians will be monitoring you during your treatment
with TRISENOX. In general, side effects associated with TRISENOX cease after treatment
is stopped. If they do occur, typically no interruption of therapy is needed. Side
effects are manageable if properly monitored and treated.
- You may be asked to weigh yourself every day during the first few weeks of TRISENOX
therapy and to report any increases in weight right away. You may also be asked
to report any fever, shortness of breath, or fainting
- Your medical team will perform tests called electrocardiograms (ECGs) during treatment
to monitor any changes in heart rhythm
- Your doctor will also check your blood frequently and may prescribe daily doses
of magnesium or potassium if your blood shows that you have low levels of electrolytes
Remember, your medical team will perform frequent laboratory tests to be certain
that TRISENOX can be continued safely, to look for side effects, and to monitor
the effects that cancer is having on your body.
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10. Will TRISENOX interfere with my other
medications?
- Studies of TRISENOX taken with other common medications have not been done, but
some information is available
- Tell your doctor all of the medications, both prescription and over-the-counter,
and any vitamins or herbal supplements you are taking
- Your doctor will monitor your condition very closely, especially if you are taking
any drugs that affect your heart
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11. What about vitamins, herbs, or natural
remedies? Will TRISENOX interact with them?
- Because very little information is available about the possible side effects and
interactions of natural remedies, such as Ginkgo Biloba or St. John's Wort, your
doctor may suggest you stop taking them during therapy
- Some herbs can affect electrolyte levels or cause diarrhea, and potentially increase
the chances of side effects with TRISENOX
- You may be able to continue to take your vitamins, but you should discuss this with
your doctor to be sure
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12. Will I need someone to accompany me when
I go for treatment?
- If you are being treated as an outpatient, you may be able to drive yourself to treatment
- If you have a particularly long drive, however, you might find you are tired after
treatment
- As a precaution, it is a good idea to let your family or friends know that you might
need their help to get to and from the treatment center
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13. Is TRISENOX covered by my insurance?
CORE (Cephalon Oncology Reimbursement Expertise) provides you and your physician
with personalized assistance with reimbursement issues. CORE reimbursement consultants
are available Monday through Friday, from 9:00 am to 8:00 pm Eastern Time to help
with:
- Benefit verification and coverage
- Policy benefits and limitations
- Pre-certifications
- Drug and services coding information
- Coverage guidelines and claim requirements of payors
- Support throughout the entire claims process
- Requested information needed to support claims submission
- Appeal support
For more information, visit
www.CephalonOncologyCORE.com
or contact the CORE Hotline toll-free at
1-888-587-3263.
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TRISENOX is indicated for induction of remission and consolidation in patients with APL who
are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose
APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression.
Serious adverse events, grade 3 or 4, were common. Those events attributable to TRISENOX in the Phase 2
study of 40 patients with refractory or relapsed APL included APL differentiation syndrome (n=3), hyperleukocytosis (n=3), QTc
interval prolongation (n=16), atrial dysrhythmias (n=2), hyperglycemia (n=2), and torsades de pointes (n=1).
In addition to QT interval prolongation, the most common drug-related side effects included leukocytosis, gastrointestinal events (nausea, vomiting, diarrhea, and abdominal pain), fatigue, swelling, hyperglycemia (an abnormal increased content of sugar in the blood), shortness of breath, cough, rash or itching, headache, and dizziness. Have your doctor review side effects with you.
In clinical trials, most patients taking TRISENOX experienced some drug-related toxicity, most commonly leukocytosis, gastrointestinal (nausea, vomiting, diarrhea, and abdominal pain), fatigue, edema, hyperglycemia, dyspnea, cough, rash or itching, headache, and dizziness. These adverse effects have not been observed to be permanent or irreversible, nor do they usually require interruption of therapy.
It is important to call your doctor if you experience any treatment side effects.
WARNING
Experienced Physician and Institution:
TRISENOX® (arsenic trioxide) injection should be administered under the supervision
of a physician who is experienced in the management of patients with acute leukemia.
APL Differentiation Syndrome:
Some patients with APL treated with TRISENOX have experienced symptoms similar to a syndrome called
the retinoic-acid-acute promyelocytic leukemia (RA-APL) or APL differentiation syndrome, characterized
by fever, dyspnea, weight gain, pulmonary infiltrates and pleural or pericardial effusions, with or
without leukocytosis. This syndrome can be fatal. The management of the syndrome has not been fully
studied, but high-dose steroids have been used at the first suspicion of the APL differentiation
syndrome and appear to mitigate signs and symptoms. At the first signs that could suggest the syndrome
(unexplained fever, dyspnea and/or weight gain, abnormal chest auscultatory findings or radiographic
abnormalities), high-dose steroids (dexamethasone 10 mg intravenously BID) should be immediately
initiated, irrespective of the leukocyte count, and continued for at least 3 days or longer until
signs and symptoms have abated. The majority of patients do not require termination of TRISENOX therapy
during treatment of the APL differentiation syndrome.
ECG Abnormalities:
Arsenic trioxide can cause QT interval prolongation and complete atrioventricular block. QT prolongation can
lead to a torsade de pointes-type ventricular arrhythmia, which can be fatal. The risk of torsade de pointes
is related to the extent of QT prolongation, concomitant administration of QT prolonging drugs, a history of
torsade de pointes, pre-existing QT interval prolongation, congestive heart failure, administration of
potassium-wasting diuretics, or other conditions that result in hypokalemia or hypomagnesemia. One patient
(also receiving amphotericin B) had torsade de pointes during induction therapy for relapsed APL with arsenic
trioxide.
ECG and Electrolyte Monitoring Recommendations:
Prior to initiating therapy with TRISENOX, a 12-lead ECG should be performed and serum electrolytes (potassium,
calcium, and magnesium) and creatinine should be assessed; pre-existing electrolyte abnormalities should be
corrected and, if possible, drugs that are known to prolong the QT interval should be discontinued. For QTc
greater than 500 msec, corrective measures should be completed and the QTc reassessed with serial ECGs prior
to considering using TRISENOX. During therapy with TRISENOX, potassium concentrations should be kept above 4 mEq/L
and magnesium concentrations should be kept above 1.8 mg/dL. Patients who reach an absolute QT interval value > 500
msec should be reassessed and immediate action should be taken to correct concomitant risk factors, if any, while
the risk/benefit of continuing versus suspending TRISENOX therapy should be considered. If syncope, rapid or irregular
heartbeat develops, the patient should be hospitalized for monitoring, serum electrolytes should be assessed, TRISENOX
therapy should be temporarily discontinued until the QTc interval regresses to below 460 msec, electrolyte abnormalities
are corrected, and the syncope and irregular heartbeat cease. There are no data on the effect of TRISENOX on the QTc
interval during the infusion.
1. TRISENOX® (arsenic trioxide) Injection [current approved prescribing information]. Frazer, PA: Cephalon, Inc.