We have provided web addresses of research and support organizations that you may
wish to visit. Through these organizations, you can connect with patients like yourself,
or find leukemia information that may be relevant to you.
American Cancer Society
The American Cancer Society is the nationwide community-based voluntary health organization
dedicated to eliminating cancer as a major health problem by preventing cancer,
saving lives, and diminishing suffering from cancer, through research, education,
advocacy, and service.
www.cancer.org
CancerCare
Cancer
Care is a national non-profit organization that provides free, professional
support services for anyone affected by cancer.
www.cancercare.org
ClinicalTrials.gov
ClinicalTrials.gov provides regularly updated information about federally and privately
supported clinical research in human volunteers. ClinicalTrials.gov gives you information
about a trial's purpose, who may participate, locations, and phone numbers for more
details.
www.clinicaltrials.gov
Leukemia Research Foundation
The mission of the Leukemia Research Foundation is to conquer leukemia, lymphoma,
and myelodysplastic syndromes by funding research into their causes and cures, and
to enrich the quality of life of those touched by these diseases.
www.leukemia-research.org
National Cancer Institute
The National Cancer Institute coordinates the National Cancer Program, which conducts
and supports research, training, health information dissemination, and other programs
with respect to the cause, diagnosis, prevention, and treatment of cancer, rehabilitation
from cancer, and the continuing care of cancer patients and the families of cancer
patients.
www.cancer.gov
People Living With Cancer
The American Society of Clinical Oncology (ASCO) produces the People Living With
Cancer website, providing oncologist-vetted cancer information to help patients
and families make informed healthcare decisions.
www.plwc.org
The Leukemia & Lymphoma Society
The Leukemia & Lymphoma Society is the world’s largest voluntary health organization
dedicated to funding blood cancer research, education, and patient services. The
Society’s mission: Cure leukemia, lymphoma, Hodgkin's disease, and myeloma, and
improve the quality of life of patients and their families.
www.leukemia-lymphoma.org
Cephalon Oncology provides these resources for information purposes only and is
not responsible for the information provided by the organizations listed. For medical
questions, please consult your physician.
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.