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Trisenox Drug Description
Trisenox
(arsenic trioxide) Injection
For Intravenous Use Only
10 mg/10 mL (1 mg/mL) Ampule

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, preexisting 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; preexisting 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.

DRUG DESCRIPTION



What are the possible side effects of arsenic trioxide (Trisenox)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:

sharp chest pain, wheezing, rapid breathing, feeling short of breath;
dry cough, feeling weak, tired, or ill;
fever, chills, swelling in your ankles or feet, weight gain;
dizziness, fainting, fast or pounding heartbeat;
...
Read All Potential Side Effects for Trisenox »




TRISENOX is a sterile injectable solution of arsenic trioxide. The molecular formula of the drug substance in the solid state is AsiOs, with a molecular weight of 197.8 g.
TRISENOX is available in 10 mL, single-use ampules containing 10 mg of arsenic trioxide. TRISENOX is formulated as a sterile, nonpyrogenic, clear solution of arsenic trioxide in water for injection using sodium hydroxide and dilute hydrochloric acid to adjust to pH 8. TRISENOX is preservative-free. Arsenic trioxide, the active ingredient, is present at a concentration of 1.0 mg/mL. Inactive ingredients and their respective approximate concentrations are sodium hydroxide (1.2 mg/mL) and hydrochloric acid, which is used to adjust the pH to 7.5 - 8.5.
Last reviewed on RxList: 8/13/2010




Trisenox Drug Description
Trisenox
(arsenic trioxide) Injection
For Intravenous Use Only
10 mg/10 mL (1 mg/mL) Ampule

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, preexisting 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; preexisting 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.

DRUG DESCRIPTION



What are the possible side effects of arsenic trioxide (Trisenox)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:

sharp chest pain, wheezing, rapid breathing, feeling short of breath;
dry cough, feeling weak, tired, or ill;
fever, chills, swelling in your ankles or feet, weight gain;
dizziness, fainting, fast or pounding heartbeat;
...
Read All Potential Side Effects for Trisenox »




TRISENOX is a sterile injectable solution of arsenic trioxide. The molecular formula of the drug substance in the solid state is AsiOs, with a molecular weight of 197.8 g.
TRISENOX is available in 10 mL, single-use ampules containing 10 mg of arsenic trioxide. TRISENOX is formulated as a sterile, nonpyrogenic, clear solution of arsenic trioxide in water for injection using sodium hydroxide and dilute hydrochloric acid to adjust to pH 8. TRISENOX is preservative-free. Arsenic trioxide, the active ingredient, is present at a concentration of 1.0 mg/mL. Inactive ingredients and their respective approximate concentrations are sodium hydroxide (1.2 mg/mL) and hydrochloric acid, which is used to adjust the pH to 7.5 - 8.5.
Last reviewed on RxList: 8/13/2010




Trisenox Drug Description
Trisenox
(arsenic trioxide) Injection
For Intravenous Use Only
10 mg/10 mL (1 mg/mL) Ampule

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, preexisting 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; preexisting 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.

DRUG DESCRIPTION



What are the possible side effects of arsenic trioxide (Trisenox)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:

sharp chest pain, wheezing, rapid breathing, feeling short of breath;
dry cough, feeling weak, tired, or ill;
fever, chills, swelling in your ankles or feet, weight gain;
dizziness, fainting, fast or pounding heartbeat;
...
Read All Potential Side Effects for Trisenox »




TRISENOX is a sterile injectable solution of arsenic trioxide. The molecular formula of the drug substance in the solid state is AsiOs, with a molecular weight of 197.8 g.
TRISENOX is available in 10 mL, single-use ampules containing 10 mg of arsenic trioxide. TRISENOX is formulated as a sterile, nonpyrogenic, clear solution of arsenic trioxide in water for injection using sodium hydroxide and dilute hydrochloric acid to adjust to pH 8. TRISENOX is preservative-free. Arsenic trioxide, the active ingredient, is present at a concentration of 1.0 mg/mL. Inactive ingredients and their respective approximate concentrations are sodium hydroxide (1.2 mg/mL) and hydrochloric acid, which is used to adjust the pH to 7.5 - 8.5.
Last reviewed on RxList: 8/13/2010




Trisenox Drug Description
Trisenox
(arsenic trioxide) Injection
For Intravenous Use Only
10 mg/10 mL (1 mg/mL) Ampule

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, preexisting 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; preexisting 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.

DRUG DESCRIPTION



What are the possible side effects of arsenic trioxide (Trisenox)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:

sharp chest pain, wheezing, rapid breathing, feeling short of breath;
dry cough, feeling weak, tired, or ill;
fever, chills, swelling in your ankles or feet, weight gain;
dizziness, fainting, fast or pounding heartbeat;
...
Read All Potential Side Effects for Trisenox »




TRISENOX is a sterile injectable solution of arsenic trioxide. The molecular formula of the drug substance in the solid state is AsiOs, with a molecular weight of 197.8 g.
TRISENOX is available in 10 mL, single-use ampules containing 10 mg of arsenic trioxide. TRISENOX is formulated as a sterile, nonpyrogenic, clear solution of arsenic trioxide in water for injection using sodium hydroxide and dilute hydrochloric acid to adjust to pH 8. TRISENOX is preservative-free. Arsenic trioxide, the active ingredient, is present at a concentration of 1.0 mg/mL. Inactive ingredients and their respective approximate concentrations are sodium hydroxide (1.2 mg/mL) and hydrochloric acid, which is used to adjust the pH to 7.5 - 8.5.
Last reviewed on RxList: 8/13/2010




Trisenox Drug Description
Trisenox
(arsenic trioxide) Injection
For Intravenous Use Only
10 mg/10 mL (1 mg/mL) Ampule

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, preexisting 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; preexisting 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.

DRUG DESCRIPTION



What are the possible side effects of arsenic trioxide (Trisenox)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:

sharp chest pain, wheezing, rapid breathing, feeling short of breath;
dry cough, feeling weak, tired, or ill;
fever, chills, swelling in your ankles or feet, weight gain;
dizziness, fainting, fast or pounding heartbeat;
...
Read All Potential Side Effects for Trisenox »




TRISENOX is a sterile injectable solution of arsenic trioxide. The molecular formula of the drug substance in the solid state is AsiOs, with a molecular weight of 197.8 g.
TRISENOX is available in 10 mL, single-use ampules containing 10 mg of arsenic trioxide. TRISENOX is formulated as a sterile, nonpyrogenic, clear solution of arsenic trioxide in water for injection using sodium hydroxide and dilute hydrochloric acid to adjust to pH 8. TRISENOX is preservative-free. Arsenic trioxide, the active ingredient, is present at a concentration of 1.0 mg/mL. Inactive ingredients and their respective approximate concentrations are sodium hydroxide (1.2 mg/mL) and hydrochloric acid, which is used to adjust the pH to 7.5 - 8.5.
Last reviewed on RxList: 8/13/2010





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Get reimbursement assistance and support with CORE: Cephalon Oncology Reimbursement Expertise TRISENOX, an acute promyelocytic leukemia treatment


Learn about the prescription medication Trisenox (Arsenic Trioxide Injection), drug uses, dosage, side effects, drug interactions, warnings, reviews and patient labeling. Trisenox (Arsenic Trioxide Injection) Drug Information: Uses, Side ...


All about Trisenox. View complete and up to date Trisenox information - part of the Drugs.com trusted medication database. Trisenox Facts and Comparisons at Drugs.com


Accurate, FDA approved Trisenox information for healthcare professionals and patients - brought to you by Drugs.com. Trisenox Official FDA information, side effects and uses.


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