trisenox
arsenic trioxide · by cephalon
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Overview
11 DESCRIPTION TRISENOX is a sterile injectable solution of arsenic trioxide. The molecular formula of arsenic trioxide in the solid state is As 2 O 3 , with a molecular weight of 197.8 and the following structural formula: TRISENOX is available in 10 mL, single-dose vials containing 12 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 2 mg/mL. Inactive ingredients and their respective approximate concentrations are sodium hydroxide (1.2 mg/mL) for solubilization, and sodium hydroxide and hydrochloric acid for pH adjustment to pH 8. structural formula
How to use
Newly-diagnosed low-risk APL: Induction: Administer 0.15 mg/kg/day intravenously daily in combination with tretinoin until bone marrow remission. Do not exceed 60 days. ( 2.1 ) Consolidation: Administer 0.15 mg/kg/day intravenously daily for 5 days per week during weeks 1-4 of each 8-week cycle for a total of 4 cycles in combination with tretinoin. ( 2.1 ) Relapsed or refractory APL: Induction: Administer 0.15 mg/kg/day intravenously daily until bone marrow remission. Do not exceed 60 days. ( 2.2 ) Consolidation: Administer 0.15 mg/kg/day intravenously daily for 25 doses over a period of up to 5 weeks. ( 2.2 ) 2.1 Recommended Dosage for Newly-Diagnosed Low-Risk Acute Promyelocytic Leukemia (APL) A treatment course for patients with newly-diagnosed low-risk APL consists of 1 induction cycle and 4 consolidation cycles. For the induction cycle, the recommended dosage of TRISENOX is 0.15 mg/kg/day intravenously daily in combination with tretinoin until bone marrow remission but not to exceed 60 days (see Table 1). For the consolidation cycles, the recommended dosage of TRISENOX is 0.15 mg/kg/day intravenously daily 5 days per week during weeks 1-4 of each 8-week cycle for a total of 4 cycles in combination with tretinoin (see Table 1). Omit tretinoin during weeks 5-6 of the fourth cycle of consolidation. Table 1: Recommended Dosage of TRISENOX in Combination with Tretinoin…
Side effects
The following clinically significant adverse reactions are described elsewhere in the labeling: Differentiation Syndrome [see Warnings and Precautions ( 5.1 )] Cardiac Conduction Abnormalities [see Warnings and Precautions ( 5.2 )] Encephalopathy [see Warnings and Precautions ( 5.3 )] Hepatotoxicity [see Warnings and Precautions ( 5.4 )] Carcinogenesis [see Warnings and Precautions ( 5.5 )] The most common adverse reactions (> 30%) are nausea, cough, fatigue, pyrexia, headache, abdominal pain, vomiting, tachycardia, diarrhea, dyspnea, hypokalemia, leukocytosis, hyperglycemia, hypomagnesemia, insomnia, dermatitis, edema, QTc prolongation, rigors, sore throat, arthralgia, paresthesia, and pruritus ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals at 1-888-483-8279 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Newly-Diagnosed Low-Risk APL The safety of TRISENOX in combination with tretinoin was evaluated in Study APL0406, a randomized trial comparing TRISENOX plus tretinoin (n=129) versus chemotherapy plus tretinoin (n=137) in patients with newly-diagnosed…
Warnings
Important safety information
WARNING: DIFFERENTIATION SYNDROME, CARDIAC CONDUCTION ABNORMALITIES AND ENCEPHALOPATHY INCLUDING WERNICKE'S Differentiation Syndrome: Patients with acute promyelocytic leukemia (APL) treated with TRISENOX have experienced differentiation syndrome, which may be life-threatening or fatal. Signs and symptoms may include unexplained fever, dyspnea, hypoxia, acute respiratory distress, pulmonary infiltrates, pleural or pericardial effusions, weight gain, peripheral edema, hypotension, renal insufficiency, hepatopathy, and multi-organ dysfunction, in the presence or absence of leukocytosis. If differentiation syndrome is suspected, immediately initiate high-dose corticosteroids and hemodynamic monitoring until resolution. Temporarily withhold TRISENOX [see Dosage and Administration ( 2.3 ), Warnings and Precautions ( 5.1 )]. Cardiac Conduction Abnormalities: TRISENOX can cause QTc interval prolongation, complete atrioventricular block and torsade de pointes, which can be fatal. Before administering TRISENOX, assess the QTc interval, correct electrolyte abnormalities, and consider discontinuing drugs known to prolong QTc interval. Do not administer TRISENOX to patients with a ventricular arrhythmia or prolonged QTc interval. Withhold TRISENOX until resolution and resume at reduced dose for QTc prolongation [see Dosage and Administration ( 2.3 ), Warnings and Precautions ( 5.2 )].…
Interactions
Drugs That Can Prolong the QT/QTc Interval Concomitant use of these drugs and TRISENOX may increase the risk of serious QT/QTc interval prolongation [see Warnings and Precautions ( 5.1 )] . Discontinue or replace with an alternative drug that does not prolong the QT/QTc interval while the patient is using TRISENOX. Monitor ECGs more frequently in patients when it is not feasible to avoid concomitant use. Drugs That Can Lead to Electrolyte Abnormalities Electrolyte abnormalities increase the risk of serious QT/QTc interval prolongation [see Warnings and Precautions ( 5.1 )] . Avoid concomitant use of drugs that can lead to electrolyte abnormalities. Monitor electrolytes more frequently in patients who must receive concomitant use of these drugs and TRISENOX. Drugs That Can Lead to Hepatotoxicity Concomitant use of these drugs and TRISENOX, particularly when given in combination with tretinoin, may increase the risk of serious hepatotoxicity [see Warnings and Precautions ( 5.4 )] . Discontinue or replace with an alternative drug that does not cause hepatotoxicity while the patient is using TRISENOX. Monitor liver function tests more frequently in patients when it is not feasible to avoid concomitant use.
Drug class
- Acetylcholine Release Inhibitor
- Anti-coagulant
- Blood Coagulation Factor
- Calculi Dissolution Agent
- Catecholamine
- Central Nervous System Stimulant
- Cholinesterase Inhibitor
- Copper Absorption Inhibitor
- Copper-containing Intrauterine Device
- Corticosteroid
- Inactivated Clostridium Tetani Vaccine
- Inactivated Hepatitis A Virus Vaccine
- Inactivated Japanese Encephalitis Virus Vaccine
- Inactivated Poliovirus Vaccine
- Lipid Emulsion
- Live Attenuated Yellow Fever Virus Vaccine
- Methylxanthine
- Mood Stabilizer
- Neuromuscular Blocker
- Nitrate Vasodilator
- Nitrogen Binding Agent
- Non-Standardized Animal Dander Allergenic Extract
- Non-Standardized Animal Hair Allergenic Extract
- Non-Standardized Animal Skin Allergenic Extract
- Non-Standardized Feather Allergenic Extract
- Non-Standardized Food Allergenic Extract
- Non-Standardized Fungal Allergenic Extract
- Non-Standardized House Dust Allergenic Extract
- Non-Standardized Insect Allergenic Extract
- Non-Standardized Plant Allergenic Extract
- Non-Standardized Pollen Allergenic Extract
- Nonsteroidal Anti-inflammatory Drug
- Osmotic Laxative
- Paramagnetic Contrast Agent
- Penicillin-class Antibacterial
- Phosphate Binder
- Platelet Aggregation Inhibitor
- Potassium Salt
- Standardized Animal Hair Allergenic Extract
- Standardized Chemical Allergen
- Standardized Insect Venom Allergenic Extract
- Standardized Pollen Allergenic Extract
- Vitamin A
- Vitamin B6 Analog
- Vitamin C
- Vitamin D
- alpha-Adrenergic Agonist
- beta-Adrenergic Agonist
- l-Thyroxine
May treat
Dosage forms
INJECTABLE
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Frequently asked questions
- What is Trisenox?
- 11 DESCRIPTION TRISENOX is a sterile injectable solution of arsenic trioxide. The molecular formula of arsenic trioxide in the solid state is As 2 O 3 , with a molecular weight of 197.8 and the following structural formula: TRISENOX is available in 10 mL, single-dose vials containing 12 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 2 mg/mL. Inactive ingredients and their respective approximate concentrations are sodium hydroxide (1.2 mg/mL) for solubilization, and sodium hydroxide and hydrochloric acid for pH adjustment to pH 8. structural formula
- What does Trisenox treat?
- Trisenox (Arsenic Trioxide) is indicated for leukemia, promyelocytic, acute, per its drug-label indications. This is general reference, not medical advice.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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