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ARSENIC TRIOXIDE FOR is a brand name for Arsenic Trioxide, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Arsenic Trioxide for Injection (arsenic trioxide) is indicated for: • induction of remission and consolidation in patients with acute promyelocytic leukemia (APL), which is refractory to or has relapsed from retinoid and anthracycline therapy, and whose APL is characterized by the presence of the t(15;17)…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Arsenic Trioxide for Injection should be administered under the supervision of a physician who is experienced in the management of patients with acute leukemia. The special monitoring procedures described in 7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests should be followed.
Pre-existing electrolyte abnormalities should be corrected prior to initiating therapy with Arsenic Trioxide for Injection. Arsenic Trioxide for Injection should not be administered to patients with baseline QT/QTc interval greater than 500 msec unless corrective measures are completed and the QT/QTc interval is reassessed with serial ECGs.
Dosing of obese patients based on total body weight may result in higher than expected plasma and tissue concentration of arsenical species. Obese patients should be closely monitored for signs of serious acute arsenic toxicity. Total number of Arsenic Trioxide for Injection doses should not exceed the maximum number of doses recommended for the induction and consolidation treatments.
15 mg/kg daily until bone marrow remission. It should be stopped at any time if substantial toxicity occurs. Total induction dose should not exceed 60 doses. • Consolidation Treatment Schedule: Consolidation treatment should begin 3 to 6 weeks after completion of induction therapy.
15 mg/kg daily for 25 doses over a period up to 5 weeks. Obese pediatric patients should be dosed based on ideal body weight. _____________________________________________________________________________________ Arsenic Trioxide for Injection Product Monograph Page 7 of 50 Patients who reach an absolute QT/QTc interval value > 500 msec while on Arsenic Trioxide for Injection therapy should be reassessed and immediate action should be taken to correct concomitant risk factors.
Interruption of Arsenic Trioxide for Injection therapy should be considered. 8 mg/dL. If syncope, rapid or irregular heartbeat develops, the patient should be hospitalized for monitoring and serum electrolytes should be assessed, Arsenic Trioxide for Injection therapy should be interrupted until the QTc interval regresses to below 460 msec, electrolyte abnormalities are corrected, and the syncope and irregular heartbeat cease.
9% Sodium Chloride Injection, USP, using proper aseptic technique, immediately after withdrawal from the vial. The Arsenic Trioxide for Injection vial is single-use and does not contain any preservatives. Unused portions of each vial should be discarded properly.
). Tumor Lysis Syndrome One case of tumor lysis syndrome has been reported in clinical trials in patients treated with arsenic trioxide. _____________________________________________________________________________________ Arsenic Trioxide for Injection Product Monograph Page 9 of 50 Carcinogenesis and Mutagenesis Formal carcinogenicity studies have not been conducted with arsenic trioxide by intravenous administration.
The active ingredient of Arsenic Trioxide for Injection, arsenic trioxide, is a known human carcinogen (see 16 NON-CLINICAL TOXICOLOGY). Arsenic was either inactive or extremely weak for the induction of gene mutations in vitro. Arsenic tested positive for clastogenicity in vivo and in vitro (see 16 NON-CLINICAL TOXICOLGY).
Cardiovascular QT Prolongation QT prolongation should be expected during treatment with arsenic trioxide. Torsade de pointes and sudden death have been reported. Torsade de pointes may be asymptomatic or experienced by the patient as dizziness, palpitations, syncope, or seizures.
If sustained, torsade de pointes can progress to ventricular fibrillation and sudden cardiac death. The risk of torsade de pointes is related to the extent of QT prolongation, concomitant administration of QT prolonging drugs or drugs that decrease electrolyte levels.
4 Drug-Drug Interactions). Particular care should be exercised when administering Arsenic Trioxide for Injection to patients who are suspected to be at an increased risk of experiencing torsade de pointes. , intracranial or subarachnoid haemorrhage, stroke, intracranial trauma); _____________________________________________________________________________________ Arsenic Trioxide for Injection Product Monograph Page 10 of 50 • diabetes mellitus; • autonomic neuropathy.
1 Dosing Considerations).
Complete Atrioventricular Block:
1 Pregnant Women 08/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ...........................................................................................
2 TABLE OF CONTENTS ............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION .....................................................................
4 1 INDICATIONS ............................................................................................................... 1 Pediatrics...................................................................................................................
2 Geriatrics ................................................................................................................... 4 2 CONTRAINDICATIONS..................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS ..................................................................... 5 4 DOSAGE AND ADMINISTRATION.................................................................................. 1 Dosing Considerations ..............................................................................................
2 Recommended Dose and Dosage Adjustment ......................................................... 3 Reconstitution ........................................................................................................... 4 Administration ..........................................................................................................
7 5 OVERDOSAGE.............................................................................................................. 7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .................................. 8 7 WARNINGS AND PRECAUTIONS ...................................................................................
• Arsenic Trioxide for Injection is contraindicated in patients who are hypersensitive to this drug or to any of ingredient in the formulation, including any non-medicinal _____________________________________________________________________________________ Arsenic Trioxide for Injection Product Monograph Page 5 of 50 ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • Arsenic Trioxide for Injection is contraindicated during pregnancy and in nursing mothers.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Do not save any unused portions for later administration. 4 Administration Arsenic Trioxide for Injection must not be mixed with or concomitantly administered in the same intravenous line with other medicinal products. Arsenic Trioxide for Injection should be administered intravenously over 1-2 hours.
The infusion duration may be extended up to 4 hours if acute vasomotor reactions are observed. A central venous catheter is not required.
Complete atrioventricular block has been reported with arsenic trioxide in the published literature including a case of a patient with APL.
Increased Heart Rate:
Arsenic trioxide has been reported to increase heart rate. Caution should be observed in patients with conditions that might be exacerbated by an increase in heart rate, such as tachyarrhythmias or ischemic heart disease. Hematologic Hyperleukocytosis Treatment with arsenic trioxide has been associated with the development of hyperleukocytosis (white blood cell (WBC) ≥ 10 x 103/uL) in some patients with relapsed or refractory APL.
A relationship did not exist between baseline WBC counts and development of hyperleukocytosis nor baseline WBC counts and peak WBC counts. Hyperleukocytosis was not treated with additional chemotherapy. WBC counts during consolidation were not as high as during induction treatment.
Hepatic/Biliary/Pancreatic Increases in transaminases have been associated with treatment with arsenic trioxide. In clinical trials the majority of cases of elevated transaminases resolved without interruption of arsenic trioxide treatment.
Patients with Hepatic Impairment:
Limited data is available across all hepatic impairment groups. Caution is advised in the use of Arsenic Trioxide for Injection in patients with hepatic impairment. 3 Pharmacokinetics). 4 Drug-Drug Interactions). _____________________________________________________________________________________ Arsenic Trioxide for Injection Product Monograph Page 11 of 50 ECGs should be obtained twice weekly, and more frequently for clinically unstable patients, during induction and consolidation.
Continuous ECG monitoring should be considered for patients with risk factors for QT prolongation/torsade de pointes. For QTc greater than 500 msec, corrective measures should be completed and the QTc reassessed with serial ECGs prior to considering using Arsenic Trioxide for Injection.
Arsenic Trioxide for Injection therapy may be started at QTc values of less than 430 msec for males, and less than 450 msec for females.
Laboratory parameters monitoring:
The patient’s electrolyte (potassium, calcium and magnesium) and glucose levels as well as hematologic, hepatic, renal and coagulation parameter tests should be monitored at least twice weekly, and more frequently for clinically unstable patients during the induction phase and at least weekly […]
1 Special Populations ................................................................................................. 1 Pregnant Women ................................................................................................
2 Breast-feeding ..................................................................................................... 3 Pediatrics .............................................................................................................
4 Geriatrics ............................................................................................................. 13 8 ADVERSE REACTIONS ................................................................................................
1 Adverse Reaction Overview .................................................................................... 2 Clinical Trial Adverse Reactions .............................................................................. 1 Clinical Trial Adverse Reactions – Pediatrics .......................................................
3 Less Common Clinical Trial Adverse Reactions ....................................................... 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data..............................................................................................................
5 Post-Market Adverse Reactions.............................................................................. 24 9 DRUG INTERACTIONS ................................................................................................ 1 Serious Drug Interactions .......................................................................................
2 Drug Interactions Overview .................................................................................... 3 Drug-Behavioural Interactions ................................................................................ 4 Drug-Drug Interactions ...........................................................................................
5 Drug-Food Interactions ........................................................................................... 6 Drug-Herb Interactions ...........................................................................................
7 Drug-Laboratory Interactions ................................................................................. 26 10 CLINICAL PHARMACOLOGY ........................................................................................ 1 Mechanism of Action ..........................................................................................
2 Pharmacodynamics ............................................................................................. 3 Pharmacokinetics ................................................................................................ 29 11 STORAGE, STABILITY AND DISPOSAL ..........................................................................
31 12 SPECIAL HANDLING INSTRUCTIONS............................................................................ 31 PART II: SCIENTIFIC INFORMATION ......................................................................................
32 13 PHARMACEUTICAL INFORMATION ............................................................................ 32 14 CLINICAL TRIALS ........................................................................................................
1 Clinical Trials by Indication .................................................................................. 33 15 MICROBIOLOGY […]