Drug interactions - summary-

Antiarrhythmias /thioridazine - caution is adviced when arsenic trioxide is coadministered
with other medicines that prolong QT intervals or lead to electrolyte abnormalities
eg. diuretics, amphotericin B

Acute promyelocyte leukemia ( APL )

Adverse Reactions-

Cardiovascular-   tachycardia  20%        ECG QT corrected interval prolonged   14% 
                               hypotension   8%

CNS -                     anxiety  10%    depression  7%    dizziness( excluding vertigo )  8%
                               headache    22%          insomnia    15%     parathesia     12%

Dermatologic -      dermatitis     15%     pruritus   12%

GI -                         nausea  28%              diarrhea   20%     vomiting   21% 
                               abdominal pain   22%     sore throat   12%       constipation  10%

Hematologic -      leukocytes  18%     anemia    8%

Infections/infestations -     sinusitis     7%

Metabolic/nutritional -    hyperkalemia   18%   hypomagnesemia  16%        

                                        hyperglycermia  16%
                                        ALT increased  7%

Respiratory -            cough   24%             dyspnea   19%     epistaxis     8%  hypoxia   8%
                                  pleural effusion   7%

Miscellaneous -       fatigue    23%     pyrxia   23%   edema  14%   rigors   13%
                                  chest pain   8%  injection site erythma   4%

Musculoskeletal-          arthalgia   12%    myalgia   9%    bone pain  8%  back pain  6%   

Arsenic trioxide is contraindicated in hypersentive patients to arsenic

Special Precautions/warnings-

QT prolongation- QT.QTc  prolongation should be expected during treatment with arsenic
trioxide

Complete AV Block - has been reported with arsenic trioxide

Renal/hepatic function impairment =safety and effectiveness of arsenic oxide  in patients with renal and hepatic impairment have not been studied

Pregnancy- women of child bearing potential should be adviced to avoid becoming pregnant

Lactation- decide whetherto discontinue nursing or the drug depending on the importance of the drug to the mother.

Children - safety and effectiveness in pediatric patients below 5 years have not been established

Monitoring- patients electrolyte, hemotalogic and coagulation profiles should be monitored
at least twice wekly and more frequently for clinically unstable patients during the induction
phase. Monitor ECG wekly and more frequently for unstable patients

Indication-

Acute promyelocyte leukemia ( APL )

Dosage- arsenic trioxide should be administered intravenously at a dose of 0.15mg/kg  until
bone marrow remision. Total induction dose should not exceed 60 doses

Consolidation dose -  should begin 3 to 6 weeks after completion of induction therapy.
Arsenic trioxide should be administered intravenously at dose of 0.15mg/kg daily for
25 doses over a period of 5 weeks.

Storage - store at 25C ( 77F ) . Do not freeze.

Pregnancy-
Women of child bearing potential should be adviced to avoid becoming pregnant

Lactation-
Decide whetherto discontinue nursing or the drug depending on the importance of
the drug to the mother.

Children -
Safety and effectiveness in pediatric patients below 5 years have not been established