Parenteral Manual

Arsenic trioxide (NON-FORMULARY or INVESTIGATIONAL)

Disclaimer: Official controlled document is the CHEO online copy. It is the responsibility of user to ensure that any paper copy version is the same as the online version before use.

Alternate Name(s): 
TRISENOX
Classification: 
Antineoplastic, miscellaneous - CYTOTOXIC
Original Date: 
April 2009
Revised Date: 
June 2015
Indications: 
  • New or relapsed acute promyelocytic leukemia

THIS MEDICATION IS TO BE ADMINISTERED BY A CHEMO-TRAINED NURSE. IF THE NURSE IS NOT CHEMO-TRAINED, THEY ARE TO CONTACT THE UNIT NURSE EDUCATOR OR ADVANCED PRACTICE NURSE.

Reconstitution and Stability: 
  • Available as 1 mg/mL clear, colourless solution in 10 mL ampoule
  • Store at room temperature; do not freeze
  • Filter contents of ampoule with 5 um filter needle
  • Discard unused portion of ampoule
  • Diluted solution stable 24 hours at room temperature or 48 hours refrigerated
Compatibility: 

-Solutions Compatible:  D5W , NS

-Incompatible:  DO NOT mix with any other drugs

Administration: 

(For approved routes of administration by nursing personnel, refer to Policy for the Administration of Intravenous Medications.)

SC NO
IM NO
IV Push NO
IV Intermittent Infusion YES
Usual dilution: in 100 - 250 mL NS or D5W
Infusion time:  over 1 - 2 hours
May give by peripheral or central line
IV Continuous Infusion NO
Dosage: 

(For neonatal dosages, refer to Neonatal IV Drug Manual.)

Pediatric:

  • 0.15 mg/kg/dose IV once daily for 20 -60 doses , depending on protocol

Adults :

  • 0.15 mg/kg/dose IV once daily until bone marrow cleared of leukemia, up to maximuim of 60 doses

Dosing Adjustment in Renal  or Liver Impairment:

  •  Refer to protocol for dose modification guidelines for:
    -creatinine clearance < 90 mL/min/1.73m2 (excreted renally)
    -elevated liver enzymes
Potential hazards of parenteral administration: 

Immediate (within 1-2 days of receiving drug):

  • Vasomotor symptoms (flushing, sweating, headache) -may extend infusion duration to 4 hours
  • Lightheadedness during infusion, headache, dizziness, fatigue, fever, rigors, nausea, vomiting(highly emetogenic), diarrhea, abdominal pain, erythema, urticaria
  • Injection site pain, irritation (not considered a vesicant or irritant)

Prompt  (within 2 - 3 weeks) :

  • Electrolyte abnormalities:  hypokalemia, hypomagnesemia, hyperglycemia
  • QT interval prolongation and cardiac arrythmias (1 - 5 weeks after infusion)
  • APL differentiation syndrome:  fever, dyspnea, weight gain, pulmonary infiltration and pleural or pericardial effusions, with or without leukocytosis
  • Hyperleukocytosis
  • Rash, pruritus
  • Neuropathy

-Treatment for unusual side effects are available through the study chair identified on the front page of the protocol and /or pharmacy

Notes: 
  • Baseline and regular ECG and electrolyte monitoring required
  • Keep serum potassium > 4 mmol/L and magnesium > 0.8 mmol/L
  • Avoid medications that can cause QT interval prolongation (e.g. erythromycin, clarithromycin, levofloxacin, risperidone)
  • Caution with medications that can cause hypokalemia or hypomagnesemia (e.g. Amphotericin B, diuretics)
  • Avoid herbal and homeopathic products (some contain arsenic, or may cause electrolyte abnormalities)
  • Signs of arsenic toxicity (convulsions, muscle weakness, confusion) require immediate discontinuation of arsenic trioxide therapy and consideration of chelation therapy

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