- 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.
- 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
-Solutions Compatible: D5W , NS
-Incompatible: DO NOT mix with any other drugs
(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 |
(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
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
- 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