Manageable monitoring profile
Proactive monitoring is essential to proper management of TRISENOX
® (arsenic trioxide)
injection therapy.
APL differentiation syndrome: Signs are subtle and easy to overlook
- Weigh patient daily to detect weight changes
- Instruct patient to immediately report fever, sudden weight gain (> 2 lbs. in 24 hours), musculoskeletal pain, fluid retention, and/or dyspnea
- At first signs of syndrome, administer dexamethasone 10 mg IV BID for a minimum of 3 days or longer until signs and symptoms have abated
- In clinical trials, termination of TRISENOX was not required in the majority of patients1; interruption of therapy is necessary if symptoms of APL syndrome do not respond to steroid treatment
- Treat weight gain symptomatic of fluid overload (in absence of differentiation syndrome) with potassium-sparing diuretics
Electrolytes: Monitor throughout treatment
- Prior to initiating therapy, assess serum electrolytes (potassium, magnesium, calcium) and creatinine; pre-existing electrolyte abnormalities should be corrected
- Induction: Monitor at least twice weekly, and more frequently for clinically unstable patients
- Consolidation: Monitor at least weekly
- Supplement electrolytes as needed
- Maintain serum potassium > 4.0 mEq/L
- Maintain serum magnesium > 1.8 mg/dL
If rash occurs:
- Interruption of therapy with TRISENOX may not be necessary
- Topical steroids may be effective; use topical antihistamines for pruritus
Other blood tests
- Hematologic and coagulation profiles should be monitored at least twice weekly and more frequently for clinically unstable patients during induction, and at least weekly during consolidation
- TRISENOX may increase blood sugar levels
- Exercise caution in patients with renal and hepatic impairment
- Transient increases in transaminase levels may occur. These events typically do not require dose reduction or interruption of therapy
Monitor 12-lead ECGs at baseline, then weekly
- Monitor more frequently in patients at risk for a cardiac event, with electrolyte abnormalities, or if QT increases
- Avoid concomitant drugs that prolong QT interval; check online at www.torsades.org
- If absolute QT is > 500 msec, immediately correct risk factors such as electrolytes and concomitant drugs
- If syncope, or rapid or irregular heartbeat occurs, hospitalize and monitor continuously; assess and correct electrolytes
- Hold TRISENOX until QTc is < 460 msec and symptoms resolve
Hyperleukocytosis
- Usually self-limiting
- Additional chemotherapy may not be required
- Interruption of therapy with TRISENOX may not be necessary
>> Click here to review the safety profile for TRISENOX.
1. TRISENOX Prescribing Information. Frazer, Pa: Cephalon, Inc.;2005.