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Pharmacologic class: Nonmetallic element, white arsenic
Therapeutic class: Antineoplastic
Pregnancy risk category D
FDA Box Warning
• Give under supervision of physician experienced in managing patients with acute leukemia.
• Some patients with acute promyelocytic leukemia (APL) treated with drug have had symptoms similar to retinoic-acid-acute promyelocytic leukemia (RA-APL) or APL differentiation syndrome, marked by fever, dyspnea, weight gain, pulmonary infiltrates, and pleural or pericardial effusions. Syndrome can be fatal; at first sign, give high-dose steroids immediately, regardless of patient's white blood cell count; continue steroids for at least 3 days or longer until signs and symptoms abate. Most patients don't require arsenic trioxide termination during treatment of APL differentiation syndrome.
• Drug may prolong QT interval and cause complete atrioventricular block. QT prolongation can lead to torsades de pointes-type ventricular arrhythmia, which can be fatal.
• Before starting therapy, obtain 12-lead ECG and assess serum electrolyte (potassium, calcium, and magnesium) and creatinine levels. Correct electrolyte abnormalities and, if possible, discontinue drugs known to cause QT prolongation. During therapy, maintain potassium level above 4 mEq/L and magnesium level above 1.8 mg/dL. If patient reaches absolute QT interval value above 500 msec, reassess and take immediate action to correct concomitant risk factors.
Unclear. May cause morphologic changes and DNA fragmentation in promyelocytic leukemia cells, causing cell death and degradation of or damage to PML/RAR alpha (a fusion protein).
Injection: 1 mg/ml
Indications and dosages
➣ APL in patients who have relapsed or are refractory to retinoid and anthracycline chemotherapy
Adults and children ages 5 and older: Induction phase-0.15 mg/kg I.V. daily until bone marrow remission occurs, to a maximum of 60 doses. Consolidation phase-0.15 mg/kg I.V. daily for 25 doses over 5 weeks, starting 3 to 6 weeks after completion of induction phase.
• Hypersensitivity to drug
Use cautiously in:
• renal impairment, cardiac abnormalities
• elderly patients
• breastfeeding patients
☞ Know that drug is carcinogenic. Follow facility policy for preparing and handling antineoplastics.
• Dilute in 100 to 250 ml of dextrose 5% in water or normal saline solution.
• Don't mix with other drugs.
• Infuse over 1 to 2 hours (may infuse over 4 hours if patient has vasomotor reaction).
CNS: headache, insomnia, paresthesia, dizziness, tremor, drowsiness, anxiety, confusion, agitation, rigors, weakness, seizures, coma
CV: ECG abnormalities, palpitations, chest pain, hypotension, hypertension, tachycardia, prolonged QT interval, torsades de pointes
EENT: blurred vision, painful red eye, dry eyes, eye irritation, swollen eyelids, tinnitus, earache, nasopharyngitis, postnasal drip, epistaxis, sinusitis, sore throat
GI: nausea, vomiting, constipation, diarrhea, abdominal pain, fecal incontinence, dyspepsia, dry mouth, mouth blisters, oral candidiasis, anorexia, GI hemorrhage
GU: urinary incontinence, intermenstrual bleeding, renal impairment, oliguria, renal failure, vaginal hemorrhage
Hematologic: anemia, lymphadenopathy, leukocytosis, thrombocytopenia, neutropenia, disseminated intravascular coagulation, hemorrhage
Metabolic: hypokalemia, hypomagnesemia, hyperglycemia, acidosis, hypoglycemia, hyperkalemia Musculoskeletal: joint, muscle, bone, back, neck, or limb pain
Respiratory: dyspnea, cough, hypoxia, wheezing, crackles, tachypnea, decreased breath sounds, crepitation, hemoptysis, rhonchi, upper respiratory tract infection, pleural effusion
Skin: flushing, erythema, pallor, bruising, petechiae, pruritus, dermatitis, dry skin, hyperpigmentation, urticaria, skin lesions, herpes simplex infection, local exfoliation, diaphoresis, night sweats
Other: fever, facial edema, weight gain or loss, bacterial infection, pain and edema at injection site, hypersensitivity reaction, sepsis
Drug-drug. Drugs that can cause electrolyte abnormalities (such as amphotericin B, diuretics): increased risk of electrolyte abnormalities
Drugs that can prolong QT interval (antiarrhythmics, thioridazines, some quinolones): increased QT-interval prolongation
Drug-diagnostic tests. Alanine aminotransferase, aspartate aminotransferase, calcium, magnesium, white blood cells: increased levels
Glucose, potassium: altered levels
Hemoglobin, neutrophils, platelets: decreased values
☞ Watch for signs and symptoms of APL differentiation syndrome (fever, dyspnea, weight gain, pulmonary infiltrates, and pleural or pericardial effusions).
• Evaluate vital signs and neurologic status.
☞ Obtain baseline ECG; monitor ECG at least weekly.
• Assess for arrhythmias and conduction disorders.
☞ Discontinue drug and notify prescriber if patient develops syncope, tachycardia, or arrhythmias.
• Monitor serum electrolyte levels, CBC, and coagulation studies.
• Assess for hypoglycemia and hyperglycemia if patient is diabetic.
☞ Watch for signs and symptoms of APL differentiation syndrome.
• Tell patient that drug increases risk of serious infection. Instruct him to report signs or symptoms of infection.
☞ Emphasize importance of avoiding pregnancy during therapy.
• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration and alertness.
• Tell patient to minimize GI upset by eating small, frequent servings of food and drinking plenty of fluids.
• Advise patient to establish effective bedtime routine to minimize insomnia.
• Notify patient that he'll undergo regular blood testing during therapy.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and tests mentioned above.
TrisenoxA chemotherapeutic agent used for patients with acute promyelocytic leukemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterised by the t(15;17) translocation or by PML/RAR-alpha gene expression.
QT interval prolongation; complete atrioventricular block; APL differentiation (retinoic acid); syndrome-like symptoms (fever, dyspnoea, weight gain, pulmonary infiltrates, pleural or pericardial effusions, ± leukocytosis) which may be fatal.