arsenic trioxide (Rx)

Brand and Other Names:Trisenox
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 1mg/mL (10mg ampule)

Acute Promyelocytic Leukemia

Newly diagnosed low-risk acute promyelocytic leukemia (APL)

  • Indicated in combination with tretinoin for treatment of adults with newly diagnosed low risk APL whose APL has the presence of the t(15;17) translocation or PML/RAR-alpha gene expression
  • Treatment course consists of 1 induction and 4 consolidation cycles
  • Induction cycle
    • Arsenic trioxide 0.15 mg/kg IV qDay until bone marrow remission; not to exceed 60 days, PLUS  
    • Tretinoin 22.5 mg/m² PO BID until bone marrow remission; not to exceed 60 days
    • Differentiation syndrome prophylaxis consisting of prednisone 0.5 mg/kg daily from day 1 until the end of induction therapy is recommended
  • Consolidation cycle
    • Arsenic trioxide 0.15 mg/kg IV daily x Days 1-5 on Weeks 1-4 of an 8-week cycle for a total of 4 cycles in combination with tretinoin
    • Tretinoin 22.5 mg/m² PO BID x Days 1-7 on Weeks 1, 2, 5, 6; omit tretinoin during weeks 5-6 of the fourth cycle of consolidation

Relapsed or refractory APL

  • Indicated for induction of remission and consolidation in patients with APL who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression
  • Treatment course consists of 1 induction and 1 consolidation cycle
  • Induction cycle
    • Arsenic trioxide 0.15 mg/kg IV qDay until bone marrow remission; not to exceed 60 days  
  • Consolidation cycle
    • Begin consolidation 3-6 weeks after completion of induction therapy
    • Arsenic trioxide 0.15 mg/kg IV daily for 25 doses over a period of up to 5 weeks  

Dosage Modifications

Differentiation syndrome

  • Defined by the presence of ≥2 of the following: Unexplained fever, dyspnea; pleural and/or pericardial effusion; pulmonary infiltrates; renal failure; hypotension; weight gain >5 kg
  • Temporarily withhold arsenic trioxide
  • Consider holding tretinoin if symptoms are severe
  • Treat with dexamethasone 10 mg IV q12h until resolution of signs and symptoms for a minimum of 3 days
  • Resume treatment when the clinical condition improves and reduce dose of the withheld drug(s) by 50%
  • After 7 days on the reduced dose in the absence of differentiation syndrome, increase dose of withheld drug(s) to recommended dosage
  • If symptoms reappear, decrease arsenic trioxide and/or tretinoin to previous dose

QTc Prolongation

  • QTc prolongation >450 msec (men) or >460 msec (women)
  • Withhold treatment and any medication known to cause QT prolongation
  • Replete electrolytes
  • After QTc normalizes, resume arsenic trioxide at a 50% reduced dose (0.075 mg/kg qDay) for 7 days
  • If the 50% reduced dose is tolerated for 7 days (in the absence of QTc prolongation), increase dose to 0.11 mg/kg qDay for 7 days
  • Dose can be increased to 0.15 mg/kg in the absence of QTc prolongation during that 14-day dose escalation period

Hepatoxicity

  • Defined by ≥1 of the following: Total bilirubin (TB) >3x ULN; AST >5x ULN; alkaline phosphatase (AP) >5x ULN
  • Withhold treatment with arsenic trioxide and/or tretinoin
  • Resume treatment at a 50% reduced dose of the withheld drug(s) when TB is <1.5x ULN and AP/AST are <3x ULN
  • After 7 days on the reduced dose in the absence of worsening of hepatotoxicity; increase dose of withheld drug(s) back to recommended dosage
  • Permanently discontinue the withheld drug(s) if hepatotoxicity recurs

Other severe or life-threatening (grade 3-4) nonhematologic reactions

  • Temporarily withhold arsenic trioxide and tretinoin
  • When adverse reaction resolves to ≤grade 1, resume treatment reduced by 2 dose levels (see below)

Moderate (grade 2) nonhematologic reactions

  • Reduce the dose of arsenic trioxide and/or tretinoin by 1 dose level (see below)

Leukocytosis (WBC count >10 Gi/L)

  • Administer hydroxyurea
  • Discontinue hydroxyurea when WBC <10 Gi/L

Myelosuppression

  • Defined by ≥1 following: ANC<1 Gi/L; platelets <50 Gi/L lasting more than 5 weeks
  • Consider reducing dose of arsenic trioxide and tretinoin by following: 1 dose level (see below)
  • If myelosuppression lasts ≥50 days or occurs on 2 consecutive cycles, assess a marrow aspirate for remission weeks status
  • In the case of molecular remission, resume treatment at 1 dose level lower

Dosing reduction levels for hematologic and nonhematologic toxicities

  • Arsenic trioxide
    • Starting level: 0.15 mg/kg IV qDay
    • Level -1: 0.11 mg/kg IV qDay
    • Level -2: 0.1 mg/kg IV qDay
    • Level -3: 0.075 mg/kg IV qDay
  • Tretinoin
    • Starting level: 22.5 mg/m² PO BID
    • Level -1: 18.75 mg/m² PO BID
    • Level -2: 12.5 mg/m² PO BID
    • Level -3: 10 mg/m² PO BID

Renal impairment

  • Severe: (CrCl<30 mL/min): Exposure of arsenic trioxide may be higher; monitor for toxicities and dose reduce when warranted
  • Dialysis: Safety and efficacy not established

Hepatic impairment

  • Limited data available for all hepatic impairment groups; use with caution
  • Severe (Child Pugh C): Monitor for toxicities

Orphan Designations

Myelocytic leukemia subtypes MO, M1, M2, M4, M5, M6, and M7

Chronic lymphocytic leukemia

Malignant glioma

Myelodysplastic syndrome

Multiple myeloma

Liver cancer

Chronic myeloid leukemia

Amyotrophic lateral sclerosis

Acute promyelocytic leukemia (oral capsule)

Graft-versus-host disease

Orphan sponsors

  • Cephalon Inc; 41 Moores Road, P. O. Box 4011; Frazer, PA 19355
  • Terra Biological LLC; 3830 Valley Centre Drive, Suite 705-561; San Diego, California 92130
  • Orsenix Holdings BV; 1105 North Market Street, Suite 1800; Wilmington, Delaware 19801
  • Medsenicl 204 avenue de Colmar; Strasbourg, France

Dosage Forms & Strengths

injectable solution

  • 1mg/mL (10mg ampule)

Acute Promyelocytic Leukemia

Refractory or relapse after retinoid and anthracycline chemotherapy

  • Indicated for induction of remission and consolidation in patients with acute promyelocytic leukemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression
  • <4 years: Safety and efficacy not established
  • ≥4 years: 0.15 mg/kg IV qDay until bone marrow remission; not to exceed 60 doses  
  • Wait 3-6 weeks, THEN
  • 0.15 mg/kg IV qDay for 25 doses (administered over time period of up to 5 weeks)

Dosing Considerations

Monitor: ECG, serum electrolytes

Next:

Interactions

Interaction Checker

and arsenic trioxide

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            Contraindicated (14)

            • artemether/lumefantrine

              arsenic trioxide and artemether/lumefantrine both increase QTc interval. Contraindicated.

            • dronedarone

              arsenic trioxide and dronedarone both increase QTc interval. Contraindicated.

            • epinephrine racemic

              epinephrine racemic and arsenic trioxide both increase QTc interval. Contraindicated.

            • erythromycin base

              arsenic trioxide and erythromycin base both increase QTc interval. Contraindicated.

            • erythromycin ethylsuccinate

              arsenic trioxide and erythromycin ethylsuccinate both increase QTc interval. Contraindicated.

            • erythromycin lactobionate

              arsenic trioxide and erythromycin lactobionate both increase QTc interval. Contraindicated.

            • erythromycin stearate

              arsenic trioxide and erythromycin stearate both increase QTc interval. Contraindicated.

            • goserelin

              goserelin increases toxicity of arsenic trioxide by QTc interval. Contraindicated. Increases risk of torsades de pointes.

            • leuprolide

              leuprolide increases toxicity of arsenic trioxide by QTc interval. Contraindicated. Increases risk of torsades de pointes.

            • nilotinib

              arsenic trioxide and nilotinib both increase QTc interval. Contraindicated.

            • octreotide (Antidote)

              arsenic trioxide and octreotide (Antidote) both increase QTc interval. Contraindicated.

            • pimozide

              arsenic trioxide and pimozide both increase QTc interval. Contraindicated.

            • trazodone

              trazodone and arsenic trioxide both increase QTc interval. Contraindicated.

            • ziprasidone

              arsenic trioxide and ziprasidone both increase QTc interval. Contraindicated.

            Serious - Use Alternative (89)

            • alfuzosin

              alfuzosin and arsenic trioxide both increase QTc interval. Avoid or Use Alternate Drug.

            • amiodarone

              amiodarone and arsenic trioxide both increase QTc interval. Avoid or Use Alternate Drug.

            • amitriptyline

              amitriptyline and arsenic trioxide both increase QTc interval. Avoid or Use Alternate Drug.

            • amoxapine

              amoxapine and arsenic trioxide both increase QTc interval. Avoid or Use Alternate Drug.

            • apomorphine

              apomorphine and arsenic trioxide both increase QTc interval. Avoid or Use Alternate Drug.

            • aripiprazole

              aripiprazole and arsenic trioxide both increase QTc interval. Avoid or Use Alternate Drug.

            • artemether

              artemether and arsenic trioxide both increase QTc interval. Avoid or Use Alternate Drug.

            • atomoxetine

              atomoxetine and arsenic trioxide both increase QTc interval. Avoid or Use Alternate Drug.

            • azithromycin

              arsenic trioxide and azithromycin both increase QTc interval. Avoid or Use Alternate Drug.

            • ceritinib

              ceritinib and arsenic trioxide both increase QTc interval. Avoid or Use Alternate Drug.

            • chloroquine

              chloroquine increases toxicity of arsenic trioxide by QTc interval. Avoid or Use Alternate Drug.

            • chlorpromazine

              chlorpromazine and arsenic trioxide both increase QTc interval. Avoid or Use Alternate Drug.

            • clarithromycin

              arsenic trioxide and clarithromycin both increase QTc interval. Avoid or Use Alternate Drug.

            • clomipramine

              clomipramine and arsenic trioxide both increase QTc interval. Avoid or Use Alternate Drug.

            • clozapine

              clozapine and arsenic trioxide both increase QTc interval. Avoid or Use Alternate Drug.

            • dasatinib

              arsenic trioxide and dasatinib both increase QTc interval. Avoid or Use Alternate Drug.

            • degarelix

              degarelix and arsenic trioxide both increase QTc interval. Avoid or Use Alternate Drug.

            • desflurane

              desflurane and arsenic trioxide both increase QTc interval. Avoid or Use Alternate Drug.

            • desipramine

              desipramine and arsenic trioxide both increase QTc interval. Avoid or Use Alternate Drug.

            • disopyramide

              arsenic trioxide and disopyramide both increase QTc interval. Avoid or Use Alternate Drug.

            • dofetilide

              arsenic trioxide and dofetilide both increase QTc interval. Avoid or Use Alternate Drug.

              dofetilide increases toxicity of arsenic trioxide by QTc interval. Avoid or Use Alternate Drug.

            • dolasetron

              arsenic trioxide and dolasetron both increase QTc interval. Avoid or Use Alternate Drug.

            • doxepin

              doxepin and arsenic trioxide both increase QTc interval. Avoid or Use Alternate Drug.

            • droperidol

              arsenic trioxide and droperidol both increase QTc interval. Avoid or Use Alternate Drug.

            • encorafenib

              encorafenib and arsenic trioxide both increase QTc interval. Avoid or Use Alternate Drug. Encorafenib is associated with dose-dependent QTc interval prolongation. Avoid with drugs known to prolong QT interval.

            • entrectinib

              arsenic trioxide and entrectinib both increase QTc interval. Avoid or Use Alternate Drug.

            • eribulin

              eribulin and arsenic trioxide both increase QTc interval. Avoid or Use Alternate Drug. Potential for enhanced QTc-prolonging effects; if concurrent use is necessary then ECG monitoring is recommended.

            • escitalopram

              escitalopram increases toxicity of arsenic trioxide by QTc interval. Avoid or Use Alternate Drug.

            • fexinidazole

              fexinidazole and arsenic trioxide both increase QTc interval. Avoid or Use Alternate Drug. Avoid coadministration of fexinidazole with drugs known to block potassium channels and/or prolong QT interval.

            • flecainide

              arsenic trioxide and flecainide both increase QTc interval. Avoid or Use Alternate Drug.

            • fluconazole

              arsenic trioxide and fluconazole both increase QTc interval. Avoid or Use Alternate Drug.

            • fluoxetine

              arsenic trioxide and fluoxetine both increase QTc interval. Avoid or Use Alternate Drug.

            • fluphenazine

              fluphenazine and arsenic trioxide both increase QTc interval. Avoid or Use Alternate Drug.

            • fluvoxamine

              fluvoxamine and arsenic trioxide both increase QTc interval. Avoid or Use Alternate Drug.

            • foscarnet

              arsenic trioxide and foscarnet both increase QTc interval. Avoid or Use Alternate Drug.

            • glasdegib

              arsenic trioxide and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • haloperidol

              arsenic trioxide and haloperidol both increase QTc interval. Avoid or Use Alternate Drug.

            • histrelin

              histrelin increases toxicity of arsenic trioxide by QTc interval. Avoid or Use Alternate Drug. Increases risk of torsades de pointes.

            • hydroxychloroquine sulfate

              hydroxychloroquine sulfate and arsenic trioxide both increase QTc interval. Avoid or Use Alternate Drug.

            • ibutilide

              arsenic trioxide and ibutilide both increase QTc interval. Avoid or Use Alternate Drug.

            • iloperidone

              arsenic trioxide and iloperidone both increase QTc interval. Avoid or Use Alternate Drug.

            • imipramine

              imipramine and arsenic trioxide both increase QTc interval. Avoid or Use Alternate Drug.

            • inotuzumab

              inotuzumab and arsenic trioxide both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

            • ivosidenib

              ivosidenib and arsenic trioxide both increase QTc interval. Avoid or Use Alternate Drug. Avoid coadministration of QTc prolonging drugs with ivosidenib or replace with alternate therapies. If coadministration of a QTc prolonging drug is unavoidable, monitor for increased risk of QTc interval prolongation.

            • lapatinib

              arsenic trioxide and lapatinib both increase QTc interval. Avoid or Use Alternate Drug.

            • lefamulin

              lefamulin and arsenic trioxide both increase QTc interval. Avoid or Use Alternate Drug.

            • levofloxacin

              arsenic trioxide and levofloxacin both increase QTc interval. Avoid or Use Alternate Drug.

            • macimorelin

              macimorelin and arsenic trioxide both increase QTc interval. Avoid or Use Alternate Drug. Macimorelin causes an increase of ~11 msec in the corrected QT interval. Avoid coadministration with drugs that prolong QT interval, which could increase risk for developing torsade de pointes-type ventricular tachycardia. Allow sufficient washout time of drugs that are known to prolong the QT interval before administering macimorelin.

            • maprotiline

              maprotiline and arsenic trioxide both increase QTc interval. Avoid or Use Alternate Drug.

            • mefloquine

              mefloquine increases toxicity of arsenic trioxide by QTc interval. Avoid or Use Alternate Drug. Mefloquine may enhance the QTc prolonging effect of high risk QTc prolonging agents.

            • methadone

              arsenic trioxide and methadone both increase QTc interval. Avoid or Use Alternate Drug.

            • mobocertinib

              mobocertinib and arsenic trioxide both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, reduce mobocertinib dose and monitor QTc interval more frequently.

            • moxifloxacin

              arsenic trioxide and moxifloxacin both increase QTc interval. Avoid or Use Alternate Drug.

            • nortriptyline

              nortriptyline and arsenic trioxide both increase QTc interval. Avoid or Use Alternate Drug.

            • ofloxacin

              arsenic trioxide and ofloxacin both increase QTc interval. Avoid or Use Alternate Drug.

            • ondansetron

              arsenic trioxide and ondansetron both increase QTc interval. Avoid or Use Alternate Drug. Avoid with congenital long QT syndrome; ECG monitoring recommended with concomitant medications that prolong QT interval, electrolyte abnormalities, CHF, or bradyarrhythmias.

            • palifermin

              palifermin increases toxicity of arsenic trioxide by Other (see comment). Avoid or Use Alternate Drug. Comment: Palifermin should not be administered within 24 hr before, during infusion of, or within 24 hr after administration of antineoplastic agents. Coadministration of palifermin within 24 hr of chemotherapy resulted in increased severity and duration of oral mucositis.

            • paliperidone

              arsenic trioxide and paliperidone both increase QTc interval. Avoid or Use Alternate Drug.

            • panobinostat

              arsenic trioxide and panobinostat both increase QTc interval. Avoid or Use Alternate Drug. Panobinostat is known to significantly prolong QT interval. Panobinostat prescribing information states use with drugs known to prolong QTc is not recommended.

            • paroxetine

              arsenic trioxide and paroxetine both increase QTc interval. Avoid or Use Alternate Drug.

            • pentamidine

              arsenic trioxide and pentamidine both increase QTc interval. Avoid or Use Alternate Drug.

            • perphenazine

              perphenazine and arsenic trioxide both increase QTc interval. Avoid or Use Alternate Drug.

            • pimavanserin

              pimavanserin and arsenic trioxide both increase QTc interval. Avoid or Use Alternate Drug. Coadministration may increase the risk of QT prolongation and cardiac arrhythmia.

            • pitolisant

              arsenic trioxide and pitolisant both increase QTc interval. Avoid or Use Alternate Drug.

            • ponesimod

              ponesimod, arsenic trioxide. Either increases effects of the other by QTc interval. Avoid or Use Alternate Drug. Consult cardiologist if considering treatment. Generally, should not be initiated in patients who are concurrently taking QT prolonging drugs with known arrhythmogenic properties, such as HR-lowering calcium channel blockers (eg, verapamil, diltiazem).

            • posaconazole

              arsenic trioxide and posaconazole both increase QTc interval. Avoid or Use Alternate Drug.

            • procainamide

              arsenic trioxide and procainamide both increase QTc interval. Avoid or Use Alternate Drug.

            • prochlorperazine

              prochlorperazine and arsenic trioxide both increase QTc interval. Avoid or Use Alternate Drug.

            • promethazine

              promethazine and arsenic trioxide both increase QTc interval. Avoid or Use Alternate Drug.

            • protriptyline

              protriptyline and arsenic trioxide both increase QTc interval. Avoid or Use Alternate Drug.

            • quinidine

              quinidine and arsenic trioxide both increase QTc interval. Avoid or Use Alternate Drug.

            • ranolazine

              arsenic trioxide and ranolazine both increase QTc interval. Avoid or Use Alternate Drug.

            • ribociclib

              ribociclib and arsenic trioxide both increase QTc interval. Avoid or Use Alternate Drug.

            • romidepsin

              arsenic trioxide and romidepsin both increase QTc interval. Avoid or Use Alternate Drug.

            • saquinavir

              saquinavir, arsenic trioxide. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Increased risk of QT prolongation and cardiac arrhythmias.

            • selinexor

              selinexor, arsenic trioxide. unspecified interaction mechanism. Avoid or Use Alternate Drug. Patients treated with selinexor may experience neurological toxicities. Avoid taking selinexor with other medications that may cause dizziness or confusion.

            • sotalol

              arsenic trioxide and sotalol both increase QTc interval. Avoid or Use Alternate Drug.

            • telavancin

              arsenic trioxide and telavancin both increase QTc interval. Avoid or Use Alternate Drug.

            • thioridazine

              thioridazine and arsenic trioxide both increase QTc interval. Avoid or Use Alternate Drug.

            • toremifene

              arsenic trioxide and toremifene both increase QTc interval. Avoid or Use Alternate Drug. Concurrent use of toremifene with agents causing QT prolongation should be avoided. If concomitant use is required it's recommended that toremifene be interrupted. If interruption not possible, patients requiring therapy with a drug that prolongs QT should be closely monitored. ECGs should be obtained for high risk patients.

            • trifluoperazine

              trifluoperazine and arsenic trioxide both increase QTc interval. Avoid or Use Alternate Drug.

            • trimipramine

              trimipramine and arsenic trioxide both increase QTc interval. Avoid or Use Alternate Drug.

            • triptorelin

              triptorelin increases toxicity of arsenic trioxide by QTc interval. Avoid or Use Alternate Drug. Increases risk of torsades de pointes.

            • umeclidinium bromide/vilanterol inhaled

              arsenic trioxide increases toxicity of umeclidinium bromide/vilanterol inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.

            • vandetanib

              arsenic trioxide, vandetanib. Either increases toxicity of the other by QTc interval. Avoid or Use Alternate Drug. Avoid coadministration with drugs known to prolong QT interval; if a drug known to prolong QT interval must be used, more frequent ECG monitoring is recommended.

            • vemurafenib

              vemurafenib and arsenic trioxide both increase QTc interval. Avoid or Use Alternate Drug. Concomitant use of vemurafenib with drugs that prolong QT interval is not recommended.

            • venlafaxine

              arsenic trioxide and venlafaxine both increase QTc interval. Avoid or Use Alternate Drug.

            • vilanterol/fluticasone furoate inhaled

              arsenic trioxide increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.

            • voriconazole

              arsenic trioxide and voriconazole both increase QTc interval. Avoid or Use Alternate Drug.

            Monitor Closely (46)

            • acalabrutinib

              acalabrutinib, arsenic trioxide. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration may increase risk of myelosuppressive effects.

            • albuterol

              albuterol and arsenic trioxide both increase QTc interval. Use Caution/Monitor.

            • amifostine

              amifostine, arsenic trioxide. Either increases effects of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Coadministration with blood pressure lowering agents may increase the risk and severity of hypotension associated with amifostine. When amifostine is used at chemotherapeutic doses, withhold blood pressure lowering medications for 24 hr prior to amifostine; if blood pressure lowering medication cannot be withheld, do not administer amifostine.

            • arformoterol

              arformoterol and arsenic trioxide both increase QTc interval. Use Caution/Monitor.

            • bedaquiline

              arsenic trioxide and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely

            • benazepril

              arsenic trioxide, benazepril. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Increases risk of hypotension.

            • bosutinib

              bosutinib and arsenic trioxide both increase QTc interval. Use Caution/Monitor.

            • capecitabine

              capecitabine and arsenic trioxide both increase QTc interval. Use Caution/Monitor.

            • captopril

              arsenic trioxide, captopril. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Both drugs lower blood pressure. Monitor blood pressure.

            • cholera vaccine

              arsenic trioxide decreases effects of cholera vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to cholera vaccine.

            • ciprofloxacin

              ciprofloxacin and arsenic trioxide both increase QTc interval. Use Caution/Monitor. Ciprofloxacin elicits minimal effects on QT interval. Caution if used in combination with other drugs known to affect QT interval or in patients with other risk factors.

            • citalopram

              arsenic trioxide and citalopram both increase QTc interval. Use Caution/Monitor. ECG monitoring is recommended, along with drugs that may prolong the QT interval.

            • crizotinib

              crizotinib and arsenic trioxide both increase QTc interval. Use Caution/Monitor. ECG monitoring is recommended, along with drugs that may prolong the QT interval.

            • dabrafenib

              dabrafenib and arsenic trioxide both increase QTc interval. Use Caution/Monitor.

            • deutetrabenazine

              arsenic trioxide and deutetrabenazine both increase QTc interval. Modify Therapy/Monitor Closely. For patients requiring deutetrabenazine doses >24 mg/day and are taking other drugs known to prolong QTc, assess the QTc interval before and after increasing the dose of deutetrabenazine or other medications known to prolong QTc.

            • ezogabine

              ezogabine, arsenic trioxide. Either increases toxicity of the other by QTc interval. Use Caution/Monitor. Slight and transient QT-prolongation observed with ezogabine, particularly when dose titrated to 1200 mg/day. QT interval should be monitored when ezogabine is prescribed with agents known to increase QT interval.

            • formoterol

              arsenic trioxide and formoterol both increase QTc interval. Use Caution/Monitor.

            • fostemsavir

              arsenic trioxide and fostemsavir both increase QTc interval. Use Caution/Monitor. QTc prolongation reported with higher than recommended doses of fostemsavir.

            • gemtuzumab

              arsenic trioxide and gemtuzumab both increase QTc interval. Use Caution/Monitor.

            • indacaterol, inhaled

              indacaterol, inhaled, arsenic trioxide. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • itraconazole

              arsenic trioxide and itraconazole both increase QTc interval. Use Caution/Monitor.

            • ketoconazole

              arsenic trioxide and ketoconazole both increase QTc interval. Use Caution/Monitor.

            • lenvatinib

              arsenic trioxide and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.

            • lofexidine

              arsenic trioxide and lofexidine both increase QTc interval. Use Caution/Monitor. ECG monitoring is recommended.

            • mifepristone

              mifepristone, arsenic trioxide. QTc interval. Modify Therapy/Monitor Closely. Use alternatives if available.

            • octreotide

              arsenic trioxide and octreotide both increase QTc interval. Use Caution/Monitor.

            • olodaterol inhaled

              arsenic trioxide and olodaterol inhaled both increase QTc interval. Use Caution/Monitor. Drugs that prolong the QTc interval and may potentiate the effects of beta2 agonists on the cardiovascular system; increased risk of ventricular arrhythmias

            • osilodrostat

              osilodrostat and arsenic trioxide both increase QTc interval. Use Caution/Monitor.

            • osimertinib

              osimertinib and arsenic trioxide both increase QTc interval. Use Caution/Monitor. Conduct periodic monitoring with ECGs and electrolytes in patients taking drugs known to prolong the QTc interval.

            • oxaliplatin

              oxaliplatin will increase the level or effect of arsenic trioxide by Other (see comment). Use Caution/Monitor. Monitor for ECG changes if therapy is initiated in patients with drugs known to prolong QT interval.

            • ozanimod

              ozanimod and arsenic trioxide both increase QTc interval. Modify Therapy/Monitor Closely. The potential additive effects on heart rate, treatment with ozanimod should generally not be initiated in patients who are concurrently treated with QT prolonging drugs with known arrhythmogenic properties.

            • pasireotide

              arsenic trioxide and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • pazopanib

              arsenic trioxide and pazopanib both increase QTc interval. Modify Therapy/Monitor Closely.

            • ponesimod

              ponesimod and arsenic trioxide both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.

            • quetiapine

              quetiapine, arsenic trioxide. Either increases toxicity of the other by QTc interval. Use Caution/Monitor. Avoid use with drugs that prolong QT and in patients with risk factors for prolonged QT interval. Postmarketing cases show QT prolongation with overdose in patients with concomitant illness or with drugs known to cause electrolyte imbalance or prolong QT.

            • quinine

              arsenic trioxide and quinine both increase QTc interval. Use Caution/Monitor.

            • rilpivirine

              rilpivirine increases toxicity of arsenic trioxide by QTc interval. Use Caution/Monitor. Rilpivirine should be used with caution when co-administered with a drug with a known risk of Torsades de Pointes.

            • risperidone

              arsenic trioxide and risperidone both increase QTc interval. Use Caution/Monitor.

            • selpercatinib

              selpercatinib increases toxicity of arsenic trioxide by QTc interval. Use Caution/Monitor.

            • siponimod

              siponimod and arsenic trioxide both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.

            • sipuleucel-T

              arsenic trioxide decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

            • sodium sulfate/?magnesium sulfate/potassium chloride

              sodium sulfate/?magnesium sulfate/potassium chloride increases toxicity of arsenic trioxide by QTc interval. Use Caution/Monitor. Consider predose and post-colonoscopy ECGs in patients at increased risk of serious cardiac arrhythmias.

            • sodium sulfate/potassium sulfate/magnesium sulfate

              sodium sulfate/potassium sulfate/magnesium sulfate increases toxicity of arsenic trioxide by QTc interval. Use Caution/Monitor. Consider predose and post-colonoscopy ECGs in patients at increased risk of serious cardiac arrhythmias.

            • sorafenib

              sorafenib and arsenic trioxide both increase QTc interval. Use Caution/Monitor.

            • triclabendazole

              triclabendazole and arsenic trioxide both increase QTc interval. Use Caution/Monitor.

            • voclosporin

              voclosporin, arsenic trioxide. Either increases effects of the other by QTc interval. Use Caution/Monitor.

            Minor (0)

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              Adverse Effects

              >10%

              Nausea (75%)

              Cough (65%)

              Fatigue (63%)

              Pyrexia (63%)

              Headache (60%)

              Abdominal pain (58%)

              Vomiting (58%)

              Tachycardia (55%)

              Diarrhea (53%)

              Dyspnea (53%)

              Leukocytosis (50%)

              Pain (including bone pain, back pain, myalgia 50%)

              Hypokalemia (50%)

              Hypomagnesemia (45%)

              Hyperglycemia (45%)

              Insomnia (43%)

              Edema (40%)

              Sore throat (40%)

              Prolonged QTc interval (38%)

              Pruritus (33%)

              Dermatitis (33%)

              Parathesia (33%)

              Arthralgia (33%)

              Anxiety (30%)

              Constipation (28%)

              Chest pain (25%)

              Epistaxis (25%)

              Hypotension (25%)

              Anorexia/decreased appetite (23%)

              Dizziness (23%)

              Hypoxia (23%)

              ALT increased (20%)

              Depression (20%)

              Pleural effusion (20%)

              Sinusitis (20%)

              Thrombocytopenia (19%)

              Hyperkalemia (18%)

              Injection site reactions (4-15%)

              Anemia (14%)

              Febrile neutropenia (13%)

              Herpes simplex (13%)

              Tremor (13%)

              Upper respiratory infection (13%)

              Vaginal hemorrhage (13%)

              Weight gain (13%)

              1-10%

              Blurred vision (10%)

              Crepitation (10%)

              Eye irritation (10%)

              Flushing (10%)

              Hypertension (10%)

              Hypocalcemia (10%)

              Neutropenia (10%)

              Pallor (10%)

              Palpitations (10%)

              Rales (10%)

              Renal failure/impairment (8%)

              Anxiety (30%)

              Coma (5%)

              Confusion (5%)

              Tinnitus (5%)

              Convulsion (5%)

              Petechiae (8%)

              Eyelid edema (5%)

              Facial edema (8%)

              GI hemorrhage (8%)

              Hypoglycemia (8%)

              Hyperpigmentation (8%)

              Night sweats (8%)

              Oral candidiasis (5%)

              Urticaria (8%)

              Earache (8%)

              Postmarketing Reports

              Cardiac disorders: Ventricular extrasystoles in association with QT prolongation, ventricular tachycardia in association with QT prolongation, including torsade de pointes, atrioventricular block, and congestive heart failure

              Nervous system disorders: Peripheral neuropathy, paresis, seizures, confusion

              Hematologic disorders: Pancytopenia, bone marrow necrosis

              Infections and infestations: Herpes zoster

              Musculoskeletal and connective tissue disorders: Bone pain, myalgia, rhabdomyolysis

              Respiratory, thoracic, and mediastinal disorders: Differentiation syndrome

              Ear and labyrinth disorders: Deafness

              Neoplasms benign, malignant and unspecified: Melanoma, pancreatic cancer, squamous cell carcinoma

              Skin and subcutaneous tissue disorders: Toxic epidermal necrolysis

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              Warnings

              Black Box Warnings

              Differentiation syndrome

              • Differentiation syndrome reported, which can be fatal if not treated
              • Symptoms may include fever, dyspnea, acute respiratory distress, pulmonary infiltrates, pleural or pericardial effusions, weight gain or peripheral edema, hypotension, and renal, hepatic, or multi-organ dysfunction, in the presence or absence of leukocytosis
              • If differentiation syndrome suspected, immediately initiate high-dose corticosteroid therapy and hemodynamic monitoring until resolution of signs and symptoms
              • Temporary discontinuation of arsenic trioxide may be required

              Cardiac conduction abnormalities

              • Can cause QTc interval prolongation, complete atrioventricular block, and torsade de pointes-type ventricular arrhythmia, which can be fatal
              • Before initiating therapy, assess the QTc interval, correct pre-existing electrolyte abnormalities, and consider discontinuing drugs known to prolong QTc interval
              • Do not administer to patients with ventricular arrhythmia or prolonged QTc
              • Withhold therapy until resolution and resume at reduced dose for QTc prolongation

              Encephalopathy

              • Serious encephalopathy, including Wernicke’s, reported; Wernicke’s is a neurologic emergency; consider testing thiamine levels in patients at risk for thiamine deficiency
              • Administer parenteral thiamine in patients with or at risk for thiamine deficiency; monitor patients for neurological symptoms and nutritional status while receiving therapy;
              • If encephalopathy is suspected, immediately interrupt therapy and initiate parenteral thiamine; monitor until symptoms resolve or improve and thiamine levels normalize

              Contraindications

              Hypersensitivity

              Cautions

              Use caution in hepatic or renal impairment

              Arsenic trioxide is a human carcinogen; monitor patients for development of second primary malignancies

              Differentiation syndrome, which may be life-threatening or fatal, observed in patients with acute promyelocytic leukemia (APL) treated with the drug (16-23% of patients developed differentiation syndrome; see Black Box Warnings and Dosage Modifications); the syndrome has been observed with and without concomitant hyperleukocytosis, and it has occurred as early as day 1 of induction to as late as second month induction therapy; when therapy is used in combination with tretinoin, prednisone prophylaxis is advised; at the first signs of differentiation syndrome, interrupt treatment and administer dexamethasone 10 mg intravenously twice daily; continue high-dose steroids until signs and symptoms have abated for at least 3 days

              Prolongs QTc interval (see Black Box Warnings and Dosage Modifications); for patients who develop a QTc >500 msec, immediately withhold treatment and any medication known to prolong the QTc interval; correct electrolyte abnormalities; when QTc normalizes, resume therapy at a reduced dose

              In the clinical trials, 44% of patients with newly-diagnosed low-risk APL treated with arsenic trioxide in combination with tretinoin experienced elevated AST, alkaline phosphatase, and/or serum bilirubin; long term liver abnormalities can occur in APL patients treated with arsenic trioxide in combination with tretinoin (see Dosage Modifications)

              Fetal harm may occur when administered to a pregnant woman (see Pregnancy)

              Encephalopathy

              • Wernicke’s encephalopathy reported in patients receiving therapy; Wernicke’s encephalopathy is a neurologic emergency that can be prevented and treated with thiamine
              • Consider testing thiamine levels in patients at risk for thiamine deficiency (eg, chronic alcohol use, malabsorption, nutritional deficiency, concomitant use of furosemide)
              • Administer parenteral thiamine in patients with or at risk for thiamine deficiency; monitor patients for neurological symptoms and nutritional status while receiving therapy if Wernicke’s encephalopathy is suspected, immediately interrupt therapy and initiate parenteral thiamine

              Drug interactions overview

              • Coadministration with drugs that can prolong QT/QTc interval may increase the risk of serious QT/QTc interval prolongation
              • Electrolyte abnormalities increase the risk of serious QT/QTc interval prolongation
              • Coadministration with drugs that can lead to hepatotoxicity, particularly when given in combination with tretinoin, may increase the risk of serious hepatotoxicity
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              Pregnancy & Lactation

              Pregnancy

              No studies with arsenic trioxide in pregnant women, and limited published data on arsenic trioxide use during pregnancy are insufficient to inform a drug associated risk of major birth defects and miscarriage

              Based on the mechanism of action and findings in animal studies, arsenic trioxide can cause fetal harm when administered to a pregnant woman

              Arsenic trioxide was embryolethal and teratogenic in rats when administered on gestation day 9 at a dose ~10 times the recommended human daily dose on a mg/m² basis

              A related trivalent arsenic, sodium arsenite, produced teratogenicity when administered during gestation in mice at a dose ~5 times the projected human dose on a mg/m² basis and in hamsters at an IV dose approximately equivalent to the projected human daily dose on a mg/m² basis

              Females and males of reproductive potential

              • Conduct pregnancy testing in females of reproductive potential prior to initiation of treatment
              • Advise females of reproductive potential to use effective contraception during and after treatment and for 6 months after the final dose
              • Based on testicular toxicities including decreased testicular weight and impaired spermatogenesis observed in animal studies, arsenic trioxide may impair fertility in males of reproductive potential
              • Advise males with female partners of reproductive potential to use effective contraception during treatment and for 3 months after last dose

              Lactation

              Arsenic is excreted in milk

              Because of the potential for serious adverse reactions in nursing infants from this drug, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother

              Pregnancy Categories

              A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

              B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

              C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

              D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

              X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

              NA: Information not available.

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              Pharmacology

              Mechanism of Action

              Causes apoptosis of promyelocytic leukemia cells; damages fusion protein PML-RAR alpha

              Absorption

              Peak plasma time: 2 hr (arsenious acid [AsIII])

              Peak plasma time, after first administration: ~10-24 hr (Monomethylarsonic acid [MMA], and dimethylarsinic acid [DMA])

              AUC (Cycle 1, Day 1): 194 ng·hr/mL (arsenious acid)

              AUC (Cycle 1, Day 25): 332 ng·hr/mL (arsenious acid)

              Distribution

              Vd (steady-state): 562 L

              Metabolism

              Arsenious acid is distributed to the tissues it methylate to the metabolites, MMA and DMA by methyltransferases primarily in the liver

              Metabolism of arsenic trioxide also involves oxidation of AsIII to AsV, which may occur in numerous tissues via enzymatic or nonenzymatic processes

              AsV is present in plasma only at relatively low levels following administration of arsenic trioxide

              Elimination

              Clearance, AsIII: 49 L/h (total); 9 L/hr (renal)

              Half-life: 32 hr (MMA); 72 hr (DMA)

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              Administration

              IV Compatibilities

              D5W

              0.9% NaCl

              IV Incompatibilities

              Do not mix with other medications

              IV Preparation

              Dilute in 100-250 mL D5W or 0.9% NaCl immediately after withdrawal from vial

              Do not save any unused portions for later administration

              IV Administration

              Visually inspect for particulate matter and discoloration prior to administration, whenever solution and container permit

              Infuse over 2 hr; infusion duration may be extended up to 4 hr if acute vasomotor reactions are observed

              Central venous catheter is not required

              Vials are single-dose and do not contain preservatives

              Arsenic trioxide is a cytotoxic drug; follow special handling and disposal procedures

              Storage

              Unused vials: Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59- 86°F)

              Diluted solutions: Store at room temperature [20-25°C (68-77°F)] for 24 hr and 48 hr when refrigerated

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              Images

              BRAND FORM. UNIT PRICE PILL IMAGE
              arsenic trioxide intravenous
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              1 mg/mL vial
              arsenic trioxide intravenous
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              1 mg/mL vial
              arsenic trioxide intravenous
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              1 mg/mL vial
              arsenic trioxide intravenous
              -
              1 mg/mL vial
              arsenic trioxide intravenous
              -
              1 mg/mL vial
              arsenic trioxide intravenous
              -
              1 mg/mL vial
              arsenic trioxide intravenous
              -
              2 mg/mL vial
              arsenic trioxide intravenous
              -
              2 mg/mL vial

              Copyright © 2010 First DataBank, Inc.

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              Patient Handout

              Patient Education
              arsenic trioxide intravenous

              ARSENIC TRIOXIDE - INJECTION

              (AR-se-nik trye-OX-ide)

              COMMON BRAND NAME(S): Trisenox

              WARNING: Arsenic trioxide is a strong medication that can cause serious, rarely fatal side effects. To decrease your risk, your doctor will monitor you closely during treatment.Rarely, this medication may cause a serious condition called APL differentiation syndrome. Tell your doctor right away if the following effects occur: unusual/unexplained fever, shortness of breath/difficulty breathing, and/or weight gain. Your doctor may direct you to weigh yourself regularly and report any sudden weight gain. Your doctor may also perform certain exams or tests (e.g., lung exam, X-rays) to determine if this syndrome has developed.Rarely, this medication can also cause serious (rarely fatal) heart problems (e.g., AV block, torsades de pointes-type arrhythmias). Tell your doctor if you have any medical history of heart problems (e.g., fast/irregular heartbeat, heart failure), kidney problems, low levels of minerals in your blood (e.g., calcium, potassium, magnesium). Also tell your doctor if you take any medications that increase your risk for these heart problems or low levels of minerals (see also Drug Interactions section). To decrease your risk, your doctor may order a heart rhythm test (EKG) or blood tests before and during treatment.Get medical help right away if you develop severe dizziness, fainting, or fast/irregular heartbeat.This medication may increase your risk of getting a rare but very serious (possibly fatal) brain disorder. This risk may be higher if you have low levels of thiamine (vitamin B1), alcohol use disorder, or difficulty absorbing nutrition from food (malabsorption syndrome). Get medical help right away if you have any of these side effects: clumsiness, loss of coordination/balance, weakness, sudden change in your thinking (such as confusion, difficulty concentrating, memory loss), difficulty talking/walking, seizures, vision changes.

              USES: Arsenic trioxide is used to treat a type of leukemia (acute promyelocytic leukemia-APL).

              HOW TO USE: This medication is given by injection into a vein by a health care professional over 2 hours, usually once daily or as directed by your doctor. The injection may be injected more slowly (e.g., over 4 hours) if you have a reaction to the medication such as dizziness, flushing, or fast heartbeat.The dosage, treatment schedule, and length of treatment are based on your weight, medical condition, and response to treatment. Your doctor will order tests (e.g., EKG, blood minerals) to find the right dose for you. Your next dose may need to be rescheduled if your heartbeat or blood tests are abnormal.

              SIDE EFFECTS: See also Warning section.Pain/redness/swelling at the injection site, nausea, vomiting, diarrhea, stomach/abdominal pain, tiredness, cough, headache, or dizziness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.Both leukemia and this medication can lower the body's ability to fight an infection. Tell your doctor promptly if you develop any signs of an infection such as unexplained fever, chills, or persistent sore throat.Tell your doctor right away if you have any serious side effects, including: easy bleeding/bruising, nosebleed, increased thirst, signs of kidney problems (such as change in the amount of urine), bone/joint pain, decreased appetite, unusual weight loss, muscle pain/stiffness/spasm, numbness/tingling, swollen hands/legs/feet, symptoms of liver disease (such as nausea/vomiting that doesn't stop, severe stomach/abdominal pain, yellowing eyes/skin, dark urine).Get medical help right away if you have any very serious side effects, including: chest pain, severe dizziness/fainting, fast/irregular heartbeat, coughing up blood, mental/mood changes (e.g., confusion), muscle weakness, bloody/black/tarry stool, vomit that looks like coffee grounds.People who are treated with this medication may rarely get other cancers. Consult your doctor for more details.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice any other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

              PRECAUTIONS: See also Warning section.Before using this medication, tell your doctor or pharmacist if you are allergic to arsenic; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially: kidney disease, diabetes.Arsenic trioxide may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using arsenic trioxide, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using arsenic trioxide safely.This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Arsenic trioxide can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).Tell your doctor if you are pregnant or plan to become pregnant. Female patients should have a pregnancy test before starting this medication. You should not become pregnant while using arsenic trioxide. Arsenic trioxide may harm an unborn baby. Female patients should ask about reliable forms of birth control while using this medication and for 6 months after stopping treatment. Male patients with female partners should ask about reliable forms of birth control while using this medication and for 3 months after stopping treatment. If you or your partner become pregnant, talk to your doctor right away about the risks and benefits of this medication.This medication passes into breast milk. Because of the possible risk to the infant, breast-feeding is not recommended while using this drug and for 2 weeks after the last dose. Consult your doctor before breast-feeding.

              DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Many drugs besides arsenic trioxide may affect the heart rhythm (QT prolongation), including amiodarone, dofetilide, pimozide, procainamide, quinidine, sotalol, macrolide antibiotics (such as erythromycin), ziprasidone, among others. Before using arsenic trioxide, report all medications you are currently using to your doctor or pharmacist.Some products that may interact with this drug are: aspirin and other NSAIDs (e.g., ibuprofen), drugs that lower blood minerals (e.g., amphotericin B), drugs that may harm the immune system (e.g., chemotherapy).Check all prescription and nonprescription medicine labels carefully since many contain pain relievers/fever reducers (NSAIDs such as ibuprofen, naproxen, or aspirin) that may increase your risk of bleeding. Low-dose aspirin should be continued if prescribed by your doctor for heart attack or stroke prevention (usually 81-162 milligrams a day). Consult your doctor or pharmacist for more details.

              OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: seizures, muscle weakness, confusion.

              NOTES: Lab and/or medical tests (such as electrolytes, complete blood count, EKG, blood glucose, liver function tests, thiamine levels) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

              MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

              STORAGE: Not applicable. This medication is given in a clinic and will not be stored at home.

              MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

              Information last revised September 2021. Copyright(c) 2021 First Databank, Inc.

              IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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              Formulary

              FormularyPatient Discounts

              Adding plans allows you to compare formulary status to other drugs in the same class.

              To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

              Adding plans allows you to:

              • View the formulary and any restrictions for each plan.
              • Manage and view all your plans together – even plans in different states.
              • Compare formulary status to other drugs in the same class.
              • Access your plan list on any device – mobile or desktop.

              The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

              Tier Description
              1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
              2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
              3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
              4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              NC NOT COVERED – Drugs that are not covered by the plan.
              Code Definition
              PA Prior Authorization
              Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
              QL Quantity Limits
              Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
              ST Step Therapy
              Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
              OR Other Restrictions
              Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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              Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.