Dosing & Uses
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
Consolidation cycle
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
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
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 (122)
- adagrasib
adagrasib, arsenic trioxide. Either increases effects of the other by QTc interval. Avoid or Use Alternate Drug. Each drug prolongs the QTc interval, which may increased the risk of Torsade de pointes, other serious arryhthmias, and sudden death. If coadministration unavoidable, more frequent monitoring is recommended for such patients.
- 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.
- amisulpride
amisulpride and arsenic trioxide both increase QTc interval. Avoid or Use Alternate Drug. ECG monitoring is recommended if coadministered.
- 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.
- anagrelide
anagrelide 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.
- asenapine
asenapine and arsenic trioxide both increase QTc interval. Avoid or Use Alternate Drug.
- asenapine transdermal
asenapine transdermal 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.
- buprenorphine
buprenorphine and arsenic trioxide both increase QTc interval. Avoid or Use Alternate Drug.
- buprenorphine buccal
buprenorphine buccal and arsenic trioxide both increase QTc interval. Avoid or Use Alternate Drug.
- buprenorphine subdermal implant
buprenorphine subdermal implant and arsenic trioxide both increase QTc interval. Avoid or Use Alternate Drug.
- buprenorphine transdermal
buprenorphine transdermal and arsenic trioxide both increase QTc interval. Avoid or Use Alternate Drug.
- buprenorphine, long-acting injection
buprenorphine, long-acting injection and arsenic trioxide 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.
- donepezil
donepezil and arsenic trioxide 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.
- eliglustat
eliglustat and arsenic trioxide 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.
- fingolimod
fingolimod and arsenic trioxide both increase QTc interval. Avoid or Use Alternate Drug.
- 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.
- gadobenate
gadobenate and arsenic trioxide both increase QTc interval. Avoid or Use Alternate Drug.
- gemifloxacin
gemifloxacin and arsenic trioxide both increase QTc interval. Avoid or Use Alternate Drug.
- gilteritinib
gilteritinib and arsenic trioxide 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.
- granisetron
granisetron and arsenic trioxide both increase QTc interval. Avoid or Use Alternate Drug.
- 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.
- hydroxyzine
hydroxyzine 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.
- isoflurane
isoflurane and arsenic trioxide both increase QTc interval. Avoid or Use Alternate Drug.
- 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.
- lithium
lithium and arsenic trioxide 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.
- mirtazapine
mirtazapine and arsenic trioxide 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.
- olanzapine
olanzapine and arsenic trioxide 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.
- oxaliplatin
oxaliplatin and arsenic trioxide both increase QTc interval. Avoid or Use Alternate Drug.
- 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.
- primaquine
primaquine and arsenic trioxide 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.
- ropeginterferon alfa 2b
ropeginterferon alfa 2b, arsenic trioxide. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.
- 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.
- sertraline
sertraline and arsenic trioxide both increase QTc interval. Avoid or Use Alternate Drug.
- sevoflurane
sevoflurane and arsenic trioxide both increase QTc interval. Avoid or Use Alternate Drug.
- siponimod
siponimod and arsenic trioxide both increase QTc interval. Avoid or Use Alternate Drug.
- solifenacin
solifenacin and arsenic trioxide both increase QTc interval. Avoid or Use Alternate Drug.
- sotalol
arsenic trioxide and sotalol both increase QTc interval. Avoid or Use Alternate Drug.
- sunitinib
sunitinib and arsenic trioxide both increase QTc interval. Avoid or Use Alternate Drug.
- tacrolimus
tacrolimus and arsenic trioxide both increase QTc interval. Avoid or Use Alternate Drug.
- telavancin
arsenic trioxide and telavancin both increase QTc interval. Avoid or Use Alternate Drug.
- tetrabenazine
tetrabenazine and arsenic trioxide 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.
- vorinostat
vorinostat and arsenic trioxide both increase QTc interval. Avoid or Use Alternate Drug.
Monitor Closely (50)
- 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. Use Caution/Monitor. At the maximum recommended dose, deutetrabenazine does not prolong QT interval to a clinically relevant extent. Certain circumstances may increase risk of torsade de pointes and/or sudden death in association with drugs that prolong the QTc interval (eg, bradycardia, hypokalemia or hypomagnesemia, coadministration with other drugs that prolong QTc interval, presence of congenital QT prolongation).
- efavirenz
efavirenz and arsenic trioxide both increase QTc interval. Use Caution/Monitor.
- 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.
- floxuridine
floxuridine and arsenic trioxide both increase QTc interval. Use Caution/Monitor.
- 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.
- levoketoconazole
arsenic trioxide and levoketoconazole both increase QTc interval. Use Caution/Monitor.
- 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.
- valbenazine
valbenazine 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)
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
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
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.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)
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
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| 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 |  | |
| arsenic trioxide intravenous - | 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 - | 1 mg/mL vial |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
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 (such as lung exam, X-rays) to determine if this syndrome has developed.Rarely, this medication can also cause serious (rarely fatal) heart problems (such as AV block, torsades de pointes-type arrhythmias). Tell your doctor if you have any medical history of heart problems (such as fast/irregular heartbeat, heart failure), kidney problems, low levels of minerals in your blood (such as 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 (such as 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 (such as 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 last or get worse, 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 sore throat that doesn't go away, unexplained fever, or chills.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 (such as 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.Tell your health care professional that you are using arsenic trioxide before having any immunizations/vaccinations. 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. You should not become pregnant while using arsenic trioxide. Arsenic trioxide may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Women using this medication should ask about reliable forms of birth control during treatment and for 6 months after the last dose. Men using this medication should ask about reliable forms of birth control during treatment and for 3 months after the last dose. If you or your partner becomes 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: drugs that lower blood minerals (such as amphotericin B), drugs that may harm the immune system (such as chemotherapy), other drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, NSAIDs such as ibuprofen/naproxen, "blood thinners" such as warfarin/dabigatran).Aspirin can increase the risk of bleeding when used with this medication. However, if your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually 81-162 milligrams a day), you should continue taking it unless your doctor instructs you otherwise. Ask 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 January 2023. Copyright(c) 2023 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.
Formulary
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