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arsenic trioxide (Rx)Brand and Other Names:Trisenox

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 1mg/mL (10mg ampule)
more...

Refractory or Relapsed Acute Promyelocytic Leukemia

0.15 mg/kg IV qDay infused over 1-2 hr until bone marrow remission; not to exceed 60 doses 

Wait 3-6 weeks, THEN

0.15 mg/kg IV qDay x25 doses (administered over time period of up to 5 weeks)

Monitor: ECG, serum electrolytes

Orphan Indications

Treatment of myelocytic leukemia subtypes MO, M1, M2, M4, M5, M6, and M7

Treatment of chronic lymphocytic leukemia

Treatment of malignant glioma

Treatment of myelodysplastic syndrome

Treatment of multiple myeloma

Treatment of liver cancer

Treatment of chronic myeloid leukemia

Treatment of amyotrophic lateral sclerosis

Treatment of acute promyelocytic leukemia (oral capsule)

Orphan indications 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

Dosage Forms & Strengths

injectable solution

  • 1mg/mL (10mg ampule)
more...

Refractory or Relapsed Acute Promyelocytic Leukemia

<4 years: Safety and efficacy not established

≥4 years: 0.15 mg/kg IV qDay infused over 1-2 hr 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)

Monitor: ECG, serum electrolytes

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Interactions

Interaction Checker

arsenic trioxide and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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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/decr 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%)

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            Warnings

            Black Box Warnings

            The drug should be administered under the supervision of an experienced cancer chemotherapy physician

            May cause retinoic-acid-acute promyelocytic leukemia (RA-APL) syndrome or APL differentiation syndrome (may be fatal). APL syndrome is characterized by fever, dyspnea, weight gain, pulmonary infiltrates, and pleural or pericardial effusions with or without leukocytosis.

            At first signs of APL, initiate high-dose steroids (dexamethasone IV 10 mg/kg q12hr for at least 3 days) until symptoms abate.

            May prolong the QT interval. Increases the risk of torsade de pointes or complete AV block. Risk factors related to extent of QT prolongation, concurrent drug therapy (drugs that may prolong QT), history of torsade de pointes, concurrent potassium-wasting diuretics, hypokalemia, or hypomagnesemia.

            Preexisting electrolyte abnormalities should be corrected prior to therapy. Perform baseline 12-lead ECG and obtain serum electrolytes (potassium, calcium, magnesium) and creatinine levels prior to treatment. Obtain ECG weekly and more frequently for unstable patients during induction and consolidation phases. Monitor electrolyte profiles at least twice weekly and more frequently for unstable patients during the induction phase and at least weekly during the consolidation phase.

            Discontinue drugs known to prolong QT interval. If baseline QTc >500 msec, correct and reassess QTc prior to therapy initiation. Maintain potassium concentrations >4 mEq/L during therapy. Maintain magnesium concentrations >1.8 mg/dL. Absolute QT interval >500 msec necessitates reassessment.

            Contraindications

            Hypersensitivity

            Cautions

            Use caution in hepatic or renal impairment

            Prolongs QTc interval

            Risk of APL differentiation synd & hyperleukocytosis

            Can cause fetal harm; advise of potential risk to a fetus and use of effective contraception

            During therapy, maintain potassium, concentrations above 4 mEq/L and magnesium concentrations above 1.8 mg/dL to avoid cardiac conduction abnormalities

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

            Monitor patient’s electrolyte, hematologic and coagulation profiles and obtain ECGs

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            Pregnancy & Lactation

            Pregnancy Category: D

            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.

            more...
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            Pharmacology

            Mechanism of Action

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

            Pharmacokinetics

            Half-life: 72 hr

            Metabolism: Liver

            Peak plasma time: 10-24 hr

            Vd: 562 L

            Excretion: Urine (15%)

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            Administration

            IV Incompatibilities

            Do not mix with other medications

            IV Preparation

            Dilute in 100-250 mL D5W or NS

            Does not contain a preservative; properly discard unused portion

            IV Administration

            Infuse over 1-2 hr

            If acute vasomotor reactions occur, may infuse over a maximum of 4 hr

            Does not require administration via a central venous catheter

            Storage

            Store at room temp; do not freeze

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            Images

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            Formulary

            FormularyPatient Discounts

            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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