dexrazoxane (Rx)

Brand and Other Names:Totect, Zinecard
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

powder for injection

  • 250mg
  • 500mg
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Doxorubicin-Induced Cardiomyopathy, Prophylaxis (Zinecard/Generic)

10:1 ratio of dexrazoxane to doxorubicin dose (500 mg/m² dexrazoxane : 50 mg/m² doxorubicin) slow IVP or rapid drip IV infusion

Give doxorubicin within 30 minutes of beginning of dexrazoxane infusion

Monitor cardiac function and discontinue combination therapy in patients who develop a decline in left ventricular ejection fraction or develop clinical congestive failure

Renal impairment

  • Moderate-to-severe: 5x doxorubicin dose

Anthracycline Extravasation (Totect)

Give first infusion within 6 hr after extravastion

Day 1: 1000 mg/m² IV; not to exceed 2000 mg 

Day 2: 1000 mg/m² IV; not to exceed 2000 mg

Day 3: 500 mg/m² IV; not to exceed 1000 mg

Infuse IV over 1-2 hr; begin treatment within 6 hr of extravasation

Renal Impairment

CrCl <40 mL/min: Reduce dose by 50%

Safety and efficacy not established

Cardiomyopathy Prophylaxis (Orphan)

Orphan designation for prevention of anthracyline-induced cardiomyopathy in children and adolescents

Sponsor

  • Satiscor, LLC; 45 Marine Road; Boston, MA 02127
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Interactions

Interaction Checker

and dexrazoxane

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            Frequency Not Defined

            Most ADRs due to concurrent antineoplastic treatment

            Injection site pain, phlebitis, and increased myelosuppression are only major specific ADR

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            Warnings

            Contraindications

            Hypersensitivity

            Use (Zinecard) in chemotherapy when an anthracycline is not being administered

            Cautions

            May interfere with activity of antineoplastic drugs; do NOT initiate until cumulative doxorubicin dose reaches 300 mg/m²

            Do NOT give doxorubicin prior to dexrazoxane

            Does not eliminate potential for anthracycline-induced cardiac toxicity; monitor cardiac function carefully

            Secondary malignancies (eg, AML, MDS) reported with combination chemotherapy

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            Pregnancy & Lactation

            Pregnancy Category: D; animal studies have shown embryotoxic and teratogenic effects during the period of organogenesis at doses significantly lower than the clinically recommended dose

            Lactation: Unknown if excreted in human breast milk; not recommended

            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

            EDTA derivative; intracellular chelating agent; exact mechanism not understood

            Pharmacokinetics

            Half-Life: 2-2.5 hr

            Peak Plasma: 36.5 mcg/mL

            Protein Bound: No

            Vd: 22.4 L/m²

            Renal Clearance: 3.35 L/hr/sq.meter

            Excretion: Urine (42%)

            Dialyzable: Yes

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            Administration

            Zinecard/generic

            IV Preparation

            • Reconstitute w/ supplied Na-lactate 1/6M diluent (25 mL for 250 mg vial, 50 mL for 500 mg vial) to obtain 10 mg/mL soln
            • Reconstituted soln may be further diluted with either NS or D5W to a concentration of 1.3-5 mg/mL in intravenous infusion bags
            • Reconstituted & diluted solns stable for 6 hr at room temp or in fridge

            IV Administration

            • Doxorubicin should not be given prior to dexrazoxane
            • Give dexrazoxane by slow IVP or rapid drip IV infusion over 5-15 min
            • Give doxorubicin within 30 min after beginning of dexrazoxane infusion

            Storage

            • Store intact vials at controlled room temp

            Totect

            IV Preparation

            • Do not mix or administer with any other drug during infusion
            • 3 days of Tx for 1 pt contains 10 vials Totect & 10 vials diluent
            • Before infusion, mix each vial (500 mg) w/ 50 mL diluent
            • THEN, inject all required mixed solutions into the same 1000 mL NS bag
            • Inspect visually for particulate matter prior to administration; should be slight yellow, discard if ppt visible
            • Use within 2 hr of preparation
            • Discard unused soln after 2 hr

            IV Administration

            • Infuse over 1-2 hr
            • Use large caliber vein in area other than one affected by extravasation
            • Remove cooling packs from area at least 15 min before Totect administration
            • Start Tx on day 2 & 3 at same hour (±3 hr) as on first day

            Storage

            • Stable for 4 hr from time of mixing/diluting when stored below 25°C (77°F)
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            Images

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            Formulary

            FormularyPatient Discounts

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            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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