dexrazoxane (Rx)

Brand and Other Names:Totect, Zinecard
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

powder for injection

  • 250mg
  • 500mg

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%

Hepatic Impairment

Not studied; not recommended

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

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    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

            Treatment is associated with leukopenia, neutropenia, and thrombocytopenia; grade 2-4 decreased white blood cells (73%), decreased neutrophils (61%), and decreased platelets (26%) occurred in patients; febrile neutropenia occurred in 2.5% of patients; monitor complete blood counts during treatment; myelosuppression and cytotoxic potential and cytotoxic chemotherapy (with a nadir occurring on days 10-12) may be additive to that of chemotherapy administered alone

            Hypersensitivity reactions including anaphylactic reaction, angioedema, skin reactions, bronchospasm, respiratory distress, hypotension and loss of consciousness have occurred in patients treated with dexrazoxane products and anthracyclines; previous history of allergy to dexrazoxane products should be carefully considered prior to administration; consider permanent discontinuation in patients with severe hypersensitivity reactions

            Therapy has not been studied in patients with hepatic impairment; since liver dysfunction (increases in transaminases and bilirubin) may occur (especially after doses of above 1000 mg/m² dexrazoxane), it is recommended that routine liver function tests be performed before each administration of dexrazoxane in patients with known liver function disorders; use in patients with hepatic impairment not recommended

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            Pregnancy & Lactation

            Pregnancy

            Based on findings from animal studies and mechanism of action, therapy can cause fetal harm when administered to a pregnant woman; limited available data in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes

            In animal reproduction studies, intravenous administration of dexrazoxane to pregnant rats and rabbits during organogenesis resulted in teratogenicity at maternal doses that were approximately 0.1 and 0.2 times, respectively, the human dose of 1000 mg/m²; advise pregnant women of potential risk to fetus

            Pregnancy testing

            • Perform pregnancy testing prior to initiation of chemotherapy; repeat pregnancy testing prior to administration of therapy not recommended, because treatment of extravasation of anthracycline chemotherapy should not be delayed

            Contraception

            • Females: Therapy can cause fetal harm when administered to a pregnant woman; because of potential for genotoxicity, advise females of reproductive potential to use effective contraception during treatment and for 6 months following the final dose
            • Males: Because of potential for genotoxicity, advise males with female partners of reproductive potential to use effective contraception during treatment and for 3 months following the final dose

            Infertility

            • Males: Based on findings in animal studies, therapy may impair fertility in males of reproductive potential; not known whether these effects on fertility are reversible

            Lactation

            There are no data on presence in human milk, effects on breastfed child, or on milk production; because of potential for serious adverse reactions, such as myelosuppression, in a breastfed child, advise women not to breastfeed during treatment and for 2 weeks following final dose

            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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            Formulary

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
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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.