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

Zinecard, Totect, and generic

Indicated for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a cumulative doxorubicin dose of 300 mg/m2 and who will continue to receive doxorubicin therapy to maintain tumor control

Do not use with initiation of doxorubicin therapy

Infuse IV over 15 minutes before doxorubicin administration

Do not administer via an IV push

Dosage ratio of dexrazoxane to doxorubicin is 10:1 (eg, 500 mg/m2 dexrazoxane to 50 mg/m2 doxorubicin)

Administer doxorubicin within 30 minutes after completion of dexrazoxane infusion

Extravasation

Totect only

Infuse IV over 1-2 hr once daily for 3 consecutive days; begin treatment within 6 hr of extravasation

Initiate first infusion as soon as possible and within 6 hr after extravasation

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

Dosage Modifications

Renal impairment

  • Mild (CrCl ≥40 mL/min): No dosage adjustment necessary
  • Moderate-to-severe (CrCl <40 mL/min): Reduce dose by 50% (dexrazoxane to doxorubicin ratio reduced to 5:1; such as dexrazoxane 250 mg/m2 to doxorubicin 50 mg/m2)

Hepatic impairment

  • Extravasation (Totect): Not recommended
  • Cardiomyopathy
    • Reduce dosage proportionately (maintaining the 10:1 ratio) in patients with hepatic impairment, since a doxorubicin dose reduction is recommended in the presence of hyperbilirubinemia

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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            Contraindicated (0)

              Serious - Use Alternative (0)

                Monitor Closely (4)

                • acalabrutinib

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

                • hydroxyurea

                  dexrazoxane, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.

                • lomustine

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

                • zidovudine

                  dexrazoxane, zidovudine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of myelosuppression.

                Minor (2)

                • aspirin rectal

                  aspirin rectal increases levels of dexrazoxane by unspecified interaction mechanism. Minor/Significance Unknown.

                • choline magnesium trisalicylate

                  choline magnesium trisalicylate increases levels of dexrazoxane by unspecified interaction mechanism. Minor/Significance Unknown.

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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

                IV Incompatibilities

                Do not mix or administer with any other drug during infusion

                IV Preparation

                Visually inspect products for particulate matter and discoloration before administration; discard solutions containing a precipitate

                Use caution when handling and preparing reconstituted solution; use of gloves is recommended

                If powder or solutions contact the skin or mucosae, wash exposed area immediately and thoroughly with soap and water; follow special handling and disposal procedures

                Totect

                • Extravasation
                  • Reconstitute each vial with 50 mL of Sterile Water for Injection (SWI) to obtain 10 mg/mL of reconstituted solution
                  • Reconstituted solution contains no antibacterial preservatives and should be further diluted within 30 min after initial reconstitution
                  • Withdraw calculated volume from reconstituted solution and further dilute into an infusion bag containing 1000 mL of Lactated Ringer injection (LR); do not mix with any other drugs
                • Doxorubicin-induced cardiomyopathy
                  • Reconstitute each vial with 50 mL of SWI; reconstituted solution contains 10 mg/mL
                  • Reconstituted solution contains no antibacterial preservatives and should be further diluted within 30 min after initial reconstitution
                  • Withdraw calculated volume from the reconstituted solution and further dilute to a concentration of 1.3-3 mg/mL in LR
                  • Do not mix with any other drugs

                Zinecard, generic

                • Reconstitute with 25 mL of SWI for a 250-mg vial and 50 mL of SWI for a 500-mg vial; reconstituted solution contains 10 mg/mL
                • Reconstituted solution contains no antibacterial preservatives and should be further diluted within 30 min after initial reconstitution
                • Withdraw calculated volume from the reconstituted solution and further dilute to a concentration of 1.3-3 mg/mL in LR
                • Do not mix with any other drugs

                IV Administration

                Do not mix with other drugs

                Doxorubicin-induced cardiomyopathy

                • Totect, Zinecard, generic
                • Do not administer IV push
                • Infuse final diluted solution IV over 15 minutes before administering the doxorubicin
                • Administer doxorubicin within 30 minutes after the completion of dexrazoxane infusion

                Extravasation

                • Totect only
                • Remove cooling procedures (eg, ice packs) if used, from extravasation area at least 15 minutes before administration in order to allow sufficient blood flow to the area of extravasation
                • Infuse final diluted solution IV over 1-2 hr at room temperature and normal light conditions in a large caliber vein in an extremity/area other than the one affected by the extravasation
                • Start Day 2 and Day 3 treatment at the same hour (+/- 3 hr) as on the first day
                • Regularly examine for extravasation after treatment and until resolution
                • If vesicant compounds other than anthracyclines are being used through the same IV access, (eg, vincristine, mitomycin, and vinorelbine), consider treatments for these other vesicant compounds
                • Not effective against the effects of vesicants other than anthracyclines

                Storage

                Zinecard

                • Unused vials
                  • Store at 20-25ºC (68-77ºF); excursions permitted to 15-30ºC (59-86ºF)
                  • Protect from light
                  • Keep vial in carton until ready for use
                • Reconstituted vials
                  • Stable for 30 min at room temperature or up to 3 hr from time of reconstitution when refrigerated at 2-8ºC (36-46ºF)
                  • pH of resultant solution is 1 to 3
                • Reconstituted solution
                  • Use immediately after further dilution
                  • If not used immediately, stable for 4 hr from time of preparation when stored at room temperature or for up to 12 hr when refrigerated at 2-8ºC (36-46ºF)
                  • For extravasation use: Infusion solutions have a pH of 3.5 to 5.5

                Totect

                • Unused vials

                  • Store at 20-25ºC (68-77ºF); excursions permitted to 15-30ºC (59-86ºF)
                  • Protect from light
                  • Keep vial in carton until ready for use
                • Reconstituted vials

                  • Stable for 30 min at room temperature
                • Reconstituted solution

                  • Use immediately after further dilution
                  • If not used immediately, stable for 4 hr from time of preparation when stored at room temperature or for up to 12 hr when refrigerated between 2-8ºC (36-46ºF)
                  • For extravasation use: Infusion solutions have a pH of 3.5 to 5.5
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                Images

                BRAND FORM. UNIT PRICE PILL IMAGE
                dexrazoxane HCl intravenous
                -
                500 mg vial
                dexrazoxane HCl intravenous
                -
                500 mg vial
                dexrazoxane HCl intravenous
                -
                500 mg vial
                dexrazoxane HCl intravenous
                -
                250 mg vial
                dexrazoxane HCl intravenous
                -
                250 mg vial

                Copyright © 2010 First DataBank, Inc.

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                Patient Handout

                Patient Education
                dexrazoxane HCl intravenous

                DEXRAZOXANE - INJECTION

                (DEX-ra-ZOX-ane)

                COMMON BRAND NAME(S): Zinecard

                USES: Dexrazoxane is used to reduce the risk and severity of heart damage caused by doxorubicin treatment and similar cancer chemotherapy medications. Heart damage limits the length of time you can be treated with doxorubicin. Dexrazoxane allows you to continue doxorubicin treatment for longer. When used for this purpose, dexrazoxane treatment is usually started after you have received several doses of doxorubicin. It is usually not given with the first doses of doxorubicin since doing so may reduce the effectiveness of doxorubicin.

                HOW TO USE: This medication is usually given by injection into a vein by a health care professional.When this medication is used to reduce the risk and severity of heart damage, the doxorubicin dose is usually given within 30 minutes after the start of the dexrazoxane infusion.If skin contact should occur, wash the area with plenty of soap and water. If irritation occurs, contact your doctor right away.Heart damage may occur at any time with doxorubicin treatment, even years after the end of your doxorubicin treatment. Tell your doctor right away if you have symptoms of heart damage such as sudden nighttime shortness of breath, difficulty breathing while lying down, or shortness of breath when active.

                SIDE EFFECTS: Pain at the injection site may occur. If this effect persists or worsens, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: signs of infection (such as fever, persistent sore throat), easy bruising/bleeding.Very rarely, people with cancer who have been treated with this medication have developed other cancers (such as leukemia, lymphoma). 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 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: Before using dexrazoxane, tell your doctor or pharmacist if you are allergic to it; 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 of: kidney disease, liver disease.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Discuss the use of reliable forms of birth control (such as condoms, birth control pills) and the risks and benefits of this medication with your doctor. If you become pregnant or think you may be pregnant, tell your doctor right away.Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using dexrazoxane. Dexrazoxane may harm an unborn baby. Women should ask about reliable forms of birth control while using this medication and for 6 months after stopping treatment. Men 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.It is unknown if this drug passes into breast milk. However, because this drug may have undesirable effects on a nursing infant, breast-feeding while using this drug and for 2 weeks after stopping treatment is not recommended. 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.

                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.

                NOTES: Keep all medical appointments while using this medication. Laboratory and/or medical tests (such as complete blood counts, heart function tests) should be performed periodically to monitor your progress or check for side effects. 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.

                Information last revised August 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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