Dosing & Uses
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
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (1)
- ropeginterferon alfa 2b
ropeginterferon alfa 2b, dexrazoxane. 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.
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.
Adverse Effects
Frequency Not Defined
Most ADRs due to concurrent antineoplastic treatment
Injection site pain, phlebitis, and increased myelosuppression are only major specific ADR
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
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.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
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
- 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
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
- 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
- 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
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| dexrazoxane HCl intravenous - | 500 mg vial |  | |
| dexrazoxane HCl intravenous - | 500 mg vial |  | |
| dexrazoxane HCl intravenous - | 250 mg vial |  | |
| dexrazoxane HCl intravenous - | 500 mg vial |  | |
| dexrazoxane HCl intravenous - | 250 mg vial |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
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 lasts or gets worse, 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 sore throat that doesn't go away, fever), 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: Lab and/or medical tests (such as complete blood counts, heart function) 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.
Information last revised December 2022. 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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