Dexrazoxane Injection
Dexrazoxane Injection is an intravenous heart-protecting (cytoprotective) medicine used to reduce the risk and severity of heart muscle damage from doxorubicin in women with metastatic breast cancer.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 5 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
How we combine label and product data →
Dexrazoxane is an IV heart-protecting medicine, a specialist add-on, on the market since at least 2005 and available as a generic, that reduces heart muscle damage from the chemotherapy drug doxorubicin in women with metastatic breast cancer, likely by binding iron and blocking damaging free radicals. Most of what people notice (nausea, tiredness, hair loss, mouth sores) overlaps with the chemotherapy itself, but it can push blood counts lower. Call your care team about fever or chills, and report new breathlessness or swelling, since it lowers heart risk without removing it. It is started only after a set amount of doxorubicin has been given, never at the first cycle.
Clinical pearls
- It must run as an infusion over about 15 minutes, never a rapid IV push, and always before the doxorubicin.
- Blood counts are checked before each course and heart function throughout, and treatment waits if counts are too low.
- Women who could become pregnant need effective birth control during treatment and 6 months after; men with such partners, 3 months.
- Reduced kidney function can call for a lower dose, so tell the team about any kidney problems.
Patient information guide — a plain-language walkthrough of Dexrazoxane Injection, written from its FDA label.
What Dexrazoxane Injection is used for
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Dexrazoxane Injection has one supported use:
- Reducing the incidence and severity of cardiomyopathy (heart muscle weakening) from doxorubicin in women with metastatic breast cancer who have received a set cumulative doxorubicin dose and will continue doxorubicin to maintain tumor control.
- It is not for use when doxorubicin treatment is first starting.
How Dexrazoxane Injection works
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Dexrazoxane is a cytoprotective agent, meaning it protects cells. It is a cyclic derivative of EDTA that enters cells.
Laboratory studies suggest it is converted inside cells to a form that binds iron and interferes with iron-driven free radicals. These are thought to contribute to heart damage from anthracycline drugs. The exact mechanism is not fully understood.
Dexrazoxane Injection dosage
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Dexrazoxane Injection is given into a vein by a healthcare professional. It is mixed and diluted first, then infused over about 15 minutes.
- It is never given as a rapid IV push.
- It is given before doxorubicin, in a set ratio to the doxorubicin dose.
- The dose is reduced for people with reduced kidney function.
Because it is given in a clinical setting, missed doses are handled by your care team.
Dosing details from the FDA-approved label
From the Dexrazoxane Injection prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Cardiomyopathy prevention with doxorubicin therapy (dexrazoxane for injection to doxorubicin dosage ratio)
- Administer by intravenous infusion over 15 minutes
- Do not administer via intravenous push
- Recommended dosage ratio of dexrazoxane for injection to doxorubicin is 10:1 (e.g., 500 mg/m2 dexrazoxane for injection to 50 mg/m2 doxorubicin)
- Do not administer doxorubicin before dexrazoxane for injection
- Reconstitute vial contents and dilute before use
- Patients with renal impairment (creatinine clearance)
- Reduce dose by 50%
- The label text provided is cut off after 'creatinine clearance', so the threshold is not stated
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION Reconstitute vial contents and dilute before use. (2.3) Administer Dexrazoxane for injection by intravenous infusion over 15 minutes. DO NOT ADMINISTER VIA AN INTRAVENOUS PUSH. ( 2.1 , 2.3 ) The recommended dosage ratio of dexrazoxane for injection to doxorubicin is 10:1 (e.g., 500 mg/m 2 dexrazoxane for injection to 50 mg/m 2 doxorubicin). Do not administer doxorubicin before dexrazoxane for injection. ( 2.1 ) Reduce dose by 50% for patients with creatinine clearance <40 mL/min. ( 2.2 , 8.7 ) 2.1 Recommended Dose Administer dexrazoxane for injection via intravenous infusion over 15 minutes. DO NOT ADMINISTER VIA AN INTRAVENOUS PUSH. The recommended dosage ratio of dexrazoxane for injection to doxorubicin is 10:1 (e.g., 500 mg/m 2 dexrazoxane for injection to 50 mg/m 2 doxorubicin). Do not administer doxorubicin before dexrazoxane for injection. Administer doxorubicin within 30 minutes after the completion of dexrazoxane for injection infusion. 2.2 Dose Modifications Dosing in Patients with Renal Impairment Reduce dexrazoxane for injection dosage in patients with moderate to severe renal impairment (creatinine clearance values less than 40 mL/min) by 50% (dexrazoxane for injection to doxorubicin ratio reduced to 5:1; such as 250 mg/m 2 dexrazoxane for injection to 50 mg/m 2 doxorubicin) [see Use in Specific Populations (8.6 ) and Clinical Pharmacology (12.3 )] . Dosing in Patients with Hepatic Impairment Since a doxorubicin dose reduction is recommended in the presence of hyperbilirubinemia, reduce the dexrazoxane for injection dosage proportionately (maintaining the 10:1 ratio) in patients with hepatic impairment. 2.3 Preparation and Administration Preparation and Handling of Infusion Solution Reconstitute dexrazoxane for injection with Sterile Water for Injection, USP. Reconstitute with 25 mL for a dexrazoxane for injection 250 mg vial and 50 mL for a dexrazoxane for injection 500 mg vial to give a concentration of 10 mg/mL. Dilute the reconstituted solution further with Lactated Ringer’s Injection, USP to a concentration of 1.3 to 3.0 mg/mL in intravenous infusion bags for intravenous infusion.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Dexrazoxane Injection side effects
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Common side effects
- Pain at the injection site
- Hair loss
- Nausea and vomiting
- Tiredness or feeling unwell
- Loss of appetite
- Mouth sores
- Fever
- Infection
When to get medical help
- Call your care team about fever, chills or other signs of infection, since blood counts can drop lower when this is combined with chemotherapy.
- Tell your care team about unusual bruising or bleeding.
- Report new shortness of breath, swelling or other heart symptoms, because the drug does not fully remove the risk of heart damage.
- Tell your doctor right away if you are or may be pregnant.
- Report pain, redness or swelling at the infusion site.
Dexrazoxane was studied alongside chemotherapy, so many side effects overlap with chemotherapy effects. Reported effects included:
- Pain on injection (more common than with placebo)
- Hair loss
- Nausea and vomiting
- Fatigue or malaise
- Loss of appetite
- Mouth sores
- Fever and infection
- Diarrhea
More severe drops in white blood cells and platelets were seen with dexrazoxane plus chemotherapy. Report fever, infection signs, bleeding or heart symptoms promptly.
Dexrazoxane Injection warnings and precautions
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- Lower blood counts: it can add to chemotherapy's effect on bone marrow, so blood counts are checked before and during each course.
- Timing: do not start it with the beginning of doxorubicin, because it may interfere with the chemotherapy's anti-tumor activity.
- Heart risk remains: heart function (LVEF) is monitored before and periodically during treatment.
- Secondary cancers: acute myeloid leukemia and myelodysplastic syndrome have been reported, including in children in studies. It is not indicated for children.
- Pregnancy: it can cause fetal harm.
Dexrazoxane Injection interactions
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The label reports no identified drug interactions. Still, keep these in mind:
- Non-anthracycline chemotherapy regimens: it should not be used with them.
- Other chemotherapy: it can add to blood count lowering.
Interactions listed in the FDA-approved label
From the Dexrazoxane Injection prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Any drug: No drug interactions have been identified.
Read the label’s full interactions text
7 DRUG INTERACTIONS No drug interactions have been identified [see Clinical Pharmacology ( 12.3 )] .
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Dexrazoxane Injection
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- Pregnancy: it can harm a fetus. A pregnancy test is advised before starting.
- Contraception: women should use effective birth control during treatment and for 6 months after. Men with partners who could become pregnant should do so for 3 months after.
- Breastfeeding: avoid during treatment and for 2 weeks after the last dose.
- Kidney problems: exposure may be higher, and the dose is reduced.
- Children: safety and effectiveness have not been established.
- Older adults: dose selection should be cautious.
- Male fertility may be impaired based on animal studies.
Dexrazoxane Injection overdose
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There is no known antidote for dexrazoxane. Suspected overdose is managed with supportive care until low blood counts and related problems resolve, including treating infections, managing fluids and maintaining nutrition. The label suggests it could be removed by dialysis.
What Dexrazoxane Injection does in the body
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Dexrazoxane acts as a cytoprotective agent. It is converted inside cells to a chelating (iron-binding) form that interferes with iron-mediated free radical generation. That process is thought to contribute in part to heart damage from anthracyclines.
How your body processes Dexrazoxane Injection
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After an IV infusion, dexrazoxane spreads quickly through total body water and is not bound to plasma proteins. Its half-life is roughly 2 to 2.5 hours. About 42% of a dose is excreted in the urine, so the kidneys play an important role in clearing it.
Clearance is lower in people with moderate to severe kidney impairment, leading to higher drug exposure.
How to store Dexrazoxane Injection
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Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) .
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Dexrazoxane Injection: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Dexrazoxane Injection — the kind of thing our pharmacy team would talk through with you at the counter.
What is this medicine for?
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How will I get it?
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What side effects should I expect?
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When should I call my care team?
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Does it completely prevent heart damage?
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What about pregnancy and breastfeeding?
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Is Dexrazoxane Injection available over the counter?
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When was Dexrazoxane Injection first available?
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Who makes Dexrazoxane Injection?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Dexrazoxane Injection on HelloPharmacist
Dexrazoxane Injection forms and strengths (how it comes)
Dexrazoxane Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Injection
How this form is used
- Dexrazoxane for injection is used to reduce the incidence and severity of cardiomyopathy from doxorubicin in women with metastatic breast cancer who have reached a set cumulative doxorubicin dose and are continuing it.
- Dexrazoxane for injection is reconstituted and diluted, then given as an intravenous infusion over 15 minutes.
- Dexrazoxane for injection must not be given as an intravenous push.
- Dexrazoxane for injection is given before doxorubicin, never after.
Dexrazoxane Injection on the U.S. market: products, makers and brands
How Dexrazoxane Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
7 companies list 26 Dexrazoxane Injection product records with the FDA, mostly as injection; the earliest marketing or approval year on record is 1995. Brand names on the directory include Totect, Zinecard; the rest are generics.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Dexrazoxane Injection is used (Medicaid data)
A general measure of how commonly Dexrazoxane Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Dexrazoxane Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Dexrazoxane Injection prescribed? Of the 1,599 medications we measure, Dexrazoxane Injection ranks #1,433 by Medicaid prescriptions — more than 10% of them.
Utilization by Dexrazoxane Injection product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
dexrazoxane 500 MG Injection Most dispensed
Summed across the 3 of 10 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1736590
dexrazoxane 250 MG Injection
Summed across the 3 of 8 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1736585
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Dexrazoxane Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 6 of 18 listed Dexrazoxane Injection NDCs with Medicaid activity.
Compare Dexrazoxane Injection products
A representative set of FDA-listed product records for Dexrazoxane Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 500 mg/50 mL | Intravenous | Almaject, Inc. × 8 listings | ANDA | View NDC → |
| 500 mg/50 mL | Intravenous | Breckenridge Pharmaceutical, Inc. × 2 listings | ANDA | View NDC → |
| 500 mg | Intravenous | Clinigen Limited | NDA | Find on DailyMed ↗ |
| 250 mg/25 mL | Intravenous | Fosun Pharma USA Inc. × 2 listings | ANDA | View NDC → |
| 500 mg/50 mL | Intravenous | Fosun Pharma USA Inc. × 2 listings | ANDA | View NDC → |
| 250 mg/25 mL | Intravenous | Gland Pharma Limited × 2 listings | ANDA | View NDC → |
| 500 mg/50 mL | Intravenous | Gland Pharma Limited × 3 listings | ANDA | View NDC → |
| 10 mg/mL | Intravenous | Hikma Pharmaceuticals USA Inc. × 2 listings | ANDA | View NDC → |
| 250 mg | Intravenous | Hikma Pharmaceuticals USA Inc. | ANDA | View NDC → |
| 500 mg | Intravenous | Hikma Pharmaceuticals USA Inc. | ANDA | View NDC → |
| 250 mg/25 mL | Intravenous | Novadoz Pharmaceuticals LLC | ANDA | View NDC → |
| 500 mg/50 mL | Intravenous | Novadoz Pharmaceuticals LLC | ANDA | View NDC → |
Showing 26 of 26 products — FDA National Drug Code Directory. See every product, package size and price: browse all 26 Dexrazoxane Injection NDCs →
Dexrazoxane Injection side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Dexrazoxane Injection — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Dexrazoxane Injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Dexrazoxane Injection FDA approval history
How Dexrazoxane Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Dexrazoxane Injection recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Dexrazoxane recalls since July 2021.
✅No Dexrazoxane recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 42736 1 dose form · 2 strengths
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Dose form (SCDF) Injection RxCUI 1736584In current FDA listings
Look up RxCUI 42736 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Dexrazoxane Injection supply and shortage status
Whether Dexrazoxane Injection is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Dexrazoxane Injection brand names
Dexrazoxane Injection is sold under 2 brand names in the FDA directory — Totect, Zinecard. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Dexrazoxane Injection: manufacturers and labelers
7 companies list Dexrazoxane Injection products with the FDA. By number of product records, the largest are Almaject, Inc., Gland Pharma Limited, Fosun Pharma USA Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Dexrazoxane Injection drug class (RxNorm)
Dexrazoxane Injection belongs to the Cytoprotective Agent class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Dexrazoxane Injection page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Hikma Pharmaceuticals USA Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →