Mitoxantrone Injection
Mitoxantrone Injection is an intravenous chemotherapy-type medicine used for certain forms of multiple sclerosis, pain from advanced hormone-refractory prostate cancer, and acute nonlymphocytic leukemia in adults.
🧬 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 3 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 →
Mitoxantrone (Novantrone) is a specialist chemotherapy drug, available generically and on the U.S. market since about 2006, given by vein for certain worsening types of multiple sclerosis (MS), advanced hormone-resistant prostate cancer pain, and one adult leukemia; it damages DNA and blocks topoisomerase II, a DNA-repair enzyme. Infusions are usually manageable, though nausea, thinning hair, mouth sores and missed periods are common. The boxed warning covers serious, sometimes fatal heart failure (even years later), severe drops in infection-fighting white blood cells, and a later blood cancer, secondary leukemia. That is why heart tests come before every MS dose and blood counts are checked often.
Clinical pearls
- Tell your care team about any past doxorubicin, daunorubicin or chest radiation, since each raises mitoxantrone's heart risk.
- Speak up right away about pain, redness or swelling at the IV site, because leaking drug can badly damage tissue.
- Women with MS need a pregnancy test before every dose, and anyone who could become pregnant should avoid pregnancy.
- Heart checks continue yearly after MS treatment ends, and people with MS have a firm lifetime dose limit.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Mitoxantrone can cause serious, sometimes fatal heart failure, severe drops in infection-fighting white blood cells, and a later blood cancer called secondary acute myeloid leukemia.
It should be given only by a doctor experienced in chemotherapy. It must go slowly into a vein only. Leakage can severely damage tissue, and it must never be given into the spinal fluid.
Heart failure risk goes up with the total amount received. It is higher with heart disease, prior chest radiation, or earlier treatment with similar drugs. Heart function is tested before treatment and, in MS, before every dose and yearly after stopping. People with MS must not exceed a lifetime dose limit.
Blood counts are checked often. Watch for infection signs, shortness of breath or swelling, and unusual bruising or bleeding.
Patient information guide A plain-language walkthrough of Mitoxantrone Injection, written from its FDA label.
What Mitoxantrone Injection is used for
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Mitoxantrone Injection is approved for these uses:
- Reducing neurologic disability and relapses in secondary progressive, progressive relapsing, or worsening relapsing-remitting multiple sclerosis
- Pain from advanced hormone-refractory prostate cancer, used with corticosteroids
- Initial therapy for acute nonlymphocytic leukemia in adults, used with other approved drugs
It is not for primary progressive MS.
How Mitoxantrone Injection works
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Mitoxantrone inserts itself into DNA and causes cross-links and strand breaks. It also blocks topoisomerase II, an enzyme that uncoils and repairs damaged DNA. This kills cells whether or not they are actively dividing.
In lab studies it also reduced the growth of B cells, T cells and macrophages (immune cells), which may help explain its effect in MS.
Mitoxantrone Injection dosage
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Mitoxantrone Injection is given by a healthcare professional as an intravenous infusion. Food does not apply.
- For MS, it is a short infusion about every 3 months.
- Heart function is checked before each MS dose.
- Your care team decides the schedule, so any missed appointment should be discussed with them.
Dosing details from the FDA-approved label
From the Mitoxantrone 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.
- Multiple Sclerosis
- 12 mg/m2 given as a short (approximately 5 to 15 minutes) intravenous infusion every 3 months
- LVEF should be evaluated by echocardiogram or MUGA prior to the initial dose and all subsequent doses; LVEF evaluations also recommended if signs or symptoms of congestive heart failure develop
Read the label’s full dosing text
DOSAGE AND ADMINISTRATION: (see also WARNINGS ). Multiple Sclerosis The recommended dosage of Mitoxantrone Injection, USP is 12 mg/m 2 given as a short (approximately 5 to 15 minutes) intravenous infusion every 3 months. Left ventricular ejection fraction (LVEF) should be evaluated by echocardiogram or MUGA prior to administration of the initial dose of Mitoxantrone Injection, USP and all subsequent doses. In addition, LVEF evaluations are recommended if signs or symptoms of congestive heart failure develop at any time during treatment with Mitoxantrone Injection, USP. Mitoxantrone Injection, USP should not be administered to multiple sclerosis patients with an LVEF <50%, with a clinically significant reduction in LVEF, or to those who have received a cumulative lifetime dose of ≥ 140 mg/m 2 . Complete blood counts, including platelets, should be monitored prior to each course of Mitoxantrone Injection, USP and in the event that signs or symptoms of infection develop. Mitoxantrone Injection, USP generally should not be administered to multiple sclerosis patients with neutrophil counts less than 1500 cells/mm 3 . Liver function tests should also be monitored prior to each course. Mitoxantrone Injection, USP therapy in multiple sclerosis patients with abnormal liver function tests is not recommended because Mitoxantrone Injection, USP clearance is reduced by hepatic impairment and no laboratory measurement can predict drug clearance and dose adjustments. Women with multiple sclerosis who are biologically capable of becoming pregnant, even if they are using birth control, should have a pregnancy test, and the results should be known, before receiving each dose of Mitoxantrone Injection, USP (see WARNINGS , Pregnancy ). Hormone-Refractory Prostate Cancer Based on data from two Phase 3 comparative trials of mitoxantrone injection plus corticosteroids versus corticosteroids alone, the recommended dosage of mitoxantrone is 12 to 14 mg/m 2 given as a short intravenous infusion every 21 days. Combination Initial Therapy for ANLL in Adults For induction, the recommended dosage is 12 mg/m 2 of Mitoxantrone Injection daily on Days 1 to 3 given as an intravenous infusion, and 100 mg/m 2 of cytarabine for 7 days given as a continuous 24-hour infusion on Days 1 to 7. Most complete remissions will occur following the initial course of induction therapy.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Mitoxantrone Injection side effects
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Common side effects seen in MS studies include:
Common side effects
- Nausea
- Hair thinning or hair loss
- Menstrual changes, including missed periods
- Urinary tract infections
- Mouth sores
- Diarrhea or constipation
- Low white blood cell counts
- Headache
When to get medical help
- Signs of heart failure, such as new shortness of breath or swelling. It can happen during treatment or months to years later.
- Fever, chills or other signs of infection, since low white blood cells can be severe.
- Unusual bruising, bleeding or repeated infections. These can be signs of secondary leukemia.
- Pain, redness, swelling or skin damage at the IV site. Leakage of the drug can severely damage tissue.
- Allergic reaction to the medicine.
- If you could be pregnant, tell your doctor right away.
Mitoxantrone Injection warnings and precautions
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- Heart failure: can be fatal and may occur during or years after treatment. Risk rises with total dose.
- Low blood counts: severe drops can lead to infection, so counts are checked often.
- Secondary leukemia: risk is higher than in the general population. Symptoms can include bruising, bleeding and repeated infections.
- Tissue damage: leakage from the vein can severely injure tissue.
- Wrong route: spinal injection has caused seizures, paralysis and permanent injury. Injection into an artery has caused nerve damage.
- Pregnancy: it may harm an unborn baby.
Mitoxantrone Injection interactions
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No significant interactions have been found, but information is limited.
- Cancer patients: no significant drug interactions have been seen after marketing.
- MS patients: interaction information is limited.
- Corticosteroids: no interaction was observed.
- Other heart-toxic drugs or prior anthracyclines: may increase heart risk.
Interactions listed in the FDA-approved label
From the Mitoxantrone Injection prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Corticosteroids: Following concurrent administration of mitoxantrone injection with corticosteroids, no evidence of drug interactions has been observed.
- Drugs in patients treated for cancer: Postmarketing experience has not revealed any significant drug interactions in patients who have received mitoxantrone injection for treatment of cancer.
- Drugs in patients with multiple sclerosis: Information on drug interactions in patients with multiple sclerosis is limited.
Read the label’s full interactions text
Drug Interactions Mitoxantrone and its metabolites are excreted in bile and urine, but it is not known whether the metabolic or excretory pathways are saturable, may be inhibited or induced, or if mitoxantrone and its metabolites undergo enterohepatic circulation. To date, postmarketing experience has not revealed any significant drug interactions in patients who have received mitoxantrone injection for treatment of cancer. Information on drug interactions in patients with multiple sclerosis is limited. Following concurrent administration of mitoxantrone injection with corticosteroids, no evidence of drug interactions has been observed.
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 Mitoxantrone Injection
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- Do not use if you have had an allergic reaction to mitoxantrone.
- Tell your doctor about heart disease, chest radiation, or prior doxorubicin or daunorubicin.
- People with MS need normal heart function (LVEF) before treatment.
- Liver problems: people with MS should ordinarily not be treated, and others need caution.
- Low white blood cell counts may delay treatment, except in some leukemia cases.
- Pregnancy: it may harm the baby. Women with MS who can become pregnant need a pregnancy test before each dose.
- Children: how the body handles it is unknown.
Mitoxantrone Injection overdose
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There is no known specific antidote. Accidental overdoses have caused severe drops in white blood cells with infection, and some deaths occurred after very large single doses. Treatment involves blood support and antibiotics during long periods of low blood counts.
What Mitoxantrone Injection does in the body
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Mitoxantrone damages DNA and blocks its repair, killing cells whether or not they are dividing. It also reduces the growth of certain immune cells in lab studies. A major effect on the body is suppression of the bone marrow, which lowers blood counts.
How your body processes Mitoxantrone Injection
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After an IV dose, mitoxantrone spreads widely into tissues. Its final half-life is long, with a median of about 75 hours. About 78% is bound to proteins in the blood.
It leaves the body in urine and feces as unchanged drug or inactive byproducts. Liver problems slow its clearance, so exposure can be more than three times higher in severe liver dysfunction.
How to store Mitoxantrone Injection
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stored at 20° to 25°C (68° to 77°F). DO NOT FREEZE.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Mitoxantrone Injection
25 supplements and herbal products have documented interactions with Mitoxantrone Injection in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 1
- Moderate · 15
- Minor · 9
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Mitoxantrone Injection: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Mitoxantrone Injection — the kind of thing our pharmacy team would talk through with you at the counter.
What is Mitoxantrone Injection used for?
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How will I receive it?
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What side effects should I expect?
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Why do I need heart tests?
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Is it safe during pregnancy?
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Does it interact with other medicines?
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Is Mitoxantrone Injection available over the counter?
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When was Mitoxantrone Injection first available?
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Who makes Mitoxantrone 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 Mitoxantrone Injection on HelloPharmacist
Mitoxantrone Injection forms and strengths (how it comes)
Mitoxantrone 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
- Mitoxantrone is used to reduce neurologic disability and relapses in secondary progressive, progressive relapsing, or worsening relapsing-remitting MS.
- Mitoxantrone with corticosteroids is used for pain from advanced hormone-refractory prostate cancer.
- Mitoxantrone with other approved drugs is used as initial therapy for acute nonlymphocytic leukemia in adults.
- Mitoxantrone is given into a vein only, slowly into a freely flowing IV.
- Mitoxantrone must never be given under the skin, into a muscle, into an artery, or into the spinal fluid.
- For MS, Mitoxantrone is given as a short infusion about every 3 months, with heart function checked before each dose.
Mitoxantrone Injection on the U.S. market: products, makers and brands
How Mitoxantrone 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.
3 companies list 4 Mitoxantrone Injection product records with the FDA, mostly as injection; the earliest marketing or approval year on record is 1987. Brand names on the directory include Novantrone; 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.
Compare Mitoxantrone Injection products
A representative set of FDA-listed product records for Mitoxantrone 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 | ||||
| 2 mg/mL | Intravenous | Fresenius Kabi USA, LLC | ANDA | View NDC → |
| 2 mg/mL | Intravenous | Hospira, Inc. | ANDA | View NDC → |
| 2 mg/mL | Intravenous | Meitheal Pharmaceuticals Inc. × 2 listings | ANDA | View NDC → |
Showing 4 of 4 products — FDA National Drug Code Directory. See every product, package size and price: browse all 4 Mitoxantrone Injection NDCs →
Mitoxantrone 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 Mitoxantrone 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 Mitoxantrone 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.
Mitoxantrone Injection FDA approval history
How Mitoxantrone Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Mitoxantrone 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 Mitoxantrone recalls since July 2021.
✅No Mitoxantrone 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 7005 1 dose form · 1 strength
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Dose form (SCDF) Injectable Solution RxCUI 375173In current FDA listingsClinical drug / strength (SCD) 2 MG/MLRxCUI 197989
Look up RxCUI 7005 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.
Mitoxantrone Injection supply and shortage status
Whether Mitoxantrone 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.
Mitoxantrone Injection brand names
Mitoxantrone Injection is sold under one brand name in the FDA directory — Novantrone. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Mitoxantrone Injection: manufacturers and labelers
3 companies list Mitoxantrone Injection products with the FDA. By number of product records, the largest are Meitheal Pharmaceuticals Inc., Fresenius Kabi USA, LLC, Hospira, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Mitoxantrone Injection drug class (RxNorm)
Mitoxantrone Injection belongs to the Topoisomerase Inhibitor 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 Mitoxantrone 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. Fresenius Kabi USA, LLC 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 →