Mitoxantrone
Pronunciation: (mi-tox-AN-trone).
- Generic name
- Mitoxantrone
- Brand names
- Novantrone
- Drug class
- Cancer & Oncology
Availability and supply rules vary by country
Trade names by country:
Australia: · Full directory
What Mitoxantrone is and how it works
Uses, formulations, monitoring, and supply rules can differ by patient, product, and country. Follow the exact local product information and professional advice.
Mechanism of action: how Mitoxantrone works
Mitoxantrone is an anthracenedione antineoplastic agent that intercalates into DNA, causing crosslinks and strand breaks. It inhibits topoisomerase II, preventing DNA repair and replication, leading to cell death. It also suppresses cellular and humoral immune responses, which is beneficial in multiple sclerosis. (1)
What Mitoxantrone is used for
Acute myeloid leukemia (AML/ANLL), in combination with other chemotherapy
FDA-approved for initial therapy of acute nonlymphocytic leukemia in adults, as part of a combination regimen. (2)
Multiple sclerosis (MS), secondary progressive, progressive relapsing, or worsening relapsing-remitting
FDA-approved to reduce neurologic disability and/or the frequency of clinical relapses in these forms of MS. Not approved for primary progressive MS. (2)
Hormone-refractory (advanced) prostate cancer, in combination with corticosteroids
FDA-approved for pain related to advanced hormone-refractory prostate cancer, used together with corticosteroids. (2)
Non-Hodgkin's lymphoma and breast cancer (off-label use)
Mitoxantrone is not FDA-approved for non-Hodgkin's lymphoma or breast cancer. These are not among its labeled indications; any use for these conditions would be an off-label clinician decision, not a labeled indication. (2)
Before taking Mitoxantrone
Do not take / not appropriate for
- Contraindicated in patients with hypersensitivity to mitoxantrone, severe hepatic impairment, or pre-existing severe cardiac dysfunction. (Contraindication) (2)
- Pregnancy and breastfeeding are contraindications. (Contraindication) (2)
Tell your clinician about
(2)How to take Mitoxantrone
- General Instructions: Mitoxantrone is given as an intravenous infusion by a healthcare professional, usually in a hospital or clinic setting.. Adult Dosing: Dosing varies by indication. For cancer, typical doses range from 12-14 mg/m² every 21 days. For multiple sclerosis, the usual dose is 12 mg/m² every 3 months, not to exceed a lifetime cumulative dose of 140 mg/m² due to risk of heart damage.. Pediatric Dosing: Safety and efficacy in children have not been established for most indications. Dosing in pediatric leukemia is individualized and should be managed by a specialist.. Administration: Administered via slow intravenous infusion over 5-30 minutes. Do not administer intrathecally or as a rapid IV push.. When To Stop: Treatment may be discontinued if there is evidence of severe cardiac toxicity, severe allergic reaction, or disease progression.. Storage: Store vials at room temperature (20–25°C/68–77°F). Protect from light. Do not freeze.
- This page does not provide a dose calculator. Dosing must follow the prescriber, pharmacist, or product label.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (2)
Missed dose
If you miss an appointment for your mitoxantrone infusion, contact your healthcare provider as soon as possible to reschedule. Do not attempt to self-administer.
Overdose
In case of overdose, seek emergency medical attention immediately. Overdose may cause severe bone marrow suppression, infections, and heart problems. Supportive care and monitoring are essential. (2)
Side effects
Side effects and their urgency vary; report severe, persistent, or concerning symptoms to a healthcare professional.
Nausea
Incidence: Reported in the clinician-authored database; frequency not established
Vomiting
Incidence: Reported in the clinician-authored database; frequency not established
Hair loss
Incidence: Reported in the clinician-authored database; frequency not established
Fatigue
Incidence: Reported in the clinician-authored database; frequency not established
Low blood cell counts
Incidence: Reported in the clinician-authored database; frequency not established
Heart problems
Incidence: Reported in the clinician-authored database; frequency not established
Mouth sores
Incidence: Reported in the clinician-authored database; frequency not established
Serious warnings
BOXED WARNING (FDA), three components — serious
Symptoms: BOXED WARNING (FDA), three components: (1) Cardiotoxicity — mitoxantrone can cause potentially fatal congestive heart failure (CHF) during therapy or months to years after treatment ends, even in patients with no prior heart problems; risk rises with increasing cumulative dose (the probability of CHF is about 2.6% at a cumulative dose of 140 mg/m2 in cancer patients). Left ventricular ejection fraction must be assessed before each dose. (2) Secondary leukemia — secondary acute myeloid leukemia has been reported in both multiple sclerosis and cancer patients treated with mitoxantrone. (3) Intrathecal administration — mitoxantrone must NOT be given by intrathecal injection; severe, sometimes irreversible neurotoxicity has resulted from this route. This is an FDA boxed warning, the strongest safety warning the FDA requires; it has been checked and added here because the clinician database recorded these same risks only as ordinary warning text without boxed-warning flagging.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
Can suppress bone marrow, increasing infection and bleeding risk — serious
Symptoms: Can suppress bone marrow, increasing infection and bleeding risk. Not recommended during pregnancy or breastfeeding. Monitor liver function closely during treatment.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
Contraindications recorded in the clinician database (the current label's formal contraindications section lists only hypersensitivity, but treats the following as important cautions) — serious
Symptoms: Contraindications recorded in the clinician database (the current label's formal contraindications section lists only hypersensitivity, but treats the following as important cautions): hypersensitivity to mitoxantrone, severe hepatic impairment, or pre-existing severe cardiac dysfunction. Use with caution in patients with prior anthracycline exposure, active infections, or compromised bone marrow reserve. Pregnancy and breastfeeding require careful clinician-guided decisions.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
Interactions
| Medicine or test | Effect | Action |
|---|---|---|
| Recorded interactions | Mitoxantrone may interact with other chemotherapy agents, immunosuppressants, and drugs that affect liver enzymes. Concurrent use with other cardiotoxic drugs increases the risk of heart damage. Always inform your healthcare provider about all medications and supplements you are taking. | (1) |
Pregnancy, breastfeeding, kidney/liver function, age
Pregnancy
Mitoxantrone can cause fetal harm and should be avoided during pregnancy. If you are pregnant, think you may be pregnant, or become pregnant while receiving mitoxantrone, seek medical advice promptly so your clinician can discuss the risks with you. (2)
Breastfeeding
Mitoxantrone passes into breast milk. Breastfeeding is not recommended during treatment; discuss feeding options with your healthcare provider before starting treatment. (2)
Children
Frequency: Not applicable.. Weight Based: Not recommended for pediatric use.. Max Daily Dose: Not applicable.. Max Single Dose: Not applicable.. Age Restrictions: Safety not established in children. (2)
Renal_impairment
The FDA label states that mitoxantrone clearance is reduced by hepatic impairment: in patients with severe hepatic dysfunction (bilirubin greater than 3.4 mg/dL), drug exposure can be more than three times higher than in patients with normal liver function receiving the same dose. Patients with multiple sclerosis who have hepatic impairment should ordinarily not be treated with mitoxantrone at all; other patients with hepatic impairment need caution and a dosage reduction decided by the treating oncology team. Mitoxantrone's pharmacokinetics in renal impairment are not established by the label; the treating team will individualize monitoring. (2)
Hepatic_impairment
The FDA label states that mitoxantrone clearance is reduced by hepatic impairment: in patients with severe hepatic dysfunction (bilirubin greater than 3.4 mg/dL), drug exposure can be more than three times higher than in patients with normal liver function receiving the same dose. Patients with multiple sclerosis who have hepatic impairment should ordinarily not be treated with mitoxantrone at all; other patients with hepatic impairment need caution and a dosage reduction decided by the treating oncology team. Mitoxantrone's pharmacokinetics in renal impairment are not established by the label; the treating team will individualize monitoring. (2)
Monitoring
(2)Storage
This is a healthcare-professional-administered infusion; storage and preparation are handled by the treating facility. Vials are stored at room temperature (20-25C/68-77F), protected from light, and not frozen.
Professional information
Clinician-facing context only. This section does not replace current product labeling.
General
Indication: Acute myeloid leukemia (AML)
Dose summary: 12 mg/m² administered as an intravenous infusion over 5 to 15 minutes every 21 days.
Renal context: Mitoxantrone pharmacokinetics in patients with renal impairment are not established by the FDA label. Severe renal failure has not been studied, but because mitoxantrone is extensively tissue-bound, it is considered unlikely that peritoneal dialysis or hemodialysis would meaningfully reduce its therapeutic effect or toxicity. The treating oncology team should individualize monitoring for patients with significant renal impairment. (1) (2)
Hepatic guidance
Mitoxantrone clearance is reduced by hepatic impairment: in severe hepatic dysfunction (bilirubin greater than 3.4 mg/dL), drug exposure (AUC) can be more than three times higher than in patients with normal hepatic function at the same dose. Patients with multiple sclerosis who have hepatic impairment should ordinarily not receive mitoxantrone at all. For other indications, hepatic impairment requires caution and an individualized lower dose set by the treating oncology team — some published protocols use a dose approximately half of the standard dose when total bilirubin is above 3.5 mg/dL, returning to the standard dose only once bilirubin falls to 3.5 mg/dL or below, though the exact adjustment should follow current institutional protocol and remains entirely the treating team's decision.
Frequently asked questions
What conditions does mitoxantrone treat?
Mitoxantrone is used to treat certain cancers (such as advanced prostate cancer and acute non-lymphocytic leukemia) and to manage worsening forms of multiple sclerosis.
How is mitoxantrone administered?
It is given as an intravenous infusion by a healthcare professional, typically in a hospital or clinic.
What are the most serious risks of mitoxantrone?
The most serious risks include heart damage, bone marrow suppression, increased risk of infections, and secondary leukemia.
Can I take mitoxantrone during pregnancy?
No, mitoxantrone can harm an unborn baby and should not be used during pregnancy. Effective contraception is required during and for at least 6 months after treatment.
What should I do if I miss a dose?
Contact your healthcare provider to reschedule your infusion. Do not attempt to self-administer the medication.
How will my doctor monitor me during treatment?
Your doctor will monitor your heart function, blood counts, and liver function regularly to detect any side effects early.
Are there any long-term risks with mitoxantrone?
Long-term risks include potential heart failure and increased risk of developing leukemia. Regular monitoring is essential.
What happens if I take too much Mitoxantrone?
Taking too much Mitoxantrone can lead to severe adverse effects, including profound myelosuppression, cardiotoxicity, and gastrointestinal disturbances. Symptoms may include extreme fatigue, easy bruising or bleeding, and severe infections. If an overdose is suspected, it is crucial to seek immediate emergency medical attention for appropriate management and supportive care.
Can I drink alcohol while taking Mitoxantrone?
It is generally recommended to avoid alcohol consumption while undergoing treatment with Mitoxantrone. Alcohol can exacerbate certain side effects of antineoplastic agents, such as nausea, vomiting, and liver toxicity. Furthermore, alcohol may interfere with the body's ability to recover from chemotherapy-induced damage, potentially compromising treatment efficacy and increasing the risk of complications. Always consult your healthcare provider for personalized advice.
Is Mitoxantrone safe during pregnancy?
Mitoxantrone is generally considered to be contraindicated during pregnancy due to its potential for causing fetal harm. It falls under a pregnancy category that indicates a high risk to the fetus. Therefore, it is essential for women of childbearing potential to use effective contraception during treatment and for a period afterward. Always consult your healthcare provider to discuss the risks and benefits and for personalized guidance regarding pregnancy and Mitoxantrone.
What is the mechanism of action of Mitoxantrone?
Mitoxantrone is an anthracenedione antineoplastic agent that intercalates into DNA, causing crosslinks and strand breaks. It inhibits topoisomerase II, preventing DNA repair and replication, leading to cell death. It also suppresses cellular and humoral immune responses, which is beneficial in multiple sclerosis. (1)
What is the generic name of Mitoxantrone?
The generic name is Mitoxantrone. It is sold under brand names including Novantrone.
What class of drug is Mitoxantrone?
Mitoxantrone is classed as: Cancer & Oncology.
References
- Mitoxantrone – Medicine RecordMedGuideGlobal internal clinician-authored medicine record · United States · accessed 2026-08-06 · source 1
- NOVANTRONE (mitoxantrone) prescribing information (2009) and Drugs.com monographU.S. Food and Drug Administration / Drugs.com professional monograph · United States · accessed 2026-08-06 · source 2
- MITOXANTRONE INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.] — US prescribing information (DailyMed SPL)U.S. National Library of Medicine (DailyMed) · US · accessed 2026-08-14 · source 3
- mitoXANTRONE — FDA approval record (Drugs@FDA ANDA077356)U.S. Food and Drug Administration · US · accessed 2026-08-14 · source 4
- Mitoxantrone — RxNorm normalized drug concept (RXCUI 203129)U.S. National Library of Medicine (RxNorm) · US · accessed 2026-08-14 · source 5
Brand names by country
Single-ingredient Mitoxantrone names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.