Version July 2025
Mitoxantrone should be administered under the supervision of a health care provider experienced in the use of cytotoxic chemotherapy agents.
Mitoxantrone should be given slowly into a freely flowing intravenous (IV) infusion. It must never be given subcutaneously, intramuscularly (IM), or intra-arterially. Severe local tissue damage may occur if there is extravasation during administration. Not for intrathecal use. Severe injury with permanent sequelae can result from intrathecal administration.
Except for the treatment of acute nonlymphocytic leukemia, mitoxantrone therapy generally should not be given to patients with baseline neutrophil counts of less than 1,500 cells/mm3. In order to monitor the occurrence of bone marrow suppression (primarily neutropenia, which may be severe and result in infection), it is recommended that frequent peripheral blood cell counts be performed on all patients receiving mitoxantrone.
Congestive heart failure (CHF), potentially fatal, may occur during therapy with mitoxantrone or months to years after termination of therapy. Cardiotoxicity risk increases with cumulative mitoxantrone dose and may occur whether or not cardiac risk factors are present. Presence or history of cardiovascular disease, radiotherapy to the mediastinal/pericardial area, previous therapy with other anthracyclines or anthracenediones, or use of other cardiotoxic drugs may increase this risk. In patients with cancer, the risk of symptomatic CHF was estimated to be 2.6% for patients receiving up to a cumulative dose of 140 mg/m2. To mitigate the cardiotoxicity risk with mitoxantrone, consider the following:
All patients should be assessed for cardiac signs and symptoms by history, physical examination, and electrocardiogram (ECG) prior to start of mitoxantrone therapy.
All patients should have baseline quantitative evaluation of left ventricular ejection fraction (LVEF) using appropriate methodology (eg, echocardiogram, multigated radionuclide angiogram [MUGA], magnetic resonance imaging [MRI]).
Multiple sclerosis (MS) patients with a baseline LVEF below the lower limit of normal should not be treated with mitoxantrone.
MS patients should be assessed for cardiac signs and symptoms by history, physical examination, and ECG prior to each dose.
MS patients should undergo quantitative reevaluation of LVEF prior to each dose using the same methodology that was used to assess baseline LVEF. Additional doses of mitoxantrone should not be administered to MS patients who have experienced a drop in LVEF to below the lower limit of normal or a clinically significant reduction in LVEF during mitoxantrone therapy.
MS patients should not receive a cumulative mitoxantrone dose greater than 140 mg/m2.
MS patients should undergo yearly quantitative LVEF evaluation after stopping mitoxantrone to monitor for late-occurring cardiotoxicity.
Mitoxantrone therapy in patients with MS and in patients with cancer increases the risk of developing secondary acute myeloid leukemia.
Dosage guidance:
Safety: Mitoxantrone usually should not be administered if baseline neutrophil count <1,500/mm3 (except for in the treatment of acute myeloid leukemia). Administer antihyperuricemic therapy and aggressive hydration as indicated. Actively manage modifiable cardiac risk factors (smoking, hypertension, diabetes, dyslipidemia, obesity) before initiating mitoxantrone treatment for patients with cancer (Ref).
Acute lymphoblastic leukemia, relapsed/refractory (off-label use): IV: 10 mg/m2 on days 3 and 10 (in combination with fludarabine and cytarabine [FLAM regimen]) (Ref) or 8 mg/m2 on days 1 to 3 (in combination with etoposide, ifosfamide, and mesna) as induction therapy; if complete remission occurred following induction, 1 additional cycle as consolidation therapy was administered (Ref).
Acute myeloid leukemias, initial therapy:
AML induction: IV: 12 mg/m2 once daily for 3 days (in combination with cytarabine); for incomplete response, may repeat (7 to 10 days later) at 12 mg/m2 once daily for 2 days (in combination with cytarabine) (Ref).
AML consolidation (beginning ~6 weeks after initiation of the final induction course): IV: 12 mg/m2 once daily for 2 days (in combination with cytarabine), repeat in 4 weeks (Ref).
Acute myeloid leukemia, relapsed/refractory (off-label use):
CLAG-M regimen: IV: 10 mg/m2 once daily for 3 days on days 1, 2, and 3 (in combination with cladribine, cytarabine, and filgrastim), may repeat once if needed (Ref).
MEC regimen: IV: 6 mg/m2 once daily for 6 days on days 1 to 6 (in combination with cytarabine and etoposide) (Ref).
Mitoxantrone/Etoposide: IV: 10 mg/m2 once daily for 5 days on days 1 to 5 (in combination with etoposide) (Ref).
Acute promyelocytic leukemia, newly diagnosed (off-label use): Consolidation: IV: 10 mg/m2 once daily for 5 days on days 1 to 5 of consolidation course 2 (in combination with tretinoin all-trans retinoic acid; ATRA [tretinoin]) (Ref); for low- and intermediate-risk patients the mitoxantrone dose has been reduced to 10 mg/m2 once daily for 3 days on days 1 to 3 of consolidation course 2 (in combination with ATRA) (Ref).
Hodgkin lymphoma (off-label use):
Relapsed or refractory Hodgkin lymphoma: MINE-ESHAP regimen: IV: 10 mg/m2 on day 1 every 28 days for up to 2 cycles (MINE is combination with mesna, ifosfamide, mitoxantrone, and etoposide; MINE alternates with ESHAP for up to 2 cycles of each) (Ref).
Newly diagnosed Hodgkin lymphoma, reduced intensity regimen: Adults ≥66 years of age: VEPEMB regimen: IV: 6 mg/m2 on day 15 every 28 days (in combination with vinblastine, cyclophosphamide, procarbazine, etoposide, and bleomycin) for 3 to 6 cycles (Ref).
Multiple sclerosis, relapsing or secondary progressive (alternative agent): Note: Reserve use for rapidly advancing, refractory multiple sclerosis (MS) (Ref). In high-risk populations or in countries with high tuberculosis burden, screen for latent infections (eg, hepatitis, tuberculosis) prior to initiating therapy. For patients who screen positive for latent infections, consult infectious disease or other appropriate specialists (eg, liver specialists) regarding treatment options before initiating therapy (Ref). Mitoxantrone generally should not be administered to patients with MS with neutrophil counts <1,500 cells/mm3.
IV: 12 mg/m2 every 3 months (maximum lifetime cumulative dose: 140 mg/m2; discontinue with LVEF <50% or clinically significant reduction in LVEF).
Non-Hodgkin lymphomas, relapsed or refractory (off-label use): B-cell lymphomas: R-MINE regimen: IV: 8 mg/m2 on day 1 (in combination with rituximab, mesna, ifosfamide, and etoposide) for up to 3 cycles (Ref).
Prostate cancer, advanced, castrate resistant: IV: 12 mg/m2 once every 3 weeks (in combination with prednisone or prednisolone) for up to 10 cycles (Ref) or 12 to 14 mg/m2 once every 3 weeks (in combination with prednisone) until disease progression or unacceptable toxicity, up to a maximum cumulative mitoxantrone dose of 144 mg/m2 (Ref).
T-cell prolymphocytic leukemia (off-label use): FMC-A regimen: IV: 8 mg/m2 on day 1 every 28 days (in combination with fludarabine and cyclophosphamide [FMC]) for 2 to 4 cycles; if response demonstrated after initial 2 FMC cycles, then an additional 2 cycles of FMC were administered, followed by alemtuzumab consolidation; if stable disease or progression observed after initial 2 FMC cycles, then proceeded directly to alemtuzumab (Ref).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Altered kidney function: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); however, in patients receiving mitoxantrone for the treatment of cancer, no need for dosage adjustment is expected (Ref).
Hemodialysis: In patients receiving mitoxantrone for the treatment of cancer, no need for dosage adjustment is expected (Ref).
Altered hepatic function: There are no dosage adjustments provided in the manufacturer's labeling; however, clearance is reduced in hepatic dysfunction. Patients with severe hepatic dysfunction (bilirubin >3.4 mg/dL) have an AUC of 3 times greater than patients with normal hepatic function.
General dosage adjustment recommendations:
Multiple sclerosis: Patients with multiple sclerosis with hepatic impairment should not receive mitoxantrone.
Patients receiving mitoxantrone for the treatment of cancer:
Altered hepatic function: Consider dosage adjustments (Ref).
Mild or moderate hepatic impairment: No need for dosage adjustment is expected (Ref).
Severe hepatic impairment: Consider reducing dose to 50% of the original dose (Ref).
American Society of Clinical Oncology guidelines for appropriate systemic therapy dosing in adults with cancer with a BMI ≥30 kg/m2 : Utilize patient's actual body weight for calculation of BSA- or weight-based dosing; manage regimen-related toxicities in the same manner as for patients with a BMI <30 kg/m2; if a dose reduction is utilized due to toxicity, may consider resumption of full, weight-based dosing (or previously tolerated dose level) with subsequent cycles only if dose escalations are allowed in the prescribing information, if contributing underlying factors (eg, hepatic or kidney impairment) are sufficiently resolved, AND if performance status has markedly improved or is considered adequate (Ref).
AML: Severe or life-threatening nonhematologic toxicity: Withhold treatment until toxicity resolves.
MS:
Neutrophils <1,500/mm3: Use is not recommended.
Signs/symptoms of HF: Evaluate for cardiac signs/symptoms and monitor LVEF.
LVEF <50% or baseline LVEF below the lower limit of normal (LLN): Use is not recommended.
Cardiotoxicity in patients receiving mitoxantrone for treatment of cancer:
Asymptomatic heart disease: Consider initiating heart failure medications (eg, an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker and/or beta-blockers) in patients with asymptomatic (stage B) heart disease (Ref).
Mild cardiac dysfunction: Continue treatment with close cardiovascular monitoring (Ref).
Moderate cardiac dysfunction: Interrupt treatment and utilize a multidisciplinary approach when deciding if/when to restart (Ref).
Symptomatic heart disease: Initiate heart failure medications (Ref).
Mild cardiac dysfunction: Consider a multidisciplinary approach for decisions regarding treatment interruption versus continuation (Ref).
Moderate cardiac dysfunction: Interrupt treatment; consider a multidisciplinary approach for decisions regarding treatment reinitiation (Ref).
Severe cardiac dysfunction: Discontinue anthracycline therapy (Ref).
Refer to adult dosing.
(For additional information see "Mitoxantrone: Pediatric drug information")
Dosage guidance:
Safety: In pediatric patients, dosing may be based on either BSA (mg/m2) or weight (mg/kg); use extra precaution to verify dosing parameters during calculations. Monitor cumulative anthracycline dose (combined); the risk for cardiomyopathy increases as the cumulative dose increases (>250 mg/m2 of doxorubicin isotoxic equivalent dose in pediatric patients <18 years and 550 mg/m2 of doxorubicin isotoxic equivalent dose in patients >18 years); also dependent on other/additional risk factors; interpatient variability exists (eg, some patients may experience left ventricular dysfunction at lower doses) (Ref). Dosing regimens may vary by dose, cycles, and combination therapy; refer to individual protocols.
Acute lymphocytic leukemia (ALL), relapsed: Limited data available: Children and Adolescents: Induction: IV: 10 mg/m2/dose once daily on days 1 and 2 in combination with dexamethasone, vincristine, pegaspargase, and intrathecal methotrexate, with follow-up therapy (allogeneic stem cell transplant or continued chemotherapy) determined by risk stratification (Ref).
Acute myeloid leukemia (AML), newly diagnosed: Limited data available:
Infants, Children, and Adolescents: Note: Some aspects of protocol dosing presented in previous reports (Ref).
Intensification Course 2:
BSA <0.6 m2: IV: 0.4 mg/kg once daily for 4 days on Days 3 to 6 of a 28-day cycle in combination with cytarabine.
BSA ≥0.6 m2: IV: 12 mg/m2 once daily for 4 days on Days 3 to 6 of a 28-day cycle in combination with cytarabine.
Acute myeloid leukemia, relapsed: Limited data available:
Infants and Children <3 years: IV: 0.4 mg/kg once daily on Days 3 to 6 for a total of 4 doses in combination with gemtuzumab ozogamicin and cytarabine (Ref).
Children ≥3 years and Adolescents: IV: 12 mg/m2 once daily on Days 3 to 6 for a total of 4 doses in combination with gemtuzumab ozogamicin and cytarabine (Ref).
Acute promyelocytic leukemia (APL), newly diagnosed: Limited data available:
LPA 96:
Consolidation Course 2: Children ≥2 years and Adolescents: IV: 10 mg/m2 once daily for 5 days of a 28-day cycle combined with tretinoin (ATRA) (Ref).
ICC-APL-01:
Consolidation Course 1 (risk-adaptive approach; standard- and high-risk patients): Children and Adolescents: IV: 10 mg/m2 on Days 4 and 5 of a 28-day cycle in combination with cytarabine, idarubicin, and tretinoin (ATRA) (Ref).
AAML1331:
Consolidation Cycle 3 (risk-adaptive approach; standard- and high-risk patients Minimal Residual Disease-positive post consolidation cycle 2):
Children and Adolescents:
BSA <0.6 m2: IV: 0.4 mg/kg once daily for 4 days on Days 3 to 6 of a 28-day cycle in combination with cytarabine and tretinoin (ATRA) (Ref).
BSA ≥0.6 m2: IV: 12 mg/m2 once daily for 4 days on Days 3 to 6 of a 28-day cycle in combination with cytarabine and tretinoin (ATRA) (Ref).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Dosing adjustment for toxicity: Specific recommendations for pediatric patients are limited; dose reductions and/or discontinuation of therapy may be necessary for cardiotoxicity or hematologic toxicity; refer to specific protocol for management in pediatric patients if available.
There are no pediatric specific recommendations; refer to individual protocols; based on experience in adults, supplemental doses are not necessary with hemodialysis or peritoneal dialysis.
There are no pediatric specific recommendations; refer to individual protocols. Based on experience in adults, clearance is reduced in hepatic dysfunction; patients with severe hepatic dysfunction (bilirubin >3.4 mg/dL) have an AUC of 3 times greater than patients with normal hepatic function; consider dose adjustments.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Includes adverse events reported with any indication; incidence varies based on treatment, dose, and/or concomitant medications.
>10%:
Cardiovascular: Cardiac disorder (including cardiac arrhythmia, ECG abnormality), edema
Dermatologic: Alopecia, nail bed changes
Endocrine & metabolic: Hyperglycemia, menstrual disease (including amenorrhea), weight gain, weight loss
Gastrointestinal: Abdominal pain, anorexia, constipation, diarrhea, nausea, stomach pain (including epigastric burning, epigastric pain), stomatitis, vomiting
Genitourinary: Urine abnormality (including hematuria)
Hematologic & oncologic: Abnormal lymphocytes (including lymphocytopenia), febrile neutropenia, hemorrhage (including bruise, ecchymoses, gastrointestinal hemorrhage, petechia), leukopenia, neutropenia, quantitative disorder of platelets (including decreased platelet count)
Hepatic: Abnormal transaminase (including increased serum alanine aminotransferase, increased serum aspartate aminotransferase), alkaline phosphatase abnormal, hepatic impairment (including jaundice), increased gamma-glutamyl transferase
Infection: Infection (including endometritis, enteritis, fungal infection, pneumonia, sepsis, tonsillitis, upper respiratory tract infection, urinary tract infection, viral infection)
Nervous system: Asthenia, central nervous system dysfunction (including headache), fatigue (including malaise), pain
Renal: Change in creatinine, increased blood urea nitrogen
Respiratory: Pharyngitis, pulmonary signs and symptoms (including cough, dyspnea)
Miscellaneous: Fever
1% to 10%:
Cardiovascular: Decreased left ventricular ejection fraction, heart failure, hypertension, ischemic heart disease
Dermatologic: Dermatological disorder, diaphoresis, skin infection (including fungal skin infection)
Endocrine & metabolic: Heavy menstrual bleeding, hypocalcemia, hypokalemia, hyponatremia
Gastrointestinal: Aphthous stomatitis, dyspepsia
Genitourinary: Erectile dysfunction (including decreased libido), proteinuria, sterility
Hematologic & oncologic: Anemia, granulocytopenia, secondary acute myelocytic leukemia (including acute promyelocytic leukemia)
Nervous system: Anxiety, chills, depression, mood disorder, motor dysfunction, seizure
Neuromuscular & skeletal: Arthralgia, back pain, myalgia
Ophthalmic: Blurred vision, ophthalmic signs and symptoms (including conjunctivitis)
Renal: Kidney failure
Respiratory: Pulmonary edema, rhinitis, sinusitis
Frequency not defined:
Cardiovascular: Chest pain, tachycardia
Neuromuscular & skeletal: Ostealgia
Postmarketing:
Cardiovascular: Phlebitis (at infusion site), sinus bradycardia (Benekli 1997)
Dermatologic: Sweet syndrome (Kümpfel 2011)
Hematologic & oncologic: Tumor lysis syndrome (Benekli 1995)
Hypersensitivity: Hypersensitivity reaction (including anaphylaxis, hypersensitivity angiitis, nonimmune anaphylaxis) (Taylor 1986)
Respiratory: Interstitial pneumonitis (Matsukawa 1993)
Hypersensitivity to mitoxantrone or any component of the formulation.
Canadian labeling: Additional contraindications (not in the US labeling): Prior hypersensitivity to anthracyclines; prior substantial anthracycline exposure (if abnormal cardiac function prior to initiation of mitoxantrone therapy); presence of severe myelosuppression due to prior chemo- and/or radiotherapy; severe hepatic impairment; intrathecal administration.
Concerns related to adverse effects:
• Bone marrow suppression: Mitoxantrone may lead to severe myelosuppression (at any dose). Unless the expected benefit outweighs the risk, mitoxantrone is generally not recommended in patients with preexisting myelosuppression due to prior chemotherapy.
• Extravasation: Mitoxantrone is an irritant with vesicant-like properties. For IV administration only into a free-flowing IV; may cause severe local tissue damage if extravasation occurs. Extravasation resulting in burning, erythema, pain, swelling, and skin discoloration (blue) has been reported; may result in tissue necrosis and require debridement for skin graft. Ensure proper needle or catheter placement prior to and during infusion. Avoid extravasation.
• Hypersensitivity: May contain sodium metabisulfite, which is associated with allergic-type reactions (including anaphylactic symptoms and potentially severe asthmatic episodes). The risk for hypersensitivity is higher in patients with asthma.
• Infections: When using for the treatment of multiple sclerosis in high-risk populations or in countries with high tuberculosis burden, screen for latent infections (eg, hepatitis, tuberculosis) prior to initiating therapy. For patients who screen positive for latent infections, consult infectious disease or other specialists (eg, liver specialists) regarding treatment options before initiating therapy (AAN [Farez 2019]).
• Myocardial toxicity: May cause myocardial toxicity and potentially fatal heart failure (HF); risk increases with cumulative dosing. Cardiotoxicity may occur during therapy or may be delayed (months or years after completion of therapy). Predisposing factors for mitoxantrone-induced cardiotoxicity include prior anthracycline or anthracenedione therapy, prior or current cardiovascular disease, concomitant use of cardiotoxic drugs, and mediastinal/pericardial irradiation, although may also occur in patients without risk factors. Mitoxantrone is not recommended for use in patients with MS when baseline LVEF below the lower limit of normal (LLN). Evaluate for cardiac signs/symptoms (by history, physical exam, and ECG) and evaluate LVEF (using same method as baseline LVEF) in patients with MS prior to each dose. Patients with MS should not receive a cumulative dose of >140 mg/m2. Do not administer mitoxantrone if LVEF falls below LLN or if a significant decrease in LVEF is observed during treatment. Patients with MS should undergo annual LVEF evaluation following discontinuation of therapy to monitor for delayed cardiotoxicity. Evaluate potential risk versus benefit in patients who have previously received anthracycline therapy. If signs/symptoms of heart failure develop, evaluate LVEF and ECG.
- According to ASCO guidelines for prevention and monitoring of cardiac dysfunction in survivors of adult cancers (ASCO [Armenian 2017]), the risk of cardiac dysfunction is increased with high-dose anthracycline therapy (eg, equivalent to doxorubicin ≥250 mg/m2); high-dose radiotherapy (≥30 Gy) with the heart in the treatment field; lower-dose anthracyclines (eg, equivalent to doxorubicin <250 mg/m2) in combination with lower-dose radiotherapy (<30 Gy) with the heart in the treatment field; lower-dose anthracyclines AND any of the following risk factors: ≥2 cardiovascular risk factors (including smoking, hypertension, diabetes, dyslipidemia, and obesity) during or after completion of therapy or ≥60 years of age at cancer treatment, or compromised cardiac function (eg, borderline low LVEF [50% to 55%], history of myocardial infarction, moderate or higher valvular heart disease) before or during treatment; treatment with lower-dose anthracycline followed by trastuzumab (sequential therapy); other risk factors for anthracycline-induced cardiotoxicity include ≥60 years of age at time of treatment and 2 or more cardiovascular risk factors (smoking, hypertension, diabetes, dyslipidemia, or obesity) during or after treatment.
• Secondary malignancy: Treatment with mitoxantrone increases the risk of developing secondary acute myeloid leukemia (AML) in patients with cancer and in patients with MS; acute promyelocytic leukemia (APL) has also been observed. Symptoms of acute leukemia include excessive bruising, bleeding and recurrent infections. The risk for secondary leukemia is increased in patients who are heavily pretreated, with higher doses, and/or with combination chemotherapy.
• Tumor lysis syndrome: Rapid lysis of tumor cells may lead to hyperuricemia and tumor lysis syndrome.
Dosage form specific issues:
• Sodium metabisulfite: May contain sodium metabisulfite; use caution in patients with asthma or a sulfite allergy.
Special populations:
• Pediatric: Children are at increased risk for developing delayed cardiotoxicity; long-term periodic cardiac function monitoring is recommended. In pediatric patients with cancer, the hazard ratio of developing grade 3 to 5 cardiomyopathy was estimated to be 4.2 for patients receiving up to a cumulative dose of <75 mg/m2 and 48 for patients receiving up to a cumulative dose of ≥75 mg/m2 (Feijen 2019). Mitoxantrone (after multiplying by a factor of 4 to account for therapeutic dose differences) was associated with a greater risk of cardiomyopathy as compared with doxorubicin (mean equivalence ratio: 10.5) (Feijen 2019). A panel from the American Society of Pediatric Hematology/Oncology (ASPHO) and International Society of Pediatric Oncology (SIOP) recommends in favor of an anthracycline infusion duration of at least 1 hour in pediatric patients to reduce the potential for cardiotoxicity (ASPHO/SIOP [Loeffen 2018]). However, extravasation risks should also be minimized and the protocol infusion duration specified in a protocol should be followed, particularly if the patient is receiving dexrazoxane as a cardioprotectant. According to the Children's Oncology Group (COG) Long-Term Follow-Up Guidelines (version 5, Oct 2018), the risk of cardiac toxicity (cardiomyopathy, subclinical left ventricular dysfunction, congestive heart failure, arrhythmia) is increased in patients who have received cumulative doses of ≥250 mg/m2 doxorubicin-equivalents, ≥35 Gy chest radiation or any dose of anthracycline in combination with chest radiation ≥15 Gy (Long-Term Follow-Up Guidelines [COG 2018]).
Other warnings/precautions:
• Appropriate administration: For IV administration only; do not administer subcutaneously, intramuscularly, or intra-arterially. Do not administer intrathecally; may cause serious and permanent neurologic damage.
• Blue-green coloration: May cause urine, saliva, tears, and sweat to turn blue-green for 24 hours postinfusion; whites of eyes may have blue-green tinge.
• Immunizations: Avoid live-attenuated vaccines in patients who currently receive or have recently discontinued mitoxantrone for multiple sclerosis; consider using live-attenuated vaccines only if risk of infection is high and killed vaccines are unavailable (AAN [Farez 2019]).
Pediatric patients are at increased risk for developing delayed cardiac toxicity and congestive heart failure during early adulthood due to an increasing census of long-term survivors; risk factors include young treatment age (<5 years), cumulative exposure, and concomitant cardiotoxic therapy. Up to 40% of pediatric patients may have subclinical cardiac dysfunction, and 5% to 10% may develop heart failure. Long-term monitoring is recommended for all pediatric patients (Long-Term Follow-Up Guidelines [COG 2018]).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Concentrate, Intravenous:
Generic: 20 mg/10 mL (10 mL); 25 mg/12.5 mL (12.5 mL); 30 mg/15 mL (15 mL)
Yes
Concentrate (mitoXANTRONE HCl Intravenous)
20 mg/10 mL (per mL): $20.71 - $48.92
25 mg/12.5 mL (per mL): $20.71 - $54.07
30 mg/15 mL (per mL): $20.71 - $51.00
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Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Concentrate, Intravenous:
Generic: 2 mg/mL (10 mL)
IV: For IV administration only; do not administer intrathecally, subcutaneously, intramuscularly, or intra-arterially. Must be diluted prior to use. Usually administered as a short IV infusion over 5 to 15 minutes; do not infuse over less than 3 to 5 minutes. Mitoxantrone was infused over 20 to 30 minutes in some (off-label) regimens; refer to protocol for infusion details.
Irritant with vesicant-like properties; ensure proper needle or catheter placement prior to and during infusion; avoid extravasation.
Extravasation management: If extravasation occurs, stop infusion immediately and disconnect (leave cannula/needle in place); gently aspirate extravasated solution (do NOT flush the line); remove needle/cannula; elevate extremity. Initiate antidote (dexrazoxane or dimethyl sulfate [DMSO]). Apply dry cold compresses for 20 minutes 4 times daily for 1 to 2 days (Ref); withhold cooling beginning 15 minutes before dexrazoxane infusion; continue withholding cooling until 15 minutes after infusion is completed. Topical DMSO should not be administered in combination with dexrazoxane; may lessen dexrazoxane efficacy.
Dexrazoxane: 1,000 mg/m2 (maximum dose: 2,000 mg) IV (administer in a large vein remote from site of extravasation) over 1 to 2 hours days 1 and 2, then 500 mg/m2 (maximum dose: 1,000 mg) IV over 1 to 2 hours day 3; begin within 6 hours of extravasation. Day 2 and day 3 doses should be administered at approximately the same time (±3 hours) as the dose on day 1 (Ref). Note: Reduce dexrazoxane dose by 50% in patients with moderate to severe renal impairment (CrCl <40 mL/minute).
DMSO: Apply topically to a region covering twice the affected area every 8 hours for 7 days; begin within 10 minutes of extravasation; do not cover with a dressing (Ref).
Parenteral: For IV administration only; do NOT administer by SUBQ, IM, intrathecal, or intra-arterial injection. Must be diluted prior to use; may administer by IV bolus over 5 to 15 minutes or IV intermittent infusion over 15 to 60 minutes; refer to protocol for infusion details.
Irritant with vesicant-like properties; ensure proper needle or catheter placement prior to and during infusion; avoid extravasation. If extravasation occurs, stop infusion immediately and disconnect (leave cannula/needle in place); gently aspirate extravasated solution (do NOT flush the line); remove needle/cannula; elevate extremity. Initiate antidote (dimethyl sulfate [DMSO] or dexrazoxane [Adults]) (see Management of Drug Extravasations for more details). Apply dry cold compresses for 20 minutes 4 times daily for 1 to 2 days (Ref); withhold cooling beginning 15 minutes before dexrazoxane infusion; continue withholding cooling until 15 minutes after infusion is completed. Topical DMSO should not be administered in combination with dexrazoxane; may lessen dexrazoxane efficacy.
Hazardous agent (NIOSH 2024 [table 1]).
Use appropriate precautions for receiving, handling, storage, preparation, dispensing, transporting, administration, and disposal. Follow NIOSH and USP 800 recommendations and institution-specific policies/procedures for appropriate containment strategy (NIOSH 2023; NIOSH 2024; USP-NF 2020).
An FDA-approved patient medication guide, which is available with the product information and at https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019297s035mg.pdf, must be dispensed with this medication.
Acute myeloid leukemias: Initial treatment (in combination with other agents) of acute nonlymphocytic leukemia (ANLL [includes myelogenous, promyelocytic, monocytic and erythroid leukemias]).
Multiple sclerosis, relapsing or secondary progressive: Treatment of secondary (chronic) progressive, progressive relapsing, or worsening or relapsing-remitting multiple sclerosis (RRMS) to reduce neurologic disability and/or the frequency of clinical relapse.
Limitation of use: Mitoxantrone is not indicated for the treatment of primary progressive MS. Reserve use for rapidly-advancing, refractory multiple sclerosis (AAN [Rae-Grant 2018]; Olek 2019).
Prostate cancer, advanced, castrate-resistant: Treatment of advanced hormone-refractory (castrate-resistant) prostate cancer (in combination with corticosteroids).
Acute lymphoblastic leukemia, relapsed/refractory; Acute myeloid leukemia, relapsed/refractory; Acute promyelocytic leukemia, newly diagnosed; Hodgkin lymphoma; Non-Hodgkin lymphomas, relapsed/refractory; T-cell prolymphocytic leukemia
MitoXANTRONE may be confused with methotrexate, mitoMYcin, mitotane, Mutamycin
The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drug classes (chemotherapeutic agent, parenteral and oral) which have a heightened risk of causing significant patient harm when used in error (High-Alert Medications in Acute Care, Community/Ambulatory Care, and Long-Term Care Settings).
MitoXANTRONE may be confused with MTX Patch brand name for lidocaine/menthol [Puerto Rico]
Substrate of BCRP, P-glycoprotein (Minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential;
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
5-Aminosalicylic Acid Derivatives: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor
Abrocitinib: May increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid
Antithymocyte Globulin (Equine): Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of cytotoxic chemotherapy is reduced. Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor
Antithyroid Agents: Myelosuppressive Agents may increase neutropenic effects of Antithyroid Agents. Risk C: Monitor
Baricitinib: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Baricitinib. Risk X: Avoid
BCG Products: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of BCG Products. Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Brincidofovir: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Brincidofovir. Risk C: Monitor
Brivudine: May increase adverse/toxic effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid
Chikungunya Vaccine (Live): Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Chikungunya Vaccine (Live). Risk X: Avoid
Chloramphenicol (Ophthalmic): May increase adverse/toxic effects of Myelosuppressive Agents. Risk C: Monitor
Chloramphenicol (Systemic): Myelosuppressive Agents may increase myelosuppressive effects of Chloramphenicol (Systemic). Risk X: Avoid
Cladribine: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Cladribine. Risk X: Avoid
CloZAPine: Myelosuppressive Agents may increase adverse/toxic effects of CloZAPine. Specifically, the risk for neutropenia may be increased. Risk C: Monitor
Coccidioides immitis Skin Test: Coadministration of Immunosuppressants (Cytotoxic Chemotherapy) and Coccidioides immitis Skin Test may alter diagnostic results. Management: Consider discontinuing cytotoxic chemotherapy several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider Therapy Modification
COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor
COVID-19 Vaccine (mRNA): Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider Therapy Modification
COVID-19 Vaccine (Subunit): Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of COVID-19 Vaccine (Subunit). Risk C: Monitor
CycloSPORINE (Systemic): May increase serum concentration of MitoXANTRONE. Risk C: Monitor
Deferiprone: Myelosuppressive Agents may increase neutropenic effects of Deferiprone. Management: Avoid the concomitant use of deferiprone and myelosuppressive agents whenever possible. If this combination cannot be avoided, monitor the absolute neutrophil count more closely. Risk D: Consider Therapy Modification
Dengue Tetravalent Vaccine (Live): Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Dengue Tetravalent Vaccine (Live). Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Denosumab: May increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and cytotoxic chemotherapy. If combined, monitor patients for signs/symptoms of serious infections. Risk D: Consider Therapy Modification
Deucravacitinib: May increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid
Etrasimod: May increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid
Fexinidazole: Myelosuppressive Agents may increase myelosuppressive effects of Fexinidazole. Risk X: Avoid
Filgotinib: May increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid
Inebilizumab: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Inebilizumab. Risk C: Monitor
Influenza Virus Vaccines: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating chemotherapy if possible. If vaccination occurs less than 2 weeks prior to or during chemotherapy, revaccinate at least 3 months after therapy discontinued if immune competence restored. Risk D: Consider Therapy Modification
Leflunomide: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents, such as cytotoxic chemotherapy. Risk D: Consider Therapy Modification
Lenograstim: Antineoplastic Agents may decrease therapeutic effects of Lenograstim. Management: Avoid the use of lenograstim 24 hours before until 24 hours after the completion of myelosuppressive cytotoxic chemotherapy. Risk D: Consider Therapy Modification
Linezolid: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor
Lipegfilgrastim: Antineoplastic Agents may decrease therapeutic effects of Lipegfilgrastim. Management: Avoid concomitant use of lipegfilgrastim and myelosuppressive cytotoxic chemotherapy. Lipegfilgrastim should be administered at least 24 hours after the completion of myelosuppressive cytotoxic chemotherapy. Risk D: Consider Therapy Modification
Mumps- Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Nadofaragene Firadenovec: Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid
Natalizumab: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Natalizumab. Risk X: Avoid
Ocrelizumab: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Ocrelizumab. Risk C: Monitor
Ofatumumab: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Ofatumumab. Risk C: Monitor
Olaparib: Myelosuppressive Agents may increase myelosuppressive effects of Olaparib. Risk C: Monitor
Palifermin: May increase adverse/toxic effects of Antineoplastic Agents. Specifically, the duration and severity of oral mucositis may be increased. Management: Do not administer palifermin within 24 hours before, during infusion of, or within 24 hours after administration of myelotoxic chemotherapy. Risk D: Consider Therapy Modification
Pidotimod: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Pidotimod. Risk C: Monitor
Pimecrolimus: May increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid
Piperacillin: May increase hypokalemic effects of Antineoplastic Agents. Risk C: Monitor
Pneumococcal Vaccines: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Pneumococcal Vaccines. Risk C: Monitor
Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Polymethylmethacrylate: Immunosuppressants (Cytotoxic Chemotherapy) may increase hypersensitivity effects of Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider Therapy Modification
Promazine: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor
Rabies Vaccine: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider Therapy Modification
Ritlecitinib: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Ritlecitinib. Risk X: Avoid
Ropeginterferon Alfa-2b: Myelosuppressive Agents may increase myelosuppressive effects of Ropeginterferon Alfa-2b. Management: Avoid coadministration of ropeginterferon alfa-2b and other myelosuppressive agents. If this combination cannot be avoided, monitor patients for excessive myelosuppressive effects. Risk D: Consider Therapy Modification
Ruxolitinib (Topical): Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Ruxolitinib (Topical). Risk X: Avoid
Sipuleucel-T: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants, such as cytotoxic chemotherapy, prior to initiating sipuleucel-T therapy. Risk D: Consider Therapy Modification
Sphingosine 1-Phosphate (S1P) Receptor Modulators: May increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk C: Monitor
Tacrolimus (Topical): Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Tacrolimus (Topical). Risk X: Avoid
Talimogene Laherparepvec: Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid
Tertomotide: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Tertomotide. Risk X: Avoid
Tofacitinib: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Tofacitinib. Risk X: Avoid
Typhoid Vaccine: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Typhoid Vaccine. Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Ublituximab: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Ublituximab. Risk C: Monitor
Upadacitinib: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Upadacitinib. Risk X: Avoid
Vaccines (Live): Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Vaccines (Live) may decrease therapeutic effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid
Vaccines (Non-Live/Inactivated/Non-Replicating): Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Give non-live/inactivated/non-replicating vaccines at least 2 weeks prior to starting chemotherapy when possible. Patients vaccinated less than 14 days before or during chemotherapy should be revaccinated at least 3 months after therapy is complete. Risk D: Consider Therapy Modification
Yellow Fever Vaccine: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Yellow Fever Vaccine. Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid
Zoster Vaccine (Live/Attenuated): Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Zoster Vaccine (Live/Attenuated). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Zoster Vaccine (Live/Attenuated). Risk X: Avoid
Pregnancy status should be evaluated prior to treatment in patients who could become pregnant. Mitoxantrone is associated with amenorrhea, ovarian failure, and male infertility (AAN [Rae-Grant 2018]).
In general, disease-modifying therapies for multiple sclerosis (MS) are stopped prior to a planned pregnancy except in patients at high risk of MS activity (AAN [Rae-Grant 2018]). Consider use of agents other than mitoxantrone for patients at high risk of disease reactivation who are planning to become pregnant. Delaying pregnancy is recommended for patients with persistent high disease activity; when disease-modifying therapy is needed in these patients, other agents are preferred (ECTRIMS/EAN [Montalban 2018]).
Based on the mechanism of action and adverse events observed in animal reproduction studies, in utero exposure to mitoxantrone may cause fetal harm.
Outcome data following maternal use of mitoxantrone during pregnancy are limited (Amato 2015; Frau 2018; Houtchens 2013; Karagiannis 2021; NTP 2013).
In general, disease-modifying therapies for multiple sclerosis (MS) are not initiated during pregnancy, except in patients at high risk of MS activity (AAN [Rae-Grant 2018]). When disease-modifying therapy is needed in these patients, other agents are preferred (ECTRIMS/EAN [Montalban 2018]).
The European Society for Medical Oncology has published guidelines for diagnosis, treatment, and follow-up of cancer during pregnancy. The guidelines recommend referral to a facility with expertise in cancer during pregnancy and encourage a multidisciplinary team (obstetrician, neonatologist, oncology team). In general, if chemotherapy is indicated, it should be avoided in the first trimester, there should be a 3-week time period between the last chemotherapy dose and anticipated delivery, and chemotherapy should not be administered beyond week 33 of gestation (ESMO [Peccatori 2013]).
Mitoxantrone is present in breast milk.
Mitoxantrone concentrations in breast milk were evaluated in a female following treatment for acute promyelocytic leukemia. The patient was administered mitoxantrone 6 mg/m2 for 3 days as part of consolidation therapy. Therapy was initiated during pregnancy; breast milk was sampled after the third dose of the third consolidation treatment postpartum. The highest milk concentrations (120 ng/mL) occurred following mitoxantrone administration; significant concentrations (18 ng/mL) were still observed 28 days after the last dose (Azuno 1995). Due to the potential for serious adverse reactions in the breastfed infant, the manufacturer recommends that breastfeeding be discontinued before starting mitoxantrone treatment.
CBC with differential (frequently when used to treat cancer; prior to each dose when treating multiple sclerosis [MS]), serum uric acid (for leukemia treatment), LFTs. Evaluate pregnancy status (prior to treatment in patients who can become pregnant; prior to each dose in patients with MS). Monitor for infections due to neutropenia, and for signs/symptoms of tumor lysis syndrome or secondary malignancies. For the treatment of MS, latent infection screening (eg, hepatitis, tuberculosis) in high-risk populations or in countries with high tuberculosis burden (at baseline). Monitor injection site for extravasation.
Cardiac monitoring: Prior to initiation, evaluate all patients for cardiac-related signs/symptoms, including history, physical exam, and ECG; evaluate baseline and periodic left ventricular ejection fraction (LVEF) with echocardiogram or multigated radionuclide angiography (MUGA) or MRI. In patients with MS, evaluate for cardiac signs/symptoms (by history, physical exam, and ECG) and evaluate LVEF (using same method as baseline LVEF) prior to each dose and if signs/symptoms of HF develop. Patients with MS should undergo annual LVEF evaluation following discontinuation of therapy to monitor for delayed cardiotoxicity.
Additional cardiovascular monitoring to consider in patients receiving mitoxantrone for the treatment of cancer (ASCO [Armenian 2017], ESC [Lyon 2022]): Comprehensive assessment prior to treatment including a history and physical examination, screening for cardiovascular disease risk factors such as hypertension, diabetes, dyslipidemia, obesity, and smoking. Echocardiogram (transthoracic preferred, perform at baseline and 12 months after therapy completion for all patients; in addition, perform every 2 cycles and within 3 months after therapy completion for high-risk or very high-risk patients). Cardiac biomarkers (troponin and natriuretic peptide at baseline for high-risk and very high-risk patients [may consider for low- and moderate-risk patients]; also prior to each cycle during anthracycline treatment and at 3 and 12 months after therapy completion for high-risk and very high-risk patients). In patients who develop signs/symptoms of cardiac dysfunction during therapy, an echocardiogram is recommended for diagnostic workup; if an echocardiogram is not available or feasible, a cardiac MRI (preferred) or MUGA scan may be utilized; obtain serum cardiac biomarkers. Refer to a cardiologist when clinically indicated.
Oncology uses: The American Society of Clinical Oncology hepatitis B virus (HBV) screening and management provisional clinical opinion (ASCO [Hwang 2020]) recommends HBV screening with hepatitis B surface antigen, hepatitis B core antibody, total Ig or IgG, and antibody to hepatitis B surface antigen prior to beginning (or at the beginning of) systemic anticancer therapy; do not delay treatment for screening/results. Detection of chronic or past HBV infection requires a risk assessment to determine antiviral prophylaxis requirements, monitoring, and follow-up.
Mitoxantrone is an anthracenedione, which is related to the anthracyclines. Mitoxantrone intercalates into DNA resulting in cross-links and strand breaks; binds to nucleic acids and inhibits DNA and RNA synthesis by template disordering and steric obstruction; replication is decreased by binding to DNA topoisomerase II and may inhibit the incorporation of uridine into RNA and thymidine into DNA; mitoxantrone is active throughout entire cell cycle (cell-cycle nonspecific).
Distribution: Vdss: >1,000 L/m2. Mitoxantrone distributes extensively into kidney, liver, heart, lung, and bone marrow, but does not cross the blood brain barrier (Perry 2012).
Protein binding: 78%
Metabolism: Hepatic
Half-life elimination: Terminal: 23 to 215 hours (median: ~75 hours)
Excretion: Feces (25%); urine (11%; 65% as unchanged drug)
Hepatic function impairment: Clearance is reduced in patients with hepatic impairment. The AUC is at least 3 times greater in patients with severe hepatic impairment (bilirubin >3.4 mg/dL) compared to patients with normal hepatic function.
