Does Novantrone (mitoxantrone) cause side effects?
Novantrone (mitoxantrone) is a synthetic (man-made) anticancer drug used to treat secondary progressive multiple sclerosis (MS), acute nonlymphocytic leukemia, and pain related to advanced hormone-refractory prostate cancer.
It kills cancer cells by disrupting the action of deoxyribonucleic acids (DNA) in human cells by causing abnormal cross-links and breaks in the DNA. It also interferes with ribonucleic acid (RNA) and inhibits the activity of topoisomerase II, an enzyme necessary for repairing damaged DNA.
Common side effects of Novantrone include
- nausea,
- upper respiratory tract infections,
- hair loss,
- diarrhea,
- interruption of menstruation,
- constipation, and
- inflammation of the mouth.
Serious side effects of Novantrone include
- heart failure,
- suppression of the immune system, and
- liver toxicity.
Drug interactions of Novantrone include other drugs that, like Novantrone, suppress the immune system, because it leads to severe immune suppression and an increased risk of infections.
Novantrone should not be administered to pregnant women due to risk of severe harm to the fetus. Novantrone is excreted in breast milk and should not be used while breastfeeding.
What are the important side effects of Novantrone (mitoxantrone)?
The most common side effects of mitoxantrone are:
- nausea,
- upper respiratory tract infections,
- hair loss (alopecia),
- diarrhea,
- interruption of menstruation,
- constipation,
- inflammation of the mouth (stomatitis).
Other important side effects include
- heart failure,
- suppression of the immune system, and
- liver toxicity.
Novantrone (mitoxantrone) side effects list for healthcare professionals
Multiple Sclerosis
Novantrone has been administered to 149 patients with multiple sclerosis in two randomized clinical trials, including 21 patients who received Novantrone in combination with corticosteroids.
In Study 1, the proportion of patients who discontinued treatment due to an adverse event was 9.7% (n = 6) in the 12 mg/m² Novantrone arm (leukopenia, depression, decreased LV function, bone pain and emesis, renal failure, and one discontinuation to prevent future complications from repeated urinary tract infections) compared to 3.1% (n = 2) in the placebo arm (hepatitis and myocardial infarction).
The following clinical adverse experiences were significantly more frequent in the Novantrone groups:
- nausea,
- alopecia,
- urinary tract infection, and
- menstrual disorders, including amenorrhea.
Table 4a summarizes clinical adverse events of all intensities occurring in ≥ 5% of patients in either dose group of Novantrone and that were numerically greater on drug than on placebo in Study 1.
The majority of these events were of mild to moderate intensity, and nausea was the only adverse event that occurred with severe intensity in more than one patient (three patients [5%] in the 12 mg/m² group). Of note, alopecia consisted of mild hair thinning.
Two of the 127 patients treated with Novantrone in Study 1 had decreased LVEF to below 50% at some point during the 2 years of treatment. An additional patient receiving 12 mg/m² did not have LVEF measured, but had another echocardiographic measure of ventricular function (fractional shortening) that led to discontinuation from the study.
Table 4a : Adverse Events of Any Intensity Occurring in ≥ 5% of Patients on Any Dose of Novantrone and That Were Numerically Greater Than in the Placebo Group Study 1
Preferred Term | Percent of Patients | ||
Placebo (N = 64) | 5 mg/m² Novantrone (N = 65) | 12 mg/m² Novantrone (N = 62) | |
Nausea | 20 | 55 | 76 |
Alopecia | 31 | 38 | 61 |
Menstrual disorder * | 26 | 51 | 61 |
Amenorrhea * | 3 | 28 | 43 |
Upper respiratory tract infection | 52 | 51 | 53 |
Urinary tract infection | 13 | 29 | 32 |
Stomatitis | 8 | 15 | 19 |
Arrhythmia | 8 | 6 | 18 |
Diarrhea | 11 | 25 | 16 |
Urine abnormal | 6 | 5 | 11 |
ECG abnormal | 3 | 5 | 11 |
Constipation | 6 | 14 | 10 |
Back pain | 5 | 6 | 8 |
Sinusitis | 2 | 3 | 6 |
Headache | 5 | 6 | 6 |
* Percentage of female patients. |
The proportion of patients experiencing any infection during Study 1 was 67% for the placebo group, 85% for the 5 mg/m² group, and 81% for the 12 mg/m² group. However, few of these infections required hospitalization:
- one placebo patient (tonsillitis),
- three 5 mg/m² patients (enteritis, urinary tract infection, viral infection), and
- four 12 mg/m² patients (tonsillitis, urinary tract infection [two], endometritis).
Table 4b summarizes laboratory abnormalities that occurred in ≥ 5% of patients in either Novantrone dose group, and that were numerically more frequent than in the placebo group.
Table 4b : Laboratory Abnormalities Occurring in ≥ 5% of Patients* on Either Dose of Novantrone and That Were More Frequent Than in the Placebo Group Study 1
Event | Percent of Patients | ||
Placebo (N = 64) | 5 mg/m² Novantrone (N = 65) | 12 mg/m² Novantrone (N = 62) | |
Leukopenia a | 0 | 9 | 19 |
Gamma-GT increased | 3 | 3 | 15 |
SGOT increased | 8 | 9 | 8 |
Granulocytopenia b | 2 | 6 | 6 |
Anemia | 2 | 9 | 6 |
SGPT increased | 3 | 6 | 5 |
*Assessed using World Health Organization (WHO) toxicity criteria. < 4000 cells/mm³ < 2000 cells/mm³ |
There was no difference among treatment groups in the incidence or severity of hemorrhagic events.
In Study 2, Novantrone was administered once a month. Clinical adverse events most frequently reported in the Novantrone group included
- amenorrhea (53% of female patients),
- alopecia (33% of patients),
- nausea (29% of patients), and
- asthenia (24% of patients).
Tables 5a and 5b respectively summarize adverse events and laboratory abnormalities occurring in > 5% of patients in the Novantrone group and numerically more frequent than in the control group.
Table 5a : Adverse Events of Any Intensity Occurring in > 5% of Patients* in the Novantrone Group and Numerically More Frequent Than in the Control Group Study 2
Event | Percent of Patients | |
MP (n = 21) | N + MP (n = 21) | |
Amenorrhea a | 0 | 53 |
Alopecia | 0 | 33 |
Nausea | 0 | 29 |
Asthenia | 0 | 24 |
Pharyngitis/throat infection | 5 | 19 |
Gastralgia/stomach burn/epigastric pain | 5 | 14 |
Aphthosis | 0 | 10 |
Cutaneous mycosis | 0 | 10 |
Rhinitis | 0 | 10 |
Menorrhagia a | 0 | 7 |
N = Novantrone, MP = methylprednisolone *Assessed using National Cancer Institute (NCI) common toxicity criteria. a Percentage of female patients. |
Table 5b : Laboratory Abnormalities Occurring in > 5% of Patients* in the Novantrone Group and Numerically More Frequent Than in the Control Group Study 2
Event | Percent of Patients | |
MP (n = 21) | N + MP (n = 21) | |
WBC low a | 14 | 100 |
ANC low b | 10 | 100 |
Lymphocytes low | 43 | 95 |
Hemoglobin low | 48 | 43 |
Platelets low c | 0 | 33 |
SGOT high | 5 | 15 |
SGPT high | 10 | 15 |
Glucose high | 5 | 10 |
Potassium low | 0 | 10 |
N = Novantrone, MP = methylprednisolone. *Assessed using National Cancer Institute (NCI) common toxicity criteria. a < 4000 cells/mm3 b < 1500 cells/mm3 c < 100,000 cells/mm3 |
Leukopenia and neutropenia were reported in the N +MP group (see Table 5b).
Neutropenia occurred within 3 weeks after Novantrone administration and was always reversible. Only mild to moderate intensity infections were reported in 9 of 21 patients in the N +MP group and in 3 of 21 patients in the MP group; none of these required hospitalization.
There was no difference among treatment groups in the incidence or severity of hemorrhagic events. There were no withdrawals from Study 2 for safety reasons.
Leukemia
- Novantrone has been studied in approximately 600 patients with acute nonlymphocytic leukemia (ANLL).
- Table 6 represents the adverse reaction experience in the large U.S. comparative study of mitoxantrone + cytarabine vs daunorubicin + cytarabine.
- Experience in the large international study was similar.
- A much wider experience in a variety of other tumor types revealed no additional important reactions other than cardiomyopathy.
- It should be appreciated that the listed adverse reaction categories include overlapping clinical symptoms related to the same condition, e.g., dyspnea, cough and pneumonia.
- In addition, the listed adverse reactions cannot all necessarily be attributed to chemotherapy as it is often impossible to distinguish effects of the drug and effects of the underlying disease.
- It is clear, however, that the combination of Novantrone + cytarabine was responsible for nausea and vomiting, alopecia, mucositis/stomatitis, and myelosuppression.
- Table 6 summarizes adverse reactions occurring in patients treated with Novantrone + cytarabine in comparison with those who received daunorubicin + cytarabine for therapy of ANLL in a large multicenter randomized prospective U.S. trial.
- Adverse reactions are presented as major categories and selected examples of clinically significant subcategories.
Table 6 : Adverse Events Occurring in ANLL Patients Receiving Novantrone or Daunorubicin
Event | Induction [% pts entering induction] | Consolidation [% pts entering induction] | ||
NOV N = 102 | DAUN N = 102 | NOV N = 55 | DAUN N = 49 | |
Cardiovascular | 26 | 28 | 11 | 24 |
CHF | 5 | 6 | 0 | 0 |
Arrhythmias | 3 | 3 | 4 | 4 |
Bleeding | 37 | 41 | 20 | 6 |
GI | 16 | 12 | 2 | 2 |
Petechiae/ecchymoses | 7 | 9 | 11 | 2 |
Gastrointestinal | 88 | 85 | 58 | 51 |
Nausea/vomiting | 72 | 67 | 31 | 31 |
Diarrhea | 47 | 47 | 18 | 8 |
Abdominal pain | 15 | 9 | 9 | 4 |
Mucositis/stomatitis | 29 | 33 | 18 | 8 |
Hepatic | 10 | 11 | 14 | 2 |
Jaundice | 3 | 8 | 7 | 0 |
Infections | 66 | 73 | 60 | 43 |
UTI | 7 | 2 | 7 | 2 |
Pneumonia | 9 | 7 | 9 | 0 |
Sepsis | 34 | 36 | 31 | 18 |
Fungal infections | 15 | 13 | 9 | 6 |
Renal failure | 8 | 6 | 0 | 2 |
Fever | 78 | 71 | 24 | 18 |
Alopecia | 37 | 40 | 22 | 16 |
Pulmonary | 43 | 43 | 24 | 14 |
Cough | 13 | 9 | 9 | 2 |
Dyspnea | 18 | 20 | 6 | 0 |
CNS | 30 | 30 | 34 | 35 |
Seizures | 4 | 4 | 2 | 8 |
Headache | 10 | 9 | 13 | 8 |
Eye | 7 | 6 | 2 | 4 |
Conjunctivitis | 5 | 1 | 0 | 0 |
NOV = Novantrone, DAUN = daunorubicin. |
Hormone-Refractory Prostate Cancer
Detailed safety information is available for a total of 353 patients with hormone-refractory prostate cancer treated with Novantrone, including 274 patients who received Novantrone in combination with corticosteroids.
Table 7 summarizes adverse reactions of all grades occurring in ≥ 5% of patients in Trial CCI-NOV22.
Table 7 : Adverse Events of Any Intensity Occurring in ≥ 5% of Patients Trial CCI-NOV22
Event | N + P (n = 80) % | P (n = 81) % |
Nausea | 61 | 35 |
Fatigue | 39 | 14 |
Alopecia | 29 | 0 |
Anorexia | 25 | 6 |
Constipation | 16 | 14 |
Dyspnea | 11 | 5 |
Nail bed changes | 11 | 0 |
Edema | 10 | 4 |
Systemic infection | 10 | 7 |
Mucositis | 10 | 0 |
UTI | 9 | 4 |
Emesis | 9 | 5 |
Pain | 8 | 9 |
Fever | 6 | 3 |
Hemorrhage/bruise | 6 | 1 |
Anemia | 5 | 3 |
Cough | 5 | 0 |
Decreased LVEF | 5 | 0 |
Anxiety/depression | 5 | 3 |
Dyspepsia | 5 | 6 |
Skin infection | 5 | 3 |
Blurred vision | 3 | 5 |
N = Novantrone, P = prednisone. |
No nonhematologic adverse events of Grade 3/4 were seen in > 5% of patients.
Table 8 summarizes adverse events of all grades occurring in ≥ 5% of patients in Trial CALGB 9182.
Table 8 : Adverse Events of Any Intensity Occurring in ≥ 5 % of Patients Trial CALGB 9182
Event | N + H (n = 112) | H (n = 113) | ||
n | % | n | % | |
Decreased WBC | 96 | 87 | 4 | 4 |
Abnormal granulocytes/bands | 88 | 79 | 3 | 3 |
Decreased hemoglobin | 83 | 75 | 42 | 39 |
Abnormal lymphocytes count | 78 | 72 | 27 | 25 |
Pain | 45 | 41 | 44 | 39 |
Abnormal platelet count | 43 | 39 | 8 | 7 |
Abnormal alkaline phosphatase | 41 | 37 | 42 | 38 |
Malaise/fatigue | 37 | 34 | 16 | 14 |
Hyperglycemia | 33 | 31 | 32 | 30 |
Edema | 31 | 30 | 15 | 14 |
Nausea | 28 | 26 | 9 | 8 |
Anorexia | 24 | 22 | 16 | 14 |
Abnormal BUN | 24 | 22 | 22 | 20 |
Abnormal Transaminase | 22 | 20 | 16 | 14 |
Alopecia | 20 | 20 | 1 | 1 |
Abnormal Cardiac function | 19 | 18 | 0 | 0 |
Infection | 18 | 17 | 4 | 4 |
Weight loss | 18 | 17 | 13 | 12 |
Dyspnea | 16 | 15 | 9 | 8 |
Diarrhea | 16 | 14 | 4 | 4 |
Fever in absence of infection | 15 | 14 | 7 | 6 |
Weight gain | 15 | 14 | 16 | 15 |
Abnormal creatinine | 14 | 13 | 11 | 10 |
Other gastrointestinal | 13 | 14 | 11 | 11 |
Vomiting | 12 | 11 | 6 | 5 |
Other neurologic | 11 | 11 | 5 | 5 |
Hypocalcemia | 10 | 10 | 5 | 5 |
Hematuria | 9 | 11 | 5 | 6 |
Hyponatremia | 9 | 9 | 3 | 3 |
Sweats | 9 | 9 | 2 | 2 |
Other liver | 8 | 8 | 8 | 8 |
Stomatitis | 8 | 8 | 1 | 1 |
Cardiac dysrhythmia | 7 | 7 | 3 | 3 |
Hypokalemia | 7 | 7 | 4 | 4 |
Neuro/constipation | 7 | 7 | 2 | 2 |
Neuro/motor disorder | 7 | 7 | 3 | 3 |
Neuro/mood disorder | 6 | 6 | 2 | 2 |
Skin disorder | 6 | 6 | 4 | 4 |
Cardiac ischemia | 5 | 5 | 1 | 1 |
Chills | 5 | 5 | 0 | 0 |
Hemorrhage | 5 | 5 | 3 | 3 |
Myalgias/arthralgias | 5 | 5 | 3 | 3 |
Other kidney/bladder | 5 | 5 | 3 | 3 |
Other endocrine | 5 | 6 | 3 | 4 |
Other pulmonary | 5 | 5 | 3 | 3 |
Hypertension | 4 | 4 | 5 | 5 |
Impotence/libido | 4 | 7 | 2 | 3 |
Proteinuria | 4 | 6 | 2 | 3 |
Sterility | 3 | 5 | 2 | 3 |
N= Novantrone, H= hydrocortisone |
General
Allergic Reaction
Hypotension, urticaria, dyspnea, and rashes have been reported occasionally. Anaphylaxis/anaphylactoid reactions have been reported rarely.
Cutaneous
Extravasation at the infusion site has been reported, which may result in erythema, swelling, pain, burning, and/or blue discoloration of the skin. Extravasation can result in tissue necrosis with resultant need for debridement and skin grafting. Phlebitis has also been reported at the site of the infusion.
Hematologic
Topoisomerase II inhibitors, including Novantrone, in combination with other antineoplastic agents or alone, have been associated with the development of acute leukemia.
Leukemia
Myelosuppression is rapid in onset and is consistent with the requirement to produce significant marrow hypoplasia in order to achieve a response in acute leukemia. The incidences of infection and bleeding seen in the U.S. trial are consistent with those reported for other standard induction regimens.
Hormone-Refractory Prostate Cancer
In a randomized study where dose escalation was required for neutrophil counts greater than 1000/mm³, Grade 4 neutropenia (ANC < 500 /mm³) was observed in 54% of patients treated with Novantrone + low-dose prednisone.
In a separate randomized trial where patients were treated with 14 mg/m², Grade 4 neutropenia in 23% of patients treated with Novantrone + hydrocortisone was observed.
Neutropenic fever/infection occurred in 11% and 10% of patients receiving Novantrone + corticosteroids, respectively, on the two trials.
Platelets < 50,000/mm³ were noted in 4% and 3% of patients receiving Novantrone + corticosteroids on these trials, and there was one patient death on Novantrone + hydrocortisone due to intracranial hemorrhage after a fall.
Gastrointestinal
Nausea and vomiting occurred acutely in most patients and may have contributed to reports of dehydration, but were generally mild to moderate and could be controlled through the use of antiemetics. Stomatitis/mucositis occurred within 1 week of therapy.
Cardiovascular
Congestive heart failure, tachycardia, EKG changes including arrhythmias, chest pain, and asymptomatic decreases in left ventricular ejection fraction have occurred.
Pulmonary
Interstitial pneumonitis has been reported in cancer patients receiving combination chemotherapy that included Novantrone.
What drugs interact with Novantrone (mitoxantrone)?
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, post-marketing experience has not revealed any significant drug interactions in patients who have received Novantrone for treatment of cancer. Information on drug interactions in patients with multiple sclerosis is limited.
Following concurrent administration of Novantrone with corticosteroids, no evidence of drug interactions has been observed.
Summary
Novantrone (mitoxantrone) is a synthetic (man-made) anticancer drug used to treat secondary progressive multiple sclerosis (MS), acute nonlymphocytic leukemia, and pain related to advanced hormone-refractory prostate cancer. Common side effects of Novantrone include nausea, upper respiratory tract infections, hair loss, diarrhea, interruption of menstruation, constipation, and inflammation of the mouth. Novantrone should not be administered to pregnant women due to risk of severe harm to the fetus. Novantrone is excreted in breast milk and should not be used while breastfeeding.
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Prostate Cancer: Radiation, Brachytherapy and Radiopharmaceuticals
Radiation treatment for prostate cancer is a powerful tool at doctors’ disposal. Using radiation vs. surgery or other invasive treatments to kill cancer cells may still cause side effects, but ideally they are less severe. Radiation therapy can be performed via external beam therapy (EBRT) or the placement of radioactive seeds into the prostate (prostate brachytherapy) or using radioactive drugs (radiopharmaceuticals).
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Prostate Cancer Treatment: Hormonal Therapy
Prostate cancer is highly sensitive to, and dependent on, the level of the male hormone testosterone, which drives the growth of prostate cancer cells. Testosterone belongs to a family of hormones called androgens, and today front-line hormonal therapy for advanced and metastatic prostate cancer is called androgen deprivation therapy (ADT).
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What Are the Very First Signs of Multiple Sclerosis?
Multiple sclerosis (MS) is an inflammatory, neurodegenerative autoimmune disease that affects the brain and spinal cord of the central nervous system (CNS). MS is one of the most common causes of non-injurious disability in young and middle-aged adults.
Treatment & Diagnosis
- Multiple Sclerosis MS FAQs
- Leukemia FAQs
- Prostate Cancer FAQs
- Prostate Cancer - New Criteria
- Prostate Cancer Risk May Be Lowered By Vitamin E
- Evolution of Treatment for a Rare Type of Leukemia
- How Familes Cope with a Leukemia Diagnosis
- A Family's Leukemia Diary - Coping
- Multiple Sclerosis: New Treatment Possibility for MS
- Multiple Sclerosis: New Multiple Sclerosis Treatment Suspended
- How Serious Is Multiple Sclerosis?
- Does Folic Acid Prevent Leukemia?
- Is Prostate Cancer Genetic?
- Can Folic Acid Prevent Leukemia?
- What Is the Prostate Cancer TNM Stage?
- What Does Prostate Cancer Do to You?
- How Do You Develop Prostate Cancer?
- What Are the Early Signs of Prostate Cancer?
- How Does Multiple Sclerosis Affect the Body?
- Multiple Sclerosis Treatment
Medications & Supplements

Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.