Mitoxantrone Side Effects
Some side effects of mitoxantrone may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer
Applies to mitoxantrone: intravenous solution
Get emergency medical help if you have any of these signs of an allergic reaction while taking mitoxantrone: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), loss of appetite, mouth sores, unusual weakness;
pain or burning when you urinate;
fast, slow, or uneven heart rate;
severe or ongoing nausea or diarrhea;
black, bloody, or tarry stools;
coughing up blood or vomit that looks like coffee grounds; or
feeling short of breath, even with mild exertion;
swelling, rapid weight gain;
urinating more or less than usual;
chest pain or tightness, trouble breathing;
skin changes where the medicine was injected.
Less serious side effects of mitoxantrone may include:
mild nausea, mild diarrhea, constipation;
heartburn, stomach pain;
heavy menstrual bleeding;
missed menstrual periods;
depressed mood; or
blue-green colored urine or a bluish color of the whites of the eyes for a few days after each dose.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.
For Healthcare Professionals
Applies to mitoxantrone: intravenous solution
Myelosuppression associated with mitoxantrone may be cumulative with successive therapy. Its severity appears to be correlated with total dose, patient performance status, treatment history, and the degree of marrow disease involvement.
Early data have shown the ratio of equi-myelosuppressive doses of mitoxantrone to doxorubicin is approximately 1:5.
Autologous bone marrow rescue and recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) have been used to ameliorate mitoxantrone-induced myelosuppression.
Hematologic side effects including leukopenia have been reported. Dose-limiting leukopenia usually occurs within 7 to 14 days, and is the most profound and potentially fatal hematologic side effect. Six percent of patients develop leukocyte counts below 1,000/mm3 and less than 50% have nadir counts below 3,000/mm3. Most patients receiving mitoxantrone for ANLL become neutropenic. Leukocyte nadirs usually occur by day 10 to 14, with recovery by day 21 (rarely day 35). Thrombocytopenia occurs less commonly, but can be severe. Only rarely do platelet counts fall below 100,000/mm3 (1% of patients develop platelet counts less than 25,000/mm3). Erythrocytes do not appear to be significantly affected. Granulocytopenia may result in mild to severe infections, including urinary tract infections (7%), pneumonia (9%), bacteremia/sepsis (34%), and fungal infections (9% to 15%). A case of acute myelogenous leukemia following treatment with mitoxantrone has also been reported.
Oncologic side effects including secondary myelogenous leukemia have been reported in both cancer patients and multiple sclerosis patients treated with mitoxantrone.
Gastrointestinal side effects are experienced by most patients and have included nausea and vomiting (31% to 72%, severe in 10% to 16%), diarrhea (18% to 47%), abdominal pain (9% to 15%), and mucositis/stomatitis (7% to 29%, severe in 4%).
Appropriate antiemetic therapy usually ameliorates mitoxantrone-induced nausea and vomiting.
Nausea and vomiting associated with mitoxantrone is usually less troublesome than with equivalent doses of doxorubicin or daunorubicin.
Cardiovascular side effects have included significantly decreased left ventricular (LV) systolic function and congestive heart failure (CHF). Mitoxantrone-induced CHF may be more common in patients with prior treatment with anthracyclines, prior mediastinal radiotherapy, advanced age, multiple sclerosis, or preexisting cardiovascular disease. The overall cumulative probability rate of moderate or serious decreases in LV ejection fraction and CHF at total doses of 140 mg/m2 averages 13% and 2%, respectively. The risk of CHF increases significantly with total doses of greater than 160 mg/m2 (140 mg/m2 if there is a history of receiving anthracyclines). Other cardiovascular side effects include tachycardia, ECG changes (including arrhythmias, prolonged PR, QT, and QRS intervals, and T-wave inversions). Bradycardia and myocardial infarction have rarely been reported.
Mitoxantrone is less cardiotoxic than similar drugs, the anthracyclines.
In first-line comparative trials of mitoxantrone + cytosine arabinoside versus daunorubicin + cytosine arabinoside in adults with previously untreated acute nonlymphocytic leukemia, the incidence of CHF in each arm was 6.5%. A causal relationship between drug therapy and cardiotoxicity is difficult to establish in this setting since myocardial function is frequently depressed by fever, anemia, infection, and hemorrhage, which often accompany the underlying disease.
Most experts recommend stopping mitoxantrone therapy or at least considering endomyocardial biopsy if the LV ejection fraction (per MUGA scan) is reduced by 20% or more during therapy.
Mitoxantrone is chemically related to the anthracyclines, doxorubicin and daunorubicin, which can form free radicals. Free radicals can directly interact with oxygen, causing peroxidation of the lipid membranes of the heart. Supposedly, mitoxantrone does not form free radicals.
Checking for blue streaking in or around the vein is recommended.
Local infusion site problems have included phlebitis and tissue necrosis following IV extravasation.
Nervous system side effects have included rare cases of lethargy, fatigue, seizures, and headache. Myelodysplasia has also been reported.
Intrathecal administration is contraindicated due to cases of paraplegia in humans and hypoactivity, muscle tremors, and paraparesis in animals associated with this route of administration.
Hypersensitivity reactions including hypotension, urticaria, dyspnea, and/or rashes have been reported occasionally.
Patients should be warned that this drug may cause a blue-green discoloration of their skin, but should be reminded that this strange discoloration will fade and is reversible.
Dermatologic side effects are often associated with hypersensitivity reactions. In addition, reversible alopecia may present in 25% to 50% of patients (complete in up to 10%). Other, rare dermatologic side effects include onycholysis, photosensitivity, and hyperpigmentation.
Renal side effects including new or worsened renal insufficiency have rarely been associated with the use of mitoxantrone.
Mild, transient elevations of bilirubin and aspartate and alanine aminotransferase levels have been reported from 4 to 24 days after treatment, returning to baseline or normal a median of 8 days later. In rare cases the abnormalities persisted.
Hepatic side effects including rare cases of elevated hepatic enzymes have been reported.
Drug rash with eosinophilia and systemic signs (DRESS) syndrome is defined by the triad of fever, dermatitis, and internal organ involvement, characteristically occurring with a delay of 3 to 8 weeks after the initiation of treatment with the associated drug.
Other side effects have included urinary and scleral blue-green discoloration and hypomagnesemia and/or hypocalcemia. A case of drug rash with eosinophilia and systemic signs (DRESS) syndrome has been reported.
Genitourinary side effects including uroepithelial necrosis and green urine (blue mixed with yellow green) have been associated with intravesicular administration of mitoxantrone for superficial bladder tumors.
The mechanism of mitoxantrone-associated amenorrhea is believed to be direct toxic effects on the ovary, as is seen with other forms of chemotherapy.
Endocrine side effects including amenorrhea have been reported.
More mitoxantrone resources
- mitoxantrone MedFacts Consumer Leaflet (Wolters Kluwer)
- mitoxantrone Concise Consumer Information (Cerner Multum)
- mitoxantrone Intravenous, Injection Advanced Consumer (Micromedex) - Includes Dosage Information
- Mitoxantrone Prescribing Information (FDA)
- Mitoxantrone Professional Patient Advice (Wolters Kluwer)
- Mitoxantrone Hydrochloride Monograph (AHFS DI)
- Novantrone Prescribing Information (FDA)
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