Mitoxantrone Side Effects

Brand Names: Novantrone

Please note - some side effects for Mitoxantrone may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Mitoxantrone - for the consumer

Mitoxantrone

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Mitoxantrone:

Back pain; blue-green urine; bluish-colored whites of the eyes; constipation; cough; diarrhea; hair loss or thinning; loss of appetite; loss of menstrual period; menstrual changes; mouth pain; nausea; stomach pain or upset; stuffy nose; tiredness; vomiting; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; dark, pink, or bloody urine; fast or irregular heartbeat; fever, chills, sore throat, or persistent cough; increased, decreased, or painful urination; mental or mood changes (eg, anxiety, depression); mouth sores, inflammation, or severe pain; pain, swelling, or redness at the injection site; severe or persistent tiredness or weakness; shortness of breath; sinus infection; sudden, unexplained weight gain; swelling of hands, legs, or feet; unusual bruising or bleeding; vision changes.

For the professional

Mitoxantrone

Leukemia

Mitoxantrone has been studied in approximately 600 patients with ANLL. Table 2 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 Mitoxantrone + cytarabine was responsible for nausea and vomiting, alopecia, mucositis/stomatitis, and myelosuppression.

Table 2 summarizes adverse reactions occurring in patients treated with Mitoxantrone + 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.

Hormone-Refractory Prostate Cancer

Detailed safety information is available for a total of 353 patients with hormone-refractory prostate cancer treated with Mitoxantrone, including 274 patients who received Mitoxantrone in combination with corticosteroids.

Table 3 summarizes adverse reactions of all grades occurring in ≥ 5% of patients in Trial CCI-NOV22.

 Table 4 summarizes adverse events of all grades occurring in ≥ 5% of patients in Trial CALGB 9182.

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 Mitoxantrone, in combination with other antineoplastic agents, 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 Mitoxantrone + 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 Mitoxantrone + hydrocortisone was observed. Neutropenic fever/infection occurred in 11% and 10% of patients receiving Mitoxantrone + corticosteroids, respectively, on the two trials. Platelets <50,000/mm3 were noted in 4% and 3% of patients receiving Mitoxantrone + corticosteroids on these trials, and there was one patient death on Mitoxantrone + 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 Mitoxantrone.

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