Mitoxantrone HCl Rx

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Mitoxantrone HCl

Leukemias, lymphomas, and other hematologic cancers
Multiple sclerosis
Prostate and other male cancers
Only 4 drugs may be compared at once

Generic Name and Formulations:

Mitoxantrone (as HCl) 2mg/mL; soln for IV infusion after dilution; preservative-free.

Select therapeutic use:

Indications for Mitoxantrone HCl:

Acute nonlymphocytic leukemia (ANLL) in combination with other approved drugs.

Adult:

Give by IV infusion. See full labeling for cytarabine dose. Induction therapy: 12mg/m2 daily on Days 1–3 + cytarabine on days 1–7; if 2nd induction course needed, give for 2 days + cytarabine for 5 days using same daily dosage levels. Consolidation therapy: 12mg/m2 on Days 1–2 + cytarabine on Days 1–5 for 2 courses (1st course given 6 weeks after the final induction course and the 2nd course given 4 weeks after the 1st course).

Children:

Not established.

Warnings/Precautions:

Risk of myelosuppression esp. in high doses (>14mg/m2 daily for 3 days); do not administer if baseline neutrophil count <1500 cell/mm3, except in ANLL. Increased risk of cardiotoxicity with pre-existing cardiovascular disease, prior radiotherapy to mediastinal/pericardial area, or previous anthracycline therapy. Assess cardiac history, physical exam, ECG, and LVEF prior to therapy. Increased risk of secondary acute myeloid leukemia. Hepatic impairment. Monitor CBCs, platelets, liver function tests prior to each course. Monitor for signs of infection. Avoid extravasation. Pregnancy (Cat. D); avoid. Nursing mothers: not recommended.

Interactions:

Caution with concomitant cardiotoxic drugs.

Pharmacological Class:

Topoisomerase inhibitor.

Adverse Reactions:

Myelosuppression, nausea, vomiting, infection, fever, fatigue, alopecia, dyspnea, hypersensitivity reactions, bluish-green urine, sclera discoloration, hyperuricemia (monitor), menstrual disorders, amenorrhea, interstitial pneumonitis; cardiotoxicity (eg, CHF).

Note:

Formerly known under the brand name Novantrone.

How Supplied:

Contact supplier.

Indications for Mitoxantrone HCl:

Reduction of neurologic disability and/or frequency of clinical relapses in secondary (chronic) progressive, progressive relapsing, or worsening relapsing-remitting multiple sclerosis (MS). Not indicated for the treatment of primary progressive MS.

Adult:

Give as a short (approx. 5–15mins) IV infusion. 12mg/m2 every 3 months. Do not administer to those with an LVEF <50%, or a clinically significant reduction in LVEF, or who have received a cumulative lifetime dose of ≥140mg/m2.

Children:

Not established.

Warnings/Precautions:

Risk of myelosuppression esp. in high doses (>14mg/m2 daily for 3 days); do not administer if baseline neutrophil count <1500 cell/mm3, except in ANLL. Increased risk of cardiotoxicity with pre-existing cardiovascular disease, prior radiotherapy to mediastinal/pericardial area, or previous anthracycline therapy. Assess cardiac history, physical exam, ECG, and LVEF prior to therapy, and undergo yearly LVEF evaluation after stopping. Increased risk of secondary acute myeloid leukemia. Hepatic impairment: not recommended. Monitor CBCs, platelets, liver function tests prior to each course. Monitor for signs of infection. Avoid extravasation. Perform pregnancy test prior to each dose in women who are capable of becoming pregnant. Pregnancy (Cat. D); avoid. Nursing mothers: not recommended.

Interactions:

Caution with concomitant cardiotoxic drugs.

Pharmacological Class:

Topoisomerase inhibitor.

Adverse Reactions:

Myelosuppression, nausea, vomiting, infection, fever, fatigue, alopecia, dyspnea, hypersensitivity reactions, bluish-green urine, sclera discoloration, hyperuricemia (monitor), menstrual disorders, amenorrhea, interstitial pneumonitis; cardiotoxicity (eg, CHF).

How Supplied:

Contact supplier.

Indications for Mitoxantrone HCl:

Treatment of pain in advanced hormone-refractory prostrate cancer in combination with corticosteroids.

Adult:

Give as a short IV infusion. 12–14mg/m2 every 21 days.

Children:

Not established.

Warnings/Precautions:

Risk of myelosuppression esp. in high doses (>14mg/m2 daily for 3 days); do not administer if baseline neutrophil count <1500 cell/mm3, except in ANLL. Increased risk of cardiotoxicity with pre-existing cardiovascular disease, prior radiotherapy to mediastinal/pericardial area, or previous anthracycline therapy. Assess cardiac history, physical exam, ECG, and LVEF prior to therapy. Increased risk of secondary acute myeloid leukemia. Hepatic impairment. Monitor CBCs, platelets, liver function tests prior to each course. Monitor for signs of infection. Avoid extravasation. Pregnancy (Cat. D); avoid. Nursing mothers: not recommended.

Interactions:

Caution with concomitant cardiotoxic drugs.

Pharmacological Class:

Topoisomerase inhibitor.

Adverse Reactions:

Myelosuppression, nausea, vomiting, infection, fever, fatigue, alopecia, dyspnea, hypersensitivity reactions, bluish-green urine, sclera discoloration, hyperuricemia (monitor), menstrual disorders, amenorrhea, interstitial pneumonitis; cardiotoxicity (eg, CHF).

Note:

Formerly known under the brand name Novantrone.

How Supplied:

Contact supplier.