• Acute nonlymphocytic leukemia (in combination with other antineoplastics).
• Initial chemotherapy for patients with pain associated with advanced hormone-refractory prostate cancer.
• Secondary (chronic) progressive, progressive relapsing, or worsening relapsing-remitting multiple sclerosis (MS).

Contraindicated in:

• Hypersensitivity
• OB: Pregnancy
• Lactation: Lactation.

Use Cautiously in:

• Cardiovascular disease (↑ risk of HF)
• Active infection
• ↓ bone marrow reserve
• Previous mediastinal radiation or use of anthracyclines (↑ risk of HF)
• Impaired hepatobiliary function
• Rep: Women of reproductive potential
• Pedi: Safety and effectiveness not established in children
• Geri: Older adults may have ↑ sensitivity to drug effects.

CV: ECG changes, HF, arrhythmias.

Derm: alopecia, rash.

EENT: blue-green sclera, conjunctivitis.

GI: abdominal pain, diarrhea, hepatotoxicity, nausea, stomatitis, vomiting.

GU: blue-green urine, gonadal suppression, renal failure.

Hemat: anemia, leukopenia, thrombocytopenia, SECONDARY LEUKEMIA.

Metab: hyperuricemia.

Neuro: headache, SEIZURES.

Resp: cough, dyspnea.

Misc: fever, HYPERSENSITIVITY REACTIONS.

Drug-Drug:

• ↑ bone marrow depression with other antineoplastics or radiation therapy.
• Risk of cardiomyopathy ↑ by previous anthracycline antineoplastics (daunorubicin, doxorubicin, idarubicin) or mediastinal radiation.
• May ↓ antibody response to live-virus vaccines and ↑ risk of adverse reactions.

(Generic available)

• Solution for injection: 2 mg/mL;

Acute Nonlympocytic Leukemia

• IV (Adults): Induction: 12 mg/m²/day for 3 days (usually given with cytosine arabinoside 100 mg/m²/day for 7 days); if incomplete remission occurs, a 2nd induction may be given. Consolidation: 12 mg/m²/day for 2 days (usually given with cytosine arabinoside 100 mg/m²/day for 5 days), given 6 wk after induction with another course 4 wk later.

Advanced Prostate Cancer

• IV (Adults): 12–14 mg/m² as single dose (with corticosteroids).

Multiple Sclerosis

• IV (Adults): 12 mg/m² every 3 mo.

Novantrone

• Inhibits DNA synthesis (cell-cycle phase–nonspecific).

• Death of rapidly replicating cells, particularly malignant ones.
• Decreased pain in patients with advanced prostate cancer.
• Decreased disability and slowed progression of MS.

Therapeutic Classification: antineoplastics, immune modifiers

Pharmacologic Classification: antitumor antibiotics

Absorption: IV administration results in complete bioavailability.

Distribution: Widely distributed to tissues; limited penetration of CSF.

Metabolism/Excretion: Mostly eliminated by hepatobiliary clearance; <10% excreted unchanged by the kidneys.

Half-life: 5.8 days.

(effects on blood counts)

• Advise patient to read the Patient Package Insert before starting therapy and before each dose in case of changes. Explain purpose of mitoxantrone to patient.
• Instruct patient to notify health care professional promptly if fever; chills; cough; hoarseness; sore throat; signs of infection; lower back or side pain; painful or difficult urination; bleeding gums; bruising; petechiae; blood in stools, urine, or emesis; increased fatigue; dyspnea; or orthostatic hypotension occurs. Caution patient to avoid crowds and persons with known infections. Instruct patient to use soft toothbrush and electric razor and to avoid falls. Caution patient not to drink alcoholic beverages or take medication containing aspirin or NSAIDs; may precipitate gastric bleeding.
• Instruct patient to notify health care professional if abdominal pain, yellow skin, cough, diarrhea, or decreased urine output occurs.
• Inform patient that medication may cause the urine and sclera to turn blue-green.
• Instruct patient to inspect oral mucosa for redness and ulceration. If mouth sores occur, advise patient to use sponge brush and rinse mouth with water after eating and drinking. Topical agents may be used if pain interferes with eating. Stomatitis pain may require treatment with opioid analgesics.
• Discuss with patient the possibility of hair loss. Explore coping strategies.
• Instruct patient not to receive any vaccinations without advice of health care professional.
• Rep: May cause fetal harm. Refer patient to a facility with expertise in cancer during pregnancy. Advise patient that although mitoxantrone may cause infertility, contraception during therapy is necessary because of possible fetal harm. Discontinue breastfeeding before starting mitoxantrone.
• Emphasize need for periodic lab tests to monitor for side effects.

mye-toe-ZAN-trone

NDC Code^*

• 0703- Teva Parenteral Medicines, Inc.
  • 0703-4680- mitoXANTRONE
    • 0703-4680-01- 1 VIAL, MULTI-DOSE in 1 CARTON (0703-4680-01) > 12.5 mL in 1 VIAL, MULTI-DOSE

• 0703- Teva Parenteral Medicines, Inc.
  • 0703-4685- mitoXANTRONE
    • 0703-4685-01- 1 VIAL, MULTI-DOSE in 1 CARTON (0703-4685-01) > 10 mL in 1 VIAL, MULTI-DOSE

• 0703- Teva Parenteral Medicines, Inc.
  • 0703-4686- mitoXANTRONE
    • 0703-4686-01- 1 VIAL, MULTI-DOSE in 1 CARTON (0703-4686-01) > 15 mL in 1 VIAL, MULTI-DOSE

• 61703- Hospira, Inc.
  • 61703-343- Mitoxantrone
    • 61703-343-18- 1 VIAL, MULTI-DOSE in 1 CARTON (61703-343-18) > 10 mL in 1 VIAL, MULTI-DOSE

• 61703- Hospira, Inc.
  • 61703-343- Mitoxantrone
    • 61703-343-65- 1 VIAL, MULTI-DOSE in 1 CARTON (61703-343-65) > 12.5 mL in 1 VIAL, MULTI-DOSE

• 61703- Hospira, Inc.
  • 61703-343- Mitoxantrone
    • 61703-343-66- 1 VIAL, MULTI-DOSE in 1 CARTON (61703-343-66) > 15 mL in 1 VIAL, MULTI-DOSE

• 63323- Fresenius Kabi USA, LLC
  • 63323-132- Mitoxantrone
    • 63323-132-10- 1 VIAL, MULTI-DOSE in 1 BOX (63323-132-10) > 10 mL in 1 VIAL, MULTI-DOSE

• 63323- Fresenius Kabi USA, LLC
  • 63323-132- Mitoxantrone
    • 63323-132-12- 1 VIAL, MULTI-DOSE in 1 BOX (63323-132-12) > 12.5 mL in 1 VIAL, MULTI-DOSE

• 63323- Fresenius Kabi USA, LLC
  • 63323-132- Mitoxantrone
    • 63323-132-15- 1 VIAL, MULTI-DOSE in 1 BOX (63323-132-15) > 15 mL in 1 VIAL, MULTI-DOSE