Mitoxantrone hydrochloride
Mitoxantrone hydrochloride (Novantrone)
Mitoxantrone hydrochloride
(my-toe-ZAN-trohn)
Pregnancy Category: D Novantrone (Rx)

Classification: Antineoplastic agent, antibiotic

See Also: See also Antineoplastic Agents.

Action/Kinetics: Most active in the late S phase of cell division but is not cell-cycle specific. Appears to bind to DNA by intercalation between base pairs and a nonintercalative electrostatic interaction, causing an inhibition of DNA and RNA synthesis. Low distribution to the brain, spinal cord, spinal fluid, and eyes. t1/2: Approximately 6 days. Highly bound to plasma proteins. Excreted through both the feces (via the bile) and the urine (up to 65% unchanged).

Uses: In combination with other drugs, for the initial treatment of acute nonlymphocytic leukemias, including monocytic, promyelocytic, myelocytic, and acute erythroid leukemias. In combination with steroids to treat pain from advanced hormone-refractory prostate cancer. Investigational: Alone or in combination with other drugs to treat breast and liver cancer; non-Hodgkin's lymphomas.

Contraindications: Preexisting myelosuppression (unless benefits outweigh risks). Lactation. Intrathecal use.

Special Concerns: Safety and efficacy have not been established in children. May be mutagenic.

Side Effects: Hematologic: Severe myelosuppression, ecchymosis, petechiae. GI: N&V;, diarrhea, stomatitis, mucositis, abdominal pain, GI bleeding. CNS: Headache, seizures. CV: CHF, decreases in LV ejection fraction, arrhythmias, tachycardia, chest pain, hypotension. Respiratory: Cough, dyspnea. Miscellaneous: Conjunctivitis, urticaria, rashes, renal failure, hyperuricemia, alopecia, fever, phlebitis (at infusion site), tissue necrosis (as a result of extravasation), jaundice. In addition, there is an increased risk of pneumonia, urinary tract and fungal infections, and sepsis.

Laboratory Test Alterations: Transient AST and ALT.

Overdose Management: Symptoms: Severe leukopenia with infection. Treatment: Antibiotic therapy. Monitor hematology.

How Supplied: Injection: 2 mg/mL

Dosage
•IV Infusion Initial therapy for acute nonlymphocytic leukemia, induction.
Mitoxantrone, 12 mg/m²/day on days 1-3 combined with cytosine arabinoside, 100 mg/m² as a continuous 24-hr infusion on days 1-7. If the response is incomplete, a second induction course may be given using the same daily dosage, but giving mitoxantrone for 2 days and cytosine arabinoside for 5 days. Consolidation therapy, approximately 6 weeks after final induction therapy: mitoxantrone, 12 mg/m²/day on days 1 and 2 combined with cytosine arabinoside, 100 mg/m² as a continuous 24-hr infusion on days 1-5. A second consolidation course of therapy may be given 4 weeks after the first.