Mitoxantrone
Pronouncation: (mye-toe-ZAN-trone)Class: Anthracenedione, Immunomodulator
Trade Names:
Novantrone
- Injection 2 mg (as base)/mL
Pharmacology
![]() | ||||||||||||
Feedback for Mitoxantrone
Compare with other drugs.
| ||||||||||||
Has a cytocidal effect on proliferating and nonproliferating cultured human cells, suggesting lack of cell cycle phase specificity.
Pharmacokinetics
Distribution
Distribution to tissues is extensive and is 78% protein bound over a 26 to 455 ng/mL concentration range. Vd exceeds 1,000 L/m 2 .
Elimination
Elimination is slow via renal and hepatobiliary systems. Only 11% is recovered in urine within 5 days (65% unchanged, 35% as metabolite); hepatobiliary is more significant, with 25% recovered in feces within 5 days. The elimination t ½ is 23ߙto 215ߙh (median, approximately 75 h).
Special Populations
Renal Function ImpairmentEffects have not been determined.
Hepatic Function ImpairmentPatients with multiple sclerosis (MS) who have hepatic function impairment should not ordinarily be treated with mitoxantrone. Dosage adjustment may be required for other patients with hepatic function impairment.
Indications and Usage
Adult acute nonlymphocytic leukemia (ANLL) as adjunctive therapy; advanced hormone-refractory prostate cancer (in combination with corticosteroids); secondary (chronic) progressive, progressive-relapsing, or worsening relapsing-remitting MS.
Unlabeled Uses
Treatment of breast cancer, non-Hodgkin lymphoma, autologous bone marrow transplantation.
Contraindications
Standard considerations.
Dosage and Administration
Combination Initial Therapy for ANLLAdults
IV For induction, give 12 mg/m 2 /day on days 1 to 3, and give cytarabine 100ߙmg/m 2 for 7 days as a continuous 24-h infusion on days 1 to 7. A second induction course may be given. Give mitoxantrone for 2ߙdays and cytarabine for 5 days using the same daily dosage levels.
Prostate CancerAdults
IV 12 to 14 mg/m 2 given as a short IV infusion every 21 days.
MSAdults
IV 12 mg/m 2 given as a short (approximately 5 to 15 min) IV infusion every 3ߙmo. Do not administer to MS patients who have received a cumulative lifetime dose of 140 mg/m 2 or more, or those with left ventricular ejection fraction (LVEF) of less than 50% or a clinically significant reduction in LVEF.
General Advice
- Concentrate must be diluted following manufacturer's recommendations before administration. Administer immediately after dilution.
- Do not administer if particulate matter or discoloration noted.
- Administer prescribed dose slowly (over period of not less than 3 min) into free-flowing IV infusion.
- Do not mix with other medications.
- Discard any unused infusion solution.
- Follow procedures for proper handling and disposal of anticancer drugs. Wear goggles, gloves, and protective gowns during preparation and administration.
Storage/Stability
Store unopened vials at controlled room temperature (59° to 77°F). Do not freeze. After penetration of multidose vial stopper, the remaining undiluted concentrate can be stored for up to 7 days at room temperature (59° to 77°F) or refrigerated for up to 14 days at 36° to 46°F. Do not freeze.
Drug Interactions
Quinolone antibioticsMitoxantrone may decrease oral absorption of quinolone antibiotics.
Laboratory Test Interactions
None well documented.
Adverse Reactions
Cardiovascular
Arrhythmia (18%); abnormal ECG (11%).
CNS
Headache (6%).
Dermatologic
Alopecia (61%).
EENT
Sinusitis (6%).
GI
Nausea (76%); diarrhea (25%); stomatitis (19%); constipation (14%).
Genitourinary
Menstrual disorder (61%); amenorrhea (43%); UTI (32%); abnormal urine (11%).
Hematologic
Leukopenia (19%); anemia, granulocytopenia (6%).
Metabolic
Increased gamma-glutamyltransferase (15%); increased AST (9%); increased ALT (6%).
Respiratory
Upper respiratory tract infection (53%).
Miscellaneous
Back pain (8%).
Precautions
WarningsAdministrationAdminister mitoxantrone under the supervision of a health care provider experienced in the use of cytotoxic chemotherapy. Administer into a free-flowing IV infusion. CardiotoxicityCardiotoxicity, including fatal CHF, may occur during, and for years after stopping, mitoxantrone therapy. The risk increases with cumulative dose. Cardiotoxicity may occur whether or not cardiac risk factors are present. However, presence or history of CV disease, prior or concomitant radiotherapy to the mediastinal/pericardial area, previous therapy with anthracyclines or anthracenediones, or concurrent use of other cardiotoxic agents may increase the risk of cardiac toxicity. Extravasation riskLocal irritation or phlebitis may occur. Refer to institution-specific protocol. IntrathecalNot for intrathecal use. LeukemiaSecondary acute myelogenous leukemia has been reported in cancer patients treated with agents related to mitoxantrone. NeutropeniaExcept for the treatment of ANLL, do not administer to patients with baseline neutrophil counts less than 1,500 cells/mm 3 . |
MonitorPerform baseline evaluation of LVEF by echocardiogram or multigated radionuclide angiography (MUGA). Do not treat MS patients with mitoxantrone when their baseline LVEF is less than 50%. Reevaluate LVEF by echocardiogram or MUGA prior to administration of each dose to patients with MS. Obtain a CBC, including platelets, and perform LFTs prior to each course of therapy. |
Pregnancy
Category D .
Lactation
Excreted in breast milk. Discontinue breast-feeding upon starting treatment.
Children
Safety and efficacy not established.
Hepatic Function
There is no laboratory measurement that allows for dose adjustment recommendations. Patients with MS who have hepatic function impairment should ordinarily not be treated with mitoxantrone. A dosage adjustment may be required for other patients with hepatic function impairment.
Cardiac
Functional cardiac changes, including irreversible CHF and decreased LVEF, can occur.
Hyperuricemia
Ensure that hypouricemic therapy is initiated before starting treatment for leukemia and that uric acid levels are monitored frequently during treatment.
Myelosuppression
Mitoxantrone administered at any dose can cause myelosuppression. Do not administer mitoxantrone to patients with preexisting myelosuppression caused by prior drug therapy.
Patient Information
- Advise patient to read patient information leaflet before starting therapy and prior to each treatment.
- Advise patient, family, or caregiver that medication will be prepared and administered by a health care provider in a medical setting.
- Review dose and dosing schedule, depending on condition being treated.
- Advise patient, family, or caregiver that urine may have a blue-green color for 24 h after administration and bluish discoloration of the sclera may occur.
- Instruct patient to immediately report any of the following to health care provider: infusion site reaction or pain; cough or difficulty breathing on exertion; swelling of legs or feet; sores in or around the mouth; fever, sore throat, or other signs of infection; bleeding or unusual bruising.
- Advise women of childbearing potential to use effective contraception during therapy.
![]() |
Link to Page | ![]() |
Print Page | ![]() |
Email Page | ![]() | Add to List |
More Mitoxantrone resources:
Mitoxantrone - Includes detailed dosage instructions.
Mitoxantrone Drug Interactions
Multiple Sclerosis, Prostate Cancer, Acute Nonlymphocytic Leukemia











