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All about: Mitoxantrone

Big Image Pronouncation: (mye-toe-ZAN-trone)
Class: Anthracenedione, Immunomodulator

Trade Names:
Novantrone
- Injection 2 mg (as base)/mL

Mechanism of Action

Pharmacology

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 23 to 215 hr (median, approximately 75 hr).

Special Populations

Renal Function Impairment

Effects have not been determined.

Hepatic Function Impairment

Patients 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 ANLL
Adults

IV For induction, give 12 mg/m 2 /day on days 1 to 3, and give cytarabine 100 mg/m 2 for 7 days as a continuous 24-hr infusion on days 1 to 7. A second induction course may be given. Give mitoxantrone for 2 days and cytarabine for 5 days using the same daily dosage levels.

Prostate Cancer
Adults

IV 12 to 14 mg/m 2 given as a short IV infusion q 21 days.

MS
Adults

IV 12 mg/m 2 given as a short (approximately 5 to 15 min) IV infusion q 3 mo. 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 antibiotics

Mitoxantrone 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

Warnings

Administration

Administer mitoxantrone under the supervision of a health care provider experienced in the use of cytotoxic chemotherapy. Administer into a free-flowing IV infusion.

Cardiotoxicity

Cardiotoxicity, 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 risk

Local irritation or phlebitis may occur. Refer to institution-specific protocol.

Intrathecal

Not for intrathecal use.

Leukemia

Secondary acute myelogenous leukemia has been reported in cancer patients treated with agents related to mitoxantrone.

Neutropenia

Except for the treatment of ANLL, do not administer to patients with baseline neutrophil counts less than 1,500 cells/mm 3 .


Monitor

Perform 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

  • Explain name, dose, action, and potential adverse reactions of drug.
  • Obtain patient history, including drug history and any known allergies.
  • 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 hr 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.
  • Advise women to notify health care provider if pregnant, planning to become pregnant, or breast-feeding.
  • Instruct patient not to take any prescription or OTC medications, herbal preparations, or dietary supplements unless advised by health care provider.
  • Advise patient that follow-up visits and lab tests will be necessary to monitor therapy and to keep appointments.

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