mitoxantrone (Rx)

Brand and Other Names:Novantrone
  • Print

Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

injectable solution

  • 2mg/mL
more...

Secondary Progressive Multiple Sclerosis

12 mg/m² short IV (5-15 minutes) infusion q3Months 

Not to exceed lifetime cumulative dose of 140 mg/m²

Acute Nonlymphocytic Leukemia

Induction

  • 12 mg/m²/day IV on days 1-3 with cytarabine 100 mg/m²/day IV contunuous infusion on days 1-7 
  • Second induction with same doses of mitoxantrone for 2 days & cytarabine for 5 days may be given if incomplete antileukemic response & no severe nonhematologic toxicity in first induction
  • Consolidation: 12mg/m²/day for 2 days, repeat in 4 weeks

Prostate Cancer

12-14 mg/m² q21Days every 3 weeks in combination with corticosteroids 

<12 years old: Safety and efficacy not established

Secondary progressive multiple sclerosis

12 mg/m² short IV (5-15 minutes) infusion q3Months 

Acute nonlymphocytic leukemia

Induction12 mg/m²/day IV on days 1-3 with cytarabine 100 mg/m²/day IV contunuous infusion on days 1-7

Second induction with same doses of mitoxantrone for 2 days & cytarabine for 5 days may be given if incomplete antileukemic response & no severe nonhematologic toxicity in first induction

Consolidation: 12mg/m²/day for 2 days, repeat in 4 weeks

Prostate cancer

12-14 mg/m² q21Days every 3 weeks in combination with corticosteroids

Next:

Interactions

Interaction Checker

and mitoxantrone

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            All Interactions Sort By:
             activity indicator 
            Previous
            Next:

            Adverse Effects

            >10%

            Nausea (55%)

            Upper respiratory infection (51%)

            Alopecia (38%

            Urinary tract infection (29%)

            Amenorrhea (28%)

            Diarrhea (25%)

            Stomatitis (15%)

            Constipation (14%)

            1-10%

            Headache (6%)

            Back pain (6%)

            Frequency Not Defined

            Decreased left ventricular ejection fraction

            Cardiotoxicity

            Myelosuppression

            Hepatotoxicity

            Abnormal LFT's

            Previous
            Next:

            Warnings

            Black Box Warnings

            The drug should be administered under the supervision of an experienced cancer chemotherapy physician in a facility equipped to manage complications

            Administer slowly into a freely flowing intravenous infusion and never administer IM, SC, or intra-arterially or intrathecally

            Severe injury with permanent sequelae can result from intrathecal administration. Severe local tissue damage can occur if extravasation occurs during administration

            Do not administer therapy to patients with baseline neutrophil counts <1,500 cells/mm³. Perform peripheral blood cell counts to monitor the occurrence of bone marrow suppression, primarily neutropenia, that may be severe and result in infection

            Cardiotoxicity

            • Potentially fatal CHF may occur either during therapy or months to years after termination of therapy. The risk increases with cumulative doses and may occur whether or not cardiac risk factors are present. History of cardiovascular disease, radiotherapy to the mediastinal/pericardial area, previous therapy with other anthracyclines or anthracenediones, or the use of other cardiotoxic drugs may increase the risk
            • To mitigate the cardiotoxicity risk with this agent, prescribers should consider the following
            • All patients should be assessed for cardiac signs and symptoms by history, physical examination, ECG prior to the start of therapy, and have a baseline evaluation of left ventricular ejection fraction (LVEF) using appropriate methodology (eg, echocardiogram, multi-gated radionuclide angiography [MUGA])
            • Patients with multiple sclerosis (MS) should be assessed for cardiac signs and symptoms by history, physical examination, and ECG prior to each dose. Patients with a baseline LVEF below the lower limit of normal should not be treated with mitoxantrone. Patients with MS should undergo quantitative reevaluation of LVEF prior to each dose using the same methodology that was used to assess baseline LVEF
            • Additional doses of mitoxantrone should not be administered to patients with MS who have experienced either a drop in LVEF to below the lower limit of normal or a clinically significant reduction in LVEF during mitoxantrone therapy. These patients should not receive a cumulative dose >140 mg/sq.meter and should undergo yearly quantitative LVEF evaluation after stopping mitoxantrone to monitor for late occurring cardiotoxicity

            Secondary acute myelogenous leukemia

            • Secondary AML has been reported in patients with MS and cancer who treated with mitoxantrone. Also seen when patients are treated concurrently with anthracyclines. Mitoxantrone is an anthracenedione, a related drug
            • The occurrence of refractory secondary leukemia is more common when anthracyclines are given in combination with DNA-damaging antineoplastic agents, when patients have been heavily pretreated with cytotoxic drugs, or when doses of anthracyclines have been escalated

            Contraindications

            Hypersensitivity

            Cautions

            Not indicated for primary progressive MS

            Risk of cardiotoxicity & secondary AML

            Avoid pregnancy

            If extravasation occurs, stop immediately & restart in another vein

            Hepatic impairment

            Previous
            Next:

            Pregnancy & Lactation

            Pregnancy Category: D

            Lactation: excreted in breast milk, do not nurse

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

            more...
            Previous
            Next:

            Pharmacology

            Mechanism of Action

            Anthracenedione; DNA-reactive agent with cell cycle nonspecific cytocidal activity that intercalates into DNA resulting in cross-links and strand breaks; inhibits DNA and RNA synthesis

            Pharmacokinetics

            Half-life elimination: 5.8 d

            Protein Bound: 95%

            Metabolism: Liver

            Absorption: Poor (PO)

            Vdss: >1000 L/m²; 14 L/kg

            Excretion: Feces (25%); urine (11%)

            Previous
            Next:

            Administration

            IV Incompatibilities

            Additive: heparin

            Y-site: amphotericin B cholesteryl sulfate, aztreonam, cefepime, doxorubicin liposomal, paclitaxel, piperacillin/tazobactam, propofol

            IV Compatibilities

            Additive: cyclophosphamide, cytarabine, hydrocortisone Na-phosphate(?), hydrocortisone Na-succinate, KCl

            Y-site: allopurinol, amifostine, cladribine, etoposide, filgrastim, fludaraine, gatifloxacin, gemcitabine, granisetron, linezolid, melphalan, ondansetron, sargramostim, teniposide, thiotepa, vinorelbine

            IV Preparation

            Dilute in at least 50 mL of NS or D5W

            Standard dilution (IVPB): dose/100 mL D5W or NS

            IV Administration

            Administered through tubing of freely running solution typically over 15-30 min (5-15 min for MS) or cont infusion over 24 hr

            Do not give in less than 3 min

            Storage

            Store intact vials at room temp or refrigeration

            Partially used concentrate vials may be stored for 7 d at 15-25°C or 14 d under refrigeration, but not frozen

            Previous
            Next:

            Images

            Previous
            Next:

            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
            Additional Offers
            Email to Patient

            From:

            To:

            The recipient will receive more details and instructions to access this offer.

            By clicking send, you acknowledge that you have permission to email the recipient with this information.

            Email Forms to Patient

            From:

            To:

            The recipient will receive more details and instructions to access this offer.

            By clicking send, you acknowledge that you have permission to email the recipient with this information.

            Previous