mitoxantrone (Rx)

Brand and Other Names:Novantrone
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 2mg/mL

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  

Peripheral T-cell Lmphoma (Orphan)

Orphan designation of liposomal mitoxantrone for peripheral T-cell lymphoma

Sponsor

  • CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co., Ltd; a subsidiary company within CSPC Pharmaceutical Group, Ltd; 226 Huanghe Avenue; Shijiazhuang Shi; China

<12 years: Safety and efficacy not established

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Interactions

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              Serious - Use Alternative (9)

              • adenovirus types 4 and 7 live, oral

                mitoxantrone decreases effects of adenovirus types 4 and 7 live, oral by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection). Live-attenuated vaccines should be avoided for at least 3mo after cessation of immunosuppressive therapy.

              • darolutamide

                darolutamide will increase the level or effect of mitoxantrone by Other (see comment). Avoid or Use Alternate Drug. Darolutamide is a BCRP inhibitor. Avoid coadministration with BCRP inhibitors. If use is unavoidable, closely monitor for adverse reactions and consider dose reduction of BCRP substrate drug (refer BCRP substrate prescribing information).

              • deferiprone

                deferiprone, mitoxantrone. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Avoid use of deferiprone with other drugs known to be associated with neutropenia or agranulocytosis; if an alternative is not possible, monitor absolute neutrophil count more frequently.

              • influenza virus vaccine quadrivalent, adjuvanted

                mitoxantrone decreases effects of influenza virus vaccine quadrivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.

              • influenza virus vaccine trivalent, adjuvanted

                mitoxantrone decreases effects of influenza virus vaccine trivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.

              • lasmiditan

                lasmiditan increases levels of mitoxantrone by Other (see comment). Avoid or Use Alternate Drug. Comment: Lasmiditan inhibits BCRP in vitro. Avoid coadministration of lasmiditan with BCRP substrates.

              • lonafarnib

                mitoxantrone will increase the level or effect of lonafarnib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. If coadministration of lonafarnib (a sensitive CYP3A substrate) with weak CYP3A inhibitors is unavoidable, reduce to, or continue lonafarnib at starting dose. Closely monitor for arrhythmias and events (eg, syncope, heart palpitations) since lonafarnib effect on QT interval is unknown.

              • palifermin

                palifermin increases toxicity of mitoxantrone by Other (see comment). Avoid or Use Alternate Drug. Comment: Palifermin should not be administered within 24 hrbefore, during infusion of, or within 24 hr after administration of antineoplastic agents. Coadministration of palifermin within 24 hr of chemotherapy resulted in increased severity and duration of oral mucositis.

              • tofacitinib

                mitoxantrone, tofacitinib. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.

              Monitor Closely (45)

              • acalabrutinib

                acalabrutinib increases levels of mitoxantrone by Other (see comment). Use Caution/Monitor. Comment: Acalabrutinib may increase exposure to coadministered BCRP substrates by inhibition of intestinal BCRP.

                acalabrutinib, mitoxantrone. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration may increase risk of myelosuppressive effects.

              • apalutamide

                apalutamide will decrease the level or effect of mitoxantrone by increasing elimination. Use Caution/Monitor. Apalutamide weakly induces BCRP and may decrease systemic exposure of drugs that are BCRP substrates.

              • atogepant

                mitoxantrone will increase the level or effect of atogepant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • avapritinib

                mitoxantrone will increase the level or effect of avapritinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • axitinib

                mitoxantrone increases levels of axitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • belatacept

                belatacept and mitoxantrone both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.

              • cyclosporine

                cyclosporine increases toxicity of mitoxantrone by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Therapeutic and toxic effects of mitoxantrone may be increased by cyclosporine. Close clinical and laboratory monitoring are indicated.

              • denosumab

                mitoxantrone, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

              • dichlorphenamide

                dichlorphenamide and mitoxantrone both decrease serum potassium. Use Caution/Monitor.

              • eluxadoline

                eluxadoline increases levels of mitoxantrone by decreasing metabolism. Use Caution/Monitor. Eluxadoline may increase the systemic exposure of coadministered BCRP substrates.

              • erythromycin base

                erythromycin base will increase the level or effect of mitoxantrone by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • erythromycin ethylsuccinate

                erythromycin ethylsuccinate will increase the level or effect of mitoxantrone by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • erythromycin lactobionate

                erythromycin lactobionate will increase the level or effect of mitoxantrone by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • erythromycin stearate

                erythromycin stearate will increase the level or effect of mitoxantrone by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

              • ethotoin

                mitoxantrone decreases levels of ethotoin by increasing metabolism. Use Caution/Monitor.

              • finerenone

                mitoxantrone will increase the level or effect of finerenone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Monitor serum potassium during initiation and dosage adjustment of either finererone or weak CYP3A4 inhibitors. Adjust finererone dosage as needed.

              • fingolimod

                mitoxantrone increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

              • flibanserin

                mitoxantrone will increase the level or effect of flibanserin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Increased flibanserin adverse effects may occur if coadministered with multiple weak CYP3A4 inhibitors.

              • fosphenytoin

                mitoxantrone decreases levels of fosphenytoin by increasing metabolism. Use Caution/Monitor.

              • fostamatinib

                fostamatinib will increase the level or effect of mitoxantrone by decreasing metabolism. Use Caution/Monitor. Concomitant use of fostamatinib may increase concentrations of BCRP substrate drugs. Monitor for toxicities of BCRP substrate drug that may require dosage reduction when given concurrently with fostamatinib.

              • fostemsavir

                fostemsavir will increase the level or effect of mitoxantrone by Other (see comment). Modify Therapy/Monitor Closely. Fostemsavir inhibits BCRP transporters. If possible, avoid coadministration or modify dose of BCRP substrate coadministered with fostemsavir.

              • glecaprevir/pibrentasvir

                glecaprevir/pibrentasvir will increase the level or effect of mitoxantrone by decreasing metabolism. Use Caution/Monitor. Glecaprevir/pibrentasvir may increase plasma concentration of BCRP substrates.

              • hydroxyurea

                mitoxantrone, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.

              • isavuconazonium sulfate

                mitoxantrone will increase the level or effect of isavuconazonium sulfate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • ivacaftor

                mitoxantrone increases levels of ivacaftor by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Monitor when coadministered with weak CYP3A4 inhibitors .

              • lemborexant

                mitoxantrone will increase the level or effect of lemborexant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Lower nightly dose of lemborexant recommended if coadministered with weak CYP3A4 inhibitors. See drug monograph for specific dosage modification.

              • lomitapide

                mitoxantrone increases levels of lomitapide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Lomitapide dose should not exceed 30 mg/day.

              • meningococcal group B vaccine

                mitoxantrone decreases effects of meningococcal group B vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Individuals with altered immunocompetence may have reduced immune responses to the vaccine.

              • midazolam intranasal

                mitoxantrone will increase the level or effect of midazolam intranasal by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration of mild CYP3A4 inhibitors with midazolam intranasal may cause higher midazolam systemic exposure, which may prolong sedation.

              • ofatumumab SC

                ofatumumab SC, mitoxantrone. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with coadministration. When switching from therapies with immune effects, take into account the duration and mechanism of action of these therapies when initiating ofatumumab SC.

              • olaparib

                mitoxantrone and olaparib both increase pharmacodynamic synergism. Use Caution/Monitor. Coadministration with other other myelosuppressive anticancer agents, including DNA damaging agents, may potentiate and prolongate the myelosuppressive toxicity.

              • oxaliplatin

                oxaliplatin and mitoxantrone both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Use of oxaliplatin with concomitant immunosuppressants or with impaired immune systems may increased risk for serious infections.

              • phenytoin

                mitoxantrone decreases levels of phenytoin by increasing metabolism. Use Caution/Monitor.

              • ponatinib

                ponatinib increases levels of mitoxantrone by Other (see comment). Use Caution/Monitor.

              • regorafenib

                regorafenib will increase the level or effect of mitoxantrone by Other (see comment). Modify Therapy/Monitor Closely. Regorafenib likely inhibits BCRP (ABCG2) transport. Coadministration with a BCRP substrate may increase systemic exposure to the substrate and related toxicity.

              • safinamide

                safinamide will increase the level or effect of mitoxantrone by Other (see comment). Use Caution/Monitor. Safinamide and its major metabolite may inhibit intestinal BCRP. Monitor BCRP substrates for increased pharmacologic or adverse effects.

              • siponimod

                siponimod and mitoxantrone both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.

              • sipuleucel-T

                mitoxantrone decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

              • sofosbuvir/velpatasvir

                sofosbuvir/velpatasvir will increase the level or effect of mitoxantrone by Other (see comment). Use Caution/Monitor. Velpatasvir is an inhibitor of the drug transporter BCRP. Coadministration may increase systemic exposure of drugs that are BCRP substrates.

              • stiripentol

                stiripentol will increase the level or effect of mitoxantrone by Other (see comment). Modify Therapy/Monitor Closely. Stiripentol is a BCRP transport inhibitor. Consider dosage reduction for BCRP substrates if adverse effects are experienced when coadministered.

              • tafamidis

                tafamidis will increase the level or effect of mitoxantrone by Other (see comment). Use Caution/Monitor. Tafamidis inhibits breast cancer resistant protein (BCRP) in vitro and may increase exposure of BCRP substrates following tafamidis or tafamidis meglumine administration. Dosage adjustment of these BCRP substrates may be necessary.

              • tafamidis meglumine

                tafamidis meglumine will increase the level or effect of mitoxantrone by Other (see comment). Use Caution/Monitor. Tafamidis inhibits breast cancer resistant protein (BCRP) in vitro and may increase exposure of BCRP substrates following tafamidis or tafamidis meglumine administration. Dosage adjustment of these BCRP substrates may be necessary.

              • tinidazole

                mitoxantrone will increase the level or effect of tinidazole by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • trastuzumab

                trastuzumab, mitoxantrone. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

              • trastuzumab deruxtecan

                trastuzumab deruxtecan, mitoxantrone. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .

              Minor (1)

              • ruxolitinib

                mitoxantrone will increase the level or effect of ruxolitinib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.

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              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

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              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

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              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.

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              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%)

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              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

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              Images

              BRAND FORM. UNIT PRICE PILL IMAGE
              mitoxantrone intravenous
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              2 mg/mL vial
              mitoxantrone intravenous
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              mitoxantrone intravenous
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              mitoxantrone intravenous
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              mitoxantrone intravenous
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              mitoxantrone intravenous
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              mitoxantrone intravenous
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              2 mg/mL vial
              mitoxantrone intravenous
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              2 mg/mL vial

              Copyright © 2010 First DataBank, Inc.

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              Patient Handout

              Patient Education
              mitoxantrone intravenous

              MITOXANTRONE - INJECTION

              (my-toe-ZAN-trone)

              COMMON BRAND NAME(S): Novantrone

              WARNING: Mitoxantrone must be given only by injection into a vein. Do not give by injection into a muscle, under the skin, or into the spinal cord. If this medication accidentally leaks into the skin/muscle around the injection site, it may cause severe damage. Tell your doctor right away if you notice redness, pain, or swelling at or near the injection site.This medication may rarely cause serious (rarely fatal) heart problems (including heart failure). This effect may occur during treatment or months to years after treatment is completed. The risk of heart problems is affected by your dose, medical history (including previous heart disease, radiation treatment to the chest area, or if you have MS-multiple sclerosis), and previous use of this and other drugs (including doxorubicin or daunorubicin). Tell your doctor right away if you notice symptoms such as irregular heartbeat, shortness of breath, swelling ankles/feet, unusual tiredness, or unusual/sudden weight gain.Very rarely, people who are treated with this type of medication have developed new cancers (e.g., secondary leukemia). The risk may be increased when this medication is given with certain anti-cancer drugs or radiation treatment. Consult your doctor for more details.Laboratory and/or medical tests (e.g., complete blood count, heart/liver function tests, ECG) should be performed before starting treatment and periodically to monitor your progress or check for side effects. Consult your doctor for more details.

              USES: Mitoxantrone is used to treat leukemia and other cancers. It is also used to treat multiple sclerosis. It belongs to a class of drugs known as anthracenediones and works by slowing or stopping the growth of certain cells (including cancer cells and cells that affect the body's natural defenses).

              HOW TO USE: Read the Medication Guide provided by your pharmacist before you start receiving mitoxantrone and each time you get a refill. If you have any questions, ask your doctor or pharmacist.This medication is given by injection into a vein by a health care professional as directed by your doctor. Dosage is based on your medical condition, body size, and response to treatment.If this medication touches your skin, immediately wash the area well with soap and water. If this medication gets in your eye, open the eyelid and flush with water for 15 minutes, then seek immediate medical attention.

              SIDE EFFECTS: See also Warning section.Nausea, vomiting, diarrhea, headache, or unusual tiredness may occur. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If these effects persist or worsen, tell your doctor or pharmacist promptly.Severe nausea, vomiting, or diarrhea may rarely cause dehydration. Contact your doctor promptly if you notice any symptoms of dehydration such as unusual decreased urination, unusual dry mouth/increased thirst, lack of tears, dizziness/lightheadedness, or pale/wrinkled skin.Temporary hair thinning/loss may occur. Normal hair growth should return after treatment has ended.This medication may cause your urine to turn blue-green. The white part of your eyes may also turn a bluish color. These effects are temporary, normal, and harmless.People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.Tell your doctor right away if you have any serious side effects, including: menstrual changes (e.g., stopped periods), unusual bleeding/bruising (e.g., small red spots on the skin, black/bloody stools, bloody urine, vomit that looks like coffee grounds), numbness/tingling feelings, seizure.This medication can lower the body's ability to fight an infection. Tell your doctor promptly if you develop any signs of an infection such as fever, chills, or persistent sore throat.Pain or sores in the mouth and throat may occur. Brush your teeth gently/carefully, avoid using mouthwash that contains alcohol, and rinse your mouth frequently with cool water mixed with baking soda or salt. It may also be best to eat soft, moist foods.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

              PRECAUTIONS: Before using mitoxantrone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood/bleeding disorders (e.g., anemia, low blood cell counts), heart disease (e.g., congestive heart failure, irregular heartbeat), liver disease, radiation treatment, recent/current infection.Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).To lower your risk of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.Before having surgery, tell your doctor or dentist that you are using this medication.This medication is not recommended for use during pregnancy. It may harm an unborn baby. Before you start treatment and during treatment with this medication, your doctor may direct you to have a pregnancy test. If you become pregnant or think you may be pregnant, tell your doctor right away. To avoid pregnancy, both males and females using this drug should use reliable form(s) of birth control (e.g., birth control pills, condoms) during treatment. Consult your doctor for details and to discuss effective forms of birth control.This medication passes into breast milk and could have undesirable effects on a nursing infant. Breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.

              DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: other anti-cancer drugs (especially anthracyclines such as doxorubicin).

              OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

              NOTES: Keep all regular medical and laboratory appointments.

              MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

              STORAGE: Not applicable. This medication is given in a clinic and will not be stored at home.

              MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

              Information last revised September 2021. Copyright(c) 2021 First Databank, Inc.

              IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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              Formulary

              FormularyPatient Discounts

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              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.
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              Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.