Names and pronunciation
(mye-toe-zan′trone)
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Drug reference
(mye-toe-zan′trone)
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Func. class.: Antineoplastic, antiinfective, immunomodulator
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Chem. class.: Synthetic anthraquinone
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Do not confuse: mitoXANTRONE/mitoMYcin/mitotane/ MTX patch
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ACTION: DNA reactive agent; cytoci- dal effect on both proliferating and non- proliferating cells; topoisomerase II inhibitor (vesicant)
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USES: Acute myelogenous leukemia (adult), relapsed leukemia; used with steroids to treat bone pain (advanced prostate cancer), multiple sclerosis (MS)
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CONTRAINDICATIONS: Preg- nancy, hypersensitivity Precautions: Breastfeeding, children; myelosuppression, renal/cardiac/hepatic disease; gout
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Black Box Warning: Bone marrow sup- pression, cardiotoxicity, SUBCUT/IM/in- traarterial/intrathecal, requires an experi- enced clinician, new primary malignancy Black Box Warning: Cardiotoxicity: ECG, ECHO, chest x-ray, MUGA, RAI angiography; assess ejection fraction before and during treatment; cardiotoxicity may develop during treatment or months to years after treatment; use vigilant cardiac monitoring in MS; risk is greater in cumulative dose >140 mg/m2 Black Box Warning: Secondary acute myelogenous leukemia (AML) can de- velop after taking this product Black Box Warning: Multiple sclero- sis: obtain MUGA, LVEF baselines; re- peat LVEF if symptoms of HF occur or if cumulative dose is >100 mg/m2; do not administer to patients who have received lifetime dose of ≥140 mg/m2 or if LVEF <50% or significant LVEF or if neutrophils <1500/mm3 • Rinsing of mouth tid-qid with water, club soda; brushing of teeth bid-qid with soft brush or cotton-tipped applicators for stomatitis; use unwaxed dental floss • Provide increased fluids to 2-3 L/day unless contraindicated • Pregnancy/breastfeeding: do not use in pregnancy, breastfeeding; obtain preg- nancy test for all women of childbearing age, even if birth control is used Black Box Warning: Requires a special- ized care setting with an experienced clinician: use only in a setting with emer- gency equipment, those trained in admin- istration of cytotoxic products
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SIDE EFFECTS CNS: Headache, seizures, fatigue CV: Cardiotoxicity, dysrhythmias, HF EENT: Conjunctivitis, blue/green sclera, blurred vision GI: Nausea, vomiting, diarrhea, anorexia, stomatitis, hepatotoxicity, abdominal pain, constipation GU: Amenorrhea, menstrual disorders, blue-green urine, renal failure HEMA: Thrombocytopenia, leukopenia, myelosuppression, anemia, secondary leukemia INTEG: Rash, necrosis at inj site, derma- titis, thrombophlebitis at inj site, alopecia MISC: Fever, hyperuricemia, infections RESP: Cough, dyspnea SYST: Tumor lysis syndrome, sepsis
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INTERACTIONS Increase: bone marrow depression toxic- ity—radiation, other antineoplastics Increase: adverse reactions—live virus vaccines, trastuzumab Increase: oral mucositis—palifermin, do not use within 24 hr of mitoxantrone Increase: immunosuppression—tofaci- tinib, avoid using together Increase: infection risk—natalizumab Increase: bleeding risk—NSAIDs, anticoagulants Increase: mitoXANTRONE, effects of— cyclosporine Decrease: digoxin, hydration level— monitor levels, adjust dose Drug/Lab Test Increase: LFTs, uric acid, bilirubin Decrease: HcT/HB, platelets, WBC, cal- cium, sodium, granulocytes
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DOSAGE AND ROUTES Acute myelogenous leukemia/ induction • Adult: IV INFUSION 12 mg/m2/day on days 1-3 and 100 mg/m2 cytarabine × 7 days as continuous 24-hr infusion may use 2nd induction Consolidation • Adult: IV 12 mg/m2 given as short 5- to 15-min infusion for 2 days with cytara- bine × 5 days, use 6 wk after induction, and another course after 4 wk Advanced prostate cancer • Adult: IV 12-14 mg/m2 as single dose or short infusion q21days Multiple sclerosis, relapsing • Adult: IV INFUSION 12 mg/m2 as 5- to 15-min infusion q3mo, cumulative lifetime dose 140 mg/m2
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Available forms: Solution for inj 2 mg/ mL
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Administer: • Antiemetic 30-60 min before product to prevent vomiting • Cytotoxic: use precautions for han- dling, preparing, and disposal of this product; use goggles, gloves, gown dur- ing preparation and administration; rinse accidentally exposed skin with warm water • Undiluted solution may be stored for 7 days (room temperature), 14 days (re- frigerated); do not freeze Direct IV route • IV after diluting with ≥50 mL NS or D5W; discard unused portion immedi- ately; do not mix in same infusion with heparin; give over 3-5 min into running IV of D5W or NS; check for extravasation; do not give IM, SUBCUT, or intraarterially Intermittent IV INFUSION route • May be diluted further in D5W, NS (0.02-0.5 mg/mL), run over 15-30 min Continuous IV INFUSION route • Give over 24 hr Y-site compatibilities: Acyclovir, alemtu- zumab, alfentanil, allopurinol, amikacin, aminocaproic acid, aminophylline, amio- darone, anidulafungin, argatroban, arse- nic trioxide, atracurium, bivalirudin, bleomycin, bretylium, bumetanide, buprenorphine, butorphanol, calcium chloride, calcium gluconate, CARBOpla- tin, carmustine, caspofungin, cefoTEtan, ceftizoxime, chloramphenicol, chlor- proMAZINE, cimetidine, ciprofloxacin, cisatracurium, CISplatin, cladribine, codeine, cyclophosphamide, cycloSPO- RINE, cytarabine, DACTINomycin, DAP- TOmycin, DAUNOrubicin citrate lipo- some, dexmedetomidine, dexrazoxane, diltiaZEM, diphenhydrAMINE, DOBUTa- mine, DOCEtaxel, dolasetron, DOPamine, doxacurium, doxycycline, droperidol, enalaprilat, ePHEDrine, EPINEPHrine, erythromycin, esmolol, etoposide, etopo- side phosphate, famotidine, fenoldopam, fentaNYL, filgrastim, fluconazole, fludara- bine, fluorouracil, ganciclovir, gatifloxa- cin, gemcitabine, gentamicin, glycopyr- rolate, granisetron, haloperidol, hydrALAZINE, hydrocortisone sodium succinate, HYDROmorphone, hydrOXY- zine, ifosfamide, imipenem-cilastatin, inamrinone, insulin (regular), irinote- can, isoproterenol, ketorolac, labetalol, leucovorin, levoFLOXacin, levorphanol, lidocaine, linezolid, LORazepam, magne- sium sulfate, mannitol, melphalan, meperidine, meropenem, mesna, meta- raminol, methohexital, methotrexate, methyldopate, metoclopramide, meto- prolol, metroNIDAZOLE, midazolam, milrinone, minocycline, mivacurium, morphine sulfate, nalbuphine, naloxone, nesiritide, niCARdipine, nitroglycerin, norepinephrine, octreotide, ondanse- tron, oxaliplatin, palonosetron, pamidro- nate, pancuronium, pentamidine, pen- tazocine, PENTObarbital, PHENObarbital, phentolamine, phenylephrine, polymyxin B, potassium acetate, potassium chlo- ride, procainamide, prochlorperazine, promethazine hydrochloride, proprano- lol, quiNIDine gluconate, quinupristin- dalfopristin, raNITIdine, remifentanil, M riTUXimab, rocuronium, sargramostim, sodium acetate, sodium bicarbonate, succinylcholine, SUFentanil, sulfa- methoxazole-trimethoprim, tacrolimus, teniposide, theophylline, thiopental, thio- tepa, tigecycline, tirofiban, tobramycin, tolazoline, trastuzumab, trimethobenza- mide, vancomycin, vasopressin, vecuronium, verapamil, vinCRIStine, vinorelbine, zidovudine, zoledronic acid
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Assess: • Black Box Warning: Bone marrow depression: CBC, differential, platelet count weekly; withhold product if WBC is <1500/mm3; leukopenia, neutropenia, thrombocytopenia are expected, leuko- cyte nadir 10-14 days, recovers in 2-3 wk Black Box Warning: Extravasa- tion: avoid extravasation; not traditionally considered a vesicant; serious skin ne- crosis requiring debridement, skin graft has occurred; if extravasation occurs, stop product, place ice packs on area • Hepatotoxicity: hepatic studies before, during therapy: bilirubin, AST, ALT, alk phos prn or monthly; dose reduction needed with hepatic disease; jaundiced skin and sclera, dark urine, clay-colored stools, itchy skin, abdominal pain, fever, diarrhea • Renal studies: BUN, serum uric acid, urine CCr, electrolytes before, during therapy • Bleeding, hematuria, guaiac, bruising or petechiae, mucosa or orifices q8hr
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Evaluate: • Therapeutic response: decreased tu- mor size, spread of malignancy, preven- tion of relapse in MS
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • To immediately report bleeding, dys- pnea, possible infections, seizure, jaun- dice, fever, cough, or dyspnea • To avoid hot foods or those with citric acid, rough texture • To report any bleeding, white spots, ul- cerations in mouth; to examine mouth daily • To avoid crowds, persons with infections • To provide package insert and review with patient • To report immediately yellow eyes, skin, clay-colored stools, dark urine, diarrhea • That follow-up exams and blood work will be needed • That sclera, urine may turn blue or green; that hair loss may occur • To notify prescriber if pregnancy is suspected or planned; to use effective contraception
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PHARMACOKINETICS Protein binding 78%; excreted via renal, hepatobiliary systems; half-life 23-215 hr
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• Adult: IV INFUSION 12 mg/m2/day on days 1-3 and 100 mg/m2 cytarabine × 7 days as continuous 24-hr infusion may use 2nd induction Consolidation
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• Adult: IV 12 mg/m2 given as short 5- to 15-min infusion for 2 days with cytara- bine × 5 days, use 6 wk after induction, and another course after 4 wk Advanced prostate cancer
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• Adult: IV 12-14 mg/m2 as single dose or short infusion q21days Multiple sclerosis, relapsing
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• Adult: IV INFUSION 12 mg/m2 as 5- to 15-min infusion q3mo, cumulative lifetime dose 140 mg/m2
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