Names and pronunciation
(er′i-bu′lin) Halaven
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Drug reference
(er′i-bu′lin) Halaven
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Func. class.: Antineoplastics—non- taxane
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Chem. class.: Microtubule inhibitor E
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ACTION: Potent antimitotic agent, dif- ferent from taxanes, vinca alkaloids, epothilones; blocks cell progression dur- ing G2-M phase; inhibits the growth phase of microtubules and sequesters tubules, leading to the disruption of mitotic spindles and apoptotic cell death
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USES: Metastatic breast cancer in patients who have received at least 2 chemotherapy regimens
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CONTRAINDICATIONS: Hyper- sensitivity, pregnancy Precautions: Breastfeeding, neonates, infants, children, bradycardia, electrolyte imbalances, heart failure, hypokalemia, hypomagnesemia, infertility, neutropenia, peripheral neuropathy, QT prolongation, hepatic/renal disease
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SIDE EFFECTS CNS: Depression, dizziness, fatigue, fever, headache, insomnia, peripheral neuropathy CV: QT prolongation, peripheral edema GI: Abdominal pain, anorexia, constipa- tion, diarrhea, dyspepsia, nausea, vomit- ing, weight loss HEMA: Anemia, neutropenia, thrombocy- topenia INTEG: Alopecia, rash, stomatitis, infu- sion-related reactions META: Hypokalemia MS: Arthralgia, myalgia, bone/back pain RESP: Cough, dyspnea SYST: Infection
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INTERACTIONS Increase: QT prolongation—arsenic triox- ide, bepridil, chloroquine, certain phenothi- azines (chlorproMAZINE, mesoridazine, thioridazine), clarithromycin, class IA antiar- rhythmics (disopyramide, procainamide, quiNIDine), class III antiarrhythmics (amiod- arone, bretylium, dofetilide, ibutilide, sotalol), dextromethorphan; quiNIDine, dronedarone, droperidol, erythromycin, halofantrine, halo- peridol, levomethadyl, methadone, pentami- dine, pimozide, posaconazole, probucol, propafenone, saquinavir, sparfloxacin, trole- andomycin, and ziprasidone; also to a lesser degree abarelix, alfuzosin, amoxapine, apo- morphine, artemether; lumefantrine, ase- napine, beta-agonists, ofloxacin, cloZAPine, cyclobenzaprine, dasatinib, dolasetron, fle- cainide, gatifloxacin, gemifloxacin, haloge- nated anesthetics, iloperidone, lapatinib, levoFLOXacin, local anesthetics, lopinavir; ritonavir, magnesium sulfate; potassium sulfate; sodium sulfate, maprotiline, meflo- quine, moxifloxacin, nilotinib, norfloxacin, octreotide, ciprofloxacin, OLANZapine, ondansetron, paliperidone, palonosetron, some phenothiazines (fluPHENAZine, per- phenazine, prochlorperazine, trifluopera- zine), QUEtiapine, ranolazine, risperiDONE, sertindole, SUNItinib, tacrolimus, telavancin, telithromycin, tetrabenazine, tricyclic anti- depressants, venlafaxine, vardenafil, vorinostat Increase: adverse reactions—live virus vaccines; do not use together
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DOSAGE AND ROUTES • Adult: IV 1.4 mg/m2 over 2-5 min on days 1 and 8, repeat q21days • Recommendations for dose delay: for ANC <1000/mm3, platelets <75,000/ mm3, or grade 3 or 4 nonhematologic tox- icities: do not administer; the day 8 dose may be delayed a maximum of 1 wk; for the day 8 dose, if toxicities do not resolve to ≤ grade 2 by day 15: omit the dose; for the day 8 dose, if toxicities resolve or improve to ≤ grade 2 by day 15: administer eriBULin at reduced dose (see later), initiate the next cycle no sooner than 2 wk later • Dose adjustments for hematologic toxicity: ANC <500/mm3 for >7 days or ANC <1000/mm3 with fever or infection: permanently reduce dose to 1.1 mg/m2; platelets <25,000/mm3 or <50,000/mm3 requiring transfusion: permanently reduce dose to 1.1 mg/m2; if day 8 of previous cycle omitted or delayed: permanently re- duce dose to 1.1 mg/m2; while receiving 1.1 mg/m2, if recurrence of hematologic event occurs, or if day 8 of previous cycle omitted or delayed: permanently reduce dose to 0.7 mg/m2; while receiving 0.7 mg/m2, if recurrence of hematologic event occurs, or if day 8 of previous cycle omit- ted or delayed: discontinue
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Available forms: Solution for injection 1 mg/2 mL
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Administer: IV direct, intermittent route • Visually inspect for particulate matter, discoloration; withdraw amount (0.5 mg/ mL) from single-use vial, give undiluted over 2-5 min or diluted in 100 mL 0.9% NaCl and give as intermittent infusion; do not give through line with dextrose or any other product • Store at room temperature for 4 hr or 24 hr refrigerated
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Assess: • Peripheral neuropathy: pain, numb- ness in extremities • Infection: increased temperature, sore throat, flulike symptoms imbalances: • Electrolyte correct prior to administration; monitor during therapy • QT prolongation: assess for drug in- teractions that may occur; monitor ECG, heart rate • Bone marrow depression: CBC, differential, serum creatinine, BUN, electrolytes, LFTs at baseline, periodi- cally; increased AST/ALT >3 × ULN or total bilirubin >1.5 × ULN involves greater chance of grade 4 or febrile neutropenia • Pregnancy/breastfeeding: may cause fetal harm; do not use in pregnancy or breastfeeding
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • Infection: to notify prescriber of in- creased temperature, sore throat, fatigue, flulike symptoms • QT prolongation: to report extra heart- beats Peripheral neuropathy: • To report tingling, pain in extremities • About reason for product and ex- pected results • To avoid other medications, supple- ments unless approved by provider; serious drug interactions may occur • About hair loss, use of wig or hairpiece • To notify prescriber if pregnancy is planned or suspected; to use contracep- tion during treatment; to avoid breast- feeding HIGH ALERT
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PHARMACOKINETICS Protein binding 49%-65%; inhibits CYP3A4; excreted in feces 82%; urine 9%; elimination half-life 40 hr; increased levels in hepatic/renal disease
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• Adult: IV 1.4 mg/m2 over 2-5 min on days 1 and 8, repeat q21days
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• Recommendations for dose delay: for ANC <1000/mm3, platelets <75,000/ mm3, or grade 3 or 4 nonhematologic tox- icities: do not administer; the day 8 dose may be delayed a maximum of 1 wk; for the day 8 dose, if toxicities do not resolve to ≤ grade 2 by day 15: omit the dose; for the day 8 dose, if toxicities resolve or improve to ≤ grade 2 by day 15: administer eriBULin at reduced dose (see later), initiate the next cycle no sooner than 2 wk later
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• Dose adjustments for hematologic toxicity: ANC <500/mm3 for >7 days or ANC <1000/mm3 with fever or infection: permanently reduce dose to 1.1 mg/m2; platelets <25,000/mm3 or <50,000/mm3 requiring transfusion: permanently reduce dose to 1.1 mg/m2; if day 8 of previous cycle omitted or delayed: permanently re- duce dose to 1.1 mg/m2; while receiving 1.1 mg/m2, if recurrence of hematologic event occurs, or if day 8 of previous cycle omitted or delayed: permanently reduce dose to 0.7 mg/m2; while receiving 0.7 mg/m2, if recurrence of hematologic event occurs, or if day 8 of previous cycle omit- ted or delayed: discontinue
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