• Metastatic breast cancer that has progressed despite 2 previous regimens which included an anthracycline and a taxane in either the adjuvant or metastatic setting.
• Unresectable or metastatic liposarcoma in patients who have received a prior regimen that included an anthracycline.

Contraindicated in:

• Severe hepatic impairment
• Severe renal impairment (CCr <15 mL/min)
• Congenital long QT syndrome
• OB: Pregnancy; may cause fetal harm
• Lactation: Avoid breast feeding.

Use Cautiously in:

• HF, bradyarrhythmias, concurrent use of drugs known to prolong the QT interval (including Class Ia and III antiarrhythmics), electrolyte abnormalities (↑ risk of arrhythmias)
• Moderate renal impairment; lower initial dose recommended for CCr 30–50 mL/min
• Mild to moderate hepatic impairment; lower initial dose recommended
• Rep: Women of reproductive potential and men with female partners of reproductive potential (use effective contraception)
• Pedi: Safety and effectiveness not established.

CNS: fatigue, weakness, depression, dizziness, headache, insomnia.

EENT: ↑lacrimation.

CV: QT INTERVAL PROLONGATION, peripheral edema.

Resp: cough, dyspnea, upper respiratory tract infection.

GI: PANCREATITIS, anorexia, constipation, nausea, abdominal pain, abnormal taste, dry mouth, dyspepsia, mucositis, diarrhea, vomiting.

Derm: stevens-johnson syndrome, toxic epidermal necrolysis, alopecia, rash.

F and E: hypokalemia.

Hemat: anemia, neutropenia.

MS: arthralgia, myalgia.

Neuro: peripheral neuropathy.

Misc: fever, urinary tract infection.

Drug-Drug:

• ↑risk of bone marrow depression with other antineoplastics or radiation therapy.
• ↓antibody response and ↑ risk of adverse reactions with live virus vaccines.

• Solution for IV administration: 0.5 mg/mL;

• IV (Adults): 1.4 mg/m² on days 1 and 8 of a 21-day cycle; dose modifications required for neutropenia, thrombocytopenia, or peripheral neuropathy.

Halaven

• Inhibits intracellular microtubule growth phase, causing G₂/M cell-cycle block resulting in apoptotic cell death.

• Death of rapidly replicating cells, particularly malignant ones.
• Improved survival in patients with breast cancer or liposarcoma.

Therapeutic Classification: antineoplastics

Pharmacologic Classification:

Absorption: IV administration results in complete bioavailability.

Distribution: Unknown.

Metabolism/Excretion: Minimal metabolism, mostly excreted unchanged in feces (82%) and less in urine (9%).

Half-life: 40 hr.

(effects on blood counts)

• Advise patient to notify health care professional if fever of 100.5° F or other signs or symptoms of infection (chills, cough, burning or pain on urination) or rash occur.
• Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
• Advise patient not to receive vaccinations without consulting health care professional.
• Rep: Advise female patient to use effective contraception during and for at least 2 wk after last dose of therapy and to notify health care professional immediately if pregnancy is planned or suspected or if breast feeding. Advise males with female partners of reproductive potential to use effective contraception for 3.5 mo after final dose. May cause male infertility.

e-RIB-yoo-lin

NDC Code^*

• 62856- Eisai Inc.
  • 62856-389- Halaven
    • 62856-389-01- 1 VIAL in 1 CARTON (62856-389-01) > 2 mL in 1 VIAL