eribulin(redirected from Halaven)
Pharmacologic class: Non-taxane microtubule dynamics inhibitor
The rapeutic class: Antineoplastic
Pregnancy risk category D
Inhibits growth phase of microtubules without affecting the shortening phase and sequesters tubulin into nonproductive aggregates; exerts its effects via a tubulin-based antimitotic mechanism leading to G2/M cell-cycle block, disruption of mitotic spindles and, ultimately, apoptotic cell death after prolonged mitotic blockage
Injection: 1 mg/2 ml (0.5 mg/ml) in single-use vials
⊘Indications and dosages
➣ Metastatic breast cancer in patients who have previously received at least two chemotherapeutic regimens for metastatic disease
Adults: 1.4 mg/m2 I.V. over 2 to 5 minutes on days 1 and 8 of 21-day cycle
• Mild and moderate hepatic impairment, moderate renal impairment
• Hematologic toxicities
• Peripheral neuropathy
Use cautiously in:
• hepatic or renal impairment
• neutropenia, neuropathy
• congenital long QT syndrome (avoid use)
• congestive heart failure, brady-arrhythmias, drugs known to prolong QT interval (including Class Ia and III antiarrhythmics), electrolyte abnormalities
• pregnant or breastfeeding patients
• children younger than age 18 (safety and efficacy not established).
• Don't dilute with dextrose-containing solutions or mix with other drugs.
• Obtain CBC before each dose; increase frequency in patients who develop Grade 3 or 4 cytopenias.
• Correct hypokalemia or hypomagnesemia before starting therapy.
☞ Don't administer day-1 or day-8 dose if any of the following occurs: Absolute neutrophil count less than 1,000/mm3, platelet count less than 75,000/mm3, or Grade 3 or 4 nonhematologic toxicities. Delay day-8 dose for maximum of 1 week.
• If toxicities don't resolve or improve to Grade 2 severity by day 15, omit dose. If toxicities resolve or improve to Grade 2 severity by day 15, give drug at reduced dosage and initiate next cycle no sooner than 2 weeks later.
☞ Delay drug administration and reduce subsequent doses in patients who experience febrile neutropenia or Grade 4 neutropenia lasting longer than 7 days.
• Withhold drug in patients who experience Grade 3 or 4 peripheral neuropathy until resolution to Grade 2 or less.
• Don't reescalate dosage after it has been reduced.
CNS: headache, dizziness, asthenia, fatigue, peripheral neuropathy, insomnia, depression
CV: prolonged QT interval
EENT: increased lacrimation
GI: nausea, vomiting, diarrhea, constipation, anorexia, dyspepsia, abdominal pain, stomatitis, dry mouth
GU: urinary tract infection
Hematologic: anemia, neutropenia, febrile neutropenia, thrombocytopenia
Hepatic: liver function test abnormalities
Musculoskeletal: arthralgia, myalgia, back pain, bone pain, extremity pain, muscle spasm, muscular weakness
Respiratory: cough, dyspnea, upper respiratory tract infection
Skin: alopecia, rash
Other: mucosal inflammation, pyrexia, weight loss, peripheral edema, dysgeusia
Drug-diagnostic tests.ALT: increased level
Potassium: decreased level
• Monitor CBC with differential and renal and hepatic function tests closely.
• Monitor serum magnesium and potassium levels periodically during therapy.
• Monitor ECG in patients with congestive heart failure, bradyarrhythmias, or electrolyte abnormalities, or if patients are taking drugs known to prolong QT interval, including Class Ia and III antiarrhythmics.
• Monitor patients closely for signs and symptoms of peripheral motor and sensory neuropathy.
☞ Instruct patient to immediately report abnormal heartbeats, dizziness, or faintness.
• Advise patient to promptly report fever, chills, burning or pain on urination, cough, or numbness, tingling, or burning of hands and feet.
• Advise female patient of childbearing age of potential hazard to fetus if drug is used during pregnancy and to inform prescriber if she becomes pregnant while taking drug.
• Advise breastfeeding patient that she should decide whether to discontinue breastfeeding or discontinue drug, taking into account importance of drug for her treatment.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the tests mentioned above.
Time/action profile (effects on blood counts)
|IV||within days||7–14 days||up to 2 wk|
Adverse Reactions/Side Effects
Central nervous system
- fatigue (most frequent)
- weakness (most frequent)
Ear, Eye, Nose, Throat
- ↑ lacrimation
- QTc prolongation (life-threatening)
- peripheral edema
- cough (most frequent)
- dyspnea (most frequent)
- upper respiratory tract infection
- pancreatitis (life-threatening)
- anorexia (most frequent)
- constipation (most frequent)
- nausea (most frequent)
- abdominal pain
- abnormal taste
- dry mouth
- alopecia (most frequent)
Fluid and Electrolyte
- arthralgia (most frequent)
- myalgia (most frequent)
- peripheral neuropathy (most frequent)
- fever (most frequent)
- urinary tract infection
Drug-Drug interaction↑ risk of bone marrow depression with other antineoplastics or radiation therapy.↓ antibody response and ↑ risk of adverse reactions with live virus vaccines.
Renal ImpairmentIntravenous (Adults) Mild hepatic impairment (Child-Pugh A)—1.1 mg/m2 on days 1 and 8 of a 21-day cycle Moderate hepatic impairment (Child-Pugh B)—0.7 mg/m2 on days 1 and 8 of a 21-day cycle.
Renal ImpairmentIntravenous (Adults) Moderate renal impairment (CCr 30–50 mL/min)—1.1 mg/m2 on days 1 and 8 of a 21-day cycle.
- Assess for peripheral motor and sensory neuropathy (numbness, tingling, burning in hands or feet). Withhold eribulin in patients who experience Grade 3 or 4 peripheral neuropathy until resolution to Grade 2 or less.
- Monitor ECG periodically as indicated.
- Lab Test Considerations: Monitor CBC prior to each dose; ↑ frequency of monitoring in patients who develop Grade 3 or 4 cytopenias. Delay administration and reduce subsequent doses in patients who develop febrile neutropenia or Grade 4 neutropenia lasting longer than 7 days.
- Monitor electrolytes periodically during therapy.
Potential Nursing DiagnosesActivity intolerance
- Correct hypokalemia or hypomagnesemia prior to initiating therapy.
- Do not administer on Day 1 or Day 8 if: ANC <1000/mm3, platelets <75,000/mm3, or Grade 3 or 4 nonhematological toxicities occur.
- Day 8 dose may be delayed for a maximum of 1 wk: If toxicities do not resolve or improve to ≤Grade 2 severity by Day 15, omit dose.
- If toxicities resolve or improve to ≤Grade 2 by Day 15, administer eribulin at a reduced dose and initiate next cycle no sooner than 2 wk later.
- If a dose has been delayed for toxicity and toxicities have recovered to Grade 2 severity or less, resume eribulin at a reduced dose of 1.1 mg/m2.
- Permanently reduce 1.4 mg/m2 eribulin dose to 1.1 mg/m2 if: ANC <500/mm3 for >7 days, ANC <1000/mm3 either fever or infection, platelets <25,000/mm3, platelets <50,000/mm3 requiring transfusion, nonhematologic Grade 3 or 4 toxicities, or omission or delay of Day 8 eribulin dose in previous cycle for toxicity.
- Permanently reduce 1.4 mg/m2 eribulin dose to 0.7 mg/m2 if: occurrence of any event requiring permanent dose reduction while receiving 1.1 mg/m2 dose.
- If occurrence of any event requiring permanent dose reduction while receiving 0.7 mg/m2: discontinue eribulin.
- Diluent: Administer undiluted or dilute in 100 mL of 0.9% NaCl. Store undiluted in syringe or diluted eribulin for up to 4 hr at room temperature or for up to 24 hr under refrigeration. Discard unused portion of vial.
- Rate: Infuse over 2–5 minutes on Days 1 and 8 of a 21-day cycle.
- Y-Site Incompatibility: Do not dilute in or administer through an IV line containing solutions with dextrose or other medications.
- 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) occur.
- Advise female patient to use effective contraception during therapy and to notify health care professional immediately if pregnancy is planned or suspected or if breast feeding.
- 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.
- ↓ spread of breast cancer.