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Eribulin mesylate

Class
Mitotic inhibitors
Subclass
Mitotic inhibitors
Substance name
eriBULin
Brand names
Halaven®
Common formulations
Solution for injection
Dosage and administration
Adults patients
Treatment of liposarcomaUnresectable, metastatic
1.4 mg/m² IV q3 weeks days 1 and 8 of a 21-day cycle
Indications for use
Labeled indications
Adults
Treatment of breast cancer in females (advanced or metastatic)
Treatment of liposarcoma (unresectable, metastatic)
Safety risks
Boxed warnings
Neutropenia
Use extreme caution with risk factors for severe hematologic toxicity.
Peripheral neuropathy
Use extreme caution with pre-existing signs of peripheral motor and sensory neuropathy.
Contraindications
A history of hypersensitivity to Eribulin mesylate
Congenital long QT syndrome or those receiving medications known to prolong the QT interval
Specific populations
Renal impairment
eGFR 30-50 mL/min/1.73 m²
Reduce dose. Maximal dose of 1.1 mg/m²/dose. Due to lack of data the manufacturer cannot recommend a dose if GFR<50 mL/min.
eGFR < 30 mL/min/1.73 m²
Reduce dose. Due to lack of data the manufacturer cannot recommend a dose if GFR<50 mL/min.
Renal replacement therapy
Continuous renal replacement
Reduce dose. Dose as in eGFR 30-50 mL/min/1.73 m². Maximal dose of 1.1 mg/m2/dose.
Intermittent hemodialysis
Reduce dose. Dose as in eGFR < 30 mL/min/1.73 m².
Peritoneal dialysis
Reduce dose. Dose as in eGFR < 30 mL/min/1.73 m².
Hepatic impairment
Child-Pugh A (mild)
Reduce dose. Start at dose of 1.1 mg/m² IV over 2 to 5 minutes. Maximal dose of 1.1 mg/m². Do not exceed frequency of q24h. Monitor serum aminotransferases. Monitor for toxicity. 1.1 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=31ce4,750-ded5-4a0b-95e9-f229fa6bc822.
Child-Pugh B (moderate)
Reduce dose. Start at dose of 0.7 mg/m² IV over 2 to 5 minute. Maximal dose of 0.7 mg/m². Do not exceed frequency of q24h. Monitor serum aminotransferases. Monitor for toxicity. 0.7 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=31ce4,750-ded5-4a0b-95e9-f229fa6bc822.
Child-Pugh C (severe)
No guidance available. Monitor serum aminotransferases. Monitor for toxicity.
Pregnancy and breastfeeding
Pregnancy
All trimesters
Avoid use. Evidence of fetal harm in humans. Eribulin may cause fetal harm during pregnancy based on its mechanism of action and findings from animal reproduction studies.
Advise females of reproductive potential to avoid becoming pregnant while taking eribulin.
Women who become pregnant while receiving eribulin should be apprised of the potential hazard to the fetus.
Breastfeeding
Little information available on breastfeeding safety.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
Adverse reactions
Very common > 10%
Alopecia, ↓ blood neutrophil count, peripheral edema, cough, diarrhea
Common 1-10%
Anemia, ↓ platelet count, ↓ serum calcium, ↓ serum phosphate, ↓ serum potassium, depression, hyperlacrimation, hypotension, ↑ blood glucose, ↑ serum TBIL, peripheral neuropathy, abdominal pain, anxiety, arthralgia, asthenia, back pain, bone pain, constipation, dizziness, dry mouth, dysgeusia, dyspepsia, dyspnea, fatigue, fever, headache, insomnia, loss of appetite, muscle cramps, musculoskeletal pain, myalgia, nausea, paresthesia, skin rash, vomiting, weakness, weight loss
Uncommon < 1%
↑ liver enzymes, left ventricular dysfunction, pulmonary embolism, stomatitis
Unknown frequency
Acute pancreatitis, ↓ blood lymphocyte count, ↓ serum magnesium, dehydration, pneumonitis, ↑QTc interval, itching, Stevens-Johnson syndrome, toxic epidermal necrolysis
Interactions
Drug(s)
Check Interactions
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