Halaven

Halaven

eribulin

Manufacturer:

Eisai

Marketer:

Eisai
Concise Prescribing Info
Contents
Eribulin mesylate
Indications/Uses
Monotherapy for adult patients w/ locally advanced or metastatic breast cancer who have progressed after at least 2 chemotherapeutic regimens for advanced disease. Prior therapy should have included an anthracycline & a taxane unless patients are not suitable in these treatments. Adult patients w/ unresectable liposarcoma who have received prior anthracycline containing therapy (unless unsuitable) for advanced or metastatic disease.
Dosage/Direction for Use
Adult 1.23 mg/m2 IV over 2-5 min on days 1 & 8 of a 21-day cycle. Mild hepatic impairment (Child-Pugh A) 0.97 mg/m2 IV over 2-5 min on days 1 & 8 of a 21-day cycle, moderate hepatic impairment (Child-Pugh B) 0.62 mg/m2 IV over 2-5 min on days 1 & 8 of a 21-day cycle.
Contraindications
Hypersensitivity. Breast-feeding.
Special Precautions
Delay Halaven treatment on day 1 or 8 if ANC <1 x 109/L, platelets <75 x 109/L or grade 3 or 4 non-hematological toxicities. Initiate only in patients w/ ANC values ≥1.5 x 109/L & platelets >100 x 109/L. Higher incidence of grade 4 neutropenia & febrile neutropenia in patients w/ ALT or AST >3 x ULN or bilirubin >1.5 x ULN. Hypokalemia or hypomagnesia should be corrected prior to treatment initiation. Monitor for signs of peripheral motor & sensory neuropathy; CBC prior to each dose; ECG in patients w/ CHF, bradyarrhythmias, electrolyte abnormalities & those taking medicinal products that prolong QT interval including class IA & III antiarrythmics. Renal impairment. May impair ability to drive or operate machinery. Pregnancy.
Adverse Reactions
Neutropenia, leukopenia, anaemia; decreased appetite; peripheral neuropathy, headache; nausea, constipation, diarrhoea, vomiting; alopecia; arthralgia & myalgia; fatigue/asthenia, pyrexia. UTI, oral candidiasis, upper resp tract infection, nasopharyngitis, rhinitis; febrile neutropenia, thrombocytopenia, lymphopenia; hypokalaemia, hypomagnesaemia, dehydration, hyperglycaemia, hypophosphataemia; insomnia, depression; dysgeusia, dizziness, hypoaesthesia, lethargy, neurotoxicity; increased lacrimation, conjunctivitis; vertigo; tachycardia; hot flush; dyspnoea, cough, oropharyngeal pain, epistaxis, rhinorrhoea; abdominal pain, stomatitis, dry mouth, dyspepsia, GERD, mouth ulceration, abdominal distention; increased ALT & AST; rash, pruritus, nail disorder, night sweats, palmar plantar erythrodysaesthesia, dry skin, erythema, hyperhidrosis; pain in extremity, muscle spasms, musculoskeletal & musculoskeletal chest pain, muscular weakness, bone & back pain; mucosal inflammation, peripheral oedema, pain, chills, flu-like illness, chest pain; decreased wt.
Drug Interactions
Monitor cautiously for any adverse events w/ concomitant use of substances that have narrow therapeutic window & eliminated via CYP3A4-mediated metabolism (eg, alfentanil, cyclosporine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus).
MIMS Class
Cytotoxic Chemotherapy
ATC Classification
L01XX41 - eribulin ; Belongs to the class of other antineoplastic agents. Used in the treatment of cancer.
Presentation/Packing
Form
Halaven soln for inj 0.88 mg/2 mL
Packing/Price
1's
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