Halaven

Halaven

Manufacturer:

Eisai

Distributor:

DKSH
Concise Prescribing Info
Contents
Eribulin mesilate
Indications/Uses
Locally advanced or metastatic breast cancer who have progressed after at least 2 chemotherapeutic regimen for advanced disease. Locally advanced or metastatic HER2 -ve breast cancer after failure of 1 chemotherapeutic regimen for advanced disease. Unresectable liposarcoma after progression following prior chemotherapy for advanced or metastatic disease in adults. Prior therapy should include anthracycline & taxane unless unsuitable.
Dosage/Direction for Use
1.4 mg/m2 IV over 2-5 min on days 1 & 8 of every 21-day cycle. Mild hepatic impairment due to metastases (Child-Pugh A) 1.1 mg/m2 IV over 2-5 min on days 1 & 8 of 21-day cycle. Moderate hepatic impairment due to metastases (Child-Pugh B) 0.7 mg/m2 IV over 2-5 min on days 1 & 8 of 21-day cycle.
Contraindications
Special Precautions
Higher incidence of grade 4 & febrile neutropenia in patients w/ ALT or AST >3 times upper limit of normal (ULN) or bilirubin >1.5 times ULN. Avoid in patients w/ congenital long QT syndrome. Peripheral neuropathy. Monitor complete blood count prior to each dose. Perform ECG in patients w/ CHF, bradyarrhythmias, concomitant use of drugs prolonging QT interval including class IA & III antiarrhythmics & electrolyte abnormalities. Correct hypokalemia & hypomagnesemia prior to therapy. Monitor electrolytes periodically during treatment. May affect ability to drive & use machines. Renal & hepatic impairment. Women of childbearing potential should use effective contraception during & up to 3 mth after treatment. Irreversible infertility in male patients. Not to be used during pregnancy & lactation. Childn ≤18 yr.
Adverse Reactions
Neutropenia, leukopenia, anaemia; decreased appetite; peripheral neuropathy, headache; dyspnoea, cough; nausea, constipation, diarrhoea, vomiting; alopecia; arthralgia & myalgia, back pain, pain in extremity; fatigue/asthenia, pyrexia; decreased wt. UTI, pneumonia, oral candidiasis & herpes, upper resp tract infection, nasopharyngitis, rhinitis, herpes zoster; lymphopenia, febrile neutropenia, thrombocytopenia; hypokalaemia, hypomagnesaemia, dehydration, hypocalcaemia, hyperglycaemia, hypophosphataemia; insomnia, depression; dysgeusia, dizziness, hypoaesthesia, lethargy, neurotoxicity; increased lacrimation, conjunctivitis; vertigo, tinnitus; tachycardia; hot flush, pulmonary embolism; oropharyngeal pain, epistaxis, rhinorrhoea; GI, hepatobiliary, skin & subcutaneous tissue disorders; bone pain, muscle spasms, musculoskeletal & chest pain, muscular weakness; dysuria; mucosal inflammation, peripheral oedema, pain, chills, chest pain, influenza-like illness.
Drug Interactions
Concomitant use w/ CYP3A4-mediated metabolism substances 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 0.5 mg/mL
Packing/Price
2 mL x 1's
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