Halaven

Halaven

Manufacturer:

Eisai

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Eribulin mesylate
Indications/Uses
Patients w/ locally-advanced or metastatic breast cancer that have progressed after at least 2 chemotherapeutic regimens for advanced disease. Prior therapy should have included an anthracycline & a taxane in either the adjuvant or metastatic setting. Unresectable liposarcoma in adults who have received prior anthracycline containing therapy (unless unsuitable) for advanced or metastatic disease.
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 (Child-Pugh A) 1.1 mg/m2 IV over 2-5 min on days 1 & 8 of a 21-day cycle. Moderate hepatic impairment (Child-Pugh B) 0.7 mg/m2 IV over 2-5 min on days 1 & 8 of a 21-day cycle.
Contraindications
Special Precautions
Monitoring of complete blood counts should be performed prior to each dose. Treatment should only be initiated in patients w/ ANC values ≥1.5 x 109/L & platelets >100 x 109 L. Higher incidence of Grade 4 & febrile neutropenia in patients w/ ALT or AST >3 x ULN or bilirubin >1.5 x ULN. Monitor for signs of peripheral motor & sensory neuropathy eg, burning sensation, hyperesthesia, hypoesthesia, paraesthesia, discomfort or neuropathic pain. Perform ECG monitoring before initiating treatment in patients w/ CHF, bradyarrhythmias, drugs known to prolong QT interval including class Ia & III antiarrhythmics & electrolyte abnormalities. Hypokalaemia, hypocalcaemia & hypomagnesaemia must be corrected prior to therapy. Monitor electrolytes periodically during treatment. Avoid in patients w/ congenital long QT syndrome. May cause irreversible infertility in male patients. Tiredness & dizziness may lead to a minor or moderate influence on the ability to drive or use machines. Renal impairment. Women of childbearing potential must be advised to avoid becoming pregnant & should use effective contraception during & up to 3 mth after treatment. Do not use during pregnancy. Not recommended for use in childn <18 yr. Elderly ≥65 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, hyperglycaemia, hypophosphataemia, hypocalcaemia; insomnia, depression; dysgeusia, dizziness, hypoaesthesia, lethargy, neurotoxicity; increased lacrimation, conjunctivitis; vertigo, tinnitus; tachycardia; hot flush, pulmonary embolism; oropharyngeal pain, epistaxis, rhinorrhoea; abdominal pain, stomatitis, dry mouth, dyspepsia, GERD, abdominal distension; increased AST, ALT, γ-glutamyl transferase, hyperbilirubinaemia; rash, pruritus, nail disorder, night sweats, dry skin, erythema, hyperhidrosis, palmar plantar erythrodysaesthesia; bone, musculoskeletal & chest pain, muscle spasms, muscular weakness; dysuria; mucosal inflammation, peripheral oedema, pain, chills, chest pain, influenza-like illness.
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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