Halaven

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 adjuvant or metastatic setting. Unresectable liposarcoma in adult patients who have received prior anthracycline containing therapy (unless unsuitable) for advanced or metastatic disease.

IV 1.4 mg/m² over 2-5 min on days 1 & 8 of every 21-day cycle. Mild hepatic impairment (Child-Pugh A) 1.1 mg/m² over 2-5 min on days 1 & 8 of a 21-day cycle. Moderate hepatic impairment (Child-Pugh B) 0.7 mg/m² over 2-5 min on days 1 & 8 of a 21-day cycle.

Hypersensitivity. Lactation.

Perform CBC monitoring 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. Possible fatal cases of febrile neutropenia, neutropenic sepsis, sepsis & septic shock. 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. Correct hypokalaemia, hypocalcaemia & hypomagnesaemia prior to therapy. Periodically monitor electrolytes during treatment. Avoid in patients w/ congenital long QT syndrome. Possible tiredness & dizziness may lead to minor or moderate influence on the ability to drive or use machines. Closely monitor patients w/ impaired liver function due to cirrhosis. Severe hepatic impairment (Child-Pugh C). Renal impairment. Advise women of childbearing potential to avoid becoming pregnant & use highly effective contraception during & for 7 mth after treatment. Advise men w/ partners of childbearing potential not to father a child during treatment; use effective contraception during & for 4 mth after treatment. Possible irreversible infertility in male patients. Pregnancy. Childn <18 yr. Elderly ≥65 yr.

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, URTI, 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, flu-like illness.

Cytotoxic Chemotherapy

L01XX41 - eribulin ; Belongs to the class of other antineoplastic agents. Used in the treatment of cancer.

POM