Sign Out
Haematology: Myelosuppression is dose dependent and primarily manifested as neutropenia (see Adverse Reactions).
Monitoring of complete blood counts should be performed on all patients prior to each dose of HALAVEN. Treatment with HALAVEN should only be initiated in patients with ANC values ≥ 1.5 x 109/l and platelets > 100 x 109/l.
Febrile neutropenia occurred in < 5% of patients treated with HALAVEN. Patients experiencing febrile neutropenia, severe neutropenia or thrombocytopenia, should be treated according to the recommendations in Dosage & Administration.
Patients with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 x upper limit of normal (ULN) experienced a higher incidence of Grade 4 neutropenia and febrile neutropenia.
Although data are limited, patients with bilirubin >1.5 x ULN also have a higher incidence of Grade 4 neutropenia and febrile neutropenia.
Fatal cases of febrile neutropenia, neutropenic sepsis, sepsis and septic shock have been reported.
Severe neutropenia may be managed by the use of granulocyte colony-stimulating factor (G-CSF) or equivalent at the physician's discretion in accordance with relevant guidelines (see Pharmacology: Pharmacodynamics under Actions).
Peripheral neuropathy: Peripheral neuropathy commonly occurs and is usually of mild to moderate severity. Monitor patients closely for signs of peripheral motor and sensory neuropathy, such as burning sensation, hyperesthesia, hypoesthesia, paraesthesia, discomfort or neuropathic pain. Peripheral neuropathy should be treated according to the recommendations in Dosage & Administration.
In clinical trials, patients with pre-existing neuropathy greater than Grade 2 were excluded. However, patients with pre-existing neuropathy Grade 1 or 2 were no more likely to develop new or worsening symptoms than those who entered the study without the condition.
QT Prolongation: In an uncontrolled open-label ECG study in 26 patients, QT prolongation was observed on Day 8, independent of eribulin concentration, with no QT prolongation observed on Day 1. ECG monitoring is recommended if therapy is initiated in patients with congestive heart failure, bradyarrhythmias, drugs known to prolong the QT interval, including Class Ia and III antiarrhythmics, and electrolyte abnormalities. Correct hypokalaemia, hypocalcaemia or hypomagnesaemia prior to initiating HALAVEN and monitor these electrolytes periodically during therapy. Avoid HALAVEN in patients with congenital long QT syndrome.
Effects on ability to drive and use machines: No studies on the effects on the ability to drive and use machines have been performed.
HALAVEN may cause side effects such as tiredness and dizziness which may lead to a minor or moderate influence on the ability to drive or use machines. Patients should be advised not to drive and use machinery if they feel tired or dizzy.
