Halaven 0.44 mg/ml

Halaven 0.44 mg/ml | INDICATIONS AND USES

Metastatic Breast Cancer: Eribulin is indicated for the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in ... Read moreMetastatic Breast Cancer: Eribulin is indicated for the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting.Liposarcoma: Eribulin is indicated for the treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen.

Halaven 0.44 mg/ml | PHARMACOLOGY

Eribulin inhibits the growth phase of microtubules without affecting the shortening phase and sequesters tubulin into nonproductive aggregates. Eribulin exerts its effects via a tubulin-based antimitotic mechanism leading to G2/M cell-cycle block, disruption of mitotic spindles, and, ultimately, apoptotic cell death after prolonged mitotic blockage. In addition, eribulin treatment of human breast cancer cells caused changes in morphology and gene expression as well as decreased migration and invasiveness in vitro. In mouse xenograft models of human breast cancer, eribulin treatment was associated with increased vascular perfusion and permeability in the tumor cores, resulting in reduced tumor hypoxia, and changes in the expression of genes in tumor specimens associated with a change in phenotype.

Halaven 0.44 mg/ml | DOSAGE & ADMINISTRATION

The recommended dose of Eribulin is 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.The recommended dose of Eribulin in patients with mild hepatic impairment (Child-Pugh A) is 1.1 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.The recommended dose of Eribulin in patients with moderate hepatic impairment (Child-Pugh B) is 0.7 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.The recommended dose of Eribulin in patients with moderate or severe renal impairment (creatinine clearance (CLcr) 15-49 mL/min) is 1.1 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.Pediatric Use: The safety and effectiveness of HALAVEN in pediatric patients have not been established.

Halaven 0.44 mg/ml | DRUG INTERACTIONS

Effects of Other Drugs on Eribulin: No drug-drug interactions are expected with CYP3A4 inhibitors, CYP3A4 inducers or P-glycoprotein (P-gp) inhibitors. Clinically meaningful differences in exposure (AUC) were not observed in patients with advanced solid tumors when Eribulin was administered with or without ketoconazole (a strong inhibitor of CYP3A4 and a P-gp inhibitor) and when Eribulin was administered with or without rifampin (a CYP3A4 inducer).Effects of Eribulin on Other Drugs: Eribulin does not inhibit CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP2E1 or CYP3A4 enzymes or induce CYP1A2, CYP2C9, CYP2C19 or CYP3A4 enzymes at relevant clinical concentrations. Eribulin is not expected to alter the plasma concentrations of drugs that are substrates of these enzymes.

Halaven 0.44 mg/ml | SIDE EFFECTS

The most common adverse reactions (≥25%) in metastatic breast cancer were neutropenia, anemia, asthenia/fatigue, alopecia, peripheral neuropathy, nausea, and constipation.The most common adverse reactions (≥25%) in liposarcoma and leiomyosarcoma were fatigue, nausea, alopecia, constipation, peripheral neuropathy, abdominal pain, and pyrexia. The most common (≥5%) Grade 3-4 laboratory abnormalities in liposarcoma and leiomyosarcoma were neutropenia, hypokalemia, and hypocalcemia.

Halaven 0.44 mg/ml | USE DURING PREGNANCY AND LACTATION

Based on findings from an animal reproduction study and its mechanism of action, Eribulin can cause fetal harm when administered to a pregnant woman. There are no available data on the use of Eribulin during pregnancy. There is no information regarding the presence of eribulin mesylate or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. No lactation studies in animals were conducted.

Halaven 0.44 mg/ml | PRECAUTIONS & WARNINGS

Neutropenia: Monitor peripheral blood cell counts and adjust dose as appropriate.Peripheral Neuropathy: Monitor for signs of neuropathy. Manage with dose delay and adjustment.Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception.QT Prolongation: Monitor for prolonged QT intervals in patients with congestive heart failure, bradyarrhythmias, drugs known to prolong the QT interval, and electrolyte abnormalities. Avoid in patients with congenital long QT syndrome.

Halaven 0.44 mg/ml | THERAPEUTIC CLASS

Cytotoxic Chemotherapy

Halaven 0.44 mg/ml | STORAGE CONDITIONS

Store at 25°C; excursions permitted to 15° to 30°C. Do not freeze or refrigerate. Store the vials in their original cartons.