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HALAVEN ™ (eribulin mesylate) injection

Please see package insert for additional information and possible updates. The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this program shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material. PLEASE READ THE DISCLAIMER CAREFULLY BEFORE ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER.    [  Read the disclaimer    |   <<Back    |    New drug index   ]

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DESCRIPTION CLINICAL PHARMACOLOGY
INDICATIONS AND USAGE CONTRAINDICATIONS
PRECAUTIONS ADVERSE REACTIONS
DOSAGE AND ADMINISTRATION HOW SUPPLIED
Drug UPDATES:  HALAVEN ™ (eribulin mesylate)
[Drug information  /  PDF]  
Dosing:  Click (+) next to Dosage and Administration section (drug info link)
ABBREVIATED MONOGRAPH - SEE PACKAGE INSERT.

(DESCRIPTION) top of page

Initial U.S. Approval: 2010
DESCRIPTION
HALAVEN (eribulin mesylate) Injection is a non-taxane microtubule dynamics inhibitor. Eribulin mesylate is a synthetic analogue of halichondrin B, a product isolated from the marine sponge Halichondria okadai.
HALAVEN is a clear, colorless, sterile solution for intravenous administration. Each vial contains 1 mg of eribulin mesylate as a 0.5 mg/mL solution in ethanol: water.

CLINICAL PHARMACOLOGY: top of page

CLINICAL PHARMACOLOGY
Mechanism of Action
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.

INDICATIONS AND USAGE  top of page

INDICATIONS AND USAGE
HALAVEN is a microtubule inhibitor 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

CONTRAINDICATIONS top of page

None.

PRECAUTIONS top of page

WARNINGS AND PRECAUTIONS
Neutropenia: Monitor peripheral blood cell counts and adjust dose as appropriate.
Peripheral Neuropathy: Monitor for signs of neuropathy. Manage with dose delay and adjustment.
Use in Pregnancy: Fetal harm can occur when administered to a pregnant woman.
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.


USE IN SPECIFIC POPULATIONS
Nursing Mothers: Discontinue drug or nursing, taking into consideration the importance of the drug to the mother.

Hepatic Impairment: A lower starting dose is recommended for patients with mild (Child-Pugh A) and moderate (Child-Pugh B) hepatic impairment. Patients with severe hepatic impairment (Child-Pugh C) were not studied.
 
Renal Impairment: A lower starting dose is recommended for patients with moderate (CrCl 30-50 mL/min) renal impairment. Patients with severe (CrCl < 30 mL/min) renal impairment were not studied.

ADVERSE REACTIONS top of page

The most common adverse reactions (incidence geq25%) were neutropenia, anemia, asthenia/fatigue, alopecia, peripheral neuropathy, nausea, and constipation

DOSAGE AND ADMINISTRATION  top of page

DOSAGE AND ADMINISTRATION
Administer 1.4 mg/m2 intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.
Reduce dose in patients with hepatic impairment and moderate renal impairment.
Do not mix with other drugs or administer with dextrose-containing solutions.
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Recommended Dose
The recommended dose of HALAVEN 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 HALAVEN 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. [see Use in Specific Populations]

The recommended dose of HALAVEN 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. [see Use in Specific Populations]

The recommended dose of HALAVEN in patients with moderate renal impairment (creatinine clearance of 30-50 mL/min) is 1.1 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle. [see Use in Specific Populations]


Dose Modification
Assess for peripheral neuropathy and obtain complete blood cell counts prior to each dose. [see PACKAGE INSERT FOR ADDITIONAL GUIDANCE ]

HOW SUPPLIED top of page

NDC 62856-389-01 Eribulin mesylate injection, 1 mg/2 mL, in a single-use vial. One vial per carton.

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). Do not freeze. Store the vials in their original cartons.


REFERENCE

Package Insert data: 

Manufactured by:
NerPharMa
Viale Pasteur, 10
20014, Nerviano
Italy

Distributed by:
Eisai Inc.
100 Tice Blvd. Woodcliff Lake, NJ 07677
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