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eribulin mesylate

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Overview

What is Halaven?

HALAVEN contains eribulin mesylate, a microtubule dynamics inhibitor. Eribulin mesylate is a synthetic analogue of halichondrin B, a product isolated from the marine sponge  . The chemical name for eribulin mesylate is 11,15:18,21:24,28-Triepoxy-7,9-ethano-12,15-methano-9,15-furo[3,2-]furo[2',3':5,6]pyrano[4,3-][1,4]dioxacyclopentacosin-5(4)-one, 2-[(2)-3-amino-2-hydroxypropyl]hexacosahydro-3-methoxy-26-methyl-20,27-bis(methylene)-, (2,3,3a,7,8a,9,10a,11,12,13a,13b,15,18,21,24,26,28,29a)-, methanesulfonate (salt). It has a molecular weight of 826.0 (729.9 for free base). The empirical formula is CHNO•CHOS. Eribulin mesylate has the following structural formula:

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 (5:95).



What does Halaven look like?



What are the available doses of Halaven?

Injection: 1 mg per 2 mL (0.5 mg per mL) ()

What should I talk to my health care provider before I take Halaven?

How should I use Halaven?

HALAVEN 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  .

The recommended dose of HALAVEN is 1.4 mg/m 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/m 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 moderate hepatic impairment (Child-Pugh B) is 0.7 mg/m 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 moderate or severe renal impairment (creatinine clearance (CLcr) 15-49 mL/min) is 1.1 mg/m administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle .


What interacts with Halaven?

Sorry No Records found


What are the warnings of Halaven?

Sorry No Records found


What are the precautions of Halaven?

Sorry No Records found


What are the side effects of Halaven?

Sorry No records found


What should I look out for while using Halaven?

None.


What might happen if I take too much Halaven?

Overdosage of HALAVEN has been reported at approximately 4 times the recommended dose, which resulted in Grade 3 neutropenia lasting seven days and a Grade 3 hypersensitivity reaction lasting one day.

There is no known antidote for HALAVEN overdose.


How should I store and handle Halaven?

Store at room temperature; avoid excessive heat. Protect from light. Keep bottle tightly closed.NDC 62856-389-01       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.NDC 62856-389-01       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.NDC 62856-389-01       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.


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Clinical Information

Chemical Structure

No Image found
Clinical 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 G/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.

Non-Clinical Toxicology
None.

The occurrence of stupor, muscular rigidity, severe agitation, and elevated temperature has been reported in some patients receiving the combination of selegiline and meperidine. Symptoms usually resolve over days when the combination is discontinued. This is typical of the interaction of meperidine and MAOIs. Other serious reactions (including severe agitation, hallucinations, and death) have been reported in patients receiving this combination (see ). Severe toxicity has also been reported in patients receiving the combination of tricyclic antidepressants and selegiline and selective serotonin reuptake inhibitors and selegiline. (See for details.) One case of hypertensive crisis has been reported in a patient taking the recommended doses of selegiline and a sympathomimetic medication (ephedrine).

In Study 1, severe neutropenia (ANC < 500/mm3) lasting more than one week occurred in 12% (62/503) of patients with metastatic breast cancer, leading to discontinuation in <1% of patients.  Febrile neutropenia (fever ≥38.5°C with Grade 3 or 4 neutropenia) occurred in 5% (23/503) of patients; two patients (0.4%) died from complications of febrile neutropenia 

In Study 1, patients with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 × ULN (upper limit of normal) experienced a higher incidence of Grade 4 neutropenia and febrile neutropenia than patients with normal aminotransferase levels. Patients with bilirubin > 1.5 × ULN also had a higher incidence of Grade 4 neutropenia and febrile neutropenia.

In Study 2, severe neutropenia (ANC < 500/mm3) lasting more than one week occurred in 12% (26/222) of patients with liposarcoma or leiomyosarcoma. Febrile neutropenia occurred in 0.9% of patients treated with HALAVEN and fatal neutropenic sepsis in 0.9% [see ].

Monitor complete blood counts prior to each dose; increase the frequency of monitoring in patients who develop Grade 3 or 4 cytopenias. Delay administration of HALAVEN and reduce subsequent doses in patients who experience febrile neutropenia or Grade 4 neutropenia lasting longer than 7 days . Clinical studies of HALAVEN did not include patients with baseline neutrophil counts below 1,500/mm.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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