Halaven package insert guideline initial approval criteria coverage is provided in the following conditions. Cytotoxic agent epirubicin should be administered only under the supervision of qualified physicians experienced in cytotoxic therapy. Eribulin may inhibit the important drug metabolising enzyme cyp3a4. The effective maintenance dose for continuous and stepwise dosing is 50 to 200 mcg per kg per minute, although doses as low as 25 mcg per kg per minute have been adequate. Halaven is a prescription medicine used to treat adults with breast cancer that has spread to other parts of the body, and who have already received other types of anticancer medicines after the cancer has spread. Eribulin mesylate in the treatment of metastatic breast cancer. Refractory testicular tumors, in combination with other chemotherapeutic drugs. Halaven monotherapy is indicated for the treatment of patients with locally advanced or metastatic. Halaven contains the active substance eribulin and is an anticancer medicine which works by stopping the growth and spread of cancer cells. Halaven is a microtubule inhibitor, therefore, it is expected to cause fetal harm when administered to pregnant women. Each vial contains 1 mg of eribulin mesylate as a 0.
Halaven eribulin mesylate injection is a nontaxane microtubule dynamics inhibitor. Each 20 ml vial contains 200 mg of dacarbazine, usp active ingredient. Dailymed dacarbazine injection, powder, for solution. This leaflet was prepared by eisai limited, mississauga, on. Halaven eribulin mesylate, e7389 is a novel anticancer agent discovered and developed by eisai, which was approved by the united states food and drug administration fda for the treatment of. Eribulin is an anticancer drug marketed by eisai co. Halaven eribulin mesylate injection, for intravenous use. Halaven eribulin mesylate for treatment of mbc halaven. Halaven is also used to treat adults with advanced or metastatic liposarcoma a type of cancer of the soft tissues that develops from fat cells that cannot be surgically removed. Embryofetal toxicity and teratogenicity occurred in pregnant rats that received eribulin. Halaven is indicated for the treatment of patients with metastatic.
Halaven eribulin mesylate injection highlights of prescribing information ll the information needed to use halaven safely and effectively. Halaven is indicated for the treatment of patients with metastatic breast cancer who have. Please refer to the full prescribing information for the aromatase inhibitor being used. The recommended dose of halaven in patients with moderate hepatic impairment childpugh b is 0. Specific package insert requirement for epirubicin caution. Interrupt empliciti elotuzumab for grade 2 or higher and permanently discontinue for severe infusion reaction. Drug information uptodate kuwait cancer control center. Yescarta is a cd19directed genetically modified autologous t cell immunotherapy indicated for the treatment of. Pharmacokinetics of eribulin mesylate in cancer patients.
The recommended dose of eribulin as the ready to use solution is 1. Specialty guideline management halaven eribulin mesylate policy. Eribulin mesylate is a synthetic analogue of halichondrin b, a product isolated from the marine sponge halichondria okadai. Halaven eribulin mesylate injection is indicated for the treatment of patients with metastatic breast cancer mbc who have previously received at least 2 chemotherapeutic regimens for the treatment of metastatic disease. Etopophos is a topoisomerase inhibitor indicated for the treatmentof patients with.
Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting. Highlights of prescribing information these highlights do not include all the information needed to use talzenna safely and effectively. Eribulin is eliminated primarily in feces unchanged. Halaven is a prescription medicine used to treat adults with breast cancer that has spread to other parts of the body, and who have already received. Pdf eribulin is an anticancer drug approved for treatment of metastatic breast cancer.
Eribulin is also known as e7389 and er086526, and also carries the us nci designation nsc707389. Research and development of halaveneribulin mesylate. When given with ibrance, the recommended dose of fulvestrant is 500 mg administered on days 1, 15, 29, and once. Highlights of prescribing information these highlights do not include all the information needed to use gleevec safely and effectively.
Halaven eribulin is a cancer medicine that interferes with the growth and spread of cancer cells in the body. Dacarbazine for injection usp is a white to an ivory colored solid which is light sensitive. And breast cancer used as subsequent therapy in metastatic. Faslodex 500 mg is administered as the same dose whether it is used as monotherapy or in combination with ribociclib, palbociclib, or abemaciclib 1. In vitro data suggest that eribulin at clinically relevant concentrations is a substrate of pgp, but is not a substrate of breast cancer resistance protein bcrp, multidrug resistance proteins mrp2, mrp4, bile salt extrusion pump bsep, organic anion transporting polypeptides oatp1b1, oatp1b3, organic anion transporters oat1, oat3, organic cation transporters oct1, oct2, or multidrug and toxin extrusion 1 mate1. After administration of 14 ceribulin to patients, approximately 82% of the dose was eliminated in feces and 9% in urine. Unchanged eribulin accounted for approximately 88% and 91% of total eribulin. Eribulin is a novel microtubule inhibitor approved for use in metastatic breast cancer after at least two other chemotherapeutic regimens in the metastatic setting. Moderate and strong cyp3a4 inducers, including enzymeinducing aeds such asphenytoin. The recommended dose of halaven in patients with moderate renal impairment creatinine clearance of 3050 mlmin. Eribulin inhibits cancer cell proliferation by binding tubulin and destabilizing microtubule dynamics. The original sample size calculation for the study, to detect a 28 % difference in neuropathy with a power of 80 %, was based on historical estimates on the incidence of neuropathy with the two treatments incidence rates of ctcae neuropathy events for eribulin 35 % as per a previous phase ii study, and the package insert. Consequently, the us eribulin package insert recommends that the eribulin mesylate dose be reduced from 1. Ixempra, a microtubule inhibitor, in combination with capecitabine is indicated for the treatment of metastatic or locally advanced breast cancer in patients after failure of an anthracycline and a taxane.
Moderate and strong cyp3a4 inducers, including enzymeinducing aeds such asphenytoin, carbamazepine, and. Resources for mbc patients halaven eribulin mesylate hcp. Embryofetal toxicity and teratogenicity occurred in rats that received eribulin mesylate. Halaven should only be administered under the supervision of a qualified physician experienced in the appropriate use of cytotoxic medicinal products. Halaven is used to treat breast cancer that has spread to other parts of the body halaven. Read all of this leaflet carefully before you start using this medicine. Eribulin mesylate versus ixabepilone in patients with. This drug is a synthetic derivative from japanese marine sponge.
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