For user convenience, the needle bevel up position is orientated to the lever arm, as shown in figure 3. The nccn compendium is a derivative work of the nccn guidelines. Epirubicin is intended for intravenous or intravesical administration only. Halaven eribulin prior auth criteria proprietary information. Carboplatin injection should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Eribulin mesylate for the treatment of patients with. The treatment of patients with metastatic nonsmall cell lung cancer nsclc whose tumors have epidermal growth factor receptor.
Refer to table 2 for management of neurologic toxicity. Halaven package insert guideline initial approval criteria coverage is provided in the following conditions. Search for clinical trials by condition, keyword or trial number. Full prescribing information 1 indications and usage yescarta is a cd19directed genetically modified autologous t cell immunotherapy indicated for the treatment of.
Withdraw the calculated dose for an individual patient into a sterile syringe. Neutropenic sepsis, including fatal cases, can occur. Please refer to the summary of product characteristics smpc before prescribing. It should be administered by an appropriately qualified healthcare professional only. Read all of this leaflet carefully before you start using this medicine. Appropriate management of therapy and complications is possible only. This finding challenges the notion that improved overall survival is an unrealistic expectation during evaluation of new anticancer therapies in the refractory setting. The most updated version and more symptom control information can be found. The recommended dose of halaven in patients with moderate renal impairment creatinine clearance of 3050 mlmin. Highlights of prescribing information halaven information. The protocol permitted the use of granulocyte colonystimulating factor gcsf. Halaven is indicated for the treatment of patients with metastatic breast cancer who have. Restricted access do not disseminate or copy without approval. Highlights of prescribing information patients at risk.
Apr 21, 2018 halaven eribulin mesylate injection is a nontaxane microtubule dynamics inhibitor. 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. Eribulin mesylate is a synthetic analogue of halichondrin b, a product isolated from the marine sponge halichondria okadai. Embryofetal toxicity and teratogenicity occurred in rats that received eribulin mesylate at approximately half of the recommended human dose based on body surface area. Labeling package insert, labelingcontainercarton labels. Intermittent courses of carboplatin injection in combination with cyclophosphamide should not be repeated until the neutrophil count is at least 2,000 and the platelet count is at least 100,000. Study design extended analysis of randomized, doubleblind, phase. Description dacarbazine for injection is a colorless to an ivory colored solid which is light sensitive. Cytotoxic agent epirubicin should be administered only under the supervision of qualified physicians experienced in cytotoxic therapy.
Halaven eribulin mesylate halaven fep clinical rationale rationale for inclusion in pa program background halaven is a prescription medicine used to treat patients with metastatic breast cancer, who have already received at least 2 other types of anticancer medicines for their breast cancer once it has spread to other parts of the body. Each vial contains 200 mg of dacarbazine the active ingredient, citric acid monohydrate and mannitol. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are. Inspect the solution in syringe for particulate matter and discoloration prior to administration or further dilution. Although some women lived longer and some women did not live as long, women who were treated with halaven lived, on average, 25% longer. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting.
Jan 07, 2019 halaven 1 mg2 ml solution for injection. Dec, 2019 imlygic is a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after. Highlights of prescribing information patients at risk of. Eribulin, sold under the brand name halaven, is an anticancer medication used to treat breast cancer and liposarcoma the most common side effects include fatigue, nausea, hair loss alopecia, constipation, certain nerve damage causing weakness or numbness in the hands and feet peripheral neuropathy, abdominal pain and fever pyrexia. Learn about ixempra ixabepilone, including safety and boxed warning, side effects, benefits and risks, and dosing information. Administer injection following package instruction. Eribulin, sold under the brand name halaven, is an anticancer medication used to treat breast cancer and liposarcoma. For directions regarding the use and administration of cyclophosphamide, please refer to its package insert see clinical studies. Eribulin mesylate is a synthetic analogue of halichondrin b, a product isolated from the marine sponge, halichondria okadai. Please see important safety information on pages 12 and and accompanying full prescribing information.
Feb 04, 2021 eribulin inhibits the growth phase of microtubules without affecting the shortening phase and sequesters tubulin into nonproductive aggregates. Page 3 of 44 full prescribing information 1 indications and usage 1. Eribulin was approved by united states food and drug administration in. Eribulin showed a significant and clinically meaningful improvement in overall survival compared with tpc in women with heavily pretreated metastatic breast cancer. Highlights of prescribing information administer at. The recommended dose of halaven in patients with moderate hepatic impairment childpugh b is 0. The recommended dose of eribulin as the ready to use solution is 1. It is best to read this information with our general information about chemotherapy and the type of cancer you have your doctor will talk to you about this treatment and its possible side effects before you agree to have treatment. Learn about yondelis trabectedin, given every 3 weeks through iv infusion. The indications below including fdaapproved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.
Halaven should only be prescribed by a qualified physician experienced in the appropriate use of anticancer therapy. Specific package insert requirement for epirubicin caution. In a clinical study of more than 750 women, halaven was compared with other chemotherapies or hormone therapies commonly used to treat metastatic breast cancer mbc. Eribulin monotherapy versus treatment of physicians choice. Immediately activate needle protection device upon withdrawal from patient by pushing lever arm completely forward until needle tip. Share your location or enter your city or zip code to find studies near you. What halaven is and what it is used for halaven contains the active substance eribulin and is an anticancer medicine which works by. Apexbio eribulin mesylate javascript seems to be disabled in your browser. Dose modifications for patients on halaven eribulin.
You are encouraged to report negative side effects of prescription drugs to the fda. Halaven is indicated for the treatment of adult patients with locally. Eribulin mesylate e7389 mesylate, a synthetic analogue of halichondrin b in phase iii clinical trials for breast cancer, binds to tubulin and microtubules. Eribulin inhibits the formation of mitotic spindles and blocks cell cycle. Highlights of prescribing information these highlights do not include all the information needed to use gleevec safely and effectively.
Mar 25, 2012 eribulin is a novel microtubule inhibitor approved for use in metastatic breast cancer after at least two other chemotherapeutic regimens in the metastatic setting. Advair diskus fluticasone propionate and salmeterol. Highlights of prescribing information these highlights do not. Eribulin exerts its effects via a tubulinbased antimitotic mechanism leading to g 2 m cellcycle block, disruption of mitotic spindles, and, ultimately, apoptotic cell death after prolonged mitotic. The printed package leaflet of the medicinal product must state the name and address of the. This leaflet was prepared by eisai limited, mississauga, on. Eribulin inhibits the growth phase of microtubules without affecting the shortening phase and sequesters tubulin into nonproductive aggregates. Gently swirl the vial for at least 15 seconds to dissolve the lyophilized powder. Insert the syringe needle into the vial through the center of the stopper and direct the stream of sterile water for injection to the glass wall of the vial to avoid excessive foaming. Immediately activate needle protection device upon withdrawal from patient by pushing lever arm completely forward until needle tip is fully covered figure 2. The printed package leaflet of the medicinal product must state the name and addres. Halaven eribulin mesylate injection, for intravenous use. In trial et743sar3007, the incidence of grade 3 or 4 neutropenia, based on laboratory values, was 43% 1678. Halaven contains eribulin mesylate, a microtubule dynamics inhibitor.
And breast cancer used as subsequent therapy in metastatic disease for patients who have previously received therapy with an anthracycline and a taxane. Results of the updated analysis were consistent with the primary analysis, which was conducted when 50% of events deaths had been observed. Highlights of prescribing information these highlights do not include all the information needed to use balversa safely and effectively. For more information about halaven, please see full prescribing information. Patients were randomized to receive either eribulin 1. Discard syringe if the solution is discolored or contains particulate matter. Halaven is a clear, colorless, sterile solution for intravenous administration.
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