Kadcyla package insert, 220 revision nccn guidelines on breast cancer v 2. Each carton contains one multipledose vial of herceptin and. The incidence and severity was highest in patients receiving trastuzumab with anthracyclinecontaining chemotherapy regimens. Herceptin trastuzumab is contraindicated in patients with known hypersensitivity to trastuzumab, chinese hamster ovary cho cell proteins, or any component of this product. Dosing and administration guide this guide provides dosing and administration guidelines for herceptin hylecta trastuzumab and hyaluronidaseoysk. Information for the user herceptin 150 mg powder for concentrate for solution for infusion trastuzumab read all of this leaflet carefully before you start using this medicine. Herceptin is a monoclonal antibody that binds to the extracellular portion of the her2 gene, preventing dimerization and the. Schematic illustration showing the proposed mechanism of trastuzumab. Kadcyla, inntrastuzumab emtansine european medicines agency. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for herceptin trastuzumab. Reconstitute each 420 mg vial of herceptin with 20 ml of bacteriostatic water for injection bwfi, usp, containing 1. Nerlynx as a single agent is indicated for the extended adjuvant treatment of adult patients with earlystage human epidermal growth factor receptor 2 her2positive breast cancer, to follow adjuvant trastuzumab based. The nccn compendium is a derivative work of the nccn guidelines. Dailymed herceptin trastuzumab kit herceptin trastuzumab.
Jan 09, 2020 fam trastuzumab deruxtecannxki is a her2directed antibody and topoisomerase inhibitor conjugate. Highlights of prescribing information initial dose of. Sep 01, 2019 herceptin trastuzumab for injection 420 mgvial is supplied in a multipledose vial as a lyophilized sterile powder, under vacuum. Initial dose of 4 mgkg over 90 minute iv infusion, then 2 mgkg over.
A phase ii trial of neoadjuvant trastuzumab and pertuzumab in her2positive breast cancer and an international phase iii randomized, doubleblind, placebocontrolled trial of trastuzumab. Do not substitute herceptin trastuzumab for or with adotrastuzumab emtansine. Pfizer provides update on proposed trastuzumab biosimilar. Safety for more detailed information refer to the product package insert comments boxed warning. On april 17, 20, the institute for safe medication practices ismp and the american society of healthsystem pharmacists ashp activated the national alert network nan to warn practitioners of the.
Oct 17, 2014 the trastuzumab package insert recommends withholding trastuzumab for at least 4 weeks in either of the following situations. The early approved drug trastuzumab herceptin, roche has shown adequate activity against her2 receptors and was then used to develop trastuzumab emtansine that linked to a derivative of. Grapefruit may also increase plasma concentrations of lapatinib and should be avoided. Trastuzumab may persist in the circulation for up to 7 mont hs after stopping herceptin treatment based on population pharmacokinetic analysis of all available data see section 5. Herceptin trastuzumab for injection 420 mgvial is supplied in a multipledose vial as a lyophilized sterile powder, under vacuum. Herceptin is also available as a powder for concentrate solution, for intravenous infusion containing. Weve made enrollment simpler, faster and more intuitive with some key changes to our forms. Famtrastuzumab deruxtecannxki is an antibodydrug conjugate adc composed. Policy document for kadcyla ado trastuzumab emtansine the overall objective of this policy is to support the appropriate and cost effective use of the medication. If patients must be coadministered, a strong cyp3a4 inhibitor, based on pharmacokinetic studies, a dose reduction to 500 mgday of lapatinib is predicted to adjust the lapatinib auc to the range. Please see additional important safety information throughout, and on pages 1215, and. Fda approves fifth biosimilar of herceptin big molecule. Herceptin sc vial contains 600mg5ml of trastuzumab. The printed package leaflet of the medicinal product must state the name and.
Herceptin can result in subclinical and clinical cardiac. Policy document for kadcyla adotrastuzumab emtansine. Phase ii trial of pertuzumab and trastuzumab in patients with. Trastuzumab 600 mg5 ml solution for subcutaneous injection. Do not substitute herceptin trastuzumab for or with ado trastuzumab emtansine. Fam trastuzumab deruxtecannxki is an antibodydrug conjugate adc composed of three components. Herceptin trastuzumab is a recombinant dnaderived humanized monoclonal antibody that selectively binds with high affinity in a cellbased assay kd 5 nm to the extracellular domain of the human epidermal growth factor receptor 2 protein, her2. The trastuzumab package insert recommends withholding trastuzumab for at least 4 weeks in either of the following situations. Safeher phase iii studys primary analysis of 2573 patients. Closely monitor the infusion site for possible subcutaneous infiltration during drug administration see warnings and precautions 5.
Policy document for herceptin trastuzumab the overall objective of this policy is to support the appropriate and cost effective use of the medication. More than 9 years of continuous trastuzumab treatment in. Trastuzumab is composed of 1,328 amino acids and has a molecular weight of 148 kda. Dailymed enhertu famtrastuzumab deruxtecannxki injection. Vectibix solution is colorless and may contain a small amount of visible translucenttowhite, amorphous, proteinaceous particles. Highlights of prescribing information the recommended. The prescriber service form and the patient consent form are required for enrollment in genentech access solutions. Herceptin hylecta full prescribing information genentech. Efficacy and safety of subcutaneous trastuzumab and.
It also induces apoptosis through antibodydependent cellular cytotoxicity. Restricted access do not disseminate or copy without approval. Herceptin hylecta trastuzumab and hyaluronidaseoysk prior auth criteria proprietary information. Famtrastuzumab deruxtecannxki is a her2directed antibody and topoisomerase inhibitor conjugate. See full prescribing information for complete boxed warning. Clinical criteria policy information specific to the clinical appropriateness for the medication. Highlights of prescribing information these highlights do not include all the information needed to use kisqalisafely and effectively. Cardiomyopathy, infusion reactions, embryofetal toxicity, and pulmonary toxicity. Biomarkers, particularly troponin i, and echo parameters such as strain imaging have been studied in an effort to predict trastuzumab cardiotoxicity. The first dose of trastuzumab 6 mgkg was begun 7 days after day 15 of cycle four.
Trastuzumab products administration can result in subclinical and clinical cardiac failure. Herceptin hylecta trastuzumab and hyaluronidaseoysk. According to its approved package insert, kanjinti. Pfizer today announced that it received a complete response letter crl from the united states food and drug administration fda in response to the biologics license application for the companys proposed trastuzumab biosimilar. When using in combination with perjeta pertuzumab and docetaxel, consult product monographs for perjeta and docetaxel for further information on these drugs.
Herceptin trastuzumab is indicated for the treatment of patients. Do not substitute enhertu for or with trastuzumab or ado trastuzumab emtansine. See full prescribing information for herceptin hylecta. Herceptin, inntrastuzumab european medicines agency europa. Herceptin trastuzumab is a recombinant dnaderived humanized monoclonal antibody that selectively binds with high affinity in a cellbased assay kd 5 nm to the extracellular.
Herceptin hylecta trastuzumab and hyaluronidaseoysk injection, for subcutaneous use. Food and drug administration fda has approved trazimera trastuzumabqyyp, a biosimilar to herceptin trastuzumab,1 for the treatment of human epidermal growth factor receptor2 her2 overexpressing breast cancer and her2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. Trastuzumab is a humanized igg1 kappa monoclonal antibody that selectively binds with high affinity to the extracellular domain of the human epidermal growth factor receptor 2 protein. Received prior therapy for metastatic disease, or developed. One vial contains 150 mg of trastuzumab, a humanised igg1 monoclonal antibody. Trastuzumab herceptin american journal of neuroradiology. If patients must be coadministered, a strong cyp3a4 inhibitor, based on. Do not substitute enhertu for or with trastuzumab or adotrastuzumab emtansine. Highlights of prescribing information these highlights do not. Information for the user herceptin 150 mg powder for concentrate for solution for infusion trastuzumab read all of this leaflet carefully before you start using this medicine because it contains important information for you. Table shows fda guidelines for monitoring for cardiotoxicity with her2targeted therapies. Herceptin is a monoclonal antibody that binds to the extracellular portion of the her2 gene, preventing dimerization and the cascade that leads to the expression of growth factors.
The humanized antibody against her2 is produced by recombinant mammalian cells chinese hamster. Patients who receive anthracyclines after stopping herceptin may possibly be at increased risk of cardiac dysfunction. Phase ii trial of pertuzumab and trastuzumab in patients. Kadcyla is a prescription medicine used as an adjuvant after surgery treatment for her2positive early breast cancer when the patient has taken neoadjuvant before surgery treatment including a taxane and trastuzumab herceptin and there is cancer remaining in the tissue removed during surgery. Received prior therapy for metastatic disease, or developed disease recurrence during or within six months of completing adjuvant therapy. Herceptin fda prescribing information, side effects and uses. The pharmacokinetics of trastuzumab have been studied in patients with breast cancer metastatic and localised and advanced gastric cancer. Each carton contains one multipledose vial of herceptin and one vial 20 ml of bacteriostatic water for injection bwfi, usp, containing 1. You have early breast cancer, with high levels of a protein called her2. This document provides specific information to each section of the overall policy. Herceptin trastuzumab treatment information for her2. Infusion reactions are a common side effect most of which are mild and easily managed, anaphylaxis.
Sep 30, 2019 trastuzumab is a humanized igg1 kappa monoclonal antibody that selectively binds with high affinity to the extracellular domain of the human epidermal growth factor receptor 2 protein, her2. Highlights of prescribing information the recommended dosage. Find information about herceptin, a treatment for early and metastatic breast cancer and stomachgej cancer. Highlights of prescribing information initial dose of 4.
Evaluate left ventricular function in all patients prior to and during treatment with. Fda approves pfizers oncology biosimilar trazimera. Trastuzumab is produced by recombinant dna technology in a mammalian cell chinese hamster ovary culture which may contain the antibiotic gentamicin. This product information was approved at the time this. The prescriber service form and the patient consent form are required for enrollment in.
Trastuzumab herceptin is used in neoadjuvant, adjuvant and metastatic breast cancer. Patients should be observed during the infusion and for at least 90 minutes following the initial dose for fever, chills, or other infusion. Highlights of prescribing information these highlights do not include all the information needed to use empliciti safely and effectively. Her2, indicating that the humanized antibody trastuzumab is likely also to have antiproliferative activity. Medical necessity criteria page 418 j9355 injection, trastuzumab, excludes biosimilar, 10 mg. Preparation visually inspect parenteral drug products for particulate matter and discoloration prior to administration. Nerlynx is a kinase inhibitor indicated for the extended adjuvant treatment of adult patients with earlystage her2overexpressedamplified breast cancer, to follow adjuvant trastuzumab based therapy. Adjuvant docetaxel and cyclophosphamide plus trastuzumab. Use of white blood cell growth factors eg, pegfilgrastim or filgrastim was permitted. Highlights of prescribing information adjuvant treatment.
Trastuzumab monograph december 2014 updated version may be found at. For healthcare professionals nerlynx neratinib tablets. Pfizer today announced that it received a complete response letter crl from the united states food and drug administration fda in response to the biologics license application for the companys. Highlights of prescribing information initial dose of 4 mg.
Herceptin trastuzumab is a human monoclonal antibody that interferes with the her2 receptor. Nerlynx as a single agent is indicated for the extended adjuvant. Your doctor may prescribe herceptin for the treatment of breast and gastric cancer when. Fda approved amgens abla for kanjinti trastuzumabanns, a biosimilar of genentechs herceptin. Nerlynx is a kinase inhibitor indicated for the extended adjuvant treatment of adult patients with earlystage her2overexpressedamplified breast cancer, to follow adjuvant trastuzumabbased therapy. Vectibix is not indicated for the treatment of patients with colorectal cancer that harbor somatic ras mutations in exon 2 codons 12 and, exon 3 codons 59 and 61, and exon 4 codons 117 and 146. Kadcyla is a prescription medicine used as an adjuvant after surgery treatment for her2positive early breast cancer when the patient has taken neoadjuvant before surgery treatment including a taxane. Do not administer vectibix as an intravenous push or bolus.
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