This is approved for the treatment of metastatic breast cancer for patients who have previously received trastuzumab and chemotherapy with either paclitaxel. Trastuzumab emtansine, adotrastuzumab emtansine, abbreviated as tdm1. The antibody is the humanized antiher2 igg1, trastuzumab. Longtime response with adotrastuzumab emtansine in a. Use as adjuvant treatment of her2positive disease in patients with locally advanced or early breast. Drug name active ingredients strength dosage formroute marketing status te code rld rs. This treatment subprotocol was designed to screen for potential signals of efficacy of adotrastuzumab emtansine. Kadcyla adotrastuzumab emtansine injection, powder, lyophilized, for solution genentech, inc. Kadcyla ado trastuzumab emtansine for injection, for intravenous use. Use caution with these agents and consider recent major changes indications and usage 1. Trastuzumab emtansine also known as adotrastuzumab emtansine and sold under the trade name kadcyla, is an antibodydrug conjugate consisting of the humanized monoclonal antibody trastuzumab.
International nonproprietary name inn, generic name of the medicine. Get emergency medical help if you have signs of an allergic reaction. Tell your doctor about the allergy and what signs you had. Kadcyla, as a single agent, is indicated for the treatment of patients with her2positive, metastatic breast cancer who previously received trastuzumab and a. Pdf indepth structural characterization of kadcyla. Kadcyla, as a single agent, is indicated for the adjuvant treatment of adult patients with her2positive early breast cancer who have residual invasive disease. Ado trastuzumab emtansine may also be called trastuzumab emtansine. The small molecule cytotoxin, dm1, is a microtubule inhibitor. Highlights of prescribing information these highlights do not include all the information. Other considerations her2 testing is essential to determine if patients are appropriate for adotrastuzumab emtansine therapy. In addition, in vitro studies have shown that similar to trastuzumab, adotrastuzumab emtansine inhibits her2 receptor signaling, mediates antibodydependent cellmediated cytotoxicity and inhibits. Fda approval of adotrastuzumab emtansine in mbc was supported by data from. Restricted access do not disseminate or copy without approval. Definition from the nci drug dictionary detailed scientific definition and other names for this drug.
Kadcyla adotrastuzumab emtansine injection for iv use. Kadcyla ado trastuzumab emtansine prior auth criteria proprietary information. Trastuzumab emtansine tdm1 is an antibodydrug conjugate made up of trastuzumab, stably linked to a highly potent chemotherapy dm1 derived from maytansine figure 1. Kadcyla ado trastuzumab emtansine for injection, for intravenous use initial u. Adotrastuzumab emtansine tdm1 is a her2antibody drug conjugate currently approved for the treatment of her2positive pretreated. Medlineplus information on ado trastuzumab emtansine a lay language summary of important information about this drug that may include the following. Adotrastuzumab emtansineinduced pulmonary toxicity. Adotrastuzumab emtansine fails phase iiiii gatsby trial. Mild to moderate exercise may also help you maintain your energy. Adotrastuzumab emtansine intravenous route before using. Adotrastuzumab emtansine page 2 of 3 developed by danafarber cancer institute last revised 042016 patient and family education committee 5. Trastuzumab emtansine for residual invasive her2positive breast cancer. Kadcyla, inntrastuzumab emtansine european medicines agency. Pdf indepth structural characterization of kadcyla ado.
Do not confuse adotrastuzumab emtansine kadcyla with trastuzumab herceptin. Pregnancy should be avoided by females taking adotrastuzumab. Adotrastuzumab emtansine is also used after surgery for a certain type of breast cancer in women who have had treatment with other chemotherapy medications before surgery, but there was still cancer. Adotrastuzumab emtansine consists of trastuzumab, the. For medicaid billing and nchc the icd9cm diagnosis code required for billing ado trastuzumab emtansine. Trastuzumab herceptin, ado trastuzumab kadcyla and. Do not substitute trastuzumab for ado trastuzumab emtansine. Kadcyla adotrastuzumab emtansine dose, indications. Adotrastuzumab emtansine for the treatment of patients with.
Kadcyla adotrastuzumab emtansine for injection, for intravenous. Adotrastuzumab emtansine is a cancer medicine that interferes with the growth and spread of cancer cells in the body. Ado trastuzumab emtansine tdm1 is an antibody drug conjugate linking trastuzumab to the chemotherapeutic agent dm1. Kadcyla adotrastuzumab emtansine is a her2targeted antibodydrug conjugate adc which contains the humanized antiher2 igg1, trastuzumab, covalently linked to the. Kadcylaadotrastuzumab emtansinefor injection, for intravenous use. See full prescribing information for complete boxed warning do not substitute kadcyla for or with trastuzumab.
Pdf clinical pharmacology of trastuzumab emtansine tdm1. Kadcyla adotrastuzumab emtansine magellan provider. Trastuzumab emtansine tdm1 is an antibodydrug conjugate that is effective and generally well tolerated when administered as a single agent to treat advanced breast cancer. Appropriate procedures for the preparation of chemotherapeutic drugs should be used. Selected laboratories need to be proficient with ihc and fish technology to ensure reliable results. Trastuzumab herceptin, adotrastuzumab kadcyla and pertuzumab perjeta page 1 of 31 05062015. Indepth structural characterization of kadcyla adotrastuzumab emtansine and its biosimilar candidate. Adotrastuzumab emtansine kadcyla pharmacy benefits. Adotrastuzumab emtansine is a her2targeted antibodydrug conjugate.
Pdf adotrastuzumab emtansineinduced pulmonary toxicity. Kadcyla prescribing information genentech pages 1 22. Some patients may feel very tired, also known as fatigue. If you have an allergy to ado trastuzumab emtansine or any other part of this drug. Adotrastuzumab emtansine national cancer institute. The bracketed structure is dm1 plus mcc which represents the emtansine component. Appropriate studies performed to date have not demonstrated geriatricspecific problems that would limit the usefulness of adotrastuzumab emtansine injection in the elderly. Trastuzumab emtansine an overview sciencedirect topics. Other considerations her2 testing is essential to determine if patients are appropriate for ado trastuzumab emtansine therapy. Trastuzumab emtansine drug bnf content published by nice. Adotrastuzumab emtansine definition of adotrastuzumab.
Kadcyla adotrastuzumab emtansine dosing, indications. Trial of adotrastuzumab emtansine for patients with her2 amplified or mutant cancers the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Prior to receiving adotrastuzumab emtansine, patients should have previously received treatment with trastuzumab herceptin and a taxane either separately or in combination. Fdaapproval of adotrastuzumab emtansine in mbc was supported by data from. Adotrastuzumab emtansine is currently approved by the u.
This medication is given by slow injection into a vein by a health care professional. Adotrastuzumab emtansine kadcyla for breast cancer adotrastuzumab emtansine was approved by the fda on feb. Pdf trastuzumab emtansine tdm1 is an antibodydrug conjugate comprising. The recommended dose of ado trastuzumab emtansine intravenous injection kadcyla is 3. Inn similar structures search, synonyms, formulas, resource links, and other chemical information. Kadcyla adotrastuzumab emtansine for injection, for intravenous use initial u. Food and drug administration fda for treatment of metastatic, her2positive breast cancer that has grown despite other her2targeting. However, ado trastuzumab emtansine is not the same as trastuzumab.
Serious fetal harm can occur if adotrastuzumab emtansine is administered during pregnancy or within 7 months prior to conception. Adotrastuzumab emtansine kadcyla breast cancer news. Use aseptic technique for reconstitution and preparation of dosing solution. Adotrastuzumab emtansine is used to treat a certain type of breast cancer that has. Adotrastuzumab emtansine has the followingchemical structure.
439 355 904 928 1301 742 770 113 1497 1364 487 733 920 145 1461 1455 487 1206 334 541 38 346 1656 185 182 236 1019 1291 951 1009 717 1524 1044 693 261 805 667 1111 461 231 1001 822 458 448 1071 1497