This product information was approved at the time this auspar was published. Highlights of prescribing information initial dose of 4. Persons with disabilities having problems accessing the pdf files below. Costeffectiveness analysis of trastuzumab emtansine t. Kadcyla ado trastuzumab emtansine for injection, for intravenous use. The cost includes antineoplastic drugs only not antiemetics, supportive medications or consumables, unless otherwise indicated. Use caution with these agents and consider recent major changes indications and usage 1. Use aseptic technique for reconstitution and preparation of dosing solution.
Get emergency medical help if you have signs of an allergic reaction. Each vial contains 100 mg or 160 mg ado trastuzumab emtansine. Trastuzumab emtansine for residual invasive her2positive. Kadcyla, as a single agent, is indicated for the adjuvant treatment of adult patients with her2positive early breast cancer who have residual invasive disease.
Kadcyla is available as a singleuse vial containing 100 mg or 160 mg of trastuzumab. The bracketed structure is dm1 plus mcc which represents the emtansine component. Product information for auspar trastuzumab emtansine kadcyla roche products pty ltd pm20120273434 final 17 march 2014. The trastuzumab moiety of this adc binds to her2 on tumor cell surface surfaces. Ado trastuzumab emtansine may enhance the cardiotoxic effect of anthracyclines. Adotrastuzumab emtansine dosage guide with precautions. Article information, pdf download for safety of trastuzumab after trastuzumab emtansineinduced. This medicine is used both for early breast cancer and for breast cancer that has spread to other parts of the body metastatic. Selected laboratories need to be proficient with ihc and fish technology to ensure reliable results. Trastuzumab emtansine drug substance bulk is stored at a temperature of 15c to 25c or colder until shipment. Ado trastuzumab 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 remaining in the tissue removed during surgery. Kadcyla, inntrastuzumab emtansine european medicines agency. The developmental history of tdm1 reaches back to the 1970s when the national cancer institute sponsored a plant screening program where plantderived compounds were.
Pdf adotrastuzumab emtansineinduced pulmonary toxicity. Trastuzumab emtansine tdm1 is an antibodydrug conjugate composed of a cytotoxic microtubule polymerization inhibitor, dm1, conjugated to trastuzumab. Following reconstitution, each singleuse vial contains ado trastuzumab emtansine 20 mgml, polysorbate 20 0. Quantification of the antibody drug conjugate, trastuzumab. Do not substitute herceptin trastuzumab for or with ado trastuzumab emtansine. Kadcyla adotrastuzumab emtansine for injection, for intravenous use initial u.
Dm1, the cytotoxic component of kadcyla, may cause serious adverse reactions in breastfed infants based on its mechanism of action. The recommended dose of trastuzumab emtansine is 3. All viralprion safety issues have been addressed, including use of animal derived excipients, supplements in the modification and conjugation reactions. Wed like to understand how you use our websites in order to improve them. Trastuzumab emtansine for her2positive advanced breast cancer. Pdf icon download a printable version of this information about trastuzumab emtansine. In addition, in vitro studies have shown that similar to trastuzumab, ado trastuzumab emtansine inhibits her2 receptor signaling, mediates antibodydependent cellmediated cytotoxicity and inhibits shedding of the her2 extracellular domain in human breast cancer cells that overexpress her2. Trastuzumab emtansine tdm1 is available in 100 mg and 160 mg vials. Dailymed kadcyla adotrastuzumab emtansine injection. Monitor closely for cardiac dysfunction in patients receiving this. Ado trastuzumab emtansine tdm1 pneu monitis pulmonary toxicity breast cancer. Imsn alert draft trastuzumab emtansine 2014 05 corrected. Definition of ado trastuzumab emtansine nci drug dictionary. Adotrastuzumab emtansine national cancer institute.
Trastuzumab emtansine also known as ado trastuzumab emtansine and sold under the trade name kadcyla, is an antibodydrug conjugate consisting of the humanized monoclonal antibody trastuzumab herceptin covalently linked to the cytotoxic agent dm1. Ado trastuzumab emtansine is usually given after other treatments have failed. Completed singleagent trastuzumab emtansine or combination trastuzumab emtansine treatment in the parent study or who continue to receive singleagent trastuzumab emtansine or combination trastuzumab emtansine treatment at the time of the parent study closure and received the last study drug dose within the 6 weeks 42 days prior to the first dose of study therapy on the. Her2positive metastatic breast cancer that has previously been treated with herceptin chemical name. Payer requirements regarding use of a 10digit or 11digit ndc may vary. Kadcyla adotrastuzumab emtansine downloadable resources. This study assesses the costeffectiveness of four treatment sequences for. Jan 03, 2019 our kadcyla ado trastuzumab emtansine side effects drug center provides a comprehensive view of available drug information on the potential side effects when taking this medication. The approval of ado trastuzumab emtansine tdm1 for clinical use represented a turning point both in her2positive breast cancer treatment and antibodydrug conjugate adc technology. The pdf file you selected should load here if your web browser has a pdf. Download selected 0 files selected files will be downloaded as. Mar 05, 2014 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. Call your doctor for medical advice about side effects.
Fda label information for this drug is available at dailymed. A tornado analysis was performed to identify the key drivers of our markov. Tell your doctor if you have ever had an unusual or allergic reaction to trastuzumab or trastuzumab emtansine before receiving trastuzumab emtansine. An antibodydrug conjugate adc consisting of the recombinant antiepidermal growth factor receptor 2 her2 monoclonal antibody trastuzumab conjugated to the maytansinoid dm1 via a nonreducible thioether linkage mcc with potential antineoplastic activity. Immunogen, waltham, ma, usa, is an antibodydrug conjugate, comprised of trastuzumab linked by a stable linker to the tubulin inhibitor emtansine. A safety extension study of trastuzumab emtansine in. When possible, patients treated with ado trastuzumab emtansine should avoid anthracyclinebased therapy for up to 7 months after stopping ado trastuzumab emtansine.
Jul 19, 2017 evidencebased recommendations on trastuzumab emtansine kadcyla for human epidermal growth factor receptor 2 her2. Do not substitute enhertu for or with trastuzumab or ado trastuzumab emtansine. Side effects of kadcyla adotrastuzumab emtansine injection. Hence an added benefit of trastuzumab emtansine in comparison with the act radiotherapy is not proven for these patients. Tdm1 is currently being evaluated as adjuvant treatment for early. European commission approves roches kadcyla for the adjuvant. Kadcyla ado trastuzumab emtansine for injection, for intravenous use initial u. Inn similar structures search, synonyms, formulas, resource links, and other chemical information. Overview trastuzumab emtansine for treating her2positive.
Adotrastuzumab emtansine is an injectable therapy administered every 3 weeks. A list of drugs that interact with trastuzumab emtansine. Interstitial pneumonitis associated with trastuzumab emtansine ali. Cost effectiveness of trastuzumab emtansine kadcyla, as a. Ado trastuzumab emtansine immunotoxin that consists of humanized monoclonal antiher2 antibody trastuzumab covalently linked to antimicrotubule agent maytansinoid dm1 for treatment of metastatic breast cancer in patients who previously received trastuzumab. Trastuzumab emtansine interactions bnf content published. Jan 03, 2019 kadcyla ado trastuzumab emtansine is a sterile, white to offwhite preservative free lyophilized powder in singleuse vials.
Kadcyla 100 mg pulbere pentru concentrat pentru solutie perfuzabila. Administer according to one of the following doses and schedules. Highlights of prescribing information initial dose of. Risk of hepatotoxicity with trastuzumab emtansine in. Trastuzumab emtansine tdm1 is an adc in which molecules of dm1, a cytotoxic microtubule polymerization inhibitor, are bound via a stable thioether linker to trastuzumab. Highlights of prescribing information initial dose of 4 mg. Safety of trastuzumab after trastuzumab emtansineinduced nodular. Kadcyla tdm1 is a targeted therapy used to treat her2positive metastatic. Moving trastuzumab emtansine tdm1 to the early setting of breast. Adotrastuzumab emtansine page 2 of 3 developed by danafarber cancer institute last revised 042016 patient and family education committee 5. Kadcyla adotrastuzumab emtansine fda approval history. Trastuzumab emtansine is a clear liquid that is injected into a vein. Ado trastuzumab emtansine tdm1 is a her2antibody drug. Ado trastuzumab emtansine tdm1 is an antibody drug conjugate of trastuzumab with emtansine.
Trastuzumab alone stops growth of cancer cells by binding to the her2 receptor, whereas trastuzumab emtansine. 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. Article information, pdf download for interstitial pneumonitis associated. Tdm1 binds to the extracellular domain of the her2 protein and carries out the. Do not substitute ado trastuzumab emtansine for or with trastuzumab. Kadcyla is a combination of herceptin and the chemotherapy.
Characterization antibodydrug conjugate consisting of the antibody trastuzumab the active ingredient in herceptin linked to a cytotoxic agent that is a derivative of maytansine dm1 ado trastuzumab emtansine. Each molecule of trastuzumab emtansine consists of a single trastuzumab molecule with several molecules of dm1, a cytotoxic maytansinoid, attached. Pacientii tratati cu trastuzumab emtansine trebuie sa aiba status tumoral. Learn about kadcyla access solutions, a resource that provides reliable, effective access and reimbursement support to assist your patients and practice after kadcyla adotrastuzumab emtansine has been prescribed. There is no information regarding the presence of ado trastuzumab emtansine. Kadcyla ado trastuzumab emtansine injection company. Initial dose of 4 mgkg over 90 minute iv infusion, then 2 mgkg over. Annals of oncology therapy in breast cancer patients.
Kadcyla adotrastuzumab emtansine dosing, indications. See full prescribing information for complete boxed warning do not substitute kadcyla for or with trastuzumab. Adotrastuzumab emtansine professional patient advice. Characterization ado trastuzumab emtansine with other inactive ingredients ado trastuzumab emtansine 1018448651 24 % combustible dust no category, ush003 acute toxicity category 2, h330. Dont confuse kadcyla with herceptin, fda says fiercepharma. Qol functional assessment of cancer therapybreast quality of life. Kadcyla, as a single agent, is indicated for the treatment of patients with her2positive, metastatic breast cancer who previously received trastuzumab and a. Kadcyla access solutions kadcyla adotrastuzumab emtansine. The pubchem cid for the mertasine component compound is cid 1437.
Monitor closely for cardiac dysfunction in patients receiving this combination. Trastuzumabdm1 tdm1 retains all the mechanisms of action of trastuzumab and efficiently inhibits growth of lapatinib insensitive breast. A study of trastuzumab emtansine in participants with human. Commonly reported side effects of ado trastuzumab emtansine include. Herceptin is trastuzumab, and kadcyla is ado trastuzumab emtansine. Ado trastuzumab emtansine is in a class of medications called antibodydrug conjugates.
Lastly, in 20, adotrastuzumab emtansine was approved as a monotherapy for mbc. Prognosis of women with metastatic breast cancer by her2 status and. It was approved in 20 for the secondline treatment of metastatic bc based on improved progression. And designating kadcyla as trastuzumab emtansine can. Kadcyla adotrastuzumab emtansine injection for iv use. The logistics of an injectable therapy may make the. Trastuzumab dm1 tdm1, trastuzumab emtansine is designed. Drug name active ingredients strength dosage formroute marketing status te code rld rs. Ado trastuzumab emtansine tdm1 is an fda approved adc, marketed under the brand name kadcyla, and used as treatment for patients with advanced breast cancer.
The scottish medicines consortium has advised april 2017 that trastuzumab emtansine kadcyla is accepted for use within nhs scotland as monotherapy for the treatment of patients with human epidermal growth factor type 2 her2positive, unresectable locally advanced or metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination, and have either. Trastuzumab emtansine tdm1 is an antibodydrug conjugate of trastuzumab and the cytotoxic agent emtansine dm1, a maytansine derivative and microtubule inhibitor. Exclusion criteria included prior treatment with lapatinib or capecitabine. Breast cancer that is her2 positive and has already been treated with a taxane and trastuzumab.
Trastuzumab emtansine tdm1 is an antibodydrug conjugate made up of trastuzumab, stably linked to a highly potent chemotherapy dm1 derived from maytansine figure 1. Tdm1 or ado trastuzumab emtansine is a targeted therapy approved by the u. A costeffectiveness analysis of trastuzumabcontaining treatment. Description of first aid measures eye contact rinse immediately with tap water for 10 minutes open eyelids forcibly skin contact remove immediately contaminated clothes, wash affected skin with water and soap do not use any. 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. Measles, mumps and rubella vaccine, live is predicted to increase the risk of generalised infection possibly lifethreatening when given with trastuzumab emtansine. The following is the supplementary data to this article. Trastuzumab emtansine tras tooz ue mab em tan seen is a drug that is used to treat some types of cancer. In november 2017, this guidance was amended after a change to the commercial arrangements in october 2017.
Efficacy has now been demonstrated in randomized trials as first line, second line, and later than the second line treatment of advanced breast cancer. Cycle frequency 21 days number of cycles until disease progression or unacceptable toxicity. Trastuzumab emtansine an overview sciencedirect topics. Kadcyla ado trastuzumab emtansine is a new class of chemotherapy drug called an antibodydrug conjugate used to treat breast cancer. Kadcyla ado trastuzumab emtansine is a her2targeted antibody and microtubule inhibitor conjugate. A study of trastuzumab emtansine in participants with human epidermal growth factor receptor 2 her2positive breast cancer who have received prior antiher2 and chemotherapybased treatment the safety and scientific validity of this study is the responsibility of the study sponsor and investigators.
The emilia trial demonstrated that trastuzumab emtansine tdm1 significantly increased the median professionfree and overall survival relative to combination therapy with lapatinib plus capecitabine lc in patients with her2positive advanced breast cancer abc previously treated with trastuzumab. Appropriate procedures for the preparation of chemotherapeutic drugs should be used. Fda approval of adotrastuzumab emtansine fills an unmet need. Here are links to possibly useful sources of information about trastuzumab emtansine. Neoadjuvant trastuzumab, pertuzumab, and chemotherapy. This is not a complete list of side effects and others may occur. There is no information regarding the presence of ado trastuzumab emtansine in human milk, the effects on. Ado trastuzumab emtansine has the following chemical structure. Adotrastuzumab emtansine adotrastuzumab emtansine kadcyla, genentech is an antiher2 monoclonal antibodydrug conjugate indicated for the treatment of her2positive breast cancer.
In order to reduce the risk of medication errors it is recommended that all trastuzumab products are referred to by brand name, i. Trastuzumab emtansine is an antibodydrug conjugate adc, a combination between a monoclonal antibody and a smallmolecule drug. A pathological complete response was achieved by 99 444% of 223 patients in the trastuzumab emtansine plus pertuzumab group and 123 557% of 221 patients in the docetaxel, carboplatin, and trastuzumab. 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. Hcpcs j9354 injection, ado trastuzumab emtansine, 1 mg drug. There is no information regarding the presence of ado trastuzumab emtansine in human milk, the effects on the breastfed infant, or the effects on milk production. Kadcyla ado trastuzumab emtansine is a her2targeted antibody and microtubule inhibitor conjugate indicated for the treatment of patients with her2positive, metastatic breast cancer. Trastuzumab emtansine drug bnf content published by nice. Mertansine or dm1 is a macrolide of the ansamycin type and can be isolated from plants of the genus maytenus. Kadcyla in early breast cancer represents a new option after. Alternatively, you can also download the pdf file directly to your computer. In such cases, the guidelines recommend that adotrastuzumab emtansine be considered as subsequent therapy. Moving trastuzumab emtansine tdm1 to the early setting of breast cancer treatment. Trastuzumab emtansine is an antibodydrug conjugate that is effective in.
Requires prior authorization by medical director or designee. Safety data sheet kadcylar lyophilized powder in vials. Ado trastuzumab emtansine is used to treat a her2positive breast cancer. Trastuzumab emtansine metadata this file contains additional information such as exif metadata which may have been added by the digital camera, scanner, or software program used to create or digitize it. Australian public assessment for trastuzumab emtansine. Trastuzumab is prescribed in doses up to 8 mgkg every 3 weeksmore than twice the maximum dose of trastuzumab emtansine. Longtime response with adotrastuzumab emtansine in a. Other considerations her2 testing is essential to determine if patients are appropriate for ado trastuzumab emtansine therapy.
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