Cvs caremark specialty programs 2969 mapunapuna place honolulu, hi 96819 phone. Action a her2targeted antibody and microtubule inhibitor. Weve made enrollment simpler, faster and more intuitive with some key changes to our forms. Kadcyla adotrastuzumab emtansine is a cancer medicine that interferes with the growth and spread of cancer cells in the body. Your new online msds binder is a place for you to store the material safety data sheets you need to deploy. Adotrastuzumab kadcyla, breast cancer chemoexperts. Herceptin may be considered medically necessary for patients 18 years of age or older for the.
Content of labeling must be identical to the enclosed labeling text for the package insert, text for the patient package insert, medication guide. Read the prescribing information for kadcyla, which contains important details about clinical study results, side effects, and important safety information. Kadcyla consists of the therapeutic antiher2 antibody trastuzumab, marketed under the brand name herceptin, covalently linked to a maytansine derivative dm1 via a. Other companies are charging thousands of dollars to set up accounts and give you access to their msds online database.
I took it for two years until my doctor insisted i stop because he felt i am cured. Restricted access do not disseminate or copy without approval. Qualitative and quantitative composition kadcyla is available as a singleuse vial containing 100 mg or 160 mg of trastuzumab emtansine. 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 herceptin covalently linked to the cytotoxic agent dm1.
Before you receive each kadcyla injection, your heart function may need to be checked using an electrocardiograph or ecg sometimes called an ekg. Kadcyla is a treatment for her2positive breast cancer which has spread to other parts of the body that cannot be surgically removed and has stopped responding to initial treatment. It targets a protein on the surface of breast cancer cells known as human epidermal growth factor receptor 2 her2. Here are the other common side effects of kadcyla or adotrastuzumab emtansine muscle pain, joint pain, tired feeling, headache, bleeding, and easy bruising. Use caution with these agents and consider recent major changes. Kadcyla is a her2targeted antibody and microtubule inhibitor conjugate. Kadcyla package insert, 220 revision nccn guidelines on breast cancer v 2. Jul 05, 2016 the fda approved adotrastuzumab emtansine for the treatment of human epidermal growth factor receptor her2positive breast cancer under the brand name kadcyla in 20. Kadcyla is given as an intravenous infusion in 21day cycles while a patient is receiving kadcyla therapy, drugs containing ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, and voriconazole should be avoided. Kadcyla, as a single agent, is indicated for the treatment of patients with her2positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination.
Criteria for approval breast cancer authorization of 3 months may be granted for members who are prescribed kadcyla as a single agent for her2positive recurrent or metastatic breast cancer when one of the following criteria is met. Kadcyla is used to treat her2positive breast cancer kadcyla is used both for early breast cancer and for breast cancer that has spread to other parts of the body metastatic. Kadcyla extends survival in heavily pretreated patients. Trade name of administered product should be clearly recorded in patient file to improve traceability.
The new agreement means if there are no appeals against the new draft guidance, the drug will move out of the cdf into routine nhs funding later this summer. This coding information may assist you as you complete the payer forms for kadcyla. 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. Kadcyla vial side effects by likelihood and severity webmd. Mar 28, 2016 those who are her2 only with brain mets should look into the trial with kadcyla and ont380. Kadcyla is a her2targeted antibody and microtubule inhibitor conjugate indicated, as a single agent, for the treatment of patients with her2positive, metastatic breast cancer who previously received trastuzumab and a taxane. Kadcyla is currently approved by the fda for the treatment of patients with her2positive, metastatic breast cancer previously treated with a taxane and herceptin. This will mean eligible patients will no longer have to apply for funding and the drug will be paid for in the normal. Selected from data included with permission and ed by first databank, inc. Before administering, clarify all ambiguous orders. 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.
Kadcyla adotrastuzumab emtansine is indicated, as a single agent, for. Important safety information for kymriah tisagenlecleucel. Patients with known active liver disease such as hepatitis b virus or hepatitis c virus were excluded from emilia for patients with metastatic breast cancer mbc and katherine for patients with early breast cancer ebc studies. Call your doctor at once if you have upper stomach pain, itching, loss of appetite, dark urine, claycolored stools, or jaundice yellowing of the skin or eyes. Dailymed kadcyla adotrastuzumab emtansine injection. Kadcyla extends survival in heavily pretreated patients with.
So, herceptin is trastuzumab, and kadcyla is adotrastuzumab emtansine. Kymriah is a cd19directed genetically modified autologous t cell immunotherapy indicated for the treatment of patients up to 25 years of age with b. Although some women lived longer and some women did not live as long, women who were treated with halaven lived, on average, 25% longer. Toxic deaths, hepatotoxicity, neutropenia, hypersensitivity reactions, and fluid retention see full prescribing information for complete boxed warning. Jan 03, 2019 kadcyla is for intravenous infusion only. Indication recommended dose indicated as a single agent for the treatment of patients. Medication order form kadcyla adotrastuzumabemtansine. Information on submitting spl files using elist may be found in the guidance for industry titled spl standard for content of labeling technical qs and as at. Cl 110 medication order kadcyla v2cl 110 medication order kadcyla page2 of 2 sept. However, because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue breastfeeding or discontinue kadcyla, taking into account the importance of the drug to the. Highlights of prescribing information these highlights do not include all the information needed to use zaltrap safely and effectively. Dont confuse kadcyla with herceptin, fda says fiercepharma. These tables are provided for informational purposes only.
The herceptin part of kadcyla the chemotherapy part of kadcyla kadcyla combines two cancerfighting treatments in one. Adotrastuzumab emtansine kadcyla, also known as trastuzumabdm1 or t dm1. See full prescribing information for complete boxed warning. These forwardlooking statements may be identified by words. Full prescribing information 1 indications and usage zaltrap, in combination with.
Kadcyla adotrastuzumab emtansine is a her2targeted antibodydrug conjugate adc which contains the humanized antiher2 igg1, trastuzumab, covalently linked to the microtubule inhibitory drug dm1 a maytansine derivative via the stable thioether linker mcc 4nmaleimidomethyl cyclohexane1carboxylate. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are. Kymriah tisagenlecleucel health care professionals. Do not mix kadcyla, or administer as an infusion, with other medicinal products. Indepth structural characterization of kadcyla ado. This ed material has been downloaded from a licensed data provider and is not for distribution, except. Member has symptomatic visceral disease or visceral crisis b. Policy history date action march 20 addition to pa look alikesound alike warning. Kadcyla fda prescribing information, side effects and uses. However, you can edit the pdf itself in word for the web, which lets you update the pdf s content, or copy and paste content from the pdf into a word document.
The prescriber service form and the patient consent form are required for enrollment in genentech access solutions. Kadcyla 100 mg injectable 502420088xx kadcyla 160 mg injectable 502420087xx vii. Do not mix kadcyla, oradminister as an infusion,withother medicinal products. Highlights of prescribing information wounds have adequately. Permanently discontinue kadcyla treatment in patients with serum transaminases 3. Adotrastuzumab emtansine kadcyla adotrastuzumab emtansine kadcyla is a chemotherapy regimen for breast cancer metastatic. Forms and documents download the form you need to enroll in genentech access solutions and a helpful guide to use when talking to your doctors. Lyophilized powder in single kadcyla adotrastuzumab emtansine for injection, for intravenous use initial u. Kadcyla adotrastuzumab emtansine downloadable materials. Kadcyla while maintaining optimal therapeutic outcomes. Select patients for therapy based on an fdaapproved companion diagnostic for kadcyla see. Kadcyla definition of kadcyla by medical dictionary.
Kadcyla adotrastuzumab emtansine injection for iv use. D indications her2positive metastatic breast cancer previously treated with trastuzumab and a taxane. I dont want to go on other chemo if that doesnt work. So here are the answers from my oncologist, at one of the best cancer centers in the us and based on my experience. Nov 01, 2019 if kadcyla is administered during pregnancy, or if a patient becomes pregnant while receiving kadcyla or within 7 months following the last dose of kadcyla, health care providers and patients should immediately report kadcyla exposure to genentech at 18888352555. It is important to check the vial labels to ensure that the drug administered is kadcyla adotrastuzumab emtansine. Initial approval criteria 1 coverage is provided in the following conditions.
A combination study of kadcyla trastuzumab emtansine and. Following reconstitution, each singleuse vial contains adotrastuzumab emtansine 20 mgml, polysorbate 20 0. Trastuzumab alone stops growth of cancer cells by binding to the her2 receptor, whereas trastuzumab emtansine. Oct 09, 20 once i figured that out, the kadcyla was a breeze. Administer kadcyla as an intravenous infusion only with a 0. In order to improve traceability of biological medicinal products, the tradename of the.
Developed disease recurrence during or within six months of completing. Capecitabine will be administered at the mtd determined in cohort 1. It is given as directed by your doctor, usually once every 3 weeks. Kadcyla adotrastuzumab emtansine for injection, for intravenous use. Please see full prescribing information for additional important safety information, including boxed warnings. Side effects of kadcyla adotrastuzumab emtansine injection. Kadcyla is currently being funded through the cancer drugs fund cdf. Indication recommended dose indicated as a single agent for the treatment of patients with her2positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in. Ime clinical criteria adotrastuzumab emutansine kadcyla page 2 of 2 references continued development of utilization management criteria.
It is not known if kadcyla is excreted in human milk. Word for the web doesnt let you insert objects, such as pdfs, into a document. The schedule of administration should be adjusted to maintain a 3 2 of 21 reference id. The approval was based on the phase 3 emilia trial, in which kadcyla significantly improved survival versus tykerbcapecitabine, with a median os of 30.
Kadcyla can cause fetal harm when administered to a pregnant woman. Information for physicians regarding kadcyla adotrastuzumabemtansineinfusion at provis infusion clinic thank you for allowing provis to assist in your patients care. Jan 03, 2019 kadcyla adotrastuzumab emtansine is a sterile, white to offwhite preservative free lyophilized powder in singleuse vials. This type of treatment is called an antibodydrug conjugate.
New product sales overcompensate for entry of biosimilars q1. Kadcyla too costly for use on the nhs news and features. Kadcyla 100 mg vial 1 vial every 21 days kadcyla 160 mg vial 3 vials every 21 days b. Do not confuse adotrastuzumab kadcyla with trastuzumab herceptin. Each vial contains 100 mg or 160 mg adotrastuzumab emtansine. Kadcyla,as a single agent, is indicated for the treatment of patients with her2positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. In clinical trials of kadcyla, cases of nodular regenerative hyperplasia nrh of the liver have been identified from liver biopsies 5 cases out of 1624, 1 of which was fatal.
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