Herceptin trastuzumab, herceptin hylectatm trastuzumab and hyaluronidaseoysk, kadcyla adotrastuzumab and perjeta pertuzumab precertification request aetna precertification notification. Sep 27, 20 my wife is doing excellent, just about 3 yrs, cancer shrunk away over 1st yr, 20102011, and no evidence of disease, since nov. See full prescribing information for complete boxed warning. Here are the other common side effects of kadcyla or adotrastuzumab emtansine muscle pain, joint pain, tired feeling, headache, bleeding, and easy bruising. Nice recommends routine nhs funding for kadcyla the lancet. Institute dose modifications or permanently discontinue as appropriate. Developed disease recurrence during or within six months of completing. Side effects of kadcyla adotrastuzumab emtansine injection. Australian product information kadcyla trastuzumab. Cl 110 medication order kadcyla v2cl 110 medication order kadcyla page2 of 2 sept.
Kadcyla too costly for use on the nhs news and features. Identification of the substancemixture and of the companyundertaking 1. Kadcyla adotrastuzumab emtansine dosing, indications. 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. Safety of trastuzumab emtansine tdm1 in patients with her2. It may be used to help prevent melanoma from coming back after it and lymph nodes that contain cancer have been removed by surgery. Kadcyla trastuzumab emtansine kadcyla is an antibodydrug conjugate adc engineered to deliver potent chemotherapy directly to her2positive cancer cells, potentially limiting damage to healthy tissues. This coding information may assist you as you complete the payer forms for kadcyla. Do not confuse adotrastuzumab emtansine kadcyla with trastuzumab herceptin. Select patients for therapy based on an fdaapproved companion diagnostic for kadcyla see.
In some cases, health care professionals may use the trade name kadcyla when referring to the generic drug name adotrastuzumab emtansine. Weve made enrollment simpler, faster and more intuitive with some key changes to our forms. Kadcyla dose should not be reescalated after a dose reduction is made. Content of labeling must be identical to the enclosed labeling text for the package insert, text for the patient package insert, medication guide. Kadcyla adotrastuzumab emtansine is indicated, as a single agent, for. The cost of the drug, manufactured exclusively by roche. Herceptin trastuzumab, herceptin hylecta trastuzumab and.
Please see full prescribing information for additional important safety information, including boxed warnings. Kadcyla can cause fetal harm when administered to a pregnant woman. It combines two anticancer properties joined together by a stable linker. 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. This will mean eligible patients will no longer have to apply for funding and the drug will be paid for in the normal. About 4 days later she got really tired and somewhat weaker which we were sort of expecting. Administer kadcyla as an intravenous infusion only with a 0.
So here are the answers from my oncologist, at one of the best cancer centers in. Do not mix kadcyla, oradminister as an infusion,withother medicinal products. The emtansine is attached conjugated to the herceptin. 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. Insert pdf file content into a powerpoint presentation. Product identifier product name kadcylar solution product code cse3090 synonyms tdm1 ro5304020 2% aqueous solution with excipients 1. Enhertu is another antibodydrug conjugate targeted therapy used to treat breast cancer. Table 1 dose reduction schedule dose reduction schedule starting dose is 3. Indepth structural characterization of kadcyla ado. Kadcyla administration may lead to reductions in left ventricular ejection fraction lvef. Kadcyla fda prescribing information, side effects and uses.
Mar 28, 2016 those who are her2 only with brain mets should look into the trial with kadcyla and ont380. It may be used when your melanoma has spread or cannot be removed by surgery advanced melanoma, or. Adotrastuzumab emtansine injection is used to treat her2positive metastatic breast cancer cancer that has spread in patients who have previously received other medicines eg, trastuzumab, taxane medicine that did not work well or whose cancer has returned during or within 6 months of completing treatment. Australian product information kadcyla trastuzumab 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. Cvs caremark is an independent company that provides pharmacy benefit management services to carefirst bluecross blueshield and carefirst bluechoice, inc. Dailymed kadcyla adotrastuzumab emtansine injection.
After the second treatment, which took a half an hour, the next day she started to feel weak. 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. Trastuzumab emtansine and costbased decision making the lancet. Mitoxantrone hydrochloride mitoxantrone hydrochloride pfizer. Information for physicians regarding kadcyla adotrastuzumabemtansineinfusion at provis infusion clinic thank you for allowing provis to assist in your patients care. Selected from data included with permission and ed by first databank, inc.
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. 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. These tables are provided for informational purposes only. Exposure to kadcyla during pregnancy can result in embryofetal harm. In order to improve traceability of biological medicinal products, the tradename of the. Cvs caremark specialty programs 2969 mapunapuna place honolulu, hi 96819 phone. The schedule of administration should be adjusted to maintain a 3 2 of 21 reference id. Following four years of beating up on each other over the costbenefit of roches cuttingedge breast cancer drug kadcyla, and heavy lobbying from. Kadcyla is the trade name for adotrastuzumab emtansine. The spl will be accessible via publicly available labeling repositories. Monitor and withhold dosing or discontinue as appropriate. This type of treatment is called an antibodydrug conjugate. The approval was based on the phase 3 emilia trial, in which kadcyla significantly improved survival versus tykerbcapecitabine, with a median os of 30. Carefirst bluecross blueshield is the shared business name of carefirst of maryland, inc.
Kadcyla is currently approved by the fda for the treatment of patients with her2positive, metastatic breast cancer previously treated with a taxane and herceptin. Lyophilized powder in single kadcyla adotrastuzumab emtansine for injection, for intravenous use initial u. Relevant identified uses of the substance or mixture and uses advised against. Mitoxantrone hydrochloride mitoxantrone hydrochloride this product information is intended only for residents of the united states. Member has symptomatic visceral disease or visceral crisis b. Kadcyla 190926 1 australian product information kadcyla trastuzumab emtansine 1. Jun 15, 2017 kadcyla is currently being funded through the cancer drugs fund cdf. Kadcyla is currently being funded through the cancer drugs fund cdf.
Use caution with these agents and consider recent major changes. Reduce dose or discontinue kadcyla as appropriate in cases of increased serum 9. Trastuzumab alone stops growth of cancer cells by binding to the her2 receptor, whereas trastuzumab emtansine undergoes receptormediated. 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 is a combination of the targeted therapy herceptin chemical name. Kadcyla is a prescription medicine used to treat her2positive breast cancer that has spread to other parts of the body metastatic breast cancer after prior treatment with trastuzumab herceptin and a taxane. Kadcyla may lead to reductions in left ventricular ejection fraction lvef. The prescriber service form and the patient consent form are required for enrollment in genentech access solutions. The herceptin part of kadcyla the chemotherapy part of kadcyla kadcyla combines two cancerfighting treatments in one. A single test that analyzes guidelinerecommended genes in solid tumors, including companion diagnostic indications with a direct path to therapy national coverage for qualifying medicare and medicare advantage patients across all solid tumors results include msi and tmb with the option to add pdl1 testing to help inform immunotherapy decisions. Dose reductions were based on tdm1prescribing information. The antibodydrug conjugate trastuzumab emtansine tdm1 is.
Monitor hepatic function prior to initiation and prior to each dose. Medication order form kadcyla adotrastuzumabemtansine. Adotrastuzumab emtansine kadcyla drug description adc. For the last 6 months, ive been on herceptin instead, and my tumor markers are at an alltime low. Kadcyla adotrastuzumab emtansine for injection package. Kadcyla is an antiher2 monoclonal antibody combined with a microtubular inhibitor. Jan 03, 2019 kadcyla is for intravenous infusion only. 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 vial side effects by likelihood and severity webmd. Jan 08, 2020 kadcyla is a combination of the targeted therapy herceptin chemical name. Herceptin trastuzumab, herceptin hylecta trastuzumab. It is also used as additional treatment in patients with her2positive early breast. Mitoxantrone hydrochloride mitoxantrone hydrochloride. This ed material has been downloaded from a licensed data provider and is not for distribution, except. 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.
Kadcyla is an antibodydrug conjugate adc engineered to deliver potent chemotherapy directly to her2positive cancer cells, potentially limiting damage to healthy tissues. Kadcyla adotrastuzumab emtansine rochegenentech launch date. Qualitative and quantitative composition kadcyla is available as a singleuse vial containing 100 mg or 160 mg of trastuzumab emtansine. Kadcyla consists of the therapeutic antiher2 antibody trastuzumab, marketed under the brand name herceptin, covalently linked to a maytansine derivative dm1 via a. Genentechroche is a human epidermal growth factor receptor 2 her2 antibodydrug conjugate that comprises the humanized antiher2 igg1 antibody trastuzumab linked to the antimitotic agent mertansine a maytansine derivative. Prior treatment could have been for the initial treatment of breast cancer or for the treatment of cancer that had spread to other. Advise patients of these risks and the need for effective contraception.
Kadcyla extends survival in heavily pretreated patients. Adotrastuzumab emtansine also know as tdm1 kadcyla. In the insert object box, select create from file, and then enter the pdf file location. Kadcyla extends survival in heavily pretreated patients with. Kadcyla adotrastuzumab emtansine for injection, for intravenous use. Calculate volume reconstituted ml selecting the appropriate vial kadcyla is supplied as a sterile powder for concentrate and comes in 2 vial types. The quality of the pdf file is reduced with this method, but you can open the full pdf file by doubleclicking the image when viewing or editing in normal view. Kadcyla should only be used in patients with her2positive tumour status. Roche gets nice approval for breast cancer drug kadcyla.
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