The fda approved adotrastuzumab emtansine for the treatment of human epidermal growth factor receptor her2positive breast cancer under the brand name. Cl 110 medication order kadcyla v2cl 110 medication order kadcyla page2 of 2 sept. Use caution with these agents and consider recent major changes. Kadcyla 100 mg vial 1 vial every 21 days kadcyla 160 mg vial 3 vials every 21 days b. This reduces the stimulation for cancer cells to divide and grow. It combines two anticancer properties joined together by a stable linker. Kadcyla dose should not be reescalated after a dose reduction is made.
Kadcyla contains the active substance trastuzumab emtansine, which is made up of two parts that are. 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. 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. Administer kadcyla as an intravenous infusion only with a 0. Mitoxantrone hydrochloride mitoxantrone hydrochloride this product information is intended only for residents of the united states. 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. Indepth structural characterization of kadcyla ado. Jan 03, 2019 kadcyla is for intravenous infusion only. Kadcyla 100 mg injectable 502420088xx kadcyla 160 mg injectable 502420087xx vii. Patients should have either received prior therapy for metastatic disease, or developed disease recurrence during or within six. Enhertu is another antibodydrug conjugate targeted therapy used to treat breast cancer. 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 office.
Kadcyla adotrastuzumab emtansine for injection, for intravenous use. Kadcyla, inntrastuzumab emtansine european medicines agency. Calculate volume reconstituted ml selecting the appropriate vial kadcyla is supplied as a sterile powder for concentrate and comes in 2 vial types. The approval was based on the phase 3 emilia trial, in which kadcyla significantly improved survival versus tykerbcapecitabine, with a median os of 30. Trastuzumab emtansine also known as adotrastuzumab emtansine and sold under the trade name kadcyla, is an antibodydrug conjugate consisting of the humanized monoclonal. I used to get zofran while on the former and used to get blurry vision, dizziness, bitter taste, lack of appetite.
Antibodycytotoxic agent conjugate consisting of the her2. Kadcyla is not considered medically necessary for indications other than those listed above due to insufficient evidence of therapeutic value. Metastatic breast cancer mbc 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 order to minimize this risk, check the vial labels to ensure that the. The prescriber service form and the patient consent form are required for enrollment in genentech access solutions. I just wanted to share this with any of you on kadcyla or herceptin. In order to improve traceability of biological medicinal products, the tradename of the administered product should be clearly recorded or stated in the patient file.
Kadcyla adotrastuzumab emtansine is a member of the her2 inhibitors drug class and is commonly used for breast cancer and breast cancer metastatic. Information for physicians regarding kadcyla adotrastuzumabemtansineinfusion at provis infusion clinic thank you for allowing provis to assist in your patients care. Highlights of prescribing information advanced renal cell. The requested variation proposed amendments to the summary of product characteristics and package. Herceptin should be prescribed using both the trade name and. Your new online msds binder is a place for you to store the material safety data sheets you need to deploy. Kadcyla prices, coupons and patient assistance programs. Its been known to reject brand monikers because theyre too similar to.
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. Mitoxantrone hydrochloride mitoxantrone hydrochloride pfizer. Dailymed kadcyla adotrastuzumab emtansine injection. Dont confuse kadcyla with herceptin, fda says fiercepharma. Select patients for therapy based on an fdaapproved companion diagnostic for kadcyla. I used to get zofran while on the former and used to get blurry vision, dizziness, bitter taste, lack of appetite, constipation, dark urine, palpitations, etc. Drug product labeling and packaging will be done at genentech hillsboro filffiiiish facifity m hillsboro, oregon. For healthcare professionals nerlynx neratinib tablets.
Kadcyla consists of the therapeutic antiher2 antibody trastuzumab, marketed under the brand name herceptin, covalently linked to a maytansine derivative dm1 via a. Closely monitor the infusion site for possible subcutaneous infiltration during drug administration see warnings and precautions 5. The herceptin part of kadcyla may also encourage the bodys own immune cells to help destroy the cancer cells. Highlights of prescribing information these highlights do not include all the information needed to use gleevec safely and effectively. The two fatal cases of severe druginduced liver injury and associated hepatic encephalopathy occurred in mbc clinical trials with kadcyla. 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. Kadcyla trastuzumab emtansine kadcyla is an antibodydrug conjugate adc engineered to deliver potent chemotherapy directly to her2positive cancer cells, potentially limiting damage. The herceptin part of kadcyla1,2 the herceptin part of kadcyla works by attaching to her2 proteins on breast cancer cells. In order to minimize this risk, check the vial labels to ensure that the drug being prepared and administered is herceptin trastuzumab and not kadcyla trastuzumab emtansine. 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. Lyophilized powder in single kadcyla adotrastuzumab emtansine for injection, for intravenous use initial u. This kadcyla price guide is based on using the discount card which is accepted at most u.
Kadcyla fda prescribing information, side effects and uses. It got so bad that my oncologist ordered a brain ct which thank gd came out clean. Kadcyla extends survival in heavily pretreated patients. Use aseptic technique for reconstitution and preparation of dosing solution. Member has symptomatic visceral disease or visceral crisis b. There is a risk of medication errors between herceptin trastuzumab and 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. Kadcyla can cause fetal harm when administered to a pregnant woman. Side effects of kadcyla adotrastuzumab emtansine injection. Herceptin trastuzumab, herceptin hylecta trastuzumab and. Inntrastuzumab emtansine european medicines agency. Dec 29, 20 i just wanted to share this with any of you on kadcyla or herceptin. Initial approval criteria 1 coverage is provided in the following conditions. Nerlynx neratinib tablets prescribing information, puma biotechnology, inc.
Herceptin trastuzumab, herceptin hylecta trastuzumab. Applicable procedure codes j9354 injection, adotrastuzumab emtansine, 1 mg. 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. Kadcyla vial side effects by likelihood and severity webmd. Adotrastuzumab emtansine kadcyla package insert locally hosted backup. Selected from data included with permission and ed by first databank, inc. This week, after her third kadcyla infusion, she developed severe shortness of breath and the docs determined kadcyla is causing heart failure and is no longer an option. She started on kadcyla this past december after herceptinperjeta combo stopped working. In the event of toxicity, doses may be delayed, but all treatment must be administered within 16 weeks of the first dose see clinical studies 14.
Do not mix kadcyla, or administer as an infusion, with other medicinal products. Medication order form kadcyla adotrastuzumabemtansine. See full prescribing information for complete boxed warning. Weve made enrollment simpler, faster and more intuitive with some key changes to our forms. You may label your product with the proprieta1y name, kadcyla, and will market it as a lyophilized product in two singleuse presentations of 100 mg per 15 ml vial and 160 mg per 20 ml vial. Calculate volume reconstituted ml selecting the appropriate vial kadcyla is supplied as a. Jan 08, 2020 kadcyla is a combination of the targeted therapy herceptin chemical name. Other companies are charging thousands of dollars to set up accounts and give you access to their msds online database.
The schedule of administration should be adjusted to maintain a 3 2 of 21 reference id. These highlights do not include all the information needed to use. The emtansine is attached conjugated to the herceptin. Kadcyla extends survival in heavily pretreated patients with. The first treatment was infused over an hour and a half with no problems. This ed material has been downloaded from a licensed data provider and is not for distribution, except. It is given as directed by your doctor, usually once every 3 weeks. 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. Gleevec imatinib mesylate tablets, for oral use initial u.
The recommended dose of yervoy ipilimumab is 3 mgkg administered intravenously iv over 90 minutes every 3 weeks for a maximum of 4 doses. Mitoxantrone hydrochloride mitoxantrone hydrochloride. Herceptin trastuzumab, herceptin hylectatm trastuzumab and hyaluronidaseoysk, kadcyla adotrastuzumab and perjeta pertuzumab precertification request aetna precertification notification. This reduces the stimulation for cancer cells to divide and. First diagnosed at stage ii in 2006 with recurrence in september 20. Monitor and withhold dosing or discontinue as appropriate. 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. 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. Kadcyla is a combination of the targeted therapy herceptin chemical name. Kadcyla is currently approved by the fda for the treatment of patients with her2positive, metastatic breast cancer previously treated with a taxane and herceptin. The prescriber service form and the patient consent form are required. This medication is given by slow injection into a vein by a health care professional. Jan 23, 2015 first diagnosed at stage ii in 2006 with recurrence in september 20.
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