A study of sc administration of trastuzumab herceptin by. Each carton contains one singledose vial of herceptin. All information contained in, or referenced by, this application is complete and accurate and is not false or misleading. A study to evaluate the efficacy and safety of trastuzumab emtansine in combination with atezolizumab or atezolizumabplacebo in participants with human epidermal growth factor2 her2 positive locally advanced or metastatic breast cancer bc who received prior trastuzumab and taxane based therapy full text view. Herceptin is the brand name of the prescription drug trastuzumab, which is used along with other medicines to treat certain types of breast cancer and stomach cancer its also used to prevent. Qualitative and quantitative composition herceptin sc vial contains 600mg5ml of trastuzumab. Herceptin aka trastuzumab is a human prescription drug product labeled by genentech, inc. For more information on herceptin sc product please refer to the separate cmi for herceptin sc or speak with your doctor or pharmacist. Vumerity diroximel fumarate delayedrelease capsules, for oral use. Herceptin treatment should only be initiated by a physician experienced in the administration of cytotoxic chemotherapy see section 4. Highlights of prescribing information these highlights do not include all the information needed to use perjeta safely and effectively. Her2 testing is mandatory prior to initiation of therapy see sections 4.
Herceptin trastuzumab for injection, for intravenous use initial u. Herceptin trastuzumab for injection 150 mgvial is supplied in a singledose vial as a lyophilized sterile powder, under vacuum. Development of the subcutaneous formulation of trastuzumab. Herceptin reimbursement herceptin access solutions.
Herceptin trastuzumab is a monoclonal antibody drug used to prevent the recurrence ofand or treatment of breast cancer that has spread beyond the breast. This product information was approved at the time this auspar was published. The injection of volumes greater than 2 ml is usually painful and is limited by the physiology of the extracellular matrix of the subcutaneous tissue 8. Review, complete, and sign the patientprescriber enrollment. Clinical effects of prior trastuzumab on combination eribulin mesylate plus trastuzumab as firstline treatment for human epidermal growth factor receptor 2 positive locally recurrent or metastatic breast cancer. Evaluate cardiac function prior to and during treatment. Aetna considers trastuzumab herceptin, genentech, inc. Sep 30, 2019 see full prescribing information for complete boxed warning. Prior authorization protocol kadcyla adotrastuzumab. National dose banding table trastuzumab emtansine 20mg20ml. Shaughnessy,3 lee s schwartzberg,4 erhan berrak,5 james song,5. For information on the coronavirus outbreak please go to our page on coronavirus or the information on gov. This coding information may assist you as you complete the payer forms for herceptin.
Current and emerging treatment regimens for her2positive. The material provided to you are guidelines used by this plan to authorize, modify or determine coverage for persons with similar illnesses or conditions. The patient information leaflet pil is the leaflet included in the pack with a medicine. Highlights of prescribing information these highlights do not include all the information needed to use herceptin hylecta safely and effectively. As part of a treatment regimen containing doxorubicin, cyclophosphamide and either paclitaxel or docetaxel. Herceptin trastuzumab intravenous infusion initial u. Full prescribing information 1 indications and usage 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. Medicine information support ask about possible side effects and any other medical questions related to your prescribed genentech medicine. The text only version may be available in large print, braille or audio cd. Herceptin is the brand name of a medicine called trastuzumab. Herceptin is indicated for adjuvant treatment of her2overexpressing nodepositive or nodenegative erprnegative or with one highrisk feature breast cancer. It is written for patients and gives information about taking or using a medicine. Dayvigotm lemborexant tablets, for oral use, controlled substance schedule pending. Its used to treat some types of breast cancer, oesophageal cancer and stomach cancer.
A study to evaluate the efficacy and safety of trastuzumab. These highlights do not include all the information needed and administration instructions. These tables are provided for informational purposes only. This web page contains comprehensive information about ndc code 50242468. The plan may request additional information or clarification, if needed, to evaluate requests. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is. It is recommended that vectibix treatment be continued until progression of the underlying disease. Indicated for her2overexpressing metastatic breast cancer as firstline treatment in combination with paclitaxel or as a single agent for patients who have received 1 or more chemotherapy regimens for metastatic disease. Highlights of prescribing information these highlights do not include all the information needed to use enhertu safely and effectively. The original leaflet can be viewed using the link above. See full prescribing information for herceptin hylecta herceptin hylecta trastuzumab and hyaluronidaseoysk injection, for subcutaneous use initial u. Highlights of prescribing information these highlights do not include all the information needed to use herceptin safely and effectively.
See full prescribing information for complete preparation. The following information is relevant to all indications. Subcutaneous trastuzumab for her2positive breast cancer. Herceptin fda prescribing information, side effects and uses. Yes how many people have herceptin side effects are studied. These highlights do not include all the information needed to use. Herceptin trastuzumab dose, indications, adverse effects.
A sample letter is also included for your reference. Trastuzumab herceptin, adotrastuzumab kadcyla and pertuzumab perjeta page 1 of 31 05062015. Herceptin can help control the growth of cancer cells that contain high amounts of. Do not substitute herceptin hylecta for or with ado. The clinical trial will be conducted according to good clinical practices. Kadcyla fda prescribing information, side effects and uses. Herceptin can result in subclinical and clinical cardiac failure manifesting as chf, and decreased lvef, with greatest risk when administered concurrently with anthracyclines. A study of sc administration of trastuzumab herceptin by sid at home in her2positive ebc participants homerus the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. See 17 for patient counseling information and medication. Listing a study does not mean it has been evaluated by the u. Educate patients on the benefits and risks of treatment with tysabri, ensure that patients receive the medication guide, and encourage them to ask questions. Jan 20, 2014 information from the national library of medicine. Oct 05, 2016 a study to evaluate the efficacy and safety of trastuzumab emtansine in combination with atezolizumab or atezolizumabplacebo in participants with human epidermal growth factor2 her2 positive locally advanced or metastatic breast cancer bc who received prior trastuzumab and taxane based therapy full text view. Highlights of prescribing information initial dose of.
Nonsteroidal anti inflammatory drugs nsaids cause an increased risk of serious cardiovascular. And if you are looking for the latest travel information, and advice about the government response to the outbreak, go to the gov. This letter is a followup to the important drug warning letter, dated may 3, 2000, from genentech, inc. Evaluate left ventricular function in all patients prior to and during treatment with herceptin. Perjeta pertuzumab injection, for intravenous use initial u.
The materials provided to you are guidelines used by this health plan to authorize, modify, or determine coverage for persons with similar illnesses or conditions. Common side effects include rash, nausea and vomiting, insomnia, and weight loss. The subcutaneous formulation is administered as a fixed dose of 600 mg over a period of up to 5 minutes. For further information call emc accessibility on 0800 198 5000. It is used to treat new cases of breast cancer or disease that has spread to other parts of the body.
In this phase 2 randomized trial, 124 patients received paclitaxel alone n 61 or paclitaxel plus. Herceptin trastuzumab, herceptin hylecta trastuzumab and. Enhertu famtrastuzumab deruxtecannxki for injection, for intravenous use initial u. The injection volume of the subcutaneous trastuzumab formulation is 5 ml. Highlights of prescribing information initial dose of 4 mg. The coformulation of trastuzumab with recombinant human hyaluronidase rhuph20 resulted in a temporary. Skyrizi risankizumabrzaa injection, for subcutaneous use. There is a black box warning for herceptin warning of the possibility of heart failure in some patients. Pdr provides the following fdaapproved services, including full prescribing information, drug summaries, fda early warning communications, fda drug safety communications, pdr drug alerts, medication guides and free continuing medical education cme course credits. Herceptin administration can result in serious and fatal infusion reactions and pulmonary toxicity. See full prescribing information for complete b oxed. The american society of healthsystem pharmacists, inc.
Dec 06, 2018 herceptin administration can result in subclinical and clinical cardiac failure. Australian product information herceptin sc trastuzumab. Trastuzumab herceptin, ado trastuzumab kadcyla and pertuzumab perjeta number. A subcutaneous formulation of trastuzumab to treat patients with her2positive breast cancer is available since august 20. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Prior authorization protocol kadcyla adotrastuzumab emtansine. Highlights of prescribing information the recommended. This web page contains comprehensive information about ndc code 50242201.
Full text clinical effects of prior trastuzumab on. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged. This guide provides tips to help you draft a letter of medical necessity. Herceptin 600 mg solution for injection in vial summary. Cardiomyopathy, embryofetal toxicity, and pulmonary toxicity. Kadcyla adotrastuzumab emtansine dosing, indications. Herceptin 600 mg solution for injection in vial patient. She uses her powers of persuasion, knowledge and writing for good in hopes of helping others similarly affected. Trastuzumab fep clinical rationale rationale for inclusion in pa program background herceptin and its biosimilars are monoclonal antibodies that selectively binds with high affinity to the human epidermal growth factor receptor 2 her2 protein. What is a year in the life of a metastatic breast cancer patient worth. Dm1, the cytotoxic component of the drug, may cause serious adverse reactions in breastfed infants based on its mechanism of action. Cardiomyopathy, infusion reactions, and pulmonary toxicity.
Sep 01, 2019 herceptin administration can result in serious and fatal infusion reactions and pulmonary toxicity. During the first infusion of herceptin chills andor fever are observed commonly in patients. Susan f was unwillingly thrust into the world of metastatic breast cancer after a routine mammogram in 2012. The incidence and severity was highest in patients receiving herceptin with anthracyclinecontaining chemotherapy regimens. Trastuzumab may prevent the growth of some breast tumors that produce extra amounts of a certain substance known as the her2 protein. Below is a text only representation of the patient information leaflet. Herceptin trastuzumab side effects, dosage, interactions. Herceptin trastuzumab treatment information for her2. Australian product information herceptin sc trastuzumab solution for injection 1. Interrupt herceptin infusion for dyspnea or clinically significant hypotension. Cardiomyopathy, infusion reactions, embryofetal toxicity, and pulmonary. Herceptin and its biosimilars are mediators of antibodydependent cellular cytotoxicity adcc. The clinical trial will be conducted in accordance with the protocol and the requirements as set out in part 4 of the natural health products regulations. Left ventricular dysfunction and embryofetal toxicity.
Call a nurse at 800 8218590, mondayfriday, 5am5pm pt. Herceptin iv trastuzumab drug medicine information. If it has not spread into the lymph nodes, the cancer needs to be estrogen receptorprogesterone receptor erprnegative. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for herceptin trastuzumab. Other signs andor symptoms may include nausea, vomiting, pain, rigors, headache, cough, dizziness, rash, asthenia and hypertension. Fda approval letter follow this link and search by the drug name prescribing information. Monitor patients until symptoms completely resolve. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use. Vyeptitm eptinezumabjjmr injection, for intravenous use. Symptoms usually occur during or within 24 hours of herceptin administration. Nov 01, 2019 kadcyla official prescribing information for healthcare professionals. See full prescribing information for complete boxed warning. See 17 for patient counseling information and fda approved patient labeling.
Dailymed herceptin trastuzumab kit herceptin trastuzumab. This guide provides tips to help you draft an appeal letter. Herceptin can help control the growth of cancer cells that contain high amounts of human epidermal growth factor receptor 2 her2. Herceptin hylecta trastuzumab and hyaluronidaseoysk injection, for subcutaneous use initial u. See full prescribing information for herceptin hylecta. Herceptin trastuzumab, herceptin hylecta trastuzumab. Choosing to participate in a study is an important personal decision. Highlights of prescribing information initial dose of 4. There is no information regarding presence of adotrastuzumab emtansine in human milk, effects on breastfed infant, or on milk production. Herceptin 600 mg solution for injection in vial summary of.
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