Apos cirurgia, quimioterapia neoadjuvante ou adjuvante e. Herceptin and anthracyclines should not be given concurrently in the adjuvant treatment setting. Herceptin may result in the death of an unborn baby or birth defects. Herceptin hylectatm vials 600 mg5 ml sc safety data sheet section 1. A study of pertuzumab and trastuzumab subcutaneous sc. Webmd provides common contraindications for herceptin intravenous. It is important to check the product labels to ensure that the appropriate formulation iv or sc is being given to the. Mabthera intravenous formulation is not intended for subcutaneous sc administration.
Herceptin infusion should be interrupted for patients experiencing dyspnea or clinically. Neutralizing antitrastuzumab antibodies were detected in postbaseline samples in 2 of 30 patients in the herceptin intravenous arm and 3 of 47 in the herceptin subcutaneous arm. Datasheet methods to determine the binding of trastuzumab to. Jun 12, 2014 herclon and herceptin are both manufactured by roche and contain the same ingredient trastuzumab. Permanently discontinue herceptin for a persistent 8 weeks lvef decline or for suspension of herceptin dosing on more than 3 occasions for cardiomyopathy. Perjeta pertuzumab is a prescription medicine approved for use in combination with herceptin trastuzumab and chemotherapy for. Sep 30, 2019 use the herceptin solution immediately following reconstitution with swfi, as it contains no preservative and is intended for singledose only. The patents on herceptin will expire in the us in june 2019 and expired in europe in july 2014 1. Herclon and herceptin are both manufactured by roche and contain the same ingredient trastuzumab. Herceptin resistance database for understanding mechanism of. A study to compare subcutaneous sc versus intravenous iv. Had my first herceptin only infusion yesterday and having a double mastectomy at the end of july then about 6 weeks later 6 12 weeks of radiation.
My hair is slowly growing back but my nails are not so hot, i keep them very short and painted. The herceptin alone gives a hyper sensitivity to light on day 4 and 5. Safety data sheet herceptin hylectatm vials 600 mg5 ml sc. Trastuzumab herceptin, j9355 multidose vial waste op per its package label, trastuzumab herceptin is supplied by the manufacturer in a 440 mg multidose vial.
Breast cancer home herceptin dosage your dosage of herceptin will depend on your weight, the progression of your cancer, and other factors. I go in for my first herceptin and perjeta only treatment next week and i am hoping i feel good. Herceptin administration can result in severe hypersensitivity reactions including anaphylaxis, infusion reactions, and pulmonary events. Herceptin is a powder for concentrate for solution for infusion, that is supplied in a glass vial with a rubber stopper containing 150 mg of trastuzumab. At my first appointment nearly a year ago the doc told me 17 doses. Subcutaneous trastuzumab herceptin sc is administered as a fixed dose of 600 mg irrespective of the patient. Treatment with trastuzumab herceptin for 1 year following standard chemotherapy improved diseasefree survival in women with her2positive early breast cancer. Subcutaneous trastuzumab for her2positive breast cancer. Contraception should be used while receiving herceptin and for 7 months after your last dose of herceptin. Trastuzumab is a monoclonal antibody used in treating her 2 neupositive carcinoma of. I started do light work outs to gain back some energy and strength and it has been a big help. Herceptin 150mg powder for concentrate for solution for infusion. Product identifier product name herceptinr vials 150 mg.
Herceptin sc e por 7 meses apos o termino do tratamento. As informacoes disponiveis nesta bula aplicamse exclusivamente a herceptin sc. The dose is administered at your healthcare providers. Mar 27, 2014 monoclonal antibody trastuzumab herceptin is considered as frontline therapy for her2positive breast cancer patients. The finding comes from the third analysis of the herceptin adjuvant hera trial, a large multicenter study that compared outcomes in patients randomly assigned to receive standard chemotherapy followed by trastuzumab with those in. Do not substitute herceptin hylecta for or with ado. The safety profiles of sc and iv trastuzumab were considered comparable, as the prefher study identified that adverse events of any grade based on the national cancer institute common. A study to compare subcutaneous versus intravenous.
I do have slight nausea which seems tolerable with compazine and any pain is controlled with oxicodone. Herceptin sc binds selectively to a protein called human epidermal growth factor receptor 2 her2. Experiences after 1 year herceptin and 1 year tamoxifen. Use the herceptin solution immediately following reconstitution with swfi, as it contains no preservative and is intended for singledose only. Safety data sheet herceptinr vials 150 mg section 1. Health professional information summary product information information as set forth in this label only applies to herceptin sc. Identification of the substancemixture and of the companyundertaking 1. Composicion, indicaciones, presentacion y contraindicaciones.
If not used immediately, store the reconstituted herceptin solution for up to 24 hours at 2c to 8c 36f to 46f. Relevant identified uses of the substance or mixture and uses advised. Route of administration dosage form strength clinically relevant nonmedicinal ingredients subcutaneous solution for injection 600 mg5 ml vial. Jul 31, 2009 herceptin sc will be given on day 1 of each 21day cycle, as a 600milligram mg fixed dose. Qualitative and quantitative composition herceptin sc vial contains 600mg5ml of trastuzumab. As informacoes disponiveis nessa bula aplicamse exclusivamente ao herceptin sc. Herceptin sc190507 1 australian product information herceptin sc trastuzumab solution for injection 1. In most cases, symptoms occurred during or within 24 hours of administration of herceptin. Herceptin is available as a singledose vial containing 60 mg or 150 mg of trastuzumab with the following excipients. Herceptin 150 mg powder for concentrate for solution forinfusion. Interrupt herceptin infusion for dyspnea or clinically significant hypotension. Herceptin is a sterile, white to pale yellow, preservative free lyophilized powder for intravenous iv infusion. Dec 24, 20 this openlabel, multicenter, phase iiib study will assess the safety, tolerability and efficacy of a combination therapy of intravenous iv pertuzumab perjeta, trastuzumab herceptin sc, and taxane chemotherapy docetaxel, paclitaxel or nabpaclitaxel as firstline therapy in participants with her2positive metastatic breast cancer mbc. Herceptin is available as a singledose vial containing 60 mg or 150 mg of trastuzumab.
Product identifier product name herceptinr vials 150 mg product code sap10046108 synonyms herceptinr lyophilized vials 150 mg 1. Trastuzumab is used for the treatment of primary breast cancers which overexpress her2. Anvisa, the brazilian national health surveillance agency. Trastuzumab is a monoclonal antibody used in treating her 2 neupositive carcinoma of breast. Trastuzumab after chemotherapy is effective in her2positive.
Risk factors for a cardiac event identified in four large adjuvant studies included advanced age 50 years, low level of baseline and declining lvef herceptin trastuzumab company. Our discount and coupon prices are based on contracts between a pharmacy or pharmacy purchasing group and a pharmacy benefit manager pbm, who provides. Expectations, immunogenicity, and safety for sc trastuzumab the metapher study is an ongoing phase iiib multi center, openlabel, singlearm study that intends to. Just some of the trastuzumab biosimilars approved or in development are presented below, see table 1. Biosimilars of trastuzumab general biosimilars home. Herceptin administration can result in serious and fatal infusion reactions and pulmonary. Her2 is found in large amounts on the surface of some cancer cells. The dose is administered at your healthcare providers office, a hospital, or an infusion center either once a week or once every three weeks, depending on your dosing schedule. The pivotal trial bo22227 was designed to demonstrate noninferiority of treatment with herceptin subcutaneous formulation versus treatment with herceptin intravenous formulation based on coprimary pk and efficacy endpoints trastuzumab c trough at predose cycle 8, and pcr rate at definitive surgery, respectively see section 5. Herceptin sc is a new more convenient formulation of herceptin that uses enhanze technology, developed by halozyme therapeutics, inc. Permanently discontinue herceptin hylecta for a persistent 8 weeks lvef decline or for suspension of herceptin hylecta dosing on more than 3 occasions for cardiomyopathy.
Now i am on herceptin only every 3 weeks until end of feb which will be my 1 year mark. Roche roches herceptin given by subcutaneous injection. Find out what health conditions may be a health risk when taken with herceptin intravenous. Persons with disabilities having problems accessing the pdf files below may call 301 7963634 for assistance. This openlabel, multicenter, phase iiib study will assess the safety, tolerability and efficacy of a combination therapy of intravenous iv pertuzumab perjeta, trastuzumab herceptin. Monoclonal antibody trastuzumabherceptin is considered as frontline therapy for her2positive breast cancer patients. Herceptin 600 mg solution for injection in vial summary of. Product identifier product name herceptin hylectatm vials 600 mg5 ml sc product code sap10112127 synonyms herceptin hylecta sc herceptin hylecta s. Mar 23, 2012 herceptin sc is a new more convenient formulation of herceptin that uses enhanze technology, developed by halozyme therapeutics, inc. Symptoms usually occur during or within 24 hours of herceptin administration.
Please use one of the following formats to cite this article in your essay, paper or report. Genentech application no 103792s5187s5189 approval date. Herceptin sc trastuzumab drug medicine information. Iii trial, which aimed to provide a more convenient and cost. The pivotal trial bo22227 was designed to demonstrate noninferiority of treatment with herceptin subcutaneous formulation versus treatment with herceptin intravenous formulation based on co. About goodrx prices and herceptin coupons goodrx s cash prices are based on multiple sources, including published price lists, purchases, claims records, and data provided by pharmacies. Principais interacoes medicamentosas nao foram observadas interacoes clinicamente significativas entre herceptin sc ou herceptin via intravenosa e a medicacao utilizada concomitantemente nos estudos clinicos. Taxoterecarboplatinherceptin regimen question cancer. However, it is not effective against several patients due to acquired or. Herceptin sc will be given on day 1 of each 21day cycle, as a 600milligram mg fixed dose. Herceptin and perjeta post chemo breast cancer discussions. If you are or become pregnant while receiving herceptin or within 7 months after your last dose of herceptin, you should immediately report herceptin exposure to. Permanently discontinue herceptin for a persistent 8 weeks lvef.