Herceptin trastuzumab is a recombinant dnaderived humanized monoclonal antibody that selectively binds with high affinity in a cellbased assay kd 5 nm to the extracellular domain of the human epidermal growth factor receptor 2 protein, her2. Pegaspargase oncaspar the authors make no claims of the accuracy of the information contained herein. Highlights of prescribing information these highlights do. Perjeta is indicated for use in combination with trastuzumab and docetaxel in.
Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for herceptin trastuzumab. By connor th, mackenzie ba, debord dg, trout db, ocallaghan jp. When using in combination with perjeta pertuzumab and docetaxel, consult product monographs for perjeta and docetaxel for further information on these drugs. For healthcare professionals nerlynx neratinib tablets. In a randomized trial comparing pertuzumab, trastuzumab, and docetaxel with placebo, trastuzumab, and docetaxel, the pertuzumab combination resulted in a median overall survival of 56 months in wom. Pdf should pertuzumab be used as part of neoadjuvant treatment. Besponsa inotuzumab ozogamicin dosage and administration. Keytruda can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. Pertuzumab perjeta national drug monograph december 2014.
Administer premedications before each dose of empliciti ee doage and s s administration 2. Docetaxel is an antineoplastic agent that acts by disrupting the microtubular network in cells that is essential for mitotic and interphase cellular functions. This document provides specific information to each section of the overall policy. Herceptin is indicated, in combination with cisplatin and capecitabine or 5fluorouracil, for the treatment of patients with her2 overexpressing metastatic gastric or gastroesophageal. If patients must be coadministered, a strong cyp3a4 inhibitor. If a significant infusionassociated reaction occurs, slow or interrupt the infusion. Er status and her2 are important factors in determining the suitable. These problems can sometimes become severe or lifethreatening and can lead to death. Information for the user nipent 10 mg powder for solution for injection, powder for solution for infusion pentostatin read all of this leaflet carefully before you start using this medicine. Perjeta should be discontinued if trastuzumab treatment is discontinued. Each singledose vial contains 420 mg of pertuzumab at a concentration of 30 mgml in 20 mm lhistidine acetate ph 6. Administer perjeta, trastuzumab, and docetaxel by intravenous. Niosh list of antineoplastic and other hazardous drugs in healthcare settings, 2016.
Perjeta injection fda prescribing information, side effects. Treatment of pregnant cynomolgus monkeys with pertuzumab resulted in oligohydramnios, delayed fetal kidney. Carboplatin carboplatin this product information is intended only for residents of the united states. Empliciti elotuzumab for injection, for intravenous use initial u. Grapefruit may also increase plasma concentrations of lapatinib and should be avoided. Cycle 1 is 3 weeks in duration, but may be extended to 4 weeks if the. Perjeta pertuzumab injection, for intravenous use initial u.
Highlights of prescribing information these highlights do not include all the information needed to use keytrudasafely and effectively. The initial dose of pertuzumab is 840 mg administered as a 60minute iv infusion, followed every 3 weeks thereafter by 420 mg administered as a 30 to 60minute infusion. Trastuzumab is produced by recombinant dna technology in a mammalian cell chinese hamster ovary culture which may contain the antibiotic gentamicin. On days that empliciti is administered, for patients 75 years or younger give. Cardiotoxicity from trastuzumab is largely reversible and therefore characterized as causing type ii chemotherapyrelated cardiac dysfunction. Initial dose of 4 mgkg over 90 minute iv infusion, then 2 mgkg over. Do not substitute herceptin trastuzumab for or with adotrastuzumab emtansine. Dailymed perjeta pertuzumab injection, solution, concentrate.
Refer to the dexamethasone and pomalidomide prescribing information for additional information. Sections or subsections omitted from the full prescribing information are not listed. Studies in animals have resulted in oligohydramnios, delayed renal development, and death. Pertuzumab is indicated in combination with trastuzumab and docetaxel for the treatment of patients with her2positive metastatic breast cancer genentech, 2012. Keytruda can cause your immune system to attack normal organs and tissues in any area of. Each single use vial contains 420 mg of pertuzumab at a concentration of 30 mgml in 20 mm lhistidine acetate ph 6. Refer to the product monographs of herceptin and docetaxel for. Campath alemtuzumab is a recombinant dnaderived humanized monoclonal antibody campath1h that is directed against the 2128 kd cell surface glycoprotein, cd52. Trastuzumab is a humanized igg1 kappa monoclonal antibody that selectively binds with high affinity to the extracellular domain of the human epidermal growth factor. Niosh list of antineoplastic and other hazardous drugs in. Highlights of prescribing information urothelial carcinoma. As pertuzumab and trastuzumab bind to different domains of the. Perjeta pertuzumab dosing, indications, interactions. Weve made enrollment simpler, faster and more intuitive with some key changes to our forms.
Cd52 is expressed on the surface of normal and malignant b and t lymphocytes, nk cells, monocytes, macrophages, and tissues of the male reproductive system. Perjeta pertuzumab injection, for intravenous use package insert. Please see full prescribing information for additional important. Sections or subsections omitted from the full prescribing information are not listed full prescribing information warning. Policy document for perjeta pertuzumab the overall objective of this policy is to support the appropriate and cost effective use of the medication. Effect of prophylaxis or neratinib dose escalation on neratinibrelated diarrhea and tolerability in patients with her2positive earlystage breast cancer. If patients must be coadministered, a strong cyp3a4 inhibitor, based on pharmacokinetic studies, a dose reduction to 500 mgday of lapatinib is predicted to adjust the lapatinib auc to the range.
Premedicate before each dose see dosage and administration 2. Patients treated with perjeta should have her2 positive tumour. Perjeta pertuzumab is a prescription medicine approved for use in combination with herceptin trastuzumab and chemotherapy for use prior to surgery neoadjuvant treatment in people with her2positive, locally advanced, inflammatory, or early stage breast cancer tumor is greater than 2 cm in diameter or nodepositive. Pertuzumab in the treatment of her2positive breast cancer. The prescriber service form and the patient consent form are required. Highlights of prescribing information initial dose of 4 mg. Dpi drug package insert epa environmental protection agency. As part of a treatment regimen containing doxorubicin, cyclophosphamide and either paclitaxel or docetaxel. In order to improve traceability of biological medicinal products, the trade name and the batch number of the administered product should be clearly recorded or stated in the patient file.
Perjeta 420 mg concentrate for solution for infusion pertuzumab. Highlights of prescribing information trisenox arsenic. Pertuzumab is a sterile, clear to slightly opalescent, colorless to pale brown liquid for intravenous infusion. Advise patients of these risks and the need for effective contraception. Perjeta 420 mg concentrate for solution for infusion. If you have any further questions, ask your doctor. Highlights of prescribing information these highlights do not. Highlights of prescribing information initial dose of. Pertuzumab in metastatic breast cancer pubmed central pmc.
Perjeta should be readministered as a 60minute intravenous infusion followed every 3 weeks thereafter by a dose of 420 mg administered as an intravenous infusion over 30 to 60 minutes. Docetaxel fda prescribing information, side effects and uses. Gemzar vials contain no antimicrobial preservatives and are intended for single use only. Reactions may include hypotension, dyspnea, upper airway edema, lip swelling, rash, pruritus, and urticaria. Information for the user herceptin 150 mg powder for concentrate for solution for infusion trastuzumab read all of this leaflet carefully before you start using this medicine because it contains important information for you. Va pharmacy benefits management services, medical advisory panel, and visn pharmacist. For the first cycle, the recommended total dose of besponsa for all patients is 1. Er status and her2 are important factors in determining the suitable treatment. Left ventricular dysfunction and embryofetal toxicity see full prescribing information for complete boxed warning. Jun 05, 2017 38 about aphinity7 aphinity adjuvant pertuzumab and herceptin in initial therapy in breast cancer, nct058877 bo25126 big 411 is an international, phase iii, randomised, doubleblind, placebocontrolled, twoarm study evaluating. Nerlynx is a kinase inhibitor indicated for the extended adjuvant treatment of adult patients with earlystage her2overexpressedamplified breast cancer, to follow adjuvant trastuzumab.
Information for the user herceptin 150 mg powder for concentrate for solution for infusion trastuzumab read all of this leaflet carefully before you start using this. Follow applicable special handling and disposal procedures. Pertuzumab also called 2c4, trade name perjeta is a monoclonal antibody used in combination with trastuzumab and docetaxel for the treatment of metastatic her2positive breast cancer. Page 1 of 36 highlights of prescribing information these highlights do not include all the information needed to use perjeta safely and effectively. If a significant infusionassociated reaction occurs, slow or interrupt the infusion and administer appropriate medical therapies. Perjeta injection is a sterile, clear to slightly opalescent, colorless to pale brown liquid for intravenous infusion. Docetaxel binds to free tubulin and promotes the assembly of tubulin into stable microtubules while simultaneously inhibiting their disassembly. Keytruda is a medicine that may treat certain cancers by working with your immune system. Perjeta pertuzumab is a prescription medicine approved for use in combination with herceptin trastuzumab and chemotherapy for. Talk to a healthcare professional for more information about the benefits and risks of perjeta. Cardiopulmonary arrest and hypomagnesemia 1 indications and usage 1. Perjeta pertuzumab 420 mg14 ml 30 mgml in a singleuse vial 4 contraindications none. See full prescribing information for complete boxed warning.
Restricted access do not disseminate or copy without approval. Va pharmacy benefits management services, medical advisory panel, and visn pharmacist executives. Highlights of prescribing information initial dose of 4. Feb 06, 2020 pertuzumab has an approximate molecular weight of 148 kda.
Pertuzumab has an approximate molecular weight of 148 kda. Feb 01, 2020 pertuzumab has an approximate molecular weight of 148 kda. Highlights of prescribing information these highlights do not include all the information needed to use empliciti safely and effectively. Xgeva includes the same active ingredient denosumab found in prolia. Clinical criteria policy information specific to the clinical appropriateness for the medication. Highrisk is defined as erprpositive with one of the following features. Perjeta pertuzumab prior auth criteria proprietary information. Pertuzumab, trastuzumab, and docetaxel in her2positive. Aphinity study shows roches perjetabased regimen reduced. The nccn compendium is a derivative work of the nccn guidelines. Highlights of prescribing information contraindications these. Exposure to perjeta can result in embryofetal death and birth defects.
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