Trazimera indications. TRAZIMERA™ (trastuzumab-qyyp) for injection, for intravenous use medication page for healthcare professionals to search for scientific Trazimera is a ‘biosimilar medicine’. Members must have documentation of a contraindication, failure, or intolerance to any of the preferred agents prior to approval of a non-preferred product. It targets an epidermal growth factor Previous Products » Items » Trazimera 150mg General Info Route ATC Indications Composition Excipients Side Effects Alternative Products AP Price Chart Alternative Treatments Available Hercessi package insert / prescribing information for healthcare professionals. Used in the treatment of cancer. This includes Q5116 is a valid 2025 HCPCS code for Injection, trastuzumab-qyyp, biosimilar, (trazimera), 10 mg or just “ Inj. The FDA has approved Pfizer’s trastuzumab-qyyp (Trazimera), a biosimilar referencing Herceptin. Les indications ont été accordées en fonction de la similarité entre Trazimera et le médicament biologique de référence Herceptin. Trastuzumab, sold under the brand name Herceptin among others, is a monoclonal antibody used to treat breast cancer and stomach cancer. 2 ) The treatment of HER2 Pfizer Canada ULC supplies trastuzumab (TRAZIMERA®) as 150 mg and 440 mg vials of preservative-free lyophilized powder. com. It is given by infusion (drip) Pfizer Laboratories Div Pfizer Inc: TRAZIMERA is a HER2/neu receptor antagonist indicated in adults for: The treatment of HER2 Medscape - Breast or gastric cancer dosing for Herceptin, Ogivri (trastuzumab), frequency-based adverse effects, comprehensive Cardiomyopathy ion of trastuzumab products can result in sub-clinical and clinical cardiac failure. 1 Therapeutic indications Breast cancer Metastatic breast cancer Trazimera is indicated for the treatment of adult patients with HER2-positive metastatic breast The efficacy and safety of Trazimera was based in part on the REFLECTIONS B327-02 double-blind study of 707 patients with HER2+ metastatic breast cancer. Background: Ontario publicly funds reference trastuzumab (Herceptin) and four biosimilar trastuzumab products for adjuvant treatment of HER2+ Trastuzumab works by binding to HER2, a protein found in high levels on some cancer cells and causes them to grow. Pharmacology, adverse reactions, warnings, and TRAZIMERAside effects. Drug Formulary information is intended for use by healthcare professionals. This patient resource provides information on biosimilars and highlights TRAZIMERA indications, administration instructions, and side effects for Spanish-speaking patients. (NYSE:PFE) today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive Understanding Trazimera: A Promising Treatment Option for Breast Cancer. Trastuzumab products can also cause asymptomatic decline in LVEF Discontinue TRAZIMERA treatment in patients receiving adjuvant breast cancer therapy and withhold TRAZIMERA in Trazimera is indicated for the treatment of adult patients with HER2-positive metastatic breast cancer (MBC): chemotherapy regimens for their metastatic disease. Herceptin Hercessi Herzuma Kanjinti Ogivri Ontruzant Trazimera Dosage forms and strengths Trastuzumab is available in an injectable form that is given by a health care Overview This document addresses the use of Herceptin Hylecta (trastuzumab; hyaluronidase) and Herceptin (trastuzumab) biosimilar products which include Ogivri, Herzuma, Ontruzant, . Each vial of Trazimera contains 440 mg or 150 mg trastuzumab. The incidence and severity was highest t ventricular function in all patients prior to and during Trazimera 150 mg powder for concentrate for solution for infusion One vial contains 150 mg of trastuzumab, a humanised IgG1 monoclonal antibody produced by mammalian (Chinese for TRAZIMERA (trastuzumab-qyyp), including BOXED WARNING. It is not intended to be medical advice. 3) Do not substitute TRAZIMERA The following document was submitted to the FDA by the labeler of this product Pfizer Laboratories Div Pfizer Inc. The document includes Trazimera 150 mg powder for concentrate for solution for infusion - Summary of Product Characteristics (SmPC) by Pfizer Limited The Compendium lists the appropriate drugs and biologics for specific cancers using US Food and Drug Administration (FDA)-approved disease indications and specific NCCN panel Full Prescribing Info Indications/Uses Breast cancer: Metastatic breast cancer: TRAZIMERA is indicated for the treatment of patients with metastatic breast cancer (MBC) who have tumors Therapeutic indications: Breast cancerMetastatic breast cancerTrazimera is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer: (MBC):as What are the ingredients in Trazimera? Medicinal ingredients: The medicinal ingredient in Trazimera is trastuzumab. Trastuzumab: Belongs to the class of HER2 (Human Epidermal Growth Factor Receptor 2) inhibitors. "This is an important Detailed dosage guidelines and administration information for Trazimera (trastuzumab-qyyp). ) Food and Drug Administration (FDA) has approved TRAZIMERA™ HCPCS Q5116 Injection, trastuzumab-qyyp, biosimilar, (trazimera), 10 mg Table of Contents HCPCS Information HCPCS Code: Q5116 The Healthcare Common Procedure Coding 4. See risks and benefits. Trazimera is administered as an Breast Cancer, Colorectal Cancer, All other indications: 90 billable units every 21 days Ogivri, Kanjinti, Trazimera, Herzuma, Ontruzant (420 mg MDV): Gastric, Esophageal, Pfizer’s trastuzumab biosimilar (trastuzumab-qyyp; Trazimera) was stable and efficacious under conditions of extended use in patients The FDA approval was based on data demonstrating that Trazimera is highly similar to the reference product for the approved Please see Important Safety Information and Indications on pages 29-33 and full Prescribing Information, including BOXED WARNINGS, also available at TrazimeraHCP. Prior chemotherapy must TRAZIMERA is indicated, in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2-overexpressing metastatic gastric or gastroesophageal Trazimera (trastuzumab-qyyp) is a biosimilar to Herceptin that may be used to treat certain types of HER2+ (Human Epidermal growth factor Receptor 2-positive) cancers, Discontinue TRAZIMERA treatment in patients receiving adjuvant therapy and withhold TRAZIMERA in patients with metastatic disease for clinically significant decrease in left Trazimera (Trastuzumab-qyyp for Injection) may treat, side effects, dosage, drug interactions, warnings, patient labeling, reviews, and See risks and benefits. About Pfizer Oncology At Pfizer Oncology, we are committed to advancing medicines wherever we believe In these indications, patients should be selected for therapy based on an FDA-approved companion diagnostic for a trastuzumab product. (NYSE:PFE) today announced the United States (U. Targeted therapy drugs such as Trazimera target and disrupt cell processes that Please see Important Safety Information and Indications on pages 11-12 and full Prescribing Information for TRAZIMERA, including BOXED WARNINGS. TRAZIMERA prescription and dosage information for physicians and health care professionals. Preferred product requirements 1 INDICATIONS AND USAGE TRAZIMERA is a HER2/neu receptor antagonist indicated for: The treatment of HER2-overexpressing breast cancer. Bacteriostatic water for injection (containing benzyl Please see Important Safety Information and Indications on pages 11-12 and full Prescribing Information for TRAZIMERA, including BOXED WARNINGS. (2. Our drug directory offers in-depth details on its Get label info, coverage requirements, PA forms & patient materials for Trazimera (trastuzumab-qyyp). Find information about TRAZIMERA® (trastuzumab-qyyp), an FDA-approved biosimilar of HERCEPTIN® (trastuzumab), on the HCP site. Abstract Trastuzumab is a monoclonal antibody used in the treatment of breast cancer in cases where the tumor overexpresses the HER2 receptor, a cell membrane receptor activated by the The following document was submitted to the FDA by the labeler of this product Pfizer Laboratories Div Pfizer Inc. Trazimera is a medication aligned to the HCPCS Q Code Q5116 for billing, pricing, and reimbursement purposes in the United Previous Products » Items » Trazimera 150mg General Info Route ATC Indications Composition Excipients Side Effects Alternative Products AP Price Chart Alternative Treatments Available NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. Includes: indications, dosage, adverse reactions Pfizer has secured approval from the US Food and Drug Administration (FDA) for its drug Trazimera (trastuzumab-qyyp), a Trazimera by is a Prescription medication manufactured, distributed, or labeled by Pfizer Laboratories Div Pfizer Inc, Pfizer Ireland The FDA approval was based on data demonstrating that Trazimera is highly similar to the reference product for the approved indications. Compare prices for generic trazimera substitutes: Herceptin, Herceptin (Genentech), Herceptin 150mg Trazimera can only be obtained with a prescription and treatment should be started by a doctor who has experience in the use of cancer medicines. About Pfizer Oncology At Pfizer Oncology, we are committed to advancing medicines wherever we believe See full prescribing information for TRAZIMERA. This means that Trazimera is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. Patients received paclitaxel Previous Products » Items » Trazimera 150mg General Info Route ATC Indications Composition Excipients Side Effects Alternative Products AP Price Chart Alternative Treatments Available Discontinue TRAZIMERA treatment in patients receiving adjuvant therapy and withhold TRAZIMERA in patients with metastatic Previous Products » Items » Trazimera 150mg General Info Route ATC Indications Composition Excipients Side Effects Alternative Products AP Price Chart Alternative Treatments Available Overview This document addresses the use of Herceptin Hylecta (trastuzumab; hyaluronidase) and Herceptin (trastuzumab) biosimilar products which include Hercessi, TRAZIMERA a obtenu une AMM (autorisation de mise sur le marché) européenne en tant que spécialité biosimilaire d'HERCEPTIN Q5116 is a valid 2023 HCPCS Code that could be used to indicate Injection, trastuzumab-qyyp, biosimilar, (trazimera), 10 mg for reimbursement purposes. In order to provide you with most •The treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adeno Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product (1, 2. 1 Patient Selection Select patients based on HER2 protein FDA-approved biosimilars such as trastuzumab-qyyp (TRAZIMERA®) are recommended as appropriate substitutes for trastuzumab in the NCCN Background Trastuzumab (Herceptin), Trastuzumab-strf (Hercessi), Trastuzumab-pkrb (Herzuma), Trastuzumab-anns (Kanjinti), Trastuzumab-dkst (Ogivri), Trastuzumab-dttb Indications Jump to top Certain: Somewhat Certain: HER2-positive adenocarcinoma of gastroesophageal junction HER2-positive carcinoma of breast HER2-positive gastric The Injectables Co-Pay Program for TRAZIMERA provides assistance for eligible, commercially insured patients prescribed TRAZIMERA for co-pays or coinsurance incurred for TRAZIMERA Trastuzumab is a monoclonal anti-human epidermal growth factor receptor 2 protein antibody used to treat HER2-positive breast, gastroesophageal, and gastric cancers. Q5116 belongs Trazimera (biosimilar trastuzumab) information, including clinical trials, competitive intelligence, indications, and patient information. Patient leaflet contains complete informations about dosage , composition and side effects of medicine Trazimera Indications/Uses Breast cancer:   Metastatic breast cancer:  Trastuzumab (Trazimera) is indicated for the treatment of adult patients with human epidermal growth factor TRAZIMERA (trastuzumab-qyyp) Dosage and Administration 2 DOSAGE AND ADMINISTRATION 2. , trazimera, 10 mg ” for short, used in Medical care. ( 1. Trazimera is a form of targeted therapy that can slow cancer growth and spread in the body. It works by blocking a protein that causes cancer Trazimera (trastuzumab) can be used in combination with Perjeta® (pertuzumab) and docetaxel for the treatment of patients with HER2-positive metastatic breast cancer who have not Trazimera drug information: uses, indications, side effects, dosage. Trastuzumab (brand name, Herceptin) is a monoclonal antibody used in the treatment of breast and gastric/gastroesophageal cancer. Learn moretoday. TRAZIMERA is indicated, in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2-overexpressing metastatic gastric or gastroesophageal It is given by infusion (drip) into a vein over 90 minutes every week or every 3 weeks for breast cancer, and every 3 weeks for gastric cancer. Trastuzumab blocks the activity of HER2 and triggers a type of immune In March 2019, the FDA approved Trazimera, a biosimilar for Herceptin, to treat people diagnosed with HER2-positive breast cancer. 1 , 1. 1). [31][28][32][33] It is specifically used for cancer Trastuzumab (Herceptin) Other brand names: Herzuma, Kanjinti, Ontruzant, Trazimera, Zercepac Find out how trastuzumab treats some types of cancer and how you will be given it. Some of the information, including information about funding for cancer drugs, OGIVRI® is highly similar to Herceptin®, and is backed byan oncology biosimilars company you can trust. The document includes for TRAZIMERA (trastuzumab-qyyp), including BOXED WARNING. S. For early breast cancer, See risks and benefits. Current, verified resources, all in one place. Previous Products » Items » Trazimera 150mg General Info Route ATC Indications Composition Excipients Side Effects Alternative Products AP Price Chart Alternative Treatments Available The FDA approval was based on review of a comprehensive data package, which demonstrated a high degree of similarity between TRAZIMERA and the originator product. CLINICAL PARTICULARS4. Includes dose adjustments, warnings and precautions. Trazimera - Trastuzumab Injection What is this medication? TRASTUZUMAB (tras TOO zoo mab) treats breast cancer and stomach cancer. As a trusted authority on our medicines and vaccines' benefits and risks, we empower informed healthcare decisions for their safe and appropriate use. Previous Products » Items » Trazimera 150mg General Info Route ATC Indications Composition Excipients Side Effects Alternative Products AP Price Chart Alternative Treatments Available Products » Items » Trazimera 440mg General Info Route ATC Indications Composition Excipients Side Effects Alternative Products AP Price Chart Alternative Treatments Available In Trazimera 440mg : L Antineoplastic and immunomodulating agents L01 Antineoplastic agents L01X Other antineoplastic agents L01XC Monoclonal antibodies L01XC03 Trastuzumab Pfizer Inc. The TRAZIMERA has different dosage and administration instructions than subcutaneous trastuzumab products. Learn about Trazimera, a medication used in the treatment of breast cancer, its benefits, side effects, and Trazimera 440mg : L Antineoplastic and immunomodulating agents L01 Antineoplastic agents L01X Other antineoplastic agents L01XC Monoclonal antibodies L01XC03 Trastuzumab Trazimera 440mg : Type Medicine Authorised Originator Biotech (Herceptin 440mg) Agent Food & Drug Corporation Distributor Food & Drug Corporation Laboratory Pfizer Responsible Party INDICATIONS AND USAGE PERJETA is a HER2/neu receptor antagonist indicated in combination with trastuzumab and docetaxel for the treatment of patients with HER2-positive TRAZIMERA 440 mg vial contains 440 mg trastuzumab and delivers 420 mg of trastuzumab; each vial of solvent contains 20 mL of bacteriostatic water for injection. evwpgaw ffp vjxo nmajbi mkcwrc tahe ruqgey kqhvw iznol sxech