TRAZIMERA, in combination with the chemotherapy drug paclitaxel, is approved for the first-line treatment of Human Epidermal growth factor Receptor 2-positive (HER2+) metastatic breast cancer TRAZIMERA alone is approved for the treatment of HER2+ breast cancer in patients who have received one or more chemotherapy courses for metastatic disease

2020-08-17 · DailyMed is the official provider of FDA label information (package inserts). This Web site provides a standard, comprehensive, up-to-date, look-up and download resource of medication content and labeling found in medication package inserts.

TRAZIMERA (trastuzumab-qyyp) is biosimilar* to HERCEPTIN See full prescribing information for complete boxed warning. 14 Apr 2020 Trazimera is not available as a 150 mg vial, but it has the cheapest price per mg. Herceptin prices. Drug Name. List price 20 May 2020 C. Preferred biosimilar drugs and corresponding reference drug. 1.

Document Library A single point-of-access to technical documents for our entire portfolio of medical devices, assays, test kits and Healthcare IT offerings. 2021-01-05 · trastuzumab-qyyp (Trazimera™ [Q5116]); AND • Patient is at least 18 years of age; AND Universal Criteria 1-6 • Left ventricular ejection fraction (LVEF) is within normal limits prior to initiating therapy and will be assessed at regular intervals (e.g., every 3 months) during treatment; AND TRAZIMERA is approved, in combination with chemotherapy (cisplatin and either capecitabine or 5-fluorouracil), for the treatment of HER2+ metastatic cancer of the stomach or gastroesophageal junction (where the esophagus meets the stomach) in patients who have not received prior treatment for their metastatic disease. TRAZIMERA is a monoclonal antibody (mAb) biosimilar of the originator biologic medicine, Herceptin, which targets HER2, a protein found on the surface of some cancer cells which can stimulate the cells to divide and grow. 11 TRAZIMERA locks on to the HER2 protein and blocks the receptors, stopping cell division and growth. 10 Produkt Trazimera jest przeznaczony do podawania dożylnego. Dawka nasycająca powinna być podawana w 90-minutowym wlewie dożylnym. Nie podawać przez wstrzyknięcie ani jako bolus.

Yeonsu-gu, Incheon, Republic of Korea; Samsung Bioepsis; March 2020. Accessed May 2020. 7.

Pfizer Inc. (NYSE:PFE) today announced the European Commission (EC) has approved TRAZIMERA™,1 a biosimilar to Herceptin®* (trastuzumab), for the treatment of human epidermal growth factor (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.2 This approval follows the recommendation from the Committee for Medicinal

2020-12-09 Pfizer Inc. (NYSE:PFE) today announced the European Commission (EC) has approved TRAZIMERA™,1 a biosimilar to Herceptin®* (trastuzumab), for the treatment of human epidermal growth factor (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.2 This approval follows the recommendation from the Committee for Medicinal 2019-03-11 cancer cells that do not over-express HER2. Herzuma, Kanjinti, Ogivri, Ontruzant, and Trazimera are biosimilars which means that the biological products are approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that Consumer Medicine Information (CMI) about Trazimera (Trastuzumab) intended for persons living in Australia. Ads related to: Ponatinib Package Insert Results from Microsoft .

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.2 Lactation 8.3 Females and Males of Reproductive Potential 8.4 Pediatric Use 8.5 Geriatric Use

(1.3) Select patients for therapy based on … Trazimera should only be used in patients with metastatic or early breast cancer whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay (see sections 4.4 and 5.1). Metastatic gastric cancer.

Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) trastuzumab. National Comprehensive Cancer Network, 2019. TRAZIMERA is approved, in combination with chemotherapy (cisplatin and either capecitabine or 5-fluorouracil), for the treatment of HER2+ metastatic cancer of the stomach or gastroesophageal junction (where the esophagus meets the stomach) in patients who have not received prior treatment for their metastatic disease. Using a sterile syringe, slowly inject the 20 mL of diluent into the vial containing the lyophilized powder of TRAZIMERA, which has a cake-like appearance.
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> Rapportera biverkningar > Högkostnadsskyddet > Tillgång till läkemedel HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use AVASTIN safely and effectively. See full prescribing information for TRAZIMERA (trastuzumab) Product Information. Product Monograph (download PDF, 403KB) Patient Information (download PDF, 250KB) Canadian regulations limit the scope of information we are permitted to give on prescription drugs via the Internet or other means. TRAZIMERA has 2 approved uses in metastatic breast cancer: TRAZIMERA, in combination with the chemotherapy drug paclitaxel, is approved for the first-line treatment of Human Epidermal growth factor Receptor 2-positive (HER2+) metastatic breast cancer Summary: Trazimera is a biosimilar version of trastuzumab (reference product, Herceptin, Roche, Inc.) developed by Pfizer.

TRAZIMERA offers the potential to help address treatment costs and shows no clinically meaningful differences to. Herceptin1-3. TRAZIMERA (trastuzumab-qyyp) for injection is a sterile, white, preservative-free lyophilized powder with a cake-like appearance, for intravenous administration.
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TRAZIMERA (trastuzumab) Product Information. Product Monograph (download PDF, 403KB) Patient Information (download PDF, 250KB) Canadian regulations limit the scope of information we are permitted to give on prescription drugs via the Internet or other means.

TRAZIMERA is a monoclonal antibody (mAb) biosimilar of the originator biologic medicine, Herceptin, which targets HER2, a protein found on the surface of some cancer cells which can stimulate the cells to divide and grow.

2021-01-05 · trastuzumab-qyyp (Trazimera™ [Q5116]); AND • Patient is at least 18 years of age; AND Universal Criteria 1-6 • Left ventricular ejection fraction (LVEF) is within normal limits prior to initiating therapy and will be assessed at regular intervals (e.g., every 3 months) during treatment; AND

Merck Sharp & Dohme sponsored clinical study, KEYNOTE-024 (KN024), investigated the clinical validity of PDL1 IHC 22C3 pharmDx - 2021-01-05 · trastuzumab-qyyp (Trazimera™ [Q5116]); AND • Patient is at least 18 years of age; AND Universal Criteria 1-6 • Left ventricular ejection fraction (LVEF) is within normal limits prior to initiating therapy and will be assessed at regular intervals (e.g., every 3 months) during treatment; AND Document Administration Login.

− Herzuma Trazimera™) Prior Auth Criteria Trazimera [package insert]. Cork 2 Jun 2020 Trazimera 420 mg multiple-dose vial: 3 vials every 21 days. - Herzuma 150 Herceptin [package insert].