The FDA’s approval of Trazimera is based on review of evidence that included extensive studies on the drug’s structure and function, animal study data, studies on how the drug is absorbed and metabolized by the human body, studies on how the drug affects people, and other clinical safety and effectiveness data that demonstrate Trazimera is biosimilar to Herceptin.

A package insert is a document included in the package of a medication that provides information about that drug and its use. For prescription medications, the insert is technical, providing information for medical professionals about how to prescribe the drug.

Special. Precautions/Notes. Leucovorin. 50 mg/5 mL GlaxoSmithKline Inc. Alkeran Package Insert. Mississauga FDA Approves Pfizer's Oncology Biosimilar TRAZIMERA.

Dec 31, 2020 00069-0305-XX TRAZIMERA 420MG Solution Reconstituted (PFIZER to an existing FDA-approved innovator product and have no clinically Apr 1, 2021 Coverage for a non-preferred product is provided based on Herceptin Hylecta [ package insert]. South San Trazimera [package insert]. Cork (trastuzumab-anns). TRAZIMERA (trastuzumab-qyyp) Herceptin [package insert].

Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) trastuzumab. National Comprehensive Cancer Network, 2019.

U.S. FDA Approves Pfizer's Oncology Biosimilar TRAZIMERA™ (Trastuzumab-Qyyp), a Biosimilar to Herceptin®1 Trazimera (trastuzumab qyyp) [package insert] Trazimera Drug Interactions Cardiomyopathy Lung Damage (Acute Pulmonary Toxicity).

Trazimera (trastuzumab-qyyp) for injection 150 mg/vial is supplied in a single-dose vial as a sterile, white lyophilized powder. Each carton contains one single-dose vial of Trazimera. NDC 0069-0308-01.

used for medicare when drug administered under the Dexametha opth insert 0.1 mg Trazimera. Injection, trastuzumab-anns, biosimilar,. (kanjinti), 10mg.

Ask your pharmacist how to dispose of medicines no longer required.

See full prescribing information for Ads related to: Ponatinib Package Insert Results from Microsoft . TRAZIMERA™ (trastuzumab-qyyp) - See Boxed Warning www.pfizerpro.com. View TRAZIMERA™ Prescribing Info, Safety Info And Boxed Warning.
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J Clin Oncol 2018;36(supple15): May 3, 2019 PF-05280014 (Trazimera™) was recently approved by the European Genentech Inc (2017) Herceptin (trastuzumab) package insert. Apr 15, 2020 Studies indicate that the drug Trastuzumab (Herceptin®) is effective in treatment ofHER2-positive (NCCN) guidelines and the package insert. Injection, Trastuzumab-qyyp, biosimilar, (Trazimera), 10 mg.

Prescribing Information for Perjeta [Internet; cited June 2020]. Available from: Feb 27, 2020 and Drug Administration (FDA) describe biosimilars as having the same expected benefits Pfizer: Trazimera prescribing information, 2019.
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Trazimera is for intravenous use. The loading dose should be administered as a 90-minute intravenous infusion. Do not administer as an intravenous push or bolus. Trazimera intravenous infusion should be administered by a healthcare provider prepared to manage anaphylaxis and an emergency kit should be available.

Incheon, Republic of Korea: Celltrion, Inc; May Initial U.S. Approval: 2019.

Trazimera 150 mg pulver til konsentrat til infusjonsvæske, oppløsning Bruk aseptisk teknikk. Hvert 150 mg hetteglass med Trazimera oppløses i 7,2 ml sterilt vann til injeksjonsvæsker (følger ikke med i pakningen). Bruk av andre oppløsningsmidler skal unngås. Dette gir 7,4 ml oppløsning for en enkeltdose, inneholdende ca. 21 mg/ml

6. Trazimera [package insert]. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use AVASTIN safely and effectively. See full prescribing information for Ads related to: Ponatinib Package Insert Results from Microsoft . TRAZIMERA™ (trastuzumab-qyyp) - See Boxed Warning www.pfizerpro.com. View TRAZIMERA™ Prescribing Info, Safety Info And Boxed Warning.

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. U.S. FDA Approves Pfizer's Oncology Biosimilar TRAZIMERA™ (Trastuzumab-Qyyp), a Biosimilar to Herceptin®1 Trazimera (trastuzumab qyyp) [package insert] Trazimera Drug Interactions Cardiomyopathy Lung Damage (Acute Pulmonary Toxicity). Ads related to: Ponatinib Package Insert Results from Microsoft . TRAZIMERA™ (trastuzumab-qyyp) - See Boxed Warning www.pfizerpro.com. View Consumer Medicine Information (CMI) about Trazimera (Trastuzumab) intended for persons living in Australia. Trazimera can have long lasting effects on your heart, especially if you receive other cancer medicines.