What is Ogivri? ADJUVANT BREAST CANCER . Ogivri is a prescription medicine used for the treatment of adjuvant breast cancer. Ogivri is used for the treatment of early-stage breast cancer that is Human Epidermal growth factor Receptor 2-positive (HER2+) and has spread into the lymph nodes or is HER2-positive and has not spread into the lymph nodes.

Summary: Trazimera is a biosimilar version of trastuzumab (reference product, Herceptin, Roche, Inc.) developed by Pfizer. Originally designated PF-05280014 , a biologic license application for approval via the 351(k) biosimilar pathway was initially submitted to the Food and Drug Administration (FDA) in the third quarter of 2017.

TM (trastuzumab-qyyp) for injection, for intravenous use Initial U.S. Approval: 2019 . TRAZIMERA (trastuzumab-qyyp) is biosimilar* to HERCEPTIN (trastuzumab). WARNING: CARDIOMYOPATHY, INFUSION REACTIONS, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY Package Leaflet: Information for the user. Trazimera ® 150 mg powder for concentrate for solution for infusion . Trazimera® 420 mg powder for concentrate for solution for infusion. t. rastuzumab .

Trazimera package insert

Policy History. Date. Action. September 2012. 3 Mar 2020 Trazimera 420 mg multiple-dose vial: 3 vials every 21 days. − Herzuma Trazimera™) Prior Auth Criteria Trazimera [package insert].

(trastuzumab-anns). TRAZIMERA (trastuzumab-qyyp) Herceptin [package insert].

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

TRAZIMERA safely and effectively. See full prescribing information for TRAZIMERA.

Trazimera 420 mg multiple-dose vial: 3 vials every 21 days − Herzuma 150 mg single-dose vial: 7 vials every 21 days − Herzuma 420 mg multiple -dose vial: 3 vials every 21 days − Ontruzant 150 mg single-dose vial: 7 vials every 21 days − Ontruzant 420 mg multiple-dose vial: 3 vials every 21 days B. Max Units (per dose and over time

Trazimera ® 150 mg powder for concentrate for solution for infusion . Trazimera® 420 mg powder for concentrate for solution for infusion. t. rastuzumab . This medicine is subject to additional monitoring. This will all ow … TRAZIMERA is a HER2/neu receptor antagonist indicated for: The treatment of HER2-overexpressing breast cancer. (1.1,1.2) The treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

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 2. Herzuma [package insert].
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Each carton contains one vial.

Ogivri [package insert]. Morgantown, WV: Mylan GmbH; June 2020. 5. Ontruzant [package insert].
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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

The Pfizer Oncology Together Co-Pay Savings Program for Injectables for TRAZIMERA is not valid for patients who are enrolled in a state or federally funded insurance program, including but not limited to Medicare, Medicaid, TRICARE, Veterans Affairs health care, a state prescription drug assistance program, or the Government Health Insurance Plan available in Puerto Rico (formerly known as Trazimera 420 mg multiple-dose vial: 3 vials every 21 days − Herzuma 150 mg single-dose vial: 7 vials every 21 days − Herzuma 420 mg multiple -dose vial: 3 vials every 21 days − Ontruzant 150 mg single-dose vial: 7 vials every 21 days − Ontruzant 420 mg multiple-dose vial: 3 vials every 21 days B. Max Units (per dose and over time) [ HCPCS Unit]: 1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use TRUXIMA safely and effectively. See full prescribing information for TRUXIMA. Trazimera 420 mg multiple-dose vial: 3 vials every 21 days − Herzuma 150 mg single-dose vial: 7 vials every 21 days − Herzuma 420 mg multiple -dose vial: 3 vials every 21 days − Ontruzant 150 mg single-dose vial: 7 vials every 21 days − Ontruzant 420 mg multiple-dose vial: 3 vials every 21 days B. Max Units (per dose and over time) [ HCPCS Unit]: − Trazimera 420 mg multiple-dose vial: 3 vials every 21 days − Herzuma 150 mg single-dose vial: 7 vials every 21 days − Herzuma 420 mg multiple-dose vial: 3 vials every 21 days 5. Herzuma [package insert]. Yeonsu-gu, Incheon, Republic of Korea; Celltrion, Inc; May 2019. Accessed January 2020.

Trazimera [package insert]. Cork, Ireland; Pfizer Ireland, Inc; March 2019. Accessed November 2019. 2. Referenced with permission from the NCCN Drugs & Biologics

Photo courtesy of: Allbirds. All the details in the Allbirds unboxing experience are focused on creating a seamless experience, from the shipping label to inks and pulp shoe inserts. 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 2. Herzuma [package insert]. North Wales, PA: Teva Pharmaceuticals USA, Inc.; May 2019. 3.

New York, NY: Pfizer Inc; 2019. 49. Meric-Bernstam F , Hurwitz H, Raghav KPS, . Pertuzumab plus trastuzumab for PRODUCT RELEVANCE: Child Health Plus (CHP), Medicaid Managed Care, A. Inadequate response, intolerance, or contraindication to a trial of Trazimera AND Ogivri (reason for intolerance Xolair (omalizumab) [package insert]. As of January 2019, the US Food and Drug Administration (FDA) had approved 17 U.S. FDA Approves Pfizer's Oncology Biosimilar TRAZIMERA™ ( trastuzumab-qyyp), a Biosimilar to Herceptin®1 [press Humatrope [package insert]. Feb 28, 2020 Balversa (erdafitinib) [package insert]. Horsham, PA: Janssen Products, LP; 2019 .