TRAZIMERA (trastuzumab-qyyp) for injection 420 mg/vial is supplied in a multiple-dose vial as a sterile, white lyophilized powder. Each carton contains one multiple-dose vial of TRAZIMERA and one vial (20 mL) of Bacteriostatic Water for Injection (BWFI) containing 1.1% benzyl alcohol as a preservative. NDC 0069-0305-01. 16.2 Storage Store TRAZIMERA vials in the refrigerator at 2�C to 8�C (36�F to 46�F) in the original carton to protect from light. If needed, unopened TRAZIMERA vials may be removed from the refrigerator and stored at room temperature up to 30�C (86�F) for a single period of up to 3 months in the original carton to protect from light. Once removed from the refrigerator, do not return to the refrigerator and discard after 3 months or by the expiration date stamped on the vial, whichever occurs first. Write the revised expiration date in the space provided on the carton labeling. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use TRAZIMERA safely and effectively. See full prescribing information for TRAZIMERA. TRAZIMERATM (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 See full prescribing information for complete boxed warning Cardiomyopathy: Trastuzumab products can result in subclinical and clinical cardiac failure manifesting as CHF, and decreased LVEF, with greatest risk when administered concurrently with anthracyclines. Evaluate cardiac function prior to and during treatment. Discontinue TRAZIMERA for cardiomyopathy. (2.3, 5.1) Infusion Reactions, Pulmonary Toxicity: Discontinue TRAZIMERA for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome. (5.2, 5.4) Embryo-Fetal Toxicity: Exposure to trastuzumab products during pregnancy can result in oligohydramnios, in some cases complicated by pulmonary hypoplasia and neonatal death. Advise patients of these risks and the need for effective contraception. (5.3, 8.1, 8.3) -------------------------INDICATIONS AND USAGE-----------------------------�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. (1.3) Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product (1, 2.1). ----------------------DOSAGE AND ADMINISTRATION-----------------------�For intravenous (IV) infusion only. Do not administer as an IV push or bolus. (2. 2) Do not substitute TRAZIMERA (trastuzumab-qyyp) for or withado-trastuzumab emtansine. (2.2)Perform HER2 testing using FDA-approved tests by laboratories withdemonstrated proficiency. (1, 2.1)Adjuvant Treatment of HER2-Overexpressing Breast Cancer (2.2) Administer at either: �Initial dose of 4 mg/kg over 90 minute IV infusion, then 2 mg/kg over 30 minute IV infusion weekly for 12 weeks (with paclitaxel or docetaxel) or 18 weeks (with docetaxel and carboplatin). One week after the last weekly dose of TRAZIMERA, administer 6 mg/kg as an IV infusion over 30 to 90 minutes every three weeks to complete a total of 52 weeks of FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: CARDIOMYOPATHY, INFUSION REACTIONS, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY 1 INDICATIONS AND USAGE 1.1 Adjuvant Breast Cancer 1.2 Metastatic Breast Cancer 1.3 Metastatic Gastric Cancer 2DOSAGE AND ADMINISTRATION 2.1 Patient Selection 2. 2 Recommended Doses and Schedules 2. 3 Important Dosing Considerations 2. 4 Preparation for Administration 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Cardiomyopathy 5.2 Infusion Reactions 5.3 Embryo-Fetal Toxicity 5.4 Pulmonary Toxicity 5.5 Exacerbation of Chemotherapy-Induced Neutropenia 6ADVERSE REACTIONS 6.1 Clinical Trials Experience 6.2 Immunogenicity 6.3 Post-Marketing Experience therapy, or �Initial dose of 8 mg/kg over 90 minutes IV infusion, then 6 mg/kg over 30 to 90 minutes IV infusion every three weeks for 52 weeks. Metastatic HER2-Overexpressing Breast Cancer (2.2) �Initial dose of 4 mg/kg as a 90 minute IV infusion followed by subsequent weekly doses of 2 mg/kg as 30 minute IV infusions. Metastatic HER2-Overexpressing Gastric Cancer (2.2) �Initial dose of 8 mg/kg over 90 minutes IV infusion, followed by 6 mg/kg over 30 to 90 minutes IV infusion every 3 weeks. --------------------DOSAGE FORMS AND STRENGTHS---------------------��For Injection: 420 mg lyophilized powder in a multiple-dose vial for reconstitution (3) ---------------------------CONTRAINDICATIONS--------------------------------��None. (4) ---------------------------WARNINGS AND PRECAUTIONS-------------------��Exacerbation of Chemotherapy-Induced Neutropenia. (5.5, 6.1) ----------------------------------ADVERSE REACTIONS---------------------------Adjuvant Breast Cancer �Most common adverse reactions (? 5%) are headache, diarrhea, nausea, and chills. (6.1) Metastatic Breast Cancer �Most common adverse reactions (? 10%) are fever, chills, headache, infection, congestive heart failure, insomnia, cough, and rash. (6.1) Metastatic Gastric Cancer �Most common adverse reactions (? 10%) are neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, upper respiratory tract infections, fever, thrombocytopenia, mucosal inflammation, nasopharyngitis, and dysgeusia. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer at 1- 800-438-1 985 and www.Pfizer.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. ------------------------USE IN SPECIFIC POPULATIONS----------------------�Females and Males of Reproductive Potential: Verify the pregnancy status of females prior to initiation of TRAZIMERA (8.3). See 17 for PATIENT COUNSELING INFORMATION. *Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product. Biosimilarity of TRAZIMERA has been demonstrated for the condition(s) of use (e.g. indication(s), dosing regimen(s)), strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information. Revised: 03/2019
