•Most common adverse reactions (≥ 10%) are neutropenia, diarrhea,
fatigue, anemia, stomatitis, weight loss, upper respiratory tract infections,
fever, thrombocytopenia, mucosal inflammation, nasopharyngitis, anddysgeusia.
To report SUSPECTED ADVERSE REACTIONS, contact Pfizer at1-800-438-1985 and www.Pfizer.com or FDA at 1-800-FDA-1088 orwww.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
Females and Males of Reproductive Potential: Verify the pregnancy status offemales prior to initiation of TRAZIMERA.
See 17 for PATIENT COUNSELING INFORMATION.
*Biosimilar means that the biological product is approved based on datademonstrating that it is highly similar to an FDA-approved biologicalproduct, known as a reference product, and that there are no clinicallymeaningful differences between the biosimilar product and the referenceproduct. Biosimilarity of TRAZIMERA has been demonstrated for thecondition(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
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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
2.DOSAGE 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
6.ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Immunogenicity
6.3 Post-Marketing Experience
7 DRUG INTERACTIONS
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
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
14.1 Adjuvant Breast Cancer
14.2 Metastatic Breast Cancer
14.3 Metastatic Gastric Cancer
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
16.2 Storage
17 PATIENT COUNSELING INFORMATION
*Sections or subsections omitted from the full prescribing information are not listed.
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FULL PRESCRIBING INFORMATION
WARNING: CARDIOMYOPATHY, INFUSION REACTIONS, EMBRYO-FETAL TOXICITY, and
PULMONARY TOXICITY
Cardiomyopathy
Administration of trastuzumab products can result in sub-clinical and clinical cardiac failure.
Theincidence and severity was highest in patients receiving trastuzumab with anthracycline-containingchemotherapy regimens.
eva luate left ventricular function in all patients prior to and during treatment with TRAZIMERA.
Discontinue TRAZIMERA treatment in patients receiving adjuvant therapy and withhold TRAZIMERAin patients with metastatic d |
