HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to useTRAZIMERA safely and effectively. See full prescribing information forTRAZIMERA.
TRAZIMERA(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 andclinical cardiac failure manifesting as CHF, and decreased LVEF, withgreatest risk when administered concurrently with anthracyclines.
eva luate cardiac function prior to and during treatment. DiscontinueTRAZIMERA for cardiomyopathy.
Infusion Reactions, Pulmonary Toxicity: Discontinue TRAZIMERA foranaphylaxis, angioedema, interstitial pneumonitis, or acute respiratorydistress syndrome.
Embryo-Fetal Toxicity: Exposure to trastuzumab products duringpregnancy can result in oligohydramnios, in some cases complicated bypulmonary hypoplasia and neonatal death. Advise patients of theserisks and the need for effective contraception.
INDICATIONS AND USAGE
TRAZIMERA is a HER2/neu receptor antagonist indicated for:
•The treatment of HER2-overexpressing breast cancer.
•The treatment of HER2-overexpressing metastatic gastric orgastroesophageal junction adenocarcinoma.
Select patients for therapy based on an FDA-approved companion diagnosticfor a trastuzumab product。
DOSAGE AND ADMINISTRATION
For intravenous (IV) infusion only. Do not administer as an IV push orbolus.
Do not substitute TRAZIMERA (trastuzumab-qyyp) for or withado-trastuzumab emtansine.
Perform HER2 testing using FDA-approved tests by laboratories withdemonstrated proficiency.
Adjuvant Treatment of HER2-Overexpressing Breast Cancer。
Administer at either:
•Initial dose of 4 mg/kg over 90 minute IV infusion, then 2 mg/kg over30 minute IV infusion weekly for 12 weeks (with paclitaxel or docetaxel)or 18 weeks (with docetaxel and carboplatin). One week after the lastweekly dose of TRAZIMERA, administer 6 mg/kg as an IV infusion over30 to 90 minutes every three weeks to complete a total of 52 weeks oftherapy, or
•Initial dose of 8 mg/kg over 90 minutes IV infusion, then 6 mg/kg over 30to 90 minutes IV infusion every three weeks for 52 weeks.
Metastatic HER2-Overexpressing Breast Cancer。
•Initial dose of 4 mg/kg as a 90 minute IV infusion followed by subsequentweekly doses of 2 mg/kg as 30 minute IV infusions.
Metastatic HER2-Overexpressing Gastric Cancer。
•Initial dose of 8 mg/kg over 90 minutes IV infusion, followed by 6 mg/kgover 30 to 90minutes IV infusion every 3 weeks.
DOSAGE FORMS AND STRENGTHS
•For Injection: 420 mg lyophilized powder in a multiple-dose vial forreconstitution。
CONTRAINDICATIONS
•None.
WARNINGS AND PRECAUTIONS
•Exacerbation of Chemotherapy-Induced Neutropenia.
ADVERSE REACTIONS
Adjuvant Breast Cancer
•Most common adverse reactions (≥ 5%) are headache, diarrhea, nausea,and chills.
Metastatic Breast Cancer
•Most common adverse reactions (≥ 10%) are fever, chills, headache,infection, congestive heart failure, insomnia, cough, and rash.
Metastatic Gastric Cancer