d KANJINTI in patients with metastatic disease for clinically significant decrease inleft ventricular function [see Dosage and Administration (2.3) and Warnings and Precautions(5.1)].
Infusion Reactions; Pulmonary Toxicity
Trastuzumab products administration can result in serious and fatal infusion reactions andpulmonary toxicity. Symptoms usually occur during or within 24 hours of administration.
Interrupt KANJINTI infusion for dyspnea or clinically significant hypotension. Monitor patientsuntil symptoms completely resolve. Discontinue KANJINTI for anaphylaxis, angioedema,interstitial pneumonitis, or acute respiratory distress syndrome [see Warnings and Precautions(5.2, 5.4)].
Embryo-Fetal Toxicity
Exposure to trastuzumab products during pregnancy can result in oligohydramnios andoligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, andneonatal death. Advise patients of these risks and the need for effective contraception[see Warnings and Precautions (5.3) and Use in Specific Populations (8.1, 8.3)].
1 INDICATIONS AND USAGE
1.1 Adjuvant Breast Cancer
KANJINTI is indicated for adjuvant treatment of HER2 overexpressing node positive or node negative(ER/PR negative or with one high risk feature [see Clinical Studies (14.1)]) breast canceras part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel ordocetaxel
as part of a treatment regimen with docetaxel and carboplatin
as a single agent following multi-modality anthracycline based therapy.Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product [seeDosage and Administration (2.1)]
1.2 Metastatic Breast Cancer
KANJINTI is indicated:
In combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancerAs a single agent for treatment of HER2-overexpressing breast cancer in patients who have received oneor more chemotherapy regimens for metastatic disease.
Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product [seeDosage and Administration (2.1)]
1.3 Metastatic Gastric Cancer
KANJINTI is indicated, in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment ofpatients with HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who havenot received prior treatment for metastatic disease.Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product [seeDosage and Administration (2.1)]
2 DOSAGE AND ADMINISTRATION
2.1 Patient Selection
Select patients based on HER2 protein overexpression or HER2 gene amplification in tumor specimens [seeIndications and Usage (1) and Clinical Studies (14)]. Assessment of HER2 protein overexpression and HER2gene amplification should be performed using FDA-approved tests specific for breast or gastric cancers bylaboratories with demonstrated proficiency. Information on the FDA-approved tests for the detection of HER2protein overexpression and HER2 gene amplification is available at:
http://www.fda.gov/CompanionDiagnostics.
Assessment of HER2 protein overexpression and HER2 gene amplification in metastatic gastric cancer shouldbe performed using FDA-approved tests specifically for gastric cancers due to differences in gastric vs. breasthistopatholog |
