HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to useKANJINTI safely and effectively. See full prescribing information for
KANJINTI.
KANJINTI(trastuzumab-anns)for injection, for intravenous useInitial U.S. Approval: 2019
KANJINTI (trastuzumab-anns) 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, withgreatest risk when administered concurrently with anthracyclines.eva luate cardiac function prior to and during treatment. DiscontinueKANJINTI for cardiomyopathy. (2.3, 5.1)
Infusion Reactions, Pulmonary Toxicity: Discontinue KANJINTI foranaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory
distress syndrome. (5.2, 5.4)
Embryo-Fetal Toxicity: Exposure to trastuzumab products duringpregnancy can result in oligohydramnios, in some cases complicated bypulmonary hypoplasia and neonatal death. Advise patients of these risksand the need for effective contraception. (5.3, 8.1, 8.3)
INDICATIONS AND USAGE
KANJINTI 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 diagnosticfor a trastuzumab product (1, 2.1).
DOSAGE AND ADMINISTRATION
For intravenous (IV) infusion only. Do not administer as an IV push orbolus. (2.2)
Do not substitute KANJINTI (trastuzumab-anns) for or with ado-trastuzumabemtansine. (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 30minute IV infusion weekly for 12 weeks (with paclitaxel or docetaxel) or18 weeks (with docetaxel and carboplatin). One week after the lastweekly dose of KANJINTI, administer 6 mg/kg as an IV infusion over30−90 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 over30–90 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 bysubsequent 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 by6 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-dosevial for reconstitution
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,