Highlights of Prescribing Information
Indications, Dosage Administration, Contraindications
KADCYLA has indications in early and metastatic breast cancer with recommended dosing schedules for each indication.
Warnings and Precautions
The Warnings and Precautions section of the Prescribing Information discusses potential risks associated with the use of KADCYLA.
Adverse Reactions
The clinical trial experience with KADCYLA includes information about the therapeutic regimen, the most common adverse reactions, and therapy discontinuations in each study.
Use in Specific Populations
The Prescribing Information provides guidance for use in specific populations, such as patients with renal or hepatic impairment.
Description, Clinical Pharmacology, and Nonclinical Toxicology
KADCYLA is a HER2-targeted antibody-drug conjugate.
Clinical Studies
FDA approvals are based on data from the EMILIA and KATHERINE clinical studies.
How Supplied/Storage and Handling and Patient Counseling information
KADCYLA injection is supplied as a 100 mg or 160 mg vial.