metastatic breast cancer
•As 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 trastuzumab [see Dosage 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 HER2 gene amplification should be performed using FDA-approved tests specific for breast cancer by laboratories with
demonstrated proficiency. Information on the FDA-approved tests for the detection of HER2 proteinoverexpression and HER2 gene amplification is available at: http://www.fda.gov/CompanionDiagnostics.
Improper assay performance, including use of suboptimally fixed tissue, failure to utilize specified reagents,deviation from specific assay instructions, and failure to include appropriate controls for assay validation, canlead to unreliable results.
2.2 Recommended Doses and Schedules
HERCEPTIN HYLECTA is for subcutaneous use only. HERCEPTIN HYLECTA has different dosage andadministration instructions than intravenous trastuzumab products. Do not administer intravenously.
Do not substitute HERCEPTIN HYLECTA for or with ado-trastuzumab emtansine.
The recommended dose of HERCEPTIN HYLECTA is 600 mg/10,000 units (600 mg trastuzumab and 10,000units hyaluronidase) administered subcutaneously over approximately 2-5 minutes once every three weeks.
No loading dose is required. No dose adjustments for patient body weight or for different concomitantchemotherapy regimens are required.
Duration of treatment
Patients with adjuvant breast cancer should be treated with HERCEPTIN HYLECTA for 52 weeks or until diseaserecurrence, whichever occurs first; extending treatment in adjuvant breast cancer beyond one year is notrecommended.
Patients with metastatic breast cancer (MBC) should be treated with HERCEPTIN HYLECTA until progressionof disease.
Missed Dose
If one dose is missed, it is recommended to administer the next 600 mg/10,000 units dose (i.e. the missed dose)as soon as possible. The interval between subsequent HERCEPTIN HYLECTA doses should not be less thanthree weeks.
2.3 Dosage Modification for Adverse Reactions
Cardiomyopathy [see Boxed Warning, Warnings and Precautions (5.1)]
Assess left ventricular ejection fraction (LVEF) prior to initiation of HERCEPTIN HYLECTA and at regularintervals during treatment. Withhold HERCEPTIN HYLECTA dosing for at least 4 weeks for either of thefollowing:
• ≥16% absolute decrease in LVEF from pre-treatment values
• LVEF below institutional limits of normal and ≥10% absolute decrease in LVEF from pretreatment values.
HERCEPTIN HYLECTA may be resumed if, within 4−8 weeks, the LVEF returns to normal limits and theabsolute decrease from baseline is ≤15%.
Permanently discontinue HERCEPTIN HYLECTA for a persistent (>8 weeks) LVEF decline or for suspensionof HERCEPTIN HYLECTA dosing on more than 3 occasions for cardiomyopathy.
2.4 Administration and Storage
To prevent medication errors, it is important to check the vial labels to ensure that the drug being prepared andadministered is HERCEPTIN HYLEC |
