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02/17/2021

Additional Indication: Daiichi Sankyo's ENHERTU® (fam-trastuzumab deruxtecan-nxki)

On January 15, 2021, the U.S. Food & Drug Administration approved an additional indication for ENHERTU® (fam-trastuzumab deruxtecan-nxki), for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen. ENHERTU has Boxed WARNINGS for Interstitial Lung Disease (ILD)/Pneumonitis and Embryo-Fetal Toxicity. Please see Important Safety Information below. 

This additional ENHERTU indication does not affect its existing package information1,2: 

Description 

Vial size 

Billing Units 

NDC 

J-code 

Injection, fam-trastuzumab deruxtecan-nxki, 1mg 

One 100 mg single-dose vial 

100 units 

65597-406-01 

J9358 

As a reminder, the ENHERTU4U website contains a suite of Access and Reimbursement resources and program information. Please visit https://www.enhertu4u.com/ for more information. 

If you have questions or would like support, you can also contact me directly or reach out to an ENHERTU4U care counselor at 1-833-ENHERTU (1-833-364-3788), Monday through Friday, 8 AM—8 PM ET. 

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