05/25/2017

FDA approved a revised USPI for Herceptin

Recently, the FDA approved a revised USPI for Herceptin (dated 04/2017) that lists a new 150mg singe-dose configuration, along with additional label changes to meet updated FDA guidance.  The new 150mg single-dose vial configuration for Herceptin will be introduced on May 30, 2017. 

Important information for you to know:

• All customers will be asked to transition to the 150mg single-dose vial, once available.  AfterJuly 7, 2017, Genentech will only ship 150mg vials to distributors and will discontinue shipping the 440mg multiple-dose vial to distributors.
• The National Drug Code (NDC) for the Herceptin 150mg vial is: 50242-132-01.
• The Herceptin Wholesale Acquisition Cost (WAC) per milligram does not change with the introduction of the 150mg single-dose vial.
• The J-Code (J9355) for Herceptin does not change.
• Authorized Herceptin distributors do not change.  A complete listing of distributors can be found on https://www.genentech-access.com/hcp/brands/herceptin/learn-about-our-services/product-distribution.html
• While not listed in this revised USPI, the current 440mg multi-use vial configuration [NDC 50242-134-68] will continue to be available and can be utilized until product expiration.Please refer to the USPI supplied with the 440mg vial for more information on the 440mg vial (approved and dated 3/2016).
• ACTION: We are requesting all payers, providers, pharmacies and distributers to add the NDC for Herceptin 150mg single-dose vials, and confirm that the current NDC for the 440mg multi-use vial remains active, within all systems (Billing, Payment, EMR, Ordering, etc.) in order to ensure this medicine remains available to providers and patients.
• The current ASP does not change for the 440mg vial.

Herceptin Brochure
Herceptin Pi