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Label Changes for:

Repatha (evolocumab)

July 2016

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

July 2016

PATIENT COUNSELING INFORMATION (additional information)

  • Provide guidance to patients and caregivers on proper subcutaneous administration technique, including aseptic technique, and how to use the single-use prefilled autoinjector, single-use prefilled syringe, or single-use on-body infusor with prefilled cartridge correctly (see Instructions for Use leaflet). Inform  patients that it may take up to 15 seconds to administer REPATHA using the single-use prefilled autoinjector or single-use prefilled syringe and about 9 minutes to administer REPATHA using the single-use on-body infusor with prefilled cartridge.
  • The single-use on-body infusor with prefilled cartridge is not made with natural rubber latex.

PATIENT INFORMATION

How should I use REPATHA?

  • See the detailed “Instructions for Use” that comes with this patient information about the right way to prepare and administer REPATHA.
    • REPATHA comes as a single-use (1 time) prefilled autoinjector (SureClick® autoinjector), as a single-use prefilled syringe or as a single-use PushtronexTM system (on-body infusor with prefilled cartridge).
  • If your healthcare provider prescribes you the monthly dose, you may use: (additional bullet below)
    • a single-use on-body infusor with prefilled cartridge over 9 minutes, or
  • Always check the label of your single-use prefilled autoinjector, single-use prefilled syringe, or single-use on-body infusor with prefilled cartridge to make sure you have the correct medicine and the correct dose of REPATHA before each administration. (new phrase added)
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