Evolocumab Injection, for Subcutaneous Injection

Dosage Forms And Strengths

REPATHA is a sterile, clear to opalescent, colorless to pale yellow solution available as follows:

• Injection: 140 mg/mL solution in a single-use prefilled syringe
• Injection: 140 mg/mL solution in a single-use prefilled SureClick® autoinjector
• Injection: 420 mg/3.5 mL solution in a single-use Pushtronex™ system (on-body infusor with prefilled cartridge)

Storage And Handling

REPATHA is a sterile, clear to opalescent, colorless to pale yellow solution for subcutaneous administration supplied in a single-use prefilled syringe, a single-use prefilled SureClick autoinjector, or a single-use Pushtronex system (on-body infusor with prefilled cartridge). Each single-use prefilled syringe or single-use prefilled SureClick autoinjector of REPATHA is designed to deliver 1 mL of 140 mg/mL solution. Each single-use Pushtronex system (on-body infusor with prefilled cartridge) is designed to deliver 420 mg evolocumab in 3.5 mL solution.

Store refrigerated at 2°C to 8°C (36° to 46°F) in the original carton to protect from light. Do not freeze. Do not shake.

Store refrigerated at 2°C to 8°C (36° to 46°F) in the original carton. Alternatively, REPATHA can be kept at room temperature at 68°F to 77°F (20°C to 25°C) in the original carton; however, under these conditions, REPATHA must be used within 30 days. If not used within the 30 days, discard REPATHA.

Protect REPATHA from direct light and do not expose to temperatures above 25°C (77°F).

Manufactured by: Amgen Inc., One Amgen Center Drive, Thousand Oaks, California 91320-1799. Revised: Jul 2016.

Included as part of the PRECAUTIONS section.

• Cholesterol
• How to Lower Your Cholesterol