Important safety information

Contraindications:

• Hypersensitivity to Repatha^® or to any ingredient in the formulation, including any non-medicinal ingredient or component of the container
• Refer to the Contraindications section of the relevant product monographs of any concomitant lipid-lowering medications

Relevant warnings and precautions:

• Refer to the Warnings and Precautions section of the relevant product monographs of any concomitant lipid-lowering medications
• Hypersensitivity reactions (e.g., rash, urticaria, angioedema) have been reported. If signs or symptoms of serious allergic reactions occur, discontinue Repatha^® and treat according to standard of care and monitor until signs and symptoms resolve
• No studies have been conducted with Repatha^® in pregnant women or nursing women and relevant data from clinical use are very limited
• There is no information regarding the presence of evolocumab in human milk, the effects on the breastfed infant, or the effects on milk production; a risk to breastfed infants cannot be excluded
• Statin product monographs recommend discontinuation when a patient becomes pregnant, therefore Repatha^® should also be discontinued
• Data on efficacy and safety in HoFH patients aged 10-11 years are limited
• Efficacy and safety have not been established in pediatric patients <10 years of age with HeFH, HoFH or in pediatric patients with other types of hyperlipidemia
• Use with caution in patients with severe renal impairment
• Use with caution in patients with severe hepatic impairment
• Needle cap of the SureClick^® Autoinjector contains dry natural rubber, which may cause an allergic reaction in latex-sensitive patients; there is no dry natural rubber in the automated mini-doser with prefilled cartridge
• Effects of Repatha^® in patients with or at risk of hepatitis C virus infection remain uncertain

For more information:

The Product Monograph is also available by calling Amgen at 1-866-502-6436.