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 - 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:Consult the Product Monograph at www.amgen.ca/Repatha_PM.pdf for important information relating to adverse reactions, drug interactions and dosing information which have not been discussed in this piece.
The Product Monograph is also available by calling Amgen Medical Information at 1-866-502-6436.