An established safety profile*

The safety profile of Repatha® in the CV outcomes trial was consistent with the known safety profile in patients with primary hyperlipidemia.1

FOURIER CV outcomes trial1,4

Summary of adverse events

Outcome Repatha® (n=13,769) Placebo (n=13,756)
Any adverse event 10,664 (77.4%) 10,644 (77.4%)
Serious 3,410 (24.8%) 3,404 (24.7%)
Thought to be related to study agent and leading to discontinuation 226 (1.6%) 201 (1.5%)

Common adverse reactions reported by ≥ 5% of patients in either treatment group (Repatha® n=13,769, any placebo n=13,756), median duration 2.2 years

  • Diabetes mellitus: Repatha® 8.8%, placebo: 8.2%; nasopharyngitis: Repatha® 7.8%, placebo 7.4%; upper respiratory tract infection: Repatha® 5.1%, placebo: 4.8%

Primary hyperlipidemia studies1

Adverse events reported by ≥ 1% of Repatha® patients with primary hyperlipidemia and HeFH and more frequently than placebo, 12-week studies (Repatha® 140 mg Q2W or 420 mg QM)

Adverse event Repatha® 140 mg Q2W or 420 mg QM (n=2,052)% Any placebo (n=1,224)%
Nasopharyngitis 4.0 3.9
Back pain 2.3 2.2
Upper respiratory tract infection 2.1 2.0
Nausea 1.8 1.2
Arthralgia 1.8 1.6
Fatigue 1.6 1.0
Urinary tract infection 1.3 1.2
Muscle spasms 1.3 1.2
Influenza 1.2 1.1
Cough 1.2 0.7
Contusion 1.0 0.5

No neutralizing antibodies were observed in Repatha® clinical studies.1

The presence of anti-evolocumab binding antibodies did not impact the pharmacokinetic profile, clinical response, or safety of Repatha®. In a pool of clinical studies, 0.3% (48/17,992) of patients treated with at least one dose of Repatha® tested positive for the development of anti-evolocumab binding antibodies. Of the patients whose sera tested positive for binding antibodies, none tested positive for neutralizing antibodies.

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