The safety profile of Repatha® in the CV outcomes trial was consistent with the known safety profile in patients with primary hyperlipidemia.1
| 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
| 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 |
Includes studies LAPLACE-1, LAPLACE-2, RUTHERFORD-1, RUTHERFORD-2, MENDEL-1, MENDEL-2, YUKAWA.
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.
* See Product Monograph for complete adverse reaction profile, including 52-week primary hyperlipidemia study data.
CV=cardiovascular; Q2W=every 2 weeks; QM=monthly
