What are the known and suspected side effects of Repatha (evolocumab) use?

Known and Suspected Side Effects of Repatha (Evolocumab)

Repatha (evolocumab) is generally well-tolerated, with the most common side effects being nasopharyngitis, upper respiratory tract infection, influenza, back pain, and injection site reactions. 1, 2

Common Side Effects (>5% of patients)

• Respiratory symptoms:

  • Nasopharyngitis (runny nose, sore throat) 1, 2
  • Upper respiratory tract infection 1, 2
  • Symptoms of common cold 2
  • Influenza or flu-like symptoms 1, 2

• Musculoskeletal issues:

  • Back pain 1, 2

• Injection site reactions:

  • Redness, pain, or bruising at injection site 1, 2
  • Generally mild (90% of cases) 1
  • Occurs in approximately 2.1% of patients versus 1.6% in placebo 1, 3
  • Most patients do not discontinue treatment due to injection site reactions 3

• Metabolic effects:

  • High blood sugar levels (diabetes) 1, 2

Serious Side Effects

• Hypersensitivity reactions:
  • If serious hypersensitivity reaction occurs, treatment should be discontinued 1
  • Symptoms include trouble breathing or swallowing, raised bumps (hives), rash, itching, and swelling of face, lips, tongue, throat or arms 2
  • Requires immediate medical attention 2

Special Considerations

• Neurocognitive events:

  • A small, non-significant increase in neurocognitive events has been reported 1
  • No evidence of increase in cognitive adverse effects was observed in FOURIER or EBBINGHAUS trials 1
  • Risk of neurocognitive events was similar between treatment and placebo groups in detailed cognitive testing 1

• Ophthalmologic events:

  • A small, non-significant increase in ophthalmologic events has been reported 1

• Very low LDL-C levels:

  • No excess adverse events have been observed in patients achieving very low LDL-C levels (<25 mg/dL) 1
  • No signal of harm was found among patients with LDL-C levels <10 mg/dL during clinical studies 1

Monitoring Recommendations

• Hypersensitivity reactions:

  • Monitor for signs and symptoms of hypersensitivity reactions 1
  • If reaction occurs, discontinue therapy and treat according to standard of care 1
  • Monitor until signs and symptoms resolve 1

• Injection site reactions:

  • Observe injection sites for reactions 2
  • Most reactions are mild and self-limiting 1

Practical Considerations

• Latex sensitivity:

  • Advise latex-sensitive patients that needle covers on the products contain latex 1

• Drug interactions:

  • No clinically significant drug-drug interactions have been identified for evolocumab 1

Important Notes for Patient 1

• Monitoring for common side effects like respiratory symptoms, back pain, and injection site reactions is recommended 1, 2
• If the patient has diabetes or is at risk for diabetes, blood glucose levels should be monitored as evolocumab may affect glycemic control 1, 2
• If the patient has latex sensitivity, they should be informed about the needle covers containing latex 1
• The patient should be educated about potential hypersensitivity reactions and when to seek medical attention 1, 2
• Reassure the patient that serious adverse events are rare, and most side effects are mild and transient 1, 4