What are the side effects of Repatha (evolocumab)?

Side Effects of Repatha (Evolocumab)

The most common side effects of Repatha (evolocumab) include nasopharyngitis, upper respiratory tract infection, influenza, back pain, and injection site reactions. 1, 2

Common Side Effects

According to the FDA label and clinical guidelines, the following side effects have been reported with Repatha:

Most Common (>5% of patients)

• Nasopharyngitis (runny nose, sore throat)
• Upper respiratory tract infection
• Influenza or flu-like symptoms
• Back pain
• Injection site reactions (redness, pain, or bruising) 1, 2

Additional Side Effects

• In patients with established cardiovascular disease:
  • Diabetes mellitus
  • Nasopharyngitis
  • Upper respiratory tract infection 1

Serious Side Effects

Hypersensitivity Reactions

• Angioedema has been reported
• If serious hypersensitivity reactions occur:
  • Discontinue Repatha
  • Treat according to standard of care
  • Monitor until signs and symptoms resolve 1, 2

Special Considerations

• Patients with latex sensitivity should be aware that some presentations of Repatha contain dry natural rubber (a derivative of latex) in the needle cover 2
• No evidence of increase in cognitive adverse effects was observed in the FOURIER or EBBINGHAUS clinical trials 1

Rare Side Effects

While extremely rare, there has been a case report of severe thrombocytopenia associated with evolocumab use after 14 months of treatment 3. This appears to be an isolated case and is not listed among the common side effects in clinical guidelines or the FDA label.

Safety Profile

The safety profile of evolocumab is generally favorable:

• No clinically significant drug-drug interactions have been identified 1
• The FOURIER trial, which included 27,564 patients, demonstrated that evolocumab was generally well-tolerated 4
• Long-term studies have shown consistent safety profiles with short-term studies 5

Administration Considerations

• Repatha is administered subcutaneously into the abdomen, thigh, or upper arm
• Injection sites should be rotated with each administration
• Available as:
  • Prefilled single-dose SureClick® autoinjector (140 mg/mL)
  • Prefilled single-dose syringe (140 mg/mL)
  • Single-dose Pushtronex® system (on-body infusor with prefilled cartridge, 420 mg/3.5 mL) 2

Patient Monitoring

• Assess LDL-C when clinically appropriate (LDL-lowering effect may be measured as early as 4 weeks after initiation)
• Monitor for signs of hypersensitivity reactions
• No specific laboratory monitoring is required for safety purposes 1, 2

Repatha has demonstrated significant cardiovascular benefits in clinical trials while maintaining a favorable safety profile, making it an important option for patients requiring additional LDL-C reduction beyond statins or for those who cannot tolerate statins.