From the Guidelines
Repatha (evolocumab) can cause several side effects, though most are mild and temporary, with common side effects including injection site reactions, cold-like symptoms, back pain, and muscle pain, as reported in the FOURIER trial 1. The most common side effects of Repatha include:
- Injection site reactions like redness or pain
- Cold-like symptoms
- Back pain
- Muscle pain Less frequently, patients may experience:
- Allergic reactions
- Joint pain
- Flu-like symptoms
- Nausea Serious side effects are rare but can include severe allergic reactions (rash, itching, difficulty breathing) which require immediate medical attention. According to the FOURIER trial, the rates of serious adverse events were comparable in both trial arms (24.8% versus 24.7%), with only injection site reaction occurring more frequently with evolocumab treatment (2.1% versus 1.6%) 1. The ODYSSEY OUTCOMES trial also reported similar findings, with injection site reactions being more common with alirocumab (3.8% versus 2.1%) 1. Most patients tolerate Repatha well, with side effects typically diminishing over time as the body adjusts to the medication. The drug works by blocking a protein called PCSK9, allowing more LDL receptors to remove cholesterol from the bloodstream, which explains its effectiveness in lowering LDL cholesterol but also accounts for some of its side effects. If you experience persistent or severe side effects while taking Repatha, contact your healthcare provider rather than discontinuing the medication on your own.
From the FDA Drug Label
ADVERSE REACTIONS Common (> 5% of patients treated with REPATHA and more frequently than placebo) adverse reactions in adults with: Primary hyperlipidemia: nasopharyngitis, upper respiratory tract infection, influenza, back pain, and injection site reactions. Established CVD: diabetes mellitus, nasopharyngitis and upper respiratory tract infection REPATHA can cause serious side effects including: Serious Allergic Reactions. Some people taking REPATHA have had serious allergic reactions Stop taking REPATHA and call your healthcare provider or seek emergency medical help right away if you or your child have any of these symptoms: trouble breathing or swallowing raised bumps (hives) rash, or itching swelling of the face, lips, tongue, throat or arms The most common side effects of REPATHA include: runny nose, sore throat, symptoms of the common cold, flu or flu-like symptoms, back pain, high blood sugar levels (diabetes) and redness, pain, or bruising at the injection site.
The common side effects of Repatha include:
- Nasopharyngitis
- Upper respiratory tract infection
- Influenza
- Back pain
- Injection site reactions
- Diabetes mellitus
- Runny nose
- Sore throat
- Symptoms of the common cold, flu or flu-like symptoms
- High blood sugar levels (diabetes)
- Redness, pain, or bruising at the injection site The serious side effects of Repatha include:
- Serious allergic reactions
- Trouble breathing or swallowing
- Raised bumps (hives)
- Rash, or itching
- Swelling of the face, lips, tongue, throat or arms 2 2
From the Research
Repatha Side Effects
- The most common adverse events reported in patients treated with evolocumab (Repatha) were back pain, arthralgia, headache, muscle spasms, and pain in extremity (all <2%) 3.
- Adverse events were reported in 36% of evolocumab-treated patients, compared to 40% of ezetimibe-treated patients and 39% of placebo-treated patients 3.
- In a study comparing evolocumab and ezetimibe, adverse events and discontinuation rates were balanced across groups, suggesting good tolerance and acceptance of both treatments 4.
- The most common adverse events in the evolocumab group were diarrhea (9.5%) and nasopharyngitis (12.5%), while in the ezetimibe group, the most common adverse event was diarrhea (9.5%) 5.
- Evolocumab was generally well-tolerated, with a safety profile similar to that of ezetimibe 4, 5.
Comparison of Evolocumab and Ezetimibe
- Evolocumab reduced LDL-C by a mean 55-61% from baseline to week 12, while ezetimibe lowered LDL-C by 18-20% from baseline 4.
- Evolocumab outperformed ezetimibe in efficacy and lipid goal attainment, with a higher percentage of patients achieving LDL-C goals 4.
- The treatment differences between evolocumab and ezetimibe were -39.4% and -40.1% for the co-primary endpoints of percent change from baseline in mean LDL-C to the mean of weeks 10 and 12 and to week 12, respectively (adjusted p＜0.0001) 5.
Statin-Intolerant Patients
- Evolocumab was superior to ezetimibe in reducing LDL-C during the 12-week double-blind period in a population of Japanese patients with statin intolerance 5.
- The efficacy and safety results of evolocumab were maintained for 1 year in statin-intolerant patients 5.
- Evolocumab may be a suitable alternative for patients who are intolerant to statins, with a favorable safety and efficacy profile 6, 5.