Applies to evinacumab: intravenous solution.

Serious side effects of Evinacumab

Along with its needed effects, evinacumab may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking evinacumab:

Less common

• Chest tightness
• cough
• difficulty swallowing
• dizziness
• fast heartbeat
• hives, itching, skin rash
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• trouble breathing
• unusual tiredness or weakness

Other side effects of Evinacumab

Some side effects of evinacumab may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Chills
• diarrhea
• fever
• general feeling of discomfort or illness
• headache
• itching at the injection site
• joint pain
• loss of appetite
• muscle aches, pains, or weakness
• nausea
• shivering
• sore throat
• stuffy or runny nose
• sweating
• trouble sleeping
• vomiting

Less common

• Body aches or pain
• constipation
• ear congestion
• lack or loss of strength
• loss of voice
• pain in the arms or legs
• sneezing
• stomach pain

For Healthcare Professionals

Applies to evinacumab: intravenous solution.

General

The more frequently reported adverse reactions have included nasopharyngitis, influenza-like illness, dizziness, rhinorrhea, and nausea.^[Ref]

Hypersensitivity

Anaphylaxis was reported in 1 patient receiving this drug during clinical trials and led to discontinuation of treatment.

Uncommon (0.1% to 1%): Anaphylaxis

Respiratory

Compared to placebo, upper respiratory tract infection and nasal congestion were reported at a higher incidence; incidence was less than 3% of patients.

Very common (10% or more): Nasopharyngitis (16%)

Common (1% to 10%): Rhinorrhea

Frequency not reported: Upper respiratory tract infection, nasal congestion

Immunologic

Frequency not reported: Influenza-like illness

Compared to placebo, influenza-like illness was reported at a higher incidence; incidence was less than 3% of patients.

Cardiovascular

During clinical trials, transient decreases in diastolic blood pressure and increases in heart rate occurred but did not require intervention and resolved post infusion.

Frequency not reported: Diastolic blood pressure decreased, increased heart rate

Nervous system

Common (1% to 10%): Dizziness

Gastrointestinal

Compared to placebo, constipation and abdominal pain were reported at a higher incidence; incidence was less than 3% of patients.

Common (1% to 10%): Nausea

Frequency not reported: Constipation, abdominal pain

Musculoskeletal

Common (1% to 10%): Extremity pain

Other

Common (1% to 10%): Asthenia

Local

Infusion site reactions including infusion site pruritus, pyrexia, muscular weakness, nausea, and nasal congestion were reported in 7% of patients (n=6) receiving this drug compared to 4% (n=2) of placebo patients.

Common (1% to 10%): Infusion site reactions