Repatha

Note: This document contains side effect information about evolocumab. Some of the dosage forms listed on this page may not apply to the brand name Repatha.

Applies to evolocumab: subcutaneous solution

Along with its needed effects, evolocumab (the active ingredient contained in Repatha) 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 immediately if any of the following side effects occur while taking evolocumab:

Incidence not known

• Difficulty with breathing or swallowing
• fever
• hives, itching, or rash
• nausea
• reddening of the skin, especially around the ears
• swelling of the eyes, face, or inside of the nose
• unusual tiredness or weakness

Some side effects of evolocumab 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

• Back pain
• bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• blurred vision
• body aches or pain
• chills
• cough
• dry mouth
• ear congestion
• flushed, dry skin
• fruit-like breath odor
• headache
• loss of voice
• muscle aches
• sneezing
• sore throat
• stomach ache
• stuffy or runny nose
• sweating
• troubled breathing
• unexplained weight loss
• vomiting

Less common

• Bladder pain
• bloody or cloudy urine
• diarrhea
• difficult, burning, or painful urination
• difficulty with moving
• dizziness
• frequent urge to urinate
• loss of appetite
• lower back or side pain
• muscle or joint pain
• muscle stiffness
• nervousness
• pain or tenderness around the eyes and cheekbones
• pounding in the ears
• slow or fast heartbeat
• swollen joints

Applies to evolocumab: subcutaneous solution

The more commonly reported adverse reactions have included nasopharyngitis, upper respiratory tract infection, back pain, and injection site reactions.

Common (1% to 10%): Hypersensitivity reactions (including rash, eczema, erythema, urticaria)

Postmarketing reports: Angioedema

Common (1% to 10%): Hypertension

Common (1% to 10%): Diarrhea, gastroenteritis, nausea (1.8%)

Common (1% to 10%): Urinary tract infection

Common (1% to 10%): Injection site reaction (including erythema, pain, bruising)

Common (1% to 10%): Back pain, myalgia, musculoskeletal pain, arthralgia (1.8%)

Common (1% to 10%): Headache, dizziness

Uncommon (0.1% to 1%): Neurocognitive events (0.2%)

Common (1% to 10%): Influenza, fatigue (1.6%)

Uncommon (0.1% to 1%): Contusion

Common (1% to 10%): Influenza, fatigue (1.6%)

Uncommon (0.1% to 1%): Contusion

Rare (less than 0.1%): Development anti-drug antibody