Praluent

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

Applies to alirocumab: subcutaneous solution

Along with its needed effects, alirocumab (the active ingredient contained in Praluent) 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 alirocumab:

More common

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

Less common

• Cough producing mucus
• tightness in the chest

Some side effects of alirocumab 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
• cough
• diarrhea
• general feeling of discomfort or illness
• headache
• joint pain
• loss of appetite
• muscle aches and pains
• redness, itching, swelling, or pain at the injection site
• shivering
• sore throat
• stuffy or runny nose
• sweating
• trouble sleeping
• vomiting

Less common

• Bladder pain
• bloody or cloudy urine
• difficult, burning, or painful urination
• difficulty with moving
• frequent urge to urinate
• lower back or side pain
• muscle stiffness or spasms
• pain or tenderness around the eyes and cheekbones
• swollen joints

Applies to alirocumab: subcutaneous solution

The most commonly reported adverse reactions have included nasopharyngitis, injection site reactions, and influenza.

Common (1% to 10%): Hypersensitivity reaction, nummular eczema, hypersensitivity vasculitis

Very common (10% or more): Nasopharyngitis (11.3%)

Common (1% to 10%): Influenza, bronchitis, sinusitis, cough

Common (1% to 10%): Diarrhea

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

During clinical trials, 2.5% of patients treated with this drug reported abnormal liver enzymes (placebo=1.8%); treatment discontinuation occurred in 0.4% and 0.2% of patients receiving this drug and placebo, respectively. Increases in serum transaminases to greater than 3 times the upper limit of normal occurred in 1.7% of patients treated with this drug (placebo=1.4%).

Common (1% to 10%): Elevated liver enzymes

Common (1% to 10%): Development of antidrug antibody (ADA), neutralizing antibodies (NAb)

Postmarketing reports: Flu-like illness

Patients who developed ADA (antidrug antibody) had a higher incidence of injection site reactions compared with patients who did not develop ADA (10.2% vs 5.9%).

Common (1% to 10%): Injection site reaction (erythema, redness, itching, swelling, pain, tenderness)

Common (1% to 10%): Myalgia, muscle spasm, contusion, musculoskeletal pain

Uncommon (0.1% to 1%): Neurocognitive events, confusion or memory impairment

During clinical trials with both every 2 week or every 4 week dosing, reports of 2 consecutive calculated LDL-C values less than 25 mg/dL, and less than 15 mg/dL were reported in 914 and 335 patients, respectively. Low LDL-C values were observed more frequently in patients treated with 150 mg every 2 weeks or 400 mg every 4 weeks. Changes to background lipid therapy was not made and adverse consequences were not identified, but the long-term effects of very low levels of LDL-C are not known.

Frequency not reported: Low LDL-C values