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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.For the Consumer
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:
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:
For Healthcare Professionals
Applies to alirocumab: subcutaneous solutionGeneral
The most commonly reported adverse reactions have included nasopharyngitis, injection site reactions, and influenza.Hypersensitivity
Common (1% to 10%): Hypersensitivity reaction, nummular eczema, hypersensitivity vasculitisRespiratory
Very common (10% or more): Nasopharyngitis (11.3%)
Common (1% to 10%): Influenza, bronchitis, sinusitis, coughGastrointestinal
Common (1% to 10%): DiarrheaGenitourinary
Common (1% to 10%): Urinary tract infectionHepatic
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 enzymesImmunologic
Common (1% to 10%): Development of antidrug antibody (ADA), neutralizing antibodies (NAb)
Postmarketing reports: Flu-like illnessLocal
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)Musculoskeletal
Common (1% to 10%): Myalgia, muscle spasm, contusion, musculoskeletal painNervous system
Uncommon (0.1% to 1%): Neurocognitive events, confusion or memory impairmentMetabolic
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
July 17, 2020
September 29, 2015
September 10, 2015
May 17, 2022
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May 17, 2022