PRALUENT® (alirocumab) Safety Profile

PRALUENT: Generally well tolerated no matter which dose you choose1

Evaluated in >2400 patients treated with PRALUENT 75 mg and/or 150 mg Q2W in 9 placebo-controlled trials1

Table of adverse reactions occurring in greater than or equal to 2% of PRALUENT-treated patients and more frequently than with placebo.
  • 2135 patients were exposed to PRALUENT for at least 6 months and 1999 patients were exposed to PRALUENT for more than 1 year (median treatment duration of 65 weeks)1

Hypersensitivity reactions

  • Hypersensitivity reactions (e.g., pruritus, rash, urticaria), including some serious events (e.g., hypersensitivity vasculitis and hypersensitivity reactions requiring hospitalization), have been reported with PRALUENT treatment. If signs or symptoms of serious allergic reactions occur, discontinue treatment with PRALUENT, treat according to the standard of care, and monitor until signs and symptoms resolve

Local injection site reactions

  • Erythema/redness, itching, swelling, and pain/tenderness were more frequent in patients treated with PRALUENT 75 mg/150 mg Q2W (7.2% vs 5.1% for PRALUENT and placebo, respectively)
    • – Few patients discontinued treatment because of these reactions (0.2% versus 0.4% for PRALUENT and placebo, respectively), but patients receiving PRALUENT had a greater number of injection site reactions, had more reports of associated symptoms, and had reactions of longer average duration than patients receiving placebo
  • Local injection site reactions were reported more frequently in patients treated with PRALUENT 300 mg Q4W as compared to those receiving PRALUENT 75 mg Q2W or placebo (16.6%, 9.6%, and 7.9%, respectively) in a trial in which all patients received an injection of drug or placebo every 2 weeks to maintain the blind
    • – Three patients (0.7%) treated with PRALUENT 300 mg Q4W discontinued treatment due to local injection site reactions versus no patients (0%) in the other 2 treatment groups

Neurocognitive events

  • Reported in 0.8% of patients treated with PRALUENT and 0.7% of patients treated with placebo
  • Confusion or memory impairment were more frequent with PRALUENT (0.2% for each) than in those treated with placebo (<0.1% for each)

Liver enzyme abnormalities

  • Abnormalities in liver enzymes were reported in 2.5% of patients treated with PRALUENT and 1.8% of patients treated with placebo, leading to treatment discontinuation in 0.4% and 0.2% of patients, respectively
  • Increases in serum transaminases to greater than 3 times the upper limit of normal occurred in 1.7% of patients treated with PRALUENT and 1.4% of patients treated with placebo

Immunogenicity

  • As with all therapeutic proteins, there is a potential for immunogenicity with PRALUENT

Low LDL-C values

  • In the placebo- and active-controlled clinical trials using an every 2 week or every 4 week dosing interval, 914 PRALUENT-treated patients had two consecutive calculated LDL-C values <25 mg/dL, and 335 had two consecutive calculated LDL-C values <15 mg/dL. LDL-C <25 mg/dL and <15 mg/dL were observed more frequently in patients treated with the PRALUENT 150 mg Q2W or 300 mg Q4W dosing regimens
  • Changes to background lipid-altering therapy (eg, maximally tolerated statins) were not made in response to low LDL-C values, and PRALUENT dosing was not modified or interrupted on this basis
  • Although adverse consequences of very low LDL-C were not identified in these trials, the long-term effects of very low levels of LDL-C induced by PRALUENT are unknown

NEXT: PRALUENT Patient Types

Reference:
  1. PRALUENT® (alirocumab) Prescribing Information. Sanofi/Regeneron Pharmaceuticals, 2017.