PRALUENT®
(alirocumab) INJECTION

Indication

PRALUENT® (alirocumab) Injection is a PCSK9 (Proprotein Convertase Subtilisin Kexin Type 9) inhibitor antibody indicated as adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease, who require additional lowering of LDL-C.

The effect of PRALUENT on cardiovascular morbidity and mortality has not been determined.

Important Safety Information

PRALUENT is contraindicated in patients with a history of a serious hypersensitivity reaction to PRALUENT. Reactions have included hypersensitivity vasculitis and hypersensitivity reactions requiring hospitalization.

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.

The most commonly occurring adverse reactions (≥5% of patients treated with PRALUENT and occurring more frequently than with placebo) are nasopharyngitis, injection site reactions and influenza.

Local injection site reactions including erythema/redness, itching, swelling and pain/tenderness were reported more frequently in patients treated with PRALUENT 75 mg and/or 150 mg every 2 weeks (7.2% versus 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.

The once-monthly (Q4W) 300 mg dosing regimen had a higher rate of local injection site reactions as compared to 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. The discontinuation rate due to injection site reactions was 0.7% in the 300 mg Q4W arm and 0% in the other 2 arms.

Neurocognitive events were reported in 0.8% of patients treated with PRALUENT and 0.7% of patients treated with placebo. Confusion or memory impairment were reported more frequently by those treated with PRALUENT (0.2% for each) than in those treated with placebo (<0.1% for each).

Liver-related disorders (primarily related to 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.

The most common adverse reactions leading to treatment discontinuation in patients treated with PRALUENT were allergic reactions (0.6% versus 0.2% for PRALUENT and placebo, respectively) and elevated liver enzymes (0.3% versus <0.1%).

PRALUENT is a human monoclonal antibody. As with all therapeutic proteins, there is a potential for immunogenicity with PRALUENT.

Full U.S. Prescribing Information for PRALUENT

The product information in this site is intended only for residents of the U.S. The products discussed herein may have different product labeling in different countries.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

More information available at www.praluent.com

10/2017
SAUS.PRL.17.09.7741