Clinical Information
Gen. Code and Des.
74511 alirocumab SUBCUT PEN INJCTR 75 MG/ML
Strength
75 mg/mL
Dose Form
PEN INJECTOR (ML)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
24062400 PCSK9 INHIBITORS
Active Ingredients
16342 alirocumab
Inactive Ingredients
2598 sucrose 57501
for: High Cholesterol
Praluent (alirocumab) is a PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor monoclonal antibody indicated:
as an adjunct to diet, alone or in combination with other lipid-lowering therapies (e.g., statins, ezetimibe), for the treatment of adults with primary hyperlipidemia (including heterozygous familial hypercholesterolemia) to reduce low-density lipoprotein cholesterol LDL-C.
to reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease.
These highlights do not include all the information needed to use PRALUENT safely and effectively. See full prescribing information for PRALUENT.
PRALUENT® (alirocumab) injection, for subcutaneous use
Initial U.S. Approval: 2015
RECENT MAJOR CHANGES
Indications and Usage (1.1, 1.2) 4/2019
Dosage and Administration (2.1) 8/2018
INDICATIONS AND USAGE
PRALUENT is a PCSK9 (proprotein convertase subtilisin kexin type 9) inhibitor antibody indicated:
to reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease. (1.1)
as adjunct to diet, alone or in combination with other lipid-lowering therapies (e.g., statins, ezetimibe), for the treatment of adults with primary hyperlipidemia (including heterozygous familial hypercholesterolemia) to reduce low-density lipoprotein cholesterol LDL-C. (1.2)
DOSAGE AND ADMINISTRATION
The recommended starting dose of PRALUENT is 75 mg once every 2 weeks administered subcutaneously, since the majority of patients achieve sufficient LDL-C reduction with this dosage. An alternative starting dosage for patients who prefer less frequent dosing is 300 mg once every 4 weeks (monthly). (2.1)
If the LDL-C response is inadequate, the dosage may be adjusted to the maximum dosage of 150 mg administered every 2 weeks. (2.1)
The recommended dose of PRALUENT in patients with HeFH undergoing LDL apheresis is 150 mg once every 2 weeks. PRALUENT can be administered without regard to timing of apheresis. (2.1)
DOSAGE FORMS AND STRENGTHS
Injection: 75 mg/mL or 150 mg/mL solution in a single-dose pre-filled pen (3)
Injection: 75 mg/mL or 150 mg/mL solution in a single-dose pre-filled syringe (3)
CONTRAINDICATIONS
History of a serious hypersensitivity reaction to PRALUENT. (4)
WARNINGS AND PRECAUTIONS
Allergic 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. (5.1)
ADVERSE REACTIONS
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. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Sanofi at 1-800-633-1610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 4/2019
