Praluent 150 mg/mL
alirocumab · INJECTION, SOLUTION · Sanofi-Aventis U.S. LLC
Praluent is a injection, solution containing alirocumab at 150 mg/mL, taken subcutaneous. Manufactured by Sanofi-Aventis U.S. LLC.
Key Facts
- Brand Name
- Praluent
- Generic Name
- alirocumab
- NDC Code (Product)
0024-5902- Manufacturer
- Sanofi-Aventis U.S. LLC
- Strength
- 150 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Marketing Status
- Application #
- BLA125559
- Drug Class
- PCSK9 Inhibitor [EPC]
- Marketing Start
- 07/24/2015
Recall History
Kroger Specialty Pharmacy, Inc.
Lack of Processing Controls.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE PRALUENT ® is indicated: To reduce the risk of major adverse cardiovascular (CV) events (coronary heart disease death, myocardial infarction, stroke, or unstable angina requiring hospitalization) in adults at increased risk for these events . As an adjunct to diet and exercise to reduce low- density lipoprotein cholesterol (LDL-C) in: adults with hypercholesterolemia. adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). adults with homozygous familial hypercholesterolemia (HoFH). PRALUENT is a proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor indicated: To reduce the risk of major adverse cardiovascular (CV) events (coronary heart disease death, myocardial infarction, stroke, or unstable angina requiring hospitalization) in adults at increased risk for these events. ( 1 ) As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in : adults with hypercholesterolemia ( 1 ) adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). ( 1 ) adults with homozygous familial hypercholesterolemia (HoFH). ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION In adults with hypercholesterolemia, including HeFH ( 2.1 ): The recommended starting dosage of PRALUENT is either 75 mg once every 2 weeks or 300 mg once every 4 weeks administered subcutaneously. For patients receiving PRALUENT 300 mg every 4 weeks, measure LDL-C just prior to the next scheduled dosage, because LDL-C can vary between dosages in some patients. If the LDL-C response is inadequate, the dosage may be adjusted 150 mg subcutaneously every 2 weeks. In adults with HeFH undergoing LDL apheresis or in adults with HoFH ( 2.1 ): The recommended dosage of PRALUENT is 150 mg once every 2 weeks administered subcutaneously. PRALUENT can be administered without regard to the timing of LDL apheresis. In pediatric patients with HeFH ( 2.2 ): The recommended dosage of PRALUENT for patients with a body weight less than 50 kg is 150 mg once every 4 weeks administered subcutaneously. The recommended dosage of PRALUENT for patients with a body weight of 50 kg or more is 300 mg once every 4 weeks administered subcutaneously. If the LDL-C response is inadequate, the dosage may be adjusted for patients with a body weight less than 50 kg to 75 mg subcutaneously o…
Contraindications
4 CONTRAINDICATIONS PRALUENT is contraindicated in patients with a history of a serious hypersensitivity reaction to alirocumab or any of the excipients in PRALUENT. Hypersensitivity vasculitis, angioedema, and hypersensitivity reactions requiring hospitalization have occurred [see Warnings and Precautions (5.1) ]. History of a serious hypersensitivity reaction to alirocumab or any of the excipients in PRALUENT. ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are also discussed in the other sections of the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Common (>5% of patients treated with PRALUENT and more frequently than placebo) adverse reactions in adults with: Primary hypercholesterolemia : injection site reactions, and influenza. ( 6 ) Established CV disease: myalgia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Regeneron at 1-844-734-6643 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions in Adults with Hypercholesterolemia The data in Table 1 are derived from 9 primary hypercholesterolemia placebo-controlled trials that included 2,476 adult patients treated with PRALUENT 75 mg and/or 150 mg every 2 weeks, including 2,135 exposed for 6 months and 1,999 exposed for more than 1 year (median treatment duration of 65 weeks). The mean age of t…
Frequently Asked Questions
What is Praluent used for?
Praluent contains alirocumab. It is a injection, solution taken subcutaneous. Consult your doctor for specific uses.
Is Praluent a controlled substance?
Praluent is not classified as a controlled substance by the DEA.
What is the generic name for Praluent?
The generic name for Praluent is alirocumab. There are no other listed brand versions of alirocumab.
What is the NDC code for Praluent 150 mg/mL?
The NDC (National Drug Code) for Praluent 150 mg/mL is 0024-5902, listed by Sanofi-Aventis U.S. LLC.
Other Praluent Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)