Praluent
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Questions & Answers
Side Effects & Adverse Reactions
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Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
PRALUENT is indicated as an 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.
History
There is currently no drug history available for this drug.
Other Information
Alirocumab is a human monoclonal antibody (IgG1 isotype) that targets proprotein convertase subtilisin kexin type 9 (PCSK9). Alirocumab is a PCSK9 inhibitor produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture. Alirocumab consists of two disulfide-linked human heavy chains, each covalently linked through a disulfide bond to a human kappa light chain. A single N-linked glycosylation site is located in each heavy chain within the CH2 domain of the Fc constant region of the molecule. The variable domains of the heavy and light chains combine to form the PCSK9 binding site within the antibody. Alirocumab has an approximate molecular weight of 146 kDa.
PRALUENT is a sterile, preservative-free, clear, colorless to pale yellow solution for subcutaneous injection. PRALUENT 75 mg/mL or 150 mg/mL solution for subcutaneous injection in a single-dose pre-filled pen or single-dose pre-filled syringe is supplied in a siliconized 1 mL Type-1 clear glass syringe. The needle shield is not made with natural rubber latex.
Each 75 mg/mL pre-filled pen or pre-filled syringe contains histidine (8 mM), polysorbate 20 (0.1 mg), sucrose (100 mg), and Water for Injection USP, to pH 6.0.
Each 150 mg/mL pre-filled pen or pre-filled syringe contains histidine (6 mM), polysorbate 20 (0.1 mg), sucrose (100 mg), and Water for Injection USP, to pH 6.0.
Sources
Praluent Manufacturers
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Sanofi-aventis U.s. Llc
![Praluent (Alirocumab) Injection, Solution [Sanofi-aventis U.s. Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Praluent | Sanofi-aventis U.s. Llc
2.1 Dosing InformationThe recommended starting dose of PRALUENT is 75 mg administered subcutaneously once every 2 weeks, since the majority of patients achieve sufficient LDL-C reduction with this dosage. If the LDL-C response is inadequate, the dosage may be increased to the maximum dosage of 150 mg administered every 2 weeks.
Measure LDL-C levels within 4 to 8 weeks of initiating or titrating PRALUENT to assess response and adjust the dose, if needed.
If a dose is missed, instruct the patient to administer the injection within 7 days from the missed dose and then resume the patient's original schedule. If the missed dose is not administered within 7 days, instruct the patient to wait until the next dose on the original schedule.
2.2 Important Administration Instructions Provide proper training to patients and/or caregivers on the preparation and administration of PRALUENT prior to use according to the Instructions for Use. Instruct patients and/or caregivers to read and follow the Instructions for Use each time they use PRALUENT. Allow PRALUENT to warm to room temperature for 30 to 40 minutes prior to use. Use PRALUENT as soon as possible after it has warmed up. Do NOT use PRALUENT if it has been at room temperature [77°F (25°C)] for 24 hours or longer. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. If the solution is discolored or contains visible particulate matter, the solution should not be used. Follow aseptic injection technique every time PRALUENT is administered. Administer PRALUENT by subcutaneous injection into the thigh, abdomen, or upper arm using a single-dose pre-filled pen or single-dose pre-filled syringe. Rotate the injection site with each injection. Do NOT inject PRALUENT into areas of active skin disease or injury such as sunburns, skin rashes, inflammation, or skin infections. Do NOT co-administer PRALUENT with other injectable drugs at the same injection site.
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