NEW
Praluent

Praluent Special Precautions

alirocumab

Manufacturer:

Sanofi

Distributor:

DCH Auriga - Healthcare
/
Four Star
Full Prescribing Info
Special Precautions
Allergic Reactions: Hypersensitivity reactions (e.g., pruritus, rash, urticaria), including some serious events (e.g., hypersensitivity vasculitis, angioedema 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 [see Contraindications].
Renal Impairment: No dose adjustment is needed for patients with mild or moderately impaired renal function. No data are available in patients with severe renal impairment. [See Pharmacology: Pharmacokinetics: Specific Populations: Renal impairment under Actions.]
Hepatic Impairment: No dose adjustment is needed for patients with mild or moderate hepatic impairment. No data are available in patients with severe hepatic impairment. [See Pharmacology: Pharmacokinetics: Specific Populations: Hepatic impairment under Actions.]
Use in Children: Safety and efficacy in pediatric patients have not been established.
Use in Elderly: In primary hypercholesterolemia controlled trials, 1158 patients treated with PRALUENT were ≥65 years of age and 241 patients treated with PRALUENT were ≥75 years of age. In a cardiovascular outcomes trial, 2505 patients treated with PRALUENT were ≥65 years of age and 493 patients treated with PRALUENT were ≥75 years of age. No overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
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