Traceability: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Allergic reactions: General allergic reactions, including pruritus, as well as rare and sometimes serious allergic reactions such as hypersensitivity, nummular eczema, urticaria, and hypersensitivity vasculitis have been reported in clinical studies. Angioedema has been reported in the postmarketing setting (see Adverse Reactions). If signs or symptoms of serious allergic reactions occur, treatment with Praluent must be discontinued and appropriate symptomatic treatment initiated (see Contraindications).
Effects on ability to drive and use machines: Praluent has no or negligible influence on the ability to drive and use machines.
Renal impairment: In clinical studies, there was limited representation of patients with severe renal impairment (defined as eGFR <30 mL/min/1.73 m2) (see Pharmacology: Pharmacokinetics under Actions). Praluent should be used with caution in patients with severe renal impairment.
Hepatic impairment: Patients with severe hepatic impairment (Child-Pugh C) have not been studied (see Pharmacology: Pharmacokinetics under Actions). Praluent should be used with caution in patients with severe hepatic impairment.