Evkeeza

Before treatment initiation of evinacumab the patient should be on an optimal LDL-C lowering regimen. Treatment with evinacumab should be initiated and monitored by a physician experienced in the treatment of lipid disorders. Posology The recommended dose is 15 mg/kg body weight administered by intravenous infusion over 60 minutes once monthly (every 4 weeks).

Missed dose If a dose is missed, it should be administered as soon as possible. Thereafter, treatment with evinacumab should be scheduled monthly from the date of the last dose. 2). 2). 2). 2). The safety and efficacy of Evkeeza in children aged less than 6 months have not been established.

No data are available. Method of administration Evkeeza is for intravenous infusion use only. Evkeeza can be administered without regard to lipoprotein apheresis. Administration • If refrigerated, the solution should be allowed to come to room temperature (up to 25 ºC) prior to administration.

2-micron to 5-micron filter. Evinacumab should not be administered as an intravenous push or bolus. • Other medicinal products should not be mixed with evinacumab or administered concomitantly via the same infusion line. 8). 6.

1%). 9%). Tabulated list of adverse reactions Table 1 lists the incidence of adverse reactions in clinical trials of evinacumab therapy involving 137 treated patients (117 adult and adolescent patients with HoFH and persistent hypercholesterolaemia from pooled controlled clinical trials and 20 paediatric patients aged >5 to 11 years with HoFH from Study R1500-CL-17100).

Adverse reactions are listed by MedDRA system organ class (SOC) and by frequency. Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); very rare (< 1/10 000); not known 5 (cannot be estimated from available data).

Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.

Table 1:

Adverse reactions System organ class Adverse reaction Frequency Infections and infestations Nasopharyngitis Very common Upper respiratory tract infection Common Immune system disorders Anaphylaxis Uncommon Nervous system disorders Dizziness Common Respiratory, thoracic and mediastinal disorders Rhinorrhoea Common Gastrointestinal disorders Nausea Common Abdominal pain Common Constipation Common Musculoskeletal and connective tissue disorders Back pain Common Pain in extremity Common General disorders and administration site conditions Fatigue* Very common Influenza like illness Common Asthenia Common Infusion related reaction Common Infusion site reactions Common * See section Paediatric population, below.

4). g. 7%) patients treated with placebo. Paediatric population The safety profile observed in 14 adolescent patients with HoFH aged 12 to 17 years treated with evinacumab 15 mg/kg for intravenous use every 4 weeks was consistent with the safety profile of adult patients with HoFH.

The safety of evinacumab was assessed in 20 paediatric patients aged ≥ 5 to 11 years. The safety profile of evinacumab observed in these patients was consistent with the safety profile observed in adult and adolescent patients aged 12 years and older, with the additional adverse reaction of fatigue.

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. 8). If signs or symptoms of serious hypersensitivity or serious infusion reactions occur, discontinue treatment with evinacumab, treat according to the standard-of-care, and monitor until signs and symptoms resolve.

Excipients with known effect This medicinal product contains 30 mg of proline in each ml. Proline may be harmful for patients with hyperprolinaemia type I or type II. 4 This medicinal product contains 1 mg of polysorbate 80 in each ml.

Polysorbates may cause allergic reactions.

1.