EVKEEZA Concentrate for solution for infusion Ref.[27942] Active ingredients: Evinacumab

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.

Hypersensitivity and infusion reactions

Hypersensitivity reactions, including anaphylaxis, and infusion reactions have been reported with evinacumab (see section 4.8). 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.

No interaction studies have been performed. No interacting mechanisms between evinacumab and other lipid-lowering medications have been observed.

Women of childbearing potential

Women of childbearing potential should use effective contraception during treatment with evinacumab and for at least 5 months after the last dose of evinacumab.

Pregnancy

There is a limited amount of data from the use of evinacumab in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). Human IgG antibodies are known to cross the placenta barrier; therefore, evinacumab has the potential to be transmitted from the mother to the developing foetus. Evinacumab may cause foetal harm when administered to a pregnant woman and it is not recommended during pregnancy and in women of childbearing potential not using effective contraception unless the expected benefit to the patient outweighs the potential risk to the foetus.

Breast-feeding

It is unknown whether evinacumab is excreted in human milk. Human IgGs are known to be excreted in breast milk during the first few days after birth, which decrease to low concentrations soon afterwards; consequently, a risk to the breast-fed infant cannot be excluded during this short period. Afterwards, Evkeeza could be used during breast-feeding if clinically needed.

Fertility

No human data on the effect of evinacumab on fertility are available. Animal studies do not indicate harmful effects with respect to male and female fertility (see section 5.3).

Evkeeza has no or negligible influence on the ability to drive and use machines.

Summary of the safety profile

The most frequently occurring adverse reactions are nasopharyngitis (13.7%), influenza like illness (7.7%), dizziness (6.0%), back pain (5.1%) and nausea (5.1%). The most serious adverse reaction is anaphylaxis (0.9%).

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 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 (cannot be estimated from available data). Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.

Table 1. Adverse reactions:

^* See section Paediatric population, below.

Description of selected adverse reactions

Hypersensitivity reactions

Anaphylaxis was reported in 1 (0.9%) patient treated with evinacumab (see section 4.4).

Infusion reactions

Infusion reactions (e.g., infusion site pruritus) were reported in 9 (7.7%) patients treated with evinacumab and in 2 (3.7%) 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 IV 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. Fatigue was reported in 3 (15%) patients (See section 5.1).

The safety of evinacumab in paediatric patients aged less than 5 years has not been established (see section 5.1).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.