There is a limited amount of data from the use of evinacumab in pregnant women. Studies in animals have shown reproductive toxicity. 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.
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, evinacumab could be used during breast-feeding if clinically needed.
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.
Women of childbearing potential should use effective contraception during treatment with evinacumab and for at least 5 months after the last dose of evinacumab.
Evinacumab has no or negligible influence on the ability to drive and use machines.
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%).
The following table lists the incidence of adverse reactions in the pooled controlled clinical trials of evinacumab therapy involving 117 patients with HoFH and persistent hypercholesterolaemia. 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.
| MedDRA System organ class | Preferred term | Frequency categories |
|---|---|---|
| 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 | Influenza like illness | Common |
| Asthenia | Common | |
| Infusion related reaction | Common | |
| Infusion site reactions | Common |
Anaphylaxis was reported in 1 (0.9%) patient treated with evinacumab.
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.
The safety profile observed in 13 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 in paediatric patients aged less than 12 years has not been established.
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