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.
Women of childbearing potential should use effective contraception during treatment with evinacumab and for at least 5 months after the last dose of evinacumab.
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.
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 table below 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.
Adverse reactions:
| 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 | Fatigue* | Very Common |
| Influenza like illness | Common | |
| Asthenia | Common | |
| Infusion related reaction | Common | |
| Infusion site reactions | Common |
* See section Paediatric population, below.
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 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.
The safety of evinacumab in paediatric patients aged less than 5 years has not been established.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
