Evinacumab
Regulatory sources consulted
- AEMPS-SPC-1211551001
- PubMed PMID:40139108 ↗
- PubMed PMID:39765369 ↗
- WHO ATC Index
- AEMPS CIMA · nº registro 1211551001 ↗
- RxNorm rxcui 2282403 ↗
Approved indications
- Treatment of homozygous familial hypercholesterolemia (HoFH) in adults and adolescents aged 12 years and older, as an adjunct to diet and other lipid-lowering therapies.
Contraindications
Absolute
- Hypersensitivity to the active substance or to any of the excipients.
Clinical warnings
- Major warning · Hypersensitivity reactions: Serious reactions, including anaphylaxis, may occur. If a serious hypersensitivity reaction occurs, stop the infusion immediately and administer appropriate treatment. — AEMPS SPC
Adverse events
Common (≥1%)
nasopharyngitis · influenza-like illness · dizziness · rhinorrhea · nausea
Rare but serious
anaphylaxis
Pregnancy and lactation
FDA category: Not Assigned
Pregnancy: Avoid use unless the woman's clinical condition requires treatment. Lactation: A decision must be made whether to discontinue breast-feeding or to discontinue therapy, taking into account the benefit for the child and the mother.
Recent literature (PubMed)
Revisión de terapias hipolipemiantes emergentes. Discute nuevos oligonucleótidos antisentido dirigidos a ANGPTL3, el objetivo molecular de Evinacumab, destacando su potencial para reducir significativamente estas moléculas y ofrecer ventajas terapéuticas en ciertas dislipidemias.
- [Practical approach to the patient with hypercholesterolemia in Spain. SEMERGEN position statement].
Documento de posicionamiento sobre el manejo de la hipercolesterolemia en España. Revisa las diferentes opciones de tratamiento hipolipemiante, incluyendo las últimas terapias disponibles, para alcanzar los objetivos de C-LDL, aunque no se centra específicamente en Evinacumab.