IMPORTANT SAFETY INFORMATION
EVKEEZA® is contraindicated in patients with a history of serious hypersensitivity reactions to evinacumab-dgnb or to any of the excipients in EVKEEZA. Serious hypersensitivity reactions, including anaphylaxis, have occurred.
Warnings and Precautions
Serious Hypersensitivity Reactions: Serious hypersensitivity reactions have occurred with EVKEEZA. If signs or symptoms of serious allergic reactions occur, discontinue EVKEEZA infusion, treat according to the standard-of-care, and monitor until signs and symptoms resolve.
Embryo-Fetal Toxicity: EVKEEZA may cause fetal harm when administered to pregnant patients. Advise patients who may become pregnant of the risk to a fetus. Consider obtaining a pregnancy test prior to initiating treatment with EVKEEZA. Advise patients who may become pregnant to use effective contraception during treatment and for at least 5 months following the last dose.
Common adverse reactions (≥5%) were nasopharyngitis (16%), influenza-like illness (7%), dizziness (6%), rhinorrhea (5%), and nausea (5%).
Use in Specific Populations
Pregnancy: EVKEEZA may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. If a patient becomes pregnant while receiving EVKEEZA, healthcare providers should report EVKEEZA exposure by calling 1-833-385-3392.
Lactation: There are no data on the presence of evinacumab-dgnb in human milk or animal milk, the effects on the breastfed infant, or the effects on milk production. Maternal IgG is known to be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for EVKEEZA and any potential adverse effects on the breastfed infant from EVKEEZA or from the underlying maternal condition.
Females and Males of Reproductive Potential: Consider pregnancy testing in patients who may become pregnant prior to starting treatment with EVKEEZA. EVKEEZA may cause fetal harm when administered to a pregnant woman. Females of reproductive potential should use effective contraception during treatment with EVKEEZA and for at least 5 months following the last dose of EVKEEZA.
Pediatrics: The safety and efficacy of EVKEEZA have not been established in pediatric patients with HoFH who are younger than 12 years old.
EVKEEZA is an ANGPTL3 (angiopoietin-like 3) inhibitor indicated as an adjunct to other low-density lipoprotein-cholesterol (LDL-C) lowering therapies for the treatment of adult and pediatric patients, aged 12 years and older, with homozygous familial hypercholesterolemia (HoFH).
Limitations of Use:
- The safety and effectiveness of EVKEEZA have not been established in patients with other causes of hypercholesterolemia, including those with heterozygous familial hypercholesterolemia (HeFH).
- The effects of EVKEEZA on cardiovascular morbidity and mortality have not been determined.