US.EVK.26.05.0003 05/2026 # EVKEEZA (evinacumab-dgnb) Injection EVKEEZA is an angiopoietin-like 3 (ANGPTL3) inhibitor indicated as an adjunct to diet and exercise and other low-density lipoprotein-cholesterol (LDL-C) lowering therapies to reduce LDL-C in adults and pediatric patients, aged 1 year and older, with homozygous familial hypercholesterolemia (HoFH). See **Important Safety Information** & full [**Prescribing Information**](https://www.regeneron.com/downloads/evkeeza_pi.pdf) on site. This site is intended for healthcare professionals only. For the Patient version of the site please visit https://evkeeza.com/. ## Indication EVKEEZA is an angiopoietin-like 3 (ANGPTL3) inhibitor indicated as an adjunct to diet and exercise and other low-density lipoprotein-cholesterol (LDL-C) lowering therapies to reduce LDL-C in adults and pediatric patients, aged 1 year and older, with homozygous familial hypercholesterolemia (HoFH). ## IMPORTANT SAFETY INFORMATION **Contraindication** EVKEEZA is contraindicated in patients with a history of serious hypersensitivity reaction 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, including anaphylaxis, have occurred with EVKEEZA. If signs or symptoms of serious hypersensitivity 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 dosage. **Adverse Reactions** **Adults and Pediatric Patients (12 to 17 years):** Common adverse reactions (≥5%) were nasopharyngitis (16%), influenza-like illness (7%), dizziness (6%), rhinorrhea (5%), and nausea (5%). **Pediatric Patients (5 to 11 years):** The safety profile was consistent with that observed in adults and pediatric patients aged 12 and older, with the additional adverse reaction of fatigue in 3 (15%) patients. **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 dosage of EVKEEZA. **Pediatrics:** The safety profile of EVKEEZA in pediatric patients aged 1 to 11 years was similar to the safety profile in adults and pediatric patients aged 12 years and older, with the additional adverse reaction of fatigue in patients aged 5 to 11 years. The safety and effectiveness of EVKEEZA have not been established in pediatric patients younger than 1 year of age. **Indication** EVKEEZA is an angiopoietin-like 3 (ANGPTL3) inhibitor indicated as an adjunct to diet and exercise and other low-density lipoprotein-cholesterol (LDL-C) lowering therapies to reduce LDL-C in adults and pediatric patients, aged 1 year and older, with homozygous familial hypercholesterolemia (HoFH). Please see full [**Prescribing Information**](https://www.regeneron.com/downloads/evkeeza_pi.pdf). ## Important Resources - [**Important Safety Information**](https://www.evkeezahcp.com/s/#isi) - [**Prescribing Information**](https://www.regeneron.com/downloads/evkeeza_pi.pdf) - [For Patients](https://evkeeza.com/) ## Additional Information This section acts as a guide for navigating the content on https://www.evkeezahcp.com/s/ based on the page descriptions. * [Diagnosing HoFH](https://www.evkeezahcp.com/s/diagnosing-hofh): Learn about homozygous FH (HoFH) and why early detection is critical. See **Important Safety Information** & full [**Prescribing Information**](https://www.regeneron.com/downloads/evkeeza_pi.pdf) on site. * [Treating HoFH](https://www.evkeezahcp.com/s/treating-hofh): Learn about homozygous FH (HoFH) and why prompt management of LDL-C levels is vital. See **Important Safety Information** & full [**Prescribing Information**](https://www.regeneron.com/downloads/evkeeza_pi.pdf) on site. * [About EVKEEZA (evinacumab-dgnb)](https://www.evkeezahcp.com/s/about-evkeeza): EVKEEZA is the first and only FDA-approved ANGPTL3 inhibitor for lowering LDL-C and other lipoproteins independently of LDL-receptor activity. See **Important Safety Information** & full [**Prescribing Information**](https://www.regeneron.com/downloads/evkeeza_pi.pdf) on site. * [Patients Aged 12 Years and Older with HoFH](https://www.evkeezahcp.com/s/patients-12-plus-with-hofh): Powerful reductions in LDL-C levels of ~50% were observed at 24 weeks in patients aged 12 years and older in combination with other LDL-C lowering medications. See **Important Safety Information** & full [**Prescribing Information**](https://www.regeneron.com/downloads/evkeeza_pi.pdf) on site. * [Patients Aged 5 to 11 Years Old with HoFH](https://www.evkeezahcp.com/s/patients-5-to-11-years-with-hofh): Powerful reductions in LDL-C of ~50% were observed at 24 weeks in patients aged 5 to 11 years old in combination with other LDL-C lowering medications. See **Important Safety Information** & full [**Prescribing Information**](https://www.regeneron.com/downloads/evkeeza_pi.pdf) on site. * [Patients with HoFH Aged 1 Year and Older](https://www.evkeezahcp.com/s/patients-1-to-4-years-with-hofh): Help your patients with HoFH aged 1 year and older break out of extremely high LDL-C levels. See **Important Safety Information** & full [**Prescribing Information**](https://www.regeneron.com/downloads/evkeeza_pi.pdf) on site. * [Long-Term Clinical Data](https://www.evkeezahcp.com/s/long-term-clinical-data): EVKEEZA (evinacumab-dgnb) long-term efficacy and safety were assessed through 2 open-label trials. See **Important Safety Information** & full [**Prescribing Information**](https://www.regeneron.com/downloads/evkeeza_pi.pdf) on site. * [Real-World Experience](https://www.evkeezahcp.com/s/real-world-experience): Efficacy and safety of EVKEEZA (evinacumab-dgnb) were assessed in a real-world analysis. See **Important Safety Information** & full [**Prescribing Information**](https://www.regeneron.com/downloads/evkeeza_pi.pdf) on site. * [Dosing & Administration](https://www.evkeezahcp.com/s/dosing-administration): EVKEEZA (evinacumab-dgnb) is a 60-minute once-monthly infusion. See **Important Safety Information** & full [**Prescribing Information**](https://www.regeneron.com/downloads/evkeeza_pi.pdf) on site. * [Appropriate Patients](https://www.evkeezahcp.com/s/appropriate-patients): Meet hypothetical patients with HoFH who added EVKEEZA (evinacumab-dgnb) to their lipid-lowering-therapy regimens. See **Important Safety Information** & full [**Prescribing Information**](https://www.regeneron.com/downloads/evkeeza_pi.pdf) on site. * [Support & Resources](https://www.evkeezahcp.com/s/support-resources): The myRARE program provides your patients support and resources to help make EVKEEZA (evinacumab-dgnb) a part of their current HoFH treatment regimen. [Sitemap](https://www.evkeezahcp.com/s/sitemap.xml)