Drug Safety-related Labeling Changes (SrLC)

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Drug Safety-related Labeling Changes (SrLC) Database

ANDA	Abbreviated New Drug Application
BLA	Biologics License Application
CDER	Center for Drug Evaluation and Research
MG	Medication Guide
NDA	New Drug Application
PCI	Patient Counseling Information
PI	Patient Information
PLR	Physician Labeling Rule
PLLR	Pregnancy and Lactation Labeling Rule
Italics	For the most part, italics indicate an FDA comment such as: Additions and/or revisions underlined These italics usually appear at the beginning of the section. In some cases, italics may be an inherent part of the label, and will most often appear in the body of the section.
Underlines	Any text that is underlined indicates text that has been added or revised. There are exceptions where underlining occurs in a section subtitle or heading. This is the case when there is just one word underlined in the body of the text.

Sections

BW	Box Warning
WP	Warnings and Precautions all in one section (PLR-format) Warnings as one section (pre-PLR format) Precautions as one section (pre-PLR format)
AR	Adverse Reactions (in pre-PLR format, this may be a subheading under precautions).
DI	Drug Interactions (in pre-PLR format, this may be a subheading under precautions).
USP	Use in Specific Populations (Inclusive on one or more of the following: Pregnancy; Lactation (PLLR- format); Nursing Mothers (pre-PLLR format); Females and Males of Reproductive Potential (PLLR format only); Pediatric Use, Geriatric Use, Renal Impairment, Hepatic Impairment, Sex, Race (these last six may be a subheading of precautions if label in pre-PLLR format.
PCI/PI/MG	Patient Counseling Information (PLR format only) - summarizes the information that a health care provider should convey to a patient (or caregiver when applicable) when a counseling discussion is taking place (e.g., a physician prescribing a drug during an office visit, a nurse providing discharge instructions at a hospital, or a pharmacist conveying information at a pharmacy). Patient Information - FDA approved patient labeling. Medication Guide - paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events.

Only NDAs and CDER regulated BLAs are included in this database. ANDAs are not included.

Applications that remain active, even if the product has been discontinued, undergo safety-related labeling changes.

EVKEEZA (BLA-761181)

(EVINACUMAB-DGNB)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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09/25/2025 (SUPPL-2)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.4 Pediatric Use

Additions and/or revisions underlined:

The safety and effectiveness of EVKEEZA as an adjunct to other LDL-C-lowering therapies for the treatment of HoFH have been established in pediatric patients aged 1 year and older. Use of EVKEEZA for this indication is supported by evidence from adequate and well-controlled trials in adults with additional pharmacokinetic, efficacy, and safety data in pediatric patients aged

1 year and older [see Adverse Reactions (6.1), Clinical Pharmacology (12.3) and Clinical Studies (14)]. 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 [see Adverse Reactions (6.1)].

The safety and effectiveness of EVKEEZA have not been established in pediatric patients younger than 1 year of age.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT INFORMATION

Additions and/or revisions underlined:

What is EVKEEZA?

EVKEEZA is an injectable prescription medicine used along with diet and exercise and other low-density lipoprotein cholesterol (LDL-C) lowering medicines to lower LDL-C in adults and children 1 year of age and older with a type of high cholesterol called homozygous familial hypercholesterolemia (HoFH).

It is not known if EVKEEZA is safe and effective in children under 1 year of age.

…

The most common side effects of EVKEEZA include:

symptoms of the common cold
dizziness
nausea
flu like symptoms
runny nose
feeling tired or weak
…

03/21/2023 (SUPPL-1)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Serious Hypersensitivity Reactions

Additions and/or revisions underlined:

Serious hypersensitivity reactions, including anaphylaxis, have occurred with EVKEEZA [see Adverse Reactions (6.1)].

…

5.2 Embryo-Fetal Toxicity

Additions and/or revisions underlined:

Based on the findings in animal reproduction studies, EVKEEZA may cause fetal harm when administered to pregnant patients. Administration of evinacumab-dgnb to rabbits during organogenesis caused increases in fetal malformations at doses below the human exposure.

…

6 Adverse Reactions

Additions and/or revisions underlined:

Serious Hypersensitivity Reactions [see Warnings and Precautions (5.1)]
6.1 Clinical Trials Experience
Revision to Table 1 Title; please refer to label for complete information
Additions and/or revisions underlined:
Adverse Reactions in Adult and Pediatric Patients (aged 12 to 17 years) with HoFH
Safety data are based on pooled results from two randomized, double-blind, placebo-controlled trials that included 81 patients treated with EVKEEZA. The mean age of EVKEEZA-treated patients was 48 years (range: 15 to 75 years), 52% were women, 5% were Hispanic, 82% were White, 7% Asian, 3% Black or African American, and 9% other races. Forty-four (54%) EVKEEZA-treated patients had HoFH. Patients received EVKEEZA as add-on therapy to other lipid-lowering therapies, including maximally tolerated statin, ezetimibe, proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors, lomitapide, and apheresis.
…
Adverse Reactions in Pediatric Patients (aged 5 to 11 years) with HoFH
Safety data are based on pooled results from a three-part, open-label trial in 20 pediatric patients with HoFH (aged 5 to 11 years) with a median treatment duration of 50 weeks. Part A was a trial of 6 patients who received a single intravenous dose of EVKEEZA 15 mg/kg to determine the dosage for the rest of the trial. Part B was a single-arm, 24-week trial of EVKEEZA 15 mg/kg given intravenously every 4 weeks in 14 unique patients [see Clinical Studies (14)]. Part C was a 48-week extension trial of EVKEEZA 15 mg/kg given intravenously every 4 weeks that consisted of 20 patients who entered directly from Parts A or B. The mean age was 9 years (range: 5 to 11 years); 60% females; 70% White, 10% Asian, 5% Black or African American, 5% American Indian or Alaska Native, and 10% other races. The safety profile of EVKEEZA observed in these patients was consistent with the safety profile observed in adults and pediatric patients aged 12 years and older, with the additional adverse reaction of fatigue. Fatigue was reported in 3 (15%) patients.

8 Use in Specific Populations

8.4 Pediatric Use

Additions and/or revisions underlined:

The safety profile of EVKEEZA in pediatric patients aged 5 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.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT INFORMATION

Additions and/or revisions underlined:

What is EVKEEZA?

EVKEEZA is an injectable prescription medicine used along with other low-density lipoprotein (LDL) lowering medicines in people 5 years of age and older with a type of high cholesterol called homozygous familial hypercholesterolemia (HoFH).

It is not known if EVKEEZA is safe and effective in people with other causes of high cholesterol.

The effect of EVKEEZA on heart problems such as heart attacks, stroke, or death is not known.

It is not known if EVKEEZA is safe and effective in children with HoFH under 5 years of age.

…

The most common side effects of EVKEEZA include:

feel tired or weak
…