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.

ZEGALOGUE (NDA-214231)

(DASIGLUCAGON HYDROCHLORIDE)

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

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06/18/2026 (SUPPL-4)

Approved Drug Label (PDF)

6 Adverse Reactions

6.1 Clinical Trials Experience

Additions and/or revisions underlined:

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of ZEGALOGUE cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In clinical trials, 316 adult patients with type 1 diabetes and 24 pediatric patients with type 1 diabetes were exposed to ZEGALOGUE.

The data in Table 1 reflects exposure of 116 adult patients to ZEGALOGUE in 2 placebo-controlled trials (mean age 40 years) (Trials A and B). Table 2 reflects exposure of 20 pediatric patients exposed to ZEGALOGUE in a placebo-controlled trial (Trial C). Eight patients were 7 to 11 years old, and 12 were 12 to 17 years old. [see Clinical Studies (14)].

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Table 2 Adverse Reactions Occurring greater than or equal to 2% and More Frequently than with Placebo in ZEGALOGUE-treated Pediatric Patients Aged 6 to 17 Years within 12 hours of Treatment in a Placebo-Controlled Trial

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The safety of ZEGALOGUE in pediatric patients aged less than 6 years with type 1 diabetes mellitus was evaluated in an open-label trial (Trial D NCT05378672). The safety profile of ZEGALOGUE observed in this trial was similar to that observed in adults and pediatric patients aged 6 to 17 years [see Clinical Studies (14.2, 14.3)].

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8 Use in Specific Populations

8.4 Pediatric Use

Additions and/or revisions underlined:

The safety and effectiveness of ZEGALOGUE for the treatment of severe hypoglycemia in patients with diabetes have been established in pediatric patients who weigh at least 20 kg. Use of ZEGALOGUE for this indication is supported by evidence from a study in 42 pediatric patients aged 6 to 17 years with type 1 diabetes mellitus and additional pharmacokinetic and safety data from a study of pediatric patients aged less than 6 years with type 1 diabetes mellitus [see Adverse Reactions (6.1), Clinical Pharmacology (12.2, 12.3) and Clinical Studies (14.3)].

The safety and effectiveness of ZEGALOGUE have not been established in pediatric patients who weigh less than 20 kg.

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

PATIENT INFORMATION

Additions and/or revisions underlined:

What is ZEGALOGUE?

ZEGALOGUE is a prescription medicine used to treat very low blood sugar (severe hypoglycemia) in people with diabetes who weigh at least 44 pounds (20 kg). It is not known if ZEGALOGUE is safe and effective in children who weigh less than 44 pounds (20kg).

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