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.

GVOKE HYPOPEN (NDA-212097)

(GLUCAGON)

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

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03/14/2025 (SUPPL-12)

Approved Drug Label (PDF)

4 Contraindications

Additions and/or revisions underlined:

GVOKE and GVOKE VialDx are contraindicated in patients with:

…

Prior hypersensitivity reaction to glucagon or to any of the excipients in GVOKE or GVOKE VialDx. Serious hypersensitivity reactions have been reported with glucagon and include anaphylactic shock with breathing difficulties and hypotension [see Warnings and Precautions (5.3)].

GVOKE VialDx for use as a diagnostic aid is also contraindicated in patients with glucagonoma because of risk of hypoglycemia [see Warnings and Precautions (5.8)].

5 Warnings and Precautions

Extensive changes; please refer to label for complete information

6 Adverse Reactions

Addition of the following to the bulleted line listing:

The following serious adverse reactions are described below and elsewhere in labeling:

Substantial Increase in Blood Pressure in Patients with Pheochromocytoma [see Warnings and Precautions (5.1)]
Hypoglycemia in Patients with Insulinoma [see Warnings and Precautions (5.2)]
Serious Hypersensitivity Reactions [see Warnings and Precautions (5.3)]
Lack of Efficacy With Subcutaneous Use for Severe Hypoglycemia in Patients with Decreased Hepatic Glycogen [see Warnings and Precautions (5.4)]
Necrolytic Migratory Erythema [see Warnings and Precautions (5.5)]
Hyperglycemia with Intravenous Use as a Diagnostic Aid in Patients with Diabetes Mellitus [see Warnings and Precautions (5.6)]
Blood Pressure and Heart Rate Increases with Intravenous Use as a Diagnostic Aid in Patients with Cardiac Disease [see Warnings and Precautions (5.7)]

Hypoglycemia in Patients with Glucagonoma with Intravenous Use as a Diagnostic Aid [see Warnings and Precautions (5.8)]

6.1 Clinical Trials Experience

Extensive changes; please refer to label for complete information

7 Drug Interactions

Extensive changes; please refer to label for complete information

8 Use in Specific Populations

8.4 Pediatric Use

Additions and/or revisions underlined:

The safety and effectiveness of GVOKE for subcutaneous use for the treatment of severe hypoglycemia in patients with diabetes have been established in pediatric patients aged 2 years and older. Use of GVOKE for this indication is supported by evidence from two adequate and well-controlled studies in adults with type 1 diabetes mellitus [see Clinical Studies (14.1)] and from a study in 31 pediatric patients ages 2 and older with type 1 diabetes mellitus [see Clinical Studies (14.2)].

The safety and effectiveness of GVOKE for subcutaneous use for the treatment of severe hypoglycemia in patients with diabetes have not been established in pediatric patients younger than 2 years of age.

Safety and effectiveness of GVOKE VialDx for intravenous use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in pediatric patients have not been established.

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

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

Recognition of Severe Hypoglycemia

Inform patients with diabetes mellitus and family members or caregivers on how to recognize the signs and symptoms of severe hypoglycemia and the risks of prolonged hypoglycemia.

Serious Hypersensitivity Reactions

Inform patients that serious hypersensitivity reactions can occur with GVOKE and GVOKE VialDx. Advise patients to seek immediate medical attention if they experience any symptoms of serious hypersensitivity reactions [see Warnings and Precautions (5.3)].

Hyperglycemia with Intravenous Use as a Diagnostic Aid in Patients with Diabetes Mellitus

Inform patients with diabetes mellitus that treatment with GVOKE VialDx may increase their risk of hyperglycemia [see Warnings and Precautions (5.6)].

Blood Pressure and Heart Rate Increase with Intravenous Use as a Diagnostic Aid in Patients with Cardiac Disease

Inform patients with cardiac disease that intravenous treatment with GVOKE VialDx may increase their risk of a transient increase in blood pressure and heart rate [see Warnings and Precautions (5.7)].

PATIENT INFORMATION

Extensive changes; please refer to label for complete information

07/15/2021 (SUPPL-8)

Approved Drug Label (PDF)

4 Contraindications

(Additions and/or revisions underlined)

GVOKE is contraindicated in patients with:

Pheochromocytoma because of the risk of substantial increase in blood pressure [see Warnings and Precautions (5.1)]
Insulinoma because of the risk of hypoglycemia [see Warnings and Precautions (5.2)]
Known hypersensitivity to glucagon or to any of the excipients in GVOKE. Allergic reactions have been reported with glucagon and include anaphylactic shock with breathing difficulties and hypotension [see Warnings and Precautions (5.3)].

5 Warnings and Precautions

5.1 Substantial Increase in Blood Pressure in Patients Pheochromocytoma

(Subsection title revised; Additions and/or revisions underlined)

GVOKE is contraindicated in patients with pheochromocytoma because glucagon may stimulate the release of catecholamines from the tumor [see Contraindications (4)]. If the patient develops a substantial increase in blood pressure and a previously undiagnosed pheochromocytoma is suspected, 5 to 10 mg of phentolamine mesylate, administered intravenously, has been shown to be effective in lowering blood pressure.

5.2 Hypoglycemia in Patients with Insulinoma

(Additions and/or revisions underlined)

In patients with insulinoma, administration of glucagon may produce an initial increase in blood glucose; however, GVOKE administration may directly or indirectly (through an initial rise in blood glucose) stimulate exaggerated insulin release from an insulinoma and cause hypoglycemia. GVOKE is contraindicated in patients with insulinoma [see Contraindications (4)]. If a patient develops symptoms of hypoglycemia after a dose of GVOKE, give glucose orally or intravenously.