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.

BAQSIMI (NDA-210134)

(GLUCAGON)

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

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03/17/2025 (SUPPL-4)

Approved Drug Label (PDF)

4 Contraindications

Additions and/or revisions underlined:

BAQSIMI 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)]
Prior hypersensitivity reaction to glucagon or to any of the excipients in BAQSIMI. 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

Subsection title revised:

5.3 Serious Hypersensitivity Reactions

Additions and/or revisions underlined:

Serious hypersensitivity reactions have been reported with glucagon products, including generalized rash, and in some cases anaphylactic shock with breathing difficulties and hypotension. Discontinue BAQSIMI if symptoms of serious hypersensitivity reactions occur. Advise patients and/or caregivers to seek immediate medical attention if the patient experiences any symptoms of serious hypersensitivity reactions. BAQSIMI is contraindicated in patients with a prior hypersensitivity reaction [see Contraindications (4)].

5.4 Lack of Efficacy in Patients with Decreased Hepatic Glycogen

Additions and/or revisions underlined:

Patients with insufficient hepatic stores of glycogen may not respond to subcutaneous BAQSIMI for the treatment of severe hypoglycemia [see Clinical Pharmacology (12.2)]. Insufficient hepatic stores of glycogen may be present in conditions such as states of starvation or in patients with adrenal insufficiency or chronic hypoglycemia.

6 Adverse Reactions

Additions and/or revisions underlined:

The following clinically significant adverse reactions are described 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 in Patients with Decreased Hepatic Glycogen [see Warnings and Precautions (5.4)].

Subsection title revised:

6.1 Clinical Trials Experience

Additions and/or revisions underlined:

. . .

Adverse Reactions in Adult Patients

Two similarly designed comparator-controlled trials, Study 1 and Study 2, evaluated the safety of a single intranasal dose of BAQSIMI compared to a 1 mg dose of intra-muscular glucagon (IMG) in adult patients with diabetes [see Clinical Studies (14.1)].

. . .

Table 2: Solicited Nasal and Non-Nasal Adverse Reactions in Adult Patients with Type 1 and Type 2 Diabetes Pooled from Study 1 and 2

Extensive changes to table; please refer to label for complete information

Revised subheading:

Adverse Reactions in Pediatric Patients Aged 1 Year and Older

A single dose of BAQSIMI was compared to weight-based doses of 0.5 mg or 1 mg of IMG in pediatric patients aged 4 to less than 17 years with type 1 diabetes in Study 3 [see Clinical Studies (14.2)].

Table 3 presents adverse reactions that occurred with BAQSIMI in pediatric patients at an incidence of greater than or equal to 2% in Study 3.

Table 3: Adverse Reactions (greater than or equal to 2%) Occurring in Pediatric Patients Aged 4 to less than 17 Years with Type 1 Diabetes in Study 3

Extensive changes to table; please refer to label for complete information

Nasal and ocular symptoms with BAQSIMI were solicited through a patient questionnaire in pediatric patients in Study 3 and these adverse reactions are presented in Table 4.

Table 4: Solicited Nasal and Non-Nasal Adverse Reactions in Pediatric Patients Aged 4 to less than 17 Years with Type 1 Diabetes in Study 3

Extensive changes to table; please refer to label for complete information

The safety of a single 3 mg intranasal dose of BAQSIMI was assessed in an open-label study of 7 pediatric patients aged 1 to less than 4 years with type 1 diabetes mellitus [see Clinical Studies (14.2)]. The safety profile observed in this trial in pediatric patients was comparable to that observed in adults and pediatric patients aged 4 to less than 17 years [see Clinical Pharmacology (12.2, 12.3)].

. . .

8 Use in Specific Populations

8.4 Pediatric Use

Additions and/or revisions underlined:

The safety and effectiveness of BAQSIMI for the treatment of severe hypoglycemia in patients with diabetes have been established in pediatric patients aged 1 year and older. Use of BAQSIMI for this indication is supported by evidence from an adequate and well-controlled study in adults with type 1 diabetes mellitus [see Clinical Studies (14.1)], a study in 48 pediatric patients aged 4 to less than 17 years with type 1 diabetes mellitus [see Clinical Studies (14.2)], and additional pharmacokinetic and safety data from a study of seven pediatric patients aged 1 to less than 4 years with type 1 diabetes mellitus [see Adverse Reactions (6.1),Clinical Pharmacology (12.2, 12.3), and Clinical Studies (14.2)].

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

8.5 Geriatric Use

Additions and/or revisions underlined:

Clinical studies of BAQSIMI did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger adult patients.

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

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

. . .

Revised subheading:

Serious Hypersensitivity Reactions:

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

PATIENT INFORMATION

Additions and/or revisions underlined:

What is BAQSIMI?

BAQSIMI is a prescription medicine used to treat very low blood sugar (severe hypoglycemia) in people with diabetes ages 1 year and above.

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

Do not use BAQSIMI if you:

have a tumor in the gland on top of your kidneys (adrenal gland) called pheochromocytoma.
have a tumor in your pancreas called insulinoma.
have had an allergic reaction to glucagon, or any of the ingredients in BAQSIMI. See the end of this Patient Information leaflet for a complete list of ingredients in BAQSIMI.

Talk with your healthcare provider before taking this medicine if you have any of these conditions.

Before using BAQSIMI, tell your healthcare provider about all of your medical conditions, including if you:

have adrenal gland problems.
have a tumor in your pancreas.
have not had food or water for a long time (prolonged fasting or starvation).
have low blood sugar that does not go away (chronic hypoglycemia).
are pregnant or plan to become pregnant. It is not known if BAQSIMI will harm your unborn baby.

. . .

How should I use BAQSIMI?

. . .

Make sure your caregiver and those around you know where you keep your BAQSIMI and how to use BAQSIMI the right way before you need their help.

. . .

Act quickly. Having very low blood sugar for a period of time may be harmful.
After giving BAQSIMI, the caregiver should call for emergency medical help right away.
When you are able to safely swallow food or drink, your caregiver should give you a fast-acting source of sugar (such as a regular soft drink or fruit juice) and a long-acting source of sugar (such as crackers with cheese or peanut butter).
If the person does not respond after 15 minutes, another dose of BAQSIMI from a new device may be given, if available while waiting for emergency services.
Tell your healthcare provider each time you use BAQSIMI.

What are the possible side effects of BAQSIMI?

BAQSIMI may cause serious side effects, including:

. . .

Low blood sugar. BAQSIMI can cause certain people with tumors in their pancreas called insulinomas to have low blood sugar.
Serious allergic reaction. Call your healthcare provider or get medical help right away if you have a serious allergic reaction including:

rash
difficulty breathing
low blood pressure
hives
trouble swallowing
feeling dizzy or faint
cough
swelling of face, lips, or tongue
fast heartbeat

The most common side effects of BAQSIMI include:

. . .

cough
nose bleed

. . .

How should I store BAQSIMI?

. . .

Throw away (discard) BAQSIMI and tube after use. Used BAQSIMI may be placed in household trash.

. . .

10/27/2020 (SUPPL-2)

Approved Drug Label (PDF)

4 Contraindications

(Additions and/or revisions underlined)

BAQSIMI 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 BAQSIMI. 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 with Pheochromocytoma

(Additions and/or revisions underlined)

BAQSIMI is contraindicated in patients with pheochromocytoma because glucagon may stimulate 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

(Revised subheading)