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.

IGALMI (NDA-215390)

(DEXMEDETOMIDINE HYDROCHLORIDE)

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

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11/19/2025 (SUPPL-2)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.4 Risk of Withdrawal Reactions

Additions and/or revisions underlined:

Symptoms of withdrawal have been observed after treatment with another dexmedetomidine product administered as a continuous IV infusion in the ICU for another indication. In this study, 12 (5%) adult patients who received intravenous dexmedetomidine up to 7 days (regardless of dose) experienced at least 1 event related to withdrawal within the first 24 hours after discontinuing dexmedetomidine and 7 (3%) adult patients who received intravenous dexmedetomidine experienced at least 1 event related with withdrawal 24 to 48 hours after discontinuing dexmedetomidine. The most common withdrawal reactions were nausea, vomiting, and agitation. In these subjects, tachycardia and hypertension requiring intervention occurred at a frequency of <5% in the 48 hours following intravenous dexmedetomidine discontinuation. Withdrawal symptoms have been reported in pediatric patients who received another dexmedetomidine product intravenously for another indication. IGALMI is not approved for pediatric use.

Withdrawal symptoms reported in published literature include cardiovascular symptoms, such as hypertension, tachycardia, arrhythmias, and in severe cases, hypertensive crisis; neurological symptoms, such as agitation, anxiety, tremors, seizures, and altered mental status; and autonomic symptoms such as diaphoresis, nausea, vomiting, hyperthermia, and mydriasis.

In a randomized, double-blind, placebo-controlled, multiple ascending dose study assessing IGALMI at doses up to 120 mcg per day administered over 7 days in healthy volunteers, elevated heart rate and systolic blood pressure and vomiting occurred at a higher frequency upon abrupt discontinuation of 120-mcg doses of IGALMI as compared to placebo. There may be a risk of physical dependence and a withdrawal syndrome if IGALMI is used in a manner other than indicated [see Dosage and Administration (2.2) and Drug Abuse and Dependence (9.3)].

5.5 Tolerance and Tachyphylaxis

Additions and/or revisions underlined:

Use of another dexmedetomidine product administered intravenously beyond 24 hours has been associated with tolerance and tachyphylaxis and a dose-related increase in adverse reactions.

The effectiveness of IGALMI beyond 24 hours after the first dose has not been established. There may be a risk of tolerance and tachyphylaxis if IGALMI is administered at higher doses or for a longer duration than were evaluated, or in a manner other than indicated [see Dosage and Administration (2.2) and Drug Abuse and Dependence (9.3)].

6 Adverse Reactions

6.1 Clinical Studies Experience

Additions and/or revisions underlined:

. . .

The most common adverse reactions (incidence greater than or equal to 5% and at least twice the rate of placebo) were: somnolence, oral paresthesia or oral hypoesthesia, dizziness, dry mouth, hypotension, and orthostatic hypotension.

. . .

Table 2: Adverse Reactions Reported in greater than or equal to 2% of IGALMI-Treated Patients and Greater than Placebo in Two Placebo-Controlled Studies of Agitated Adult Patients with Schizophrenia or Bipolar I or II Disorder (Studies 1 and 2)

Addition of Paresthesia oral to the Adverse Reaction section of table; please refer to label for complete information.

. . .