Generic Name
DEXmedetomidine
Brand Names
Igalmi, Precedex
FDA approval date: November 30, 2004
Classification: Central alpha-2 Adrenergic Agonist
Form: Injection, Film
What is Igalmi (DEXmedetomidine)?
IGALMI is indicated for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. IGALMI is an alpha-2 adrenergic receptor agonist indicated in adults for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder. Limitations of Use : The safety and effectiveness of IGALMI has not been established beyond 24 hours from the first dose. ( 1.
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Brand Information
IGALMI (DEXMEDETOMIDINE)
1INDICATIONS AND USAGE
IGALMI is indicated for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults.
2DOSAGE FORMS AND STRENGTHS
IGALMI is a blue rectangular sublingual film containing on its surface two darker blue spots in dose strengths of 120 mcg and 180 mcg.
3CONTRAINDICATIONS
None.
4ADVERSE REACTIONS
The following adverse reactions are discussed in detail in other sections of the labeling:
- Hypotension, Orthostatic Hypotension, and Bradycardia
- QT Interval Prolongation
- Somnolence
- Risk of Withdrawal Reactions
- Tolerance and Tachyphylaxis
4.1Clinical Studies Experience
Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in practice.
The safety of IGALMI was evaluated in 507 adult patients with agitation associated with schizophrenia (N=255) or bipolar I or II disorder (N=252) in two randomized, placebo-controlled studies (Studies 1 and 2)
In these studies, patients received an initial dose of IGALMI 180 mcg (N=252), IGALMI 120 mcg (N=255), or placebo (N=252). Patients who were hemodynamically stable (i.e., those with systolic blood pressure (SBP) > 90 mmHg, diastolic blood pressure (DBP) > 60 mmHg, and heart rate (HR) > 60 beats per minute) and without orthostatic hypotension (i.e., reduction in SBP < 20 mmHg or DBP < 10 mmHg upon standing) were eligible for an additional dose after 2 hours. An additional half dose (90 mcg, 60 mcg, or placebo) was given to 7.1% (18/252), 22.7% (58/255) and 44.0% (111/252) of patients in the IGALMI 180 mcg, IGALMI 120 mcg or placebo arms, respectively. After at least an additional 2 hours, an additional second half dose (total IGALMI dose of 360 mcg, total IGALMI dose of 240 mcg, or placebo, respectively) was given to 3.2% (8/252), 9.4% (24/255), and 21.0% (53/252) of patients in the IGALMI 180 mcg, IGALMI 120 mcg or placebo arms, respectively.
In these studies, one patient discontinued treatment due to an adverse reaction of oropharyngeal pain.
The most common adverse reactions (incidence ≥ 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 presents the adverse reactions that occurred in IGALMI-treated patients at a rate of at least 2% and at a higher rate than in placebo-treated patients in Studies 1 and 2.
4.2Postmarketing Experience
The following adverse reactions have been identified during post approval use of another dexmedetomidine product given intravenously (IGALMI is not approved for intravenous use). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- Blood and Lymphatic System Disorders: Anemia
- Cardiac Disorders: Arrhythmia, atrial fibrillation, atrioventricular block, bradycardia, cardiac arrest, cardiac disorder, extrasystoles, myocardial infarction, supraventricular tachycardia, tachycardia, ventricular arrhythmia, ventricular tachycardia
- Eye Disorders: Photopsia, visual impairment
- Gastrointestinal Disorders: Abdominal pain, diarrhea, nausea, vomiting
- General Disorders and Administration Site Conditions: Chills, hyperpyrexia, pain, pyrexia, thirst
- Hepatobiliary Disorders: Hepatic function abnormal, hyperbilirubinemia
- Investigations: Alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, blood urea increased, electrocardiogram T wave inversion, gammaglutamyltransferase increased, electrocardiogram QT prolonged
- Metabolism and Nutrition Disorders: Acidosis, hyperkalemia, hypoglycemia, hypovolemia, hypernatremia
- Nervous System Disorders: Convulsion, dizziness, headache, neuralgia, neuritis, speech disorder
- Psychiatric Disorders: Agitation, confusional state, delirium, hallucination, illusion
- Renal and Urinary Disorders: Oliguria, polyuria
- Respiratory, Thoracic and Mediastinal Disorders: Apnea, bronchospasm, dyspnea, hypercapnia, hypoventilation, hypoxia, pulmonary congestion, respiratory acidosis
- Skin and Subcutaneous Tissue Disorders: Hyperhidrosis, pruritus, rash, urticaria
- Surgical and Medical Procedures: Light anesthesia
- Vascular Disorders: Blood pressure fluctuation, hemorrhage, hypertension, hypotension
5OVERDOSAGE
In a tolerability study of intravenous dexmedetomidine in which healthy adult subjects were administered doses at and above the recommended dose of 0.2 to 0.7 mcg/kg/hour, the maximum blood concentration was approximately 13 times the upper boundary of the therapeutic range for the intravenous dexmedetomidine (IGALMI is not approved for intravenous use). The most notable effects observed in two subjects who achieved the highest doses were first degree atrioventricular block and second-degree heart block.
Five adult patients received an overdose of intravenous dexmedetomidine in intensive care unit sedation studies. Two patients who received a 2 mcg/kg loading dose (twice the recommended loading dose) over 10 minutes, experienced bradycardia and/or hypotension.
One patient who received a loading intravenous bolus dose of undiluted dexmedetomidine (19.4 mcg/kg), had cardiac arrest from which he was successfully resuscitated.
Consider contacting a Poison Center (1-800-222-1222) or a medical toxicologist for overdosage management recommendations for IGALMI.
6DESCRIPTION
IGALMI contains dexmedetomidine, an alpha-2 adrenergic receptor agonist, present as dexmedetomidine hydrochloride, the S-enantiomer of medetomidine chemically described as 4-[(1S)-1- (2, 3-dimethylphenyl) ethyl]-1H-imidazole hydrochloride. The empirical formula is C
Dexmedetomidine hydrochloride is a white or almost white powder that is freely soluble in water and has a pKa of 7.1. Its partition coefficient in octanol/water at pH 7.4 is 2.89.
IGALMI is for sublingual or buccal use. Each IGALMI sublingual film contains 120 mcg or 180 mcg of dexmedetomidine equivalent to 141.8 mcg and 212.7 mcg of dexmedetomidine hydrochloride, respectively.
IGALMI contains the following inactive ingredients: FD&C Blue #1 colorant, hydroxypropyl cellulose, peppermint oil, polyethylene oxide, and sucralose.
7CLINICAL STUDIES
The effectiveness of IGALMI for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults was established in two randomized, double-blind, placebo-controlled, fixed-dose studies (Studies 1 and 2):
- Study 1 (NCT04268303) included 380 patients who met DSM-5 criteria for schizophrenia, schizoaffective or schizophreniform disorder. The population was 18 to 71 years of age (mean age was 46 years old); 37% female and 63% male; 78% Black, 20% White, 1% multiracial, and 1% Asian.
- Study 2 (NCT04276883) included 378 patients who met DSM-5 criteria for bipolar I or II disorder. The population was 18 to 70 years of age (mean age was 47 years old); 55% female and 45% male; 56% Black, 41% White, 1% Asian, 1% multiracial, and 1% other.
The Positive and Negative Syndrome Scale-Excited Component (PEC) is an investigator-rated instrument consisting of 5 items: poor impulse control, tension, hostility, uncooperativeness, and excitement. Each item is scored on a scale from 1 to 7 (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate-severe, 6=severe, 7=extremely severe). The total PEC score ranges from 5 to 35, with higher scores reflecting greater overall symptom severity. For enrollment in the studies, patients had to be judged to be clinically agitated with a total PEC score of ≥ 14, with at least one individual item score ≥ 4. In both studies, patients were admitted to a clinical research unit or a hospital and remained under medical supervision for at least 24 hours following treatment.
Patients were randomized to receive a single sublingual dose of 180 mcg of IGALMI, 120 mcg of IGALMI, or placebo. The primary efficacy endpoint in both studies was the change from baseline in the PEC score, assessed two hours following the initial dose. The key secondary endpoint was the time to effect onset, assessed by measuring the change from baseline in PEC score at 10, 20, 30, 45, 60, and 90 minutes after the initial dose administration.
In both studies, mean baseline PEC scores were similar in all treatment groups (Table 5). The mean change from baseline in the PEC total score at two hours after the first dose in patients treated with 180 mcg and 120 mcg of IGALMI was statistically greater than patients who received placebo (Table 5).
Examination of population subsets (race and sex) on the primary endpoint did not show evidence for differential responsiveness between White and Black or female and male patients. The clinical studies did not include enough patients of other races or patients ≥65 years of age to determine whether there were differences in effectiveness for those groups.
Figures 1 and 2 show the changes from baseline in PEC score at each time point assessed up to two hours following the initial dose. In Study 1, the decrease in agitation with IGALMI, compared to placebo, was statistically significant beginning at 20 minutes following dosing with the 180 mcg dose and 30 minutes after the 120 mcg dose. In Study 2, the decrease in agitation with IGALMI, compared to placebo, was statistically significant beginning at 20 minutes after treatment with both 120 mcg and 180 mcg doses.
Figure 1: Mean Change from Baseline in PEC Score Through Two Hours after a Single Dose in Agitated Patients with Schizophrenia (Study 1)
Figure 2: Mean Change from Baseline in PEC Score Through Two Hours after a Single Dose in Agitated Patients with Bipolar I or II Disorder (Study 2)
8PRINCIPAL DISPLAY PANEL - 120 mcg Film Pouch Carton
Rx Only
Igalmi
For sublingual or buccal use
120 mcg
10 pouches
NDC 81092-1120-1
9PRINCIPAL DISPLAY PANEL - 180 mcg Film Pouch Carton
Rx Only
Igalmi
For sublingual or buccal use
180 mcg
10 pouches
NDC 81092-1180-1
