General MedicationsSUBLINGUALHigh Alert

IGALMI

DEXMEDETOMIDINE

Standard Dose

2 DOSAGE AND ADMINISTRATION IGALMI should be administered under the supervision of a healthcare provider. A healthcare provider should monitor vital signs and alertness after IGALMI administration to prevent falls and syncope. ( 2.1 ) Administer sublingually or buccally. Do not chew or swallow. ( 2.1 ) Recommended dosage ( 2.2 ): Patient Population Agitation Severity Initial Dose See Full Prescribing Information for recommendations on administering up to two additional doses and maximum recommended dosages. Adults Mild or Moderate 120 mcg Severe 180 mcg Mild or Moderate Hepatic Impairment Mild or Moderate 90 mcg Severe 120 mcg Severe Hepatic Impairment Mild or Moderate 60 mcg Severe 90 mcg Geriatric Patients (≥ 65 years old) Mild, Moderate, or Severe 120 mcg IGALMI 120 mcg and 180 mcg dosage strengths may be cut in half to obtain the 60 mcg and 90 mcg doses, respectively. See Full Prescribing Information for preparation and administration instructions. ( 2.3 ) 2.1 Important Recommendations Prior to Initiating IGALMI and During Therapy IGALMI should be administered under the supervision of a healthcare provider. A healthcare provider should monitor vital signs and alertness after IGALMI administration to prevent falls and syncope [see Warnings and Precautions (5.5) ] . IGALMI is for sublingual or buccal administration. Do not chew or swallow IGALMI. Do not eat or drink for at least 15 minutes after sublingual administration, or at least one hour after buccal administration. 2.2 Recommended Dosage Table 1 includes dosage recommendations for IGALMI based on agitation severity for adults, patients with hepatic impairment, and geriatric patients. Lower dosages are recommended for patients with hepatic impairment and geriatric patients [see Warnings and Precautions (5.1) and Use in Specific Populations (8.5 , 8.6) ]. If agitation persists after the initial dose, up to two additional doses may be administered at least two hours apart. The dosage recommendations for additional doses vary depending upon the patient population and agitation severity (see Table 1 ). Assess vital signs including orthostatic measurements prior to the administration of any subsequent doses. Due to risk of hypotension, additional half-doses are not recommended in patients with systolic blood pressure (SBP) less than 90 mmHg, diastolic blood pressure (DBP) less than 60 mmHg, heart rate (HR) less than 60 beats per minute, or postural decrease in SBP ≥ 20 mmHg or in DBP ≥ 10 mmHg. Table 1: Dosage Recommendations for IGALMI in Adults, Adult Patients with Hepatic Impairment, and Geriatric Patients with Agitation Associated with Schizophrenia or Bipolar I or II Disorder Patient Population Agitation Severity Initial Dose IGALMI 120 mcg and 180 mcg dosage strengths may be cut in half to obtain the 60 mcg and 90 mcg doses, respectively [see Dosage and Administration (2.3) ] . Optional 2 nd /3 rd Doses Maximum Recommended Total Daily Dosage Adults Mild or Moderate 120 mcg 60 mcg 240 mcg Severe 180 mcg 90 mcg 360 mcg Patients with Mild or Moderate Hepatic Impairment Hepatic impairment: Mild (Child-Pugh Class A); Moderate (Child-Pugh Class B); Severe (Child-Pugh Class C) Mild or Moderate 90 mcg 60 mcg 210 mcg Severe 120 mcg 60 mcg 240 mcg Patients with Severe Hepatic Impairment Mild or Moderate 60 mcg 60 mcg 180 mcg Severe 90 mcg 60 mcg 210 mcg Geriatric Patients (≥ 65 years old) Mild, Moderate, or Severe 120 mcg 60 mcg 240 mcg 2.3 Preparation and Administration Instructions Keep IGALMI in the foil pouch until ready to administer. IGALMI should be immediately administered once the pouch is opened and the dose prepared. Prepare and administer IGALMI under the supervision of a healthcare provider as follows: Healthcare Professional: Prepare IGALMI Dose for Patient 1 Open the sealed foil pouch by tearing straight across at the notch. Perform Steps 2a, 2b, 2c and 2d only if a 60 mcg or 90 mcg dose (half of a film) is needed, then proceed to Step 3. If administering a full dose (1 film), proceed directly to Step 3. 2a Remove the film from the pouch with clean dry hands. 2b Cut the film in half between the dots with clean, dry scissors. 2c Discard unused half in waste container. 2d Place the half film for administration to the patient back into the pouch. 3 Immediately give the pouch to the patient. 4 Instruct patient to remove the film from the pouch with clean dry hands. 5 For sublingual administration: Instruct patient to place film under the tongue. The film will stick in place. Note: Patient may not eat or drink for 15 minutes after sublingual administration. For buccal administration: Instruct patient to place film behind lower lip. The film will stick in place. Note: Patient may not eat or drink for one hour after buccal administration. 6 Instruct patient to: Close their mouth. Allow the film to dissolve. Do not chew or swallow the film. Figure Figure Figure Figure Figure Figure Figure Figure Figure Figure

Max Dose

See official label

Primary Use

1 INDICATIONS AND USAGE IGALMI is indicated for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults.

Summary

Indications and usage 1 INDICATIONS AND USAGE 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. ( 1 ) Limitations of Use : The safety and effectiveness of IGALMI has not been established beyond 24 hours from the first dose. ( 1 , 5.4 , 5.5 ) Limitations of Use The safety and effectiveness of IGALMI have not been established beyond 24 hours from the first dose [see Warnings and Precautions (5.4 , 5.5) ] .

Structured Monograph

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE 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. ( 1 ) Limitations of Use : The safety and effectiveness of IGALMI has not been established beyond 24 hours from the first dose. ( 1 , 5.4 , 5.5 ) Limitations of Use The safety and effectiveness of IGALMI have not been established beyond 24 hours from the first dose [see Warnings and Precautions (5.4 , 5.5) ] . Dosage and administration 2 DOSAGE AND ADMINISTRATION IGALMI should be administered under the supervision of a healthcare provider. A healthcare provider should monitor vital signs and alertness after IGALMI administration to prevent falls and syncope. ( 2.1 ) Administer sublingually or buccally. Do not chew or swallow. ( 2.1 ) Recommended dosage ( 2.2 ): Patient Population Agitation Severity Initial Dose See Full Prescribing Information for recommendations on administering up to two additional doses and maximum recommended dosages. Adults Mild or Moderate 120 mcg Severe 180 mcg Mild or Moderate Hepatic Impairment Mild or Moderate 90 mcg Severe 120 mcg Severe Hepatic Impairment Mild or Moderate 60 mcg Severe 90 mcg Geriatric Patients (≥ 65 years old) Mild, Moderate, or Severe 120 mcg IGALMI 120 mcg and 180 mcg dosage strengths may be cut in half to obtain the 60 mcg and 90 mcg doses, respectively. See Full Prescribing Information for preparation and administration instructions. ( 2.3 ) 2.1 Important Recommendations Prior to Initiating IGALMI and During Therapy IGALMI should be administered under the supervision of a healthcare provider. A healthcare provider should monitor vital signs and alertness after IGALMI administration to prevent falls and syncope [see Warnings and Precautions (5.5) ] . IGALMI is for sublingual or buccal administration. Do not chew or swallow IGALMI. Do not eat or drink for at least 15 minutes after sublingual administration, or at least one hour after buccal administration. 2.2 Recommended Dosage Table 1 includes dosage recommendations for IGALMI based on agitation severity for adults, patients with hepatic impairment, and geriatric patients. Lower dosages are recommended for patients with hepatic impairment and geriatric patients [see Warnings and Precautions (5.1) and Use in Specific Populations (8.5 , 8.6) ]. If agitation persists after the initial dose, up to two additional doses may be administered at least two hours apart. The dosage recommendations for additional doses vary depending upon the patient population and agitation severity (see Table 1 ). Assess vital signs including orthostatic measurements prior to the administration of any subsequent doses. Due to risk of hypotension, additional half-doses are not recommended in patients with systolic blood pressure (SBP) less than 90 mmHg, diastolic blood pressure (DBP) less than 60 mmHg, heart rate (HR) less than 60 beats per minute, or postural decrease in SBP ≥ 20 mmHg or in DBP ≥ 10 mmHg. Table 1: Dosage Recommendations for IGALMI in Adults, Adult Patients with Hepatic Impairment, and Geriatric Patients with Agitation Associated with Schizophrenia or Bipolar I or II Disorder Patient Population Agitation Severity Initial Dose IGALMI 120 mcg and 180 mcg dosage strengths may be cut in half to obtain the 60 mcg and 90 mcg doses, respectively [see Dosage and Administration (2.3) ] . Optional 2 nd /3 rd Doses Maximum Recommended Total Daily Dosage Adults Mild or Moderate 120 mcg 60 mcg 240 mcg Severe 180 mcg 90 mcg 360 mcg Patients with Mild or Moderate Hepatic Impairment Hepatic impairment: Mild (Child-Pugh Class A); Moderate (Child-Pugh Class B); Severe (Child-Pugh Class C) Mild or Moderate 90 mcg 60 mcg 210 mcg Severe 120 mcg 60 mcg 240 mcg Patients with Severe Hepatic Impairment Mild or Moderate 60 mcg 60 mcg 180 mcg Severe 90 mcg 60 mcg 210 mcg Geriatric Patients (≥ 65 years old) Mild, Moderate, or Severe 120 mcg 60 mcg 240 mcg 2.3 Preparation and Administration Instructions Keep IGALMI in the foil pouch until ready to administer. IGALMI should be immediately administered once the pouch is opened and the dose prepared. Prepare and administer IGALMI under the supervision of a healthcare provider as follows: Healthcare Professional: Prepare IGALMI Dose for Patient 1 Open the sealed foil pouch by tearing straight across at the notch. Perform Steps 2a, 2b, 2c and 2d only if a 60 mcg or 90 mcg dose (half of a film) is needed, then proceed to Step 3. If administering a full dose (1 film), proceed directly to Step 3. 2a Remove the film from the pouch with clean dry hands. 2b Cut the film in half between the dots with clean, dry scissors. 2c Discard unused half in waste container. 2d Place the half film for administration to the patient back into the pouch. 3 Immediately give the pouch to the pa

Monitoring

• 5 WARNINGS AND PRECAUTIONS Hypotension, Orthostatic Hypotension, and Bradycardia: Avoid use of IGALMI in patients with hypotension, orthostatic hypotension, advanced heart block, severe ventricular dysfunction, or history of syncope.
• Ensure that patients are alert and not experiencing orthostatic or symptomatic hypotension prior to resuming ambulation.
• ( 5.1 ) QT Interval Prolongation: IGALMI prolongs the QT interval; avoid use in patients with risk factors for prolonged QT interval.
• ( 5.2 ) Somnolence: Patients should not perform activities requiring mental alertness, such as operating a motor vehicle or operating hazardous machinery for at least eight hours after taking IGALMI.

Interaction Notes

• 7 DRUG INTERACTIONS Drugs that Prolong the QT interval: Avoid use.
• ( 7.1 ) Anesthetics, Sedatives, Hypnotics, Opioids: Concomitant use may cause enhanced CNS depressant effects.
• Reduction in dosage of IGALMI or the concomitant medication may be required.
• ( 7.2 ) 7.1 Drugs that Prolong the QT Interval Concomitant use of drugs that prolong the QT interval may add to the QT-prolonging effects of IGALMI and increase the risk of cardiac arrhythmia.