SPRAVATO- esketamine hydrochloride solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ESKETAMINE HYDROCHLORIDE (UNII: L8P1H35P2Z) (ESKETAMINE - UNII:50LFG02TXD)

Available from:

Janssen Pharmaceuticals Inc.

Administration route:

NASAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

SPRAVATO ® is indicated, in conjunction with an oral antidepressant, for the treatment of: - Treatment-resistant depression (TRD) in adults - Depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior Limitations of Use: - The effectiveness of SPRAVATO in preventing suicide or in reducing suicidal ideation or behavior has not been demonstrated [see Clinical Studies (14.2)] . Use of SPRAVATO does not preclude the need for hospitalization if clinically warranted, even if patients experience improvement after an initial dose of SPRAVATO. - SPRAVATO is not approved as an anesthetic agent. The safety and effectiveness of SPRAVATO as an anesthetic agent have not been established. SPRAVATO is contraindicated in patients with: - Aneurysmal vascular disease (including thoracic and abdominal aorta, intracranial, and peripheral arterial vessels) or arteriovenous malformation [see Warnings and Precautions (5.7)] - History of intracere

Product summary:

SPRAVATO ® nasal spray is available as an aqueous solution of esketamine hydrochloride in a stoppered glass vial within a nasal spray device. Each nasal spray device delivers two sprays containing a total of 28 mg of esketamine (supplied as 32.3 mg of esketamine hydrochloride). SPRAVATO is available in the following presentations: Within each kit, each 28 mg device is individually packaged in a sealed blister (NDC 50458-028-00). Storage Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature] . Disposal SPRAVATO nasal spray devices must be handled with adequate security, accountability, and proper disposal, per facility procedure for a Schedule III drug product, and per applicable federal, state, and local regulations.

Authorization status:

New Drug Application

Patient Information leaflet

Janssen Pharmaceuticals Inc.
----------
This Medication Guide has been approved by the U.S.
Food and Drug Administration.
Revised: 10/2023
MEDICATION GUIDE
SPRAVATO ®(sprah vah' toe) CIII
(esketamine)
nasal spray
What is the most important information I should know about SPRAVATO?
SPRAVATO can cause serious side effects, including:
•
Sedation, dissociation, and respiratory depression. SPRAVATO may cause
sleepiness (sedation),
fainting, dizziness, spinning sensation, anxiety, or feeling
disconnected from yourself, your
thoughts, feelings, space and time (dissociation), and breathing
problems (respiratory depression
and respiratory arrest).
•
Tell your healthcare provider right away if you feel like you cannot
stay awake or if you
feel like you are going to pass out.
•
Your healthcare provider must monitor you for serious side effects for
at least 2 hours
after taking SPRAVATO. Your healthcare provider will decide when you
are ready to
leave the healthcare setting.
•
Abuse and misuse.There is a risk for abuse and physical and
psychological dependence with
SPRAVATO treatment. Your healthcare provider should check you for
signs of abuse and
dependence before and during treatment with SPRAVATO.
•
Tell your healthcare provider if you have ever abused or been
dependent on alcohol,
prescription medicines, or street drugs.
•
Your healthcare provider can tell you more about the differences
between physical and
psychological dependence and drug addiction.
•
SPRAVATO Risk Evaluation and Mitigation Strategy (REMS).Because of the
risks for sedation,
dissociation, respiratory depression, abuse and misuse, SPRAVATO is
only available through a
restricted program called the SPRAVATO Risk Evaluation and Mitigation
Strategy (REMS)
Program. SPRAVATO can only be administered at healthcare settings
certified in the
SPRAVATO REMS Program. Patients treated in outpatient healthcare
settings (e.g. medical
offices and clinics) must be enrolled in the program.
•
Increased risk of suicidal thoughts and actions.Antidepressant

Summary of Product characteristics

SPRAVATO- ESKETAMINE HYDROCHLORIDE SOLUTION
JANSSEN PHARMACEUTICALS INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SPRAVATO
SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SPRAVATO
.
SPRAVATO
(ESKETAMINE) NASAL SPRAY, CIII
INITIAL U.S. APPROVAL: 1970 (KETAMINE)
WARNING: SEDATION; DISSOCIATION; RESPIRATORY DEPRESSION; ABUSE AND
MISUSE;
AND SUICIDAL THOUGHTS AND BEHAVIORS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
RISK FOR SEDATION, DISSOCIATION, AND RESPIRATORY DEPRESSION AFTER
ADMINISTRATION.
MONITOR PATIENTS FOR AT LEAST TWO HOURS AFTER ADMINISTRATION. ( 5.1,
5.2, 5.3)
POTENTIAL FOR ABUSE AND MISUSE. CONSIDER THE RISKS AND BENEFITS OF
PRESCRIBING
SPRAVATO PRIOR TO USING IN PATIENTS AT HIGHER RISK OF ABUSE. MONITOR
PATIENTS FOR
SIGNS AND SYMPTOMS OF ABUSE AND MISUSE. ( 5.4)
SPRAVATO IS ONLY AVAILABLE THROUGH A RESTRICTED PROGRAM CALLED THE
SPRAVATO
REMS. ( 5.5)
INCREASED RISK OF SUICIDAL THOUGHTS AND BEHAVIORS IN PEDIATRIC AND
YOUNG ADULT
PATIENTS TAKING ANTIDEPRESSANTS. CLOSELY MONITOR ALL
ANTIDEPRESSANT-TREATED PATIENTS
FOR CLINICAL WORSENING AND EMERGENCE OF SUICIDAL THOUGHTS AND
BEHAVIORS. SPRAVATO
IS NOT APPROVED FOR USE IN PEDIATRIC PATIENTS. ( 5.6)
RECENT MAJOR CHANGES
Boxed Warning
10/2023
Dosage and Administration ( 2.1)
10/2023
Warnings and Precautions ( 5.1, 5.3, 5.5)
10/2023
INDICATIONS AND USAGE
SPRAVATO
is a non-competitive _N_-methyl _D_-aspartate (NMDA) receptor
antagonist indicated, in
conjunction with an oral antidepressant, for the treatment of:
Treatment-resistant depression (TRD) in adults. ( 1)
Depressive symptoms in adults with major depressive disorder (MDD)
with acute suicidal ideation or
behavior. ( 1)
Limitations of Use:
The effectiveness of SPRAVATO in preventing suicide or in reducing
suicidal ideation or behavior has not
been demonstrated. Use of SPRAVATO does not preclude the need for
hospitalization if clinically
warranted, even if patients experience improvement after an initi