Spravato

What is Spravato?

SPRAVATO® is the first FDA-approved nasal spray medication, taken with an oral antidepressant, for treatment-resistant depression in adults.

How Does SPRAVATO® work?

SPRAVATO® targets the N-methyl-Daspartate (NMDA) receptor and is believed to work differently than currently available oral antidepressants.

Indications and Usage:

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 suicidal thoughts or actions SPRAVATO® is not for use as a medicine to prevent or relieve pain (anesthetic).
• It is not known if SPRAVATO® is safe or effective as an anesthetic medicine. It is not known if SPRAVATO® is safe and effective for use in preventing suicide or in reducing suicidal thoughts or actions. SPRAVATO® is not for use in place of hospitalization if your healthcare provider determines that hospitalization is needed, even if the improvement is experienced after the first dose of SPRAVATO®.

DOSAGE AND ADMINISTRATION

Important Considerations Prior to Initiating and During Therapy

SPRAVATO must be administered under the direct supervision of a healthcare provider.

• A treatment session consists of nasal administration of SPRAVATO and post-administration observation under supervision. Blood Pressure Assessment Before and After Treatment

• Assess blood pressure prior to dosing with SPRAVATO [see Warnings and Precautions.

• If baseline blood pressure is elevated (e.g., >140 mmHg systolic, >90 mmHg diastolic), consider the risks of short-term increases in blood pressure and the benefit of SPRAVATO treatment. Do not administer SPRAVATO if an increase in blood pressure or intracranial pressure poses a serious risk.

• After dosing with SPRAVATO, reassess blood pressure at approximately 40 minutes (which corresponds with the Cmax) and subsequently as clinically warranted.

• If blood pressure is decreasing and the patient appears clinically stable for at least two hours, the patient may be discharged at the end of the post-dose monitoring period; if not, continue to monitor [see Warnings and Precautions

What Is the most important information I should know about Spravato?

SPRAVATO® can cause serious side effects, including:

• Sedation and dissociation. SPRAVATO® may cause sleepiness (sedation), fainting, dizziness, spinning sensation, anxiety, or feeling disconnected from yourself, your thoughts, feelings, space, and time (dissociation).

• 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

• Increased risk of suicidal thoughts and actions.

• Antidepressant medicines may increase suicidal thoughts and actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed.

• SPRAVATO® is not for use in children.