SPRAVATO® Safety: Boxed Warnings and Who Should Not Use It

Boxed warnings (the FDA's most prominent warnings) - Sedation and dissociation — patients must be monitored for at least two hours after each dose. - Respiratory depression — breathing can slow; monitoring includes watching for this. - Abuse and misuse — esketamine is a Schedule III controlled substance; prescribers assess each patient's risk. - Suicidal thoughts and behaviors — antidepressants increased this risk in pediatric and young adult patients in studies. SPRAVATO® is not approved for patients under 18.

Because of these risks, SPRAVATO® is available only through a restricted REMS program.

Contraindications (people who should not use it) Per the label, SPRAVATO® should not be used by people with: - aneurysmal vascular disease (including thoracic and abdominal aorta, intracranial, and peripheral arterial vessels) or arteriovenous malformation; - a history of intracerebral hemorrhage; - hypersensitivity to esketamine, ketamine, or any of the product's ingredients.

Other warnings to discuss The label also addresses increases in blood pressure, cognitive impairment, impaired ability to drive, ulcerative or interstitial cystitis, and embryo-fetal toxicity — SPRAVATO® is not recommended during pregnancy. Tell your prescriber if you are pregnant, planning pregnancy, or breastfeeding.

Summarized in our own words from the current FDA prescribing information. Read the full label and speak with a healthcare professional.