Esketamine (nasal spray) (Spravato)
Esketamine (nasal spray) risk profile, scheduling, and guidance for claims professionals and care workers . Also known as Spravato.
Esketamine (nasal spray) (brand names: Spravato) is classified as Moderate risk (5 risk points) by AllMeds. It is a S8 medication under the TGA in Australia. TGA registered for treatment-resistant depression. S8. Must be administered under supervision.
Key Takeaways
- TGA Schedule: S8 in Australia
- Risk level: Moderate (5 points)
- CNS depressant: May cause sedation, impair driving, and affect work capacity
Scheduling and Classification
| Jurisdiction | Classification | Status |
|---|---|---|
| Australia (TGA) | S8 | Not PBS listed |
Risk Profile
TGA registered for treatment-resistant depression. S8. Must be administered under supervision.
Regulatory and Compliance Guidance
When Esketamine (nasal spray) appears on a claimant's medication list, claims professionals should assess whether the prescribing is appropriate for the compensable injury, whether the duration is within guidelines, and whether there are interactions with other medications on the claim.
Work capacity impact: As a CNS depressant, Esketamine (nasal spray) may impair driving, operating machinery, and cognitive function. Work capacity certificates should reflect any medication-related restrictions.
Australia TGA / PBS / State Schemes
Classified as S8 under the Therapeutic Goods Administration (TGA).
Clinical Evidence
- TGA Registration: Spravato (esketamine) nasal spray — ARTG (2021)
Spravato registered on ARTG for treatment-resistant depression. Must be administered under healthcare professional supervision. S8.
Full TGA registration
- FDA Approval of Spravato (esketamine) for TRD (2019)
FDA approved esketamine nasal spray with REMS (Risk Evaluation and Mitigation Strategy) requiring supervised administration.
FDA approval with REMS restrictions
- WorkSafe Victoria: Esketamine Guidelines for Workers Comp (2024)
Specific guidance on esketamine in VIC workers comp. Covers eligibility, prior approval requirements, and treatment protocols.
State regulator — specific to workers comp
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Medical Disclaimer: This content is for informational purposes for claims professionals and care workers. It is not medical advice. Always consult a qualified healthcare professional for clinical decisions. Drug information is sourced from TGA, FDA, MHRA, PBS, NICE, and CDC databases and may not reflect the latest updates. AllMeds does not replace clinical judgement.