Mood disorders:
Indications for: SPRAVATO
In conjunction with an oral antidepressant, for treatment-resistant depression (TRD) or depressive symptoms with major depressive disorder (MDD) with acute suicidal ideation or behavior in adults.
Limitations of Use:
The effectiveness in preventing suicide or reducing suicidal ideation or behavior has not been demonstrated. Not approved as an anesthetic.
Adult Dosage:
See full labeling. Avoid food (≥2hrs) and liquids (≥30mins) prior to use. Wait 5mins between use of each device. ≥18yrs: TRD: Induction phase (Weeks 1–4): Day 1 starting dose: 56mg; subsequent doses: 56mg or 84mg twice weekly. Evaluate for continued treatment after the induction phase. Maintenance phase (Weeks 5–8): 56mg or 84mg once weekly; (Weeks 9 and after): 56mg or 84mg every 2 weeks or once weekly (frequency should be individualized). MDD: 84mg twice weekly for 4 weeks; may reduce to 56mg twice weekly based on tolerability. Evaluate for continued treatment after 4 weeks (treatment >4 weeks has not been systematically evaluated).
Children Dosage:
<18yrs: not established.
SPRAVATO Contraindications:
Aneurysmal vascular disease (including thoracic and abdominal aorta, intracranial and peripheral arterial vessels) or arteriovenous malformation. History of intracerebral hemorrhage. Hypersensitivity to ketamine.
Boxed Warning:
Sedation. Dissociation. Abuse and misuse. Suicidal thoughts and behaviors.
SPRAVATO Warnings/Precautions:
Must be administered under supervision of a healthcare provider. Risk of sedation, dissociation; monitor for ≥2hrs at each treatment session and until clinically stable. Assess benefit/risk in those with psychosis prior to initiation. History of substance use disorder including alcohol; monitor for abuse or dependence. Monitor all patients for clinical worsening and emergence of suicidal thoughts and behaviors. Cardiovascular and cerebrovascular conditions. Assess BP prior to initiation; consider delaying therapy if >140/90mmHg. History of hypertensive encephalopathy; monitor frequently. Cognitive impairment. Impaired ability to drive. Ulcerative/interstitial cystitis: monitor for urinary tract and bladder symptoms during therapy. Hepatic impairment (moderate): monitor for longer time; (severe): not recommended. Embryo-fetal toxicity. Advise females of reproductive potential to consider pregnancy planning and prevention. Pregnancy, nursing mothers: not recommended.
SPRAVATO Classification:
NMDA receptor antagonist.
SPRAVATO Interactions:
Concomitant CNS depressants (eg, benzodiazepines, opioids, alcohol) may increase sedation; monitor closely. Concomitant psychostimulants (eg, amphetamines, methylphenidate, modafanil, armodafinil) or MAOIs may increase blood pressure; monitor BP closely. Give concomitant nasal corticosteroid or decongestant ≥1hr before Spravato.
Adverse Reactions:
Dissociation, dizziness, nausea, sedation, vertigo, hypoesthesia, anxiety, lethargy, increased blood pressure, vomiting, feeling drunk, euphoric mood.
Note:
Register pregnant patients in the National Pregnancy Registry for Antidepressants by calling (844) 405-6185.
REMS:
Generic Drug Availability:
NO
How Supplied:
Dose Kit 56mg—2; 84mg—3
