Is there a difference between SPRAVATO® Nasal Spray (esketamine) CIII and a ketamine infusion?
SPRAVATO® (esketamine) CIII nasal spray is the S-enantiomer of racemic ketamine. SPRAVATO® is an FDA-approved nasal spray for TRD and MDSI. Ketamine infusion has not been approved by the FDA to treat depression. There are no head-to-head studies comparing esketamine and ketamine infusion. Both SPRAVATO® and ketamine are Schedule III controlled substances under the U.S. Controlled Substances Act.
How much does SPRAVATO® cost?
The cost of SPRAVATO® to patients is dependent on their insurance plan. Janssen CarePath offers information on access and affordability resources for patients, depending on their plan.
How can I get access to SPRAVATO®?
SPRAVATO® is only administered in a medically supervised healthcare setting that is certified under the SPRAVATO® REMS. SPRAVATO® is not to be delivered directly to patients.
SPRAVATO® is a nasal spray that is administered under the supervision of a healthcare professional. Certified SPRAVATO® treatment centers will provide the infrastructure and operational support to prepare and monitor patients during self-administration and prior to release from the treatment center.
What happens if a patient misses a dose of SPRAVATO®?
If a patient misses treatment sessions, provided there is no worsening of their depressive symptoms, the patient should continue the current dosing schedule.
For patients who miss treatment sessions during maintenance treatment and have worsening of depression symptoms, per clinical judgment, consider returning to the previous dosing schedule (e.g., if doses missed during weekly dosing, revert to twice weekly dosing).
Can my patients pick up SPRAVATO® at their pharmacy and self-administer at home?
No, under the REMS, SPRAVATO® must be administered in a certified healthcare setting. Due to the possibility of delayed or prolonged sedation or dissociation in some cases, patients should be monitored by a healthcare provider for at least 2 hours following each treatment session, or until the clinician determines the patient is safe to leave.
How soon can a patient drive after taking SPRAVATO®?
SPRAVATO® may impair a patient’s ability to drive or operate machinery. Patients should not engage in potentially hazardous activities requiring complete mental alertness and motor coordination, such as driving a motor vehicle or operating machinery, until the next day after a restful sleep.
