FAQs
FAQs
SPRAVATO® (esketamine) CIII nasal spray is the S-enantiomer of racemic ketamine. SPRAVATO® is an FDA-approved nasal spray for treatment-resistant depression (TRD) and major depressive disorder (MDD) with acute suicidal ideation or behavior (MDSI). Ketamine 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.
There are no samples of SPRAVATO® available — in accordance with federal guidelines — which prohibit the distribution of samples of class III medications.
SPRAVATO® has a controlled distribution network that ensures SPRAVATO® is distributed only to certified healthcare settings and certified pharmacies. SPRAVATO® is not to be delivered directly to patients.
REMS-certified pharmacies will follow standard acquisition protocols via full-line wholesalers and dispense SPRAVATO® to REMS-certified treatment centers.
REMS-certified healthcare centers can purchase SPRAVATO® directly from specialty distributors.
For a list of full-line wholesalers or specialty distributors and other downloadable resources, visit www.spravatotreatmentcenter.com/education
To learn more about REMS certification, visit www.SPRAVATOrems.com or call 855-382-6022.
SPRAVATO® should be administered in conjunction with an oral antidepressant (AD).
In TRD, the new open-label oral AD initiated during Study 1 (short-term) was an SSRI in 32% of patients and an SNRI in 68% of patients.
In MDSI trials for adults with MDSI, all patients received comprehensive standard-of-care treatment, including an initial inpatient hospitalization and a newly initiated or optimized oral AD therapy as determined by the investigator.
SSRI=selective serotonin reuptake inhibitor.
SNRI=serotonin and norepinephrine reuptake inhibitor.
The cost of SPRAVATO® to your patients is dependent on their insurance plan. SPRAVATO withMe offers access and affordability options for your patients, depending on their plan.
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 provider. Certified SPRAVATO® treatment centers will need to provide the infrastructure and operational support to prepare and monitor patients during self-administration and prior to release from the treatment center.
If you are interested in establishing your practice as a treatment center for SPRAVATO®, you must enroll in the SPRAVATO® REMS and become certified.
To learn more about REMS certification, visit www.SPRAVATOrems.com or call 855-382-6022.
To find a certified SPRAVATO® treatment center, you or your patients may visit
www.spravatohcp.com/find-a-center
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 (if doses missed during weekly dosing, revert to twice-weekly dosing).
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.
SPRAVATO® is also administered under REMS due to the potential for abuse and misuse. Consider the risks and benefits of prescribing SPRAVATO® prior to using in patients at higher risk of abuse. Monitor patients for signs and symptoms of abuse and misuse.
The effectiveness of SPRAVATO® in preventing suicide or in reducing suicidal ideation or behavior has not been demonstrated. Use of SPRAVATO® does not preclude the need for hospitalization if clinically warranted, even if patients experience improvement after an initial dose of SPRAVATO®.
Caution patients that SPRAVATO® may impair their ability to drive or operate machinery. Instruct patients not to 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.
USED DEVICES
Once the SPRAVATO® device has been used by the patient, it should be dispensed of as medical waste according to local, state, and federal regulations for controlled substances.
UNUSED DEVICES
If the patient hasn’t been treated with SPRAVATO® within 14 days of receipt of the patient-labeled product dispensed from a pharmacy, then the product must be disposed of.
Turn to the SPRAVATO® Disposal Program to dispose of unused or partially used devices if your healthcare setting is not equipped to do so. Simply call SPRAVATO® Disposal Program at 888-912-7348.
PARTIALLY USED DEVICES
If the patient received 1 spray and then either the patient or the healthcare provider decided not to continue with treatment, then the partially used product must be disposed of.
Turn to the SPRAVATO® Disposal Program to dispose of unused or partially used devices if your healthcare setting is not equipped to do so. Simply call SPRAVATO® Disposal Program at 888-912-7348.
EXPIRED PRODUCT
If the product is past the expiration date printed on the box and blister pack, then coordinate with the pharmacy that sent you the expired product to exchange it for new product.
If you purchased the product from a distributor or wholesaler, you can learn about the returns process and eligibility criteria by calling INMAR® at 800-967-5952, or click here to review Janssen’s Returns Policy.
