We are now Risk Evaluation and Mitigation Strategy (REMS) certified to
provide SPRAVATO™ (esketamine) CIII, a nasal spray approved for use in
conjunction with an oral antidepressant in adults with treatment-resistant
depression (TRD).1 People who are currently struggling
with major depressive disorder (MDD) may have TRD if they have not
responded adequately to at least two different antidepressants of adequate
dose and duration in the current depressive episode.2
As a certified treatment center, our medical staff have been trained to
prescribe, dispense and administer SPRAVATO™and have established processes
and procedures in accordance with the REMS. A healthcare provider will
provide direct supervision as the patient self-administers SPRAVATO™ and
will monitor every patient after every dose for at least two hours for
resolution of sedation and dissociation and changes in vital signs.
SPRAVATO™ must never be dispensed directly to a patient for home use.
Additionally, all patients will require transportation from APG Healthcare following the observation period,as they should not drive or operate
machinery until the day after a treatment session, following a restful
sleep.
For more information regarding administration, REMS requirements, or other
related questions, please contact one of our administrative assistants at
407-423-7149.
Because of the risks for sedation, dissociation(feeling disconnected from
yourself, your thoughts, feelings, space and time),and abuse and misuse,
SPRAVATO™ carries a Boxed WARNING and is only available through a
restricted program called the SPRAVATO™ Risk Evaluation and Mitigation
Strategy (REMS) Program. SPRAVATO™ can only be administered at healthcare
settings certified in the SPRAVATO™ REMS Program and to patients enrolled
in the program.
For more information on SPRAVATO™, please refer to the
manufacturer’s Prescribing Information and Medication Guide or visit www.SPRAVATO.com. If you are a patient, please speak to your healthcare provider for more
information.