Dosing and Administration

Dosing and Administration

What adult patients can expect when taking SPRAVATO™

Dosing SPRAVATO™1

In Study 2 (long-term), 39% of patients received the 56-mg dose, and 61% received the 84-mg dose of SPRAVATO™

SPRAVATO™ does not require daily dosing and should be administered in conjunction with an oral AD

Careful consideration is advised prior to treatment of individuals with a history of substance use disorder, including alcohol. Monitoring for signs of abuse and dependence is recommended.

*Dosing frequency should be individualized to the lowest frequency required to maintain remission/response.

As determined by the prescribing physician.

SPRAVATO™ administration1

SPRAVATO™ should be self-administered by the patient under the supervision of a healthcare professional in a certified SPRAVATO™ treatment center

The Day 1 starting dose of SPRAVATO™ is 56 mg (2 devices).

Each single-use device contains 2 sprays, 1 spray for each nostril.

Wait 5 minutes after each device to allow medication to absorb.

For patients requiring an 84-mg dose, taken only after an initial starting dose of 56 mg, use 3 devices.

Dosage adjustments should be made based on efficacy and tolerability of the previous dose

Read the full Dosing & Administration Resource before training and supervising patients.

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Please see "Dosing and Administration" and "Instructions for Use" in the full Prescribing Information.

 

Post-administration observation and discharge

Healthcare provider observation for at least 2 hours will be required
  • Because of the possibility of delayed or prolonged sedation or dissociation in some cases, patients should be monitored by a healthcare professional for at least 2 hours following each treatment
Patients will require transportation from the treatment center
  • Caution patients that SPRAVATO™ may impair their ability to drive, and 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
Reference

1.SPRAVATO™ [Prescribing Information]. Titusville, NJ: Janssen Pharmaceuticals, Inc. March 2019.