Spravato Esketamine Nasal Spray Device Instruction Manual

June 6, 2024
Spravato

Spravato Esketamine Nasal Spray Device

Nasal Spray Device


Each device delivers two sprays containing a total of 28 mg of esketamine.

Step 1 Get ready

Before first device only:
Instruct patient to blow nose before first device only.


Confirm required number of devices.

56 mg = 2 devices

84 mg = 3 devices

Step 2 Prepare device

Healthcare professional:

  • Check expiration date (`EXP’). If expired, get a new device.

  • Peel blister and remove device.

    Healthcare professional:

  • Do not prime device. This will result in a loss of medication.

  • Check that indicator shows 2 green dots. If not, dispose of device and get a new one

  • Hand device to patient. cp-81317v2

Step 3 Prepare patient

Instruct the patient to:

  • Hold device as shown with the thumb gently supporting the plunger.
  • Do not press the plunger.

Instruct the patient to:

  • Recline head at about
    45 degrees during administration to keep medication inside the nose.

Step 4 Patient sprays once into each nostril

Instruct the patient to:

  • Insert tip straight into the first nostril.

  • Nose rest should touch the skin between the nostrils.

    Instruct the patient to:

  • Close opposite nostril.

  • Breathe in through nose whilepushing plunger all the way up until it stops.

    Instruct the patient to:

  • Sniff gently after spraying to keep medication inside nose.

    Instruct the patient to:

  • Switch hands to insert tip into the second nostril.

  • Repeat Step 4 to deliver second spray.

Step 5 Confirm delivery and rest

Healthcare professional:

  • Take device from patient.

  • Check that indicator shows no green dots. If you see a green dot, have patient spray again into the second nostril.

  • Check indicator again to confirm device is empty.

    Instruct the patient to:

  • Rest in a comfortable position (preferably, semi -reclined) for 5 minutes
    after each device.

  • If liquid drips out, dab nose with a tissue.

Do not blow nose.

Next device

Healthcare professional:

  • Repeat Steps 2-5 for the next device.

IMPORTANT: Ensure that patient waits 5 minutes after each device to allow medication to absorb.

Disposal
Dispose of used device(s) per facility procedure for a Schedule III drug product and per applicable federal, state, and local regulations.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Manufactured for:
Janssen Pharmaceuticals, Inc. Titusville, NJ 08560
Revised: November 2019
© 2019 Janssen Pharmaceutical Companies

Documents / Resources

| Spravato Esketamine Nasal Spray Device [pdf] Instruction Manual
Esketamine, Nasal Spray Device
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