Spravato Esketamine Nasal Spray Device Instruction Manual

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.

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