ZAVZPRET™ Instructions For Use ([zavegepant] nasal spray)

INSTRUCTIONS FOR USE

ZAVZPRET [zav-spret]

(zavegepant) nasal spray

For Nasal Use Only

This Instructions for Use contains information on how to give a single dose (10 mg) with ZAVZPRET nasal spray

One (1) device delivers a single dose of ZAVZPRET. The device provides 1 spray that should be delivered into 1 nostril.

ZAVZPRET Device Parts

Important Information You Need to Know Before Dosing with ZAVZPRET

•

For nasal use only (spray into nose).

•

Do not spray in the eyes.

•

Keep ZAVZPRET and all medicines out of reach of children.

•

Do not use if the expiration (EXP) date has passed. Throw away the expired device in the trash if the expiration (EXP) date has passed.

•

Do not remove the device from its blister packaging until you are ready to use it.

•

Do not test spray, prime, or press the plunger before dosing. Each device is single use and can only be used 1 time. If you press the plunger before dosing, the spray will be lost, and the device will no longer function.

•

Do not try to spray (dose) into more than 1 nostril. A dose is 1 spray into 1 nostril.

•

Do not use more than 1 dose in a 24-hour period. Only 1 dose can be used per day.

•

Do not use more than 8 doses per month. A maximum of 8 doses can be used per month.

Storage Information

•

The device should be stored at room temperature between 68°F to 77°F (20°C to 25°C).

•

Do not freeze.

•

Keep the device in the sealed blister package until time of use.

•

Keep ZAVZPRET and all medicines out of reach of children.

Preparing to Dose with ZAVZPRET Nasal Spray

1

Gently Blow Your Nose

1.1

Before using ZAVZPRET, blow your nose to clear your nostrils (see Figure B). This can be done while sitting or standing.

2

Remove 1 Blister from the Carton

2.1

Remove 1 blister containing a device from the carton (see Figure C).

3

Check Expiration Date on the Blister

3.1

Check the expiration date on the blister containing a device (see Figure D).

Do not use if the expiration date has passed. Throw away the expired device in the trash if the expiration date has passed.

4

Remove Device from Blister

4.1

Peel open the blister seal from the corner and remove it completely (see Figure E).

4.2

Carefully remove the device from the plastic tray.

Dosing with ZAVZPRET Nasal Spray

5

Check Expiration Date on the Device

5.1

Check the expiration date on the device (see Figure F).

Do not use if the expiration date has passed. Throw away the expired device in the trash if the expiration date has passed.

6

Grip the Device

6.1

Hold the device upright with your thumb on the bottom of the plunger and two fingers on either side of the nozzle (see Figure G).

Do not press the plunger yet. If you press the plunger now, the medicine will spray and be wasted.

Dosing with ZAVZPRET Nasal Spray (Continued)

7

Close 1 Nostril

7.1

With your free hand, gently press 1 nostril to close it (see Figure H).

7.2

Continue breathing normally through your mouth.

8

Insert Spray Nozzle Into Open Nostril

8.1

Insert the nozzle into the open nostril as much as you comfortably can (see Figure I).

9

Deliver the Dose by Spraying Into Nostril and Breathing In

9.1

Keep your head level and upright and close your mouth.

Do not tilt your head.

Do not lay down while delivering the dose.

9.2

Slowly breathe in through your nose as you firmly press the plunger up with your thumb to release the spray (see Figure J).

Important: Hold the nozzle firmly in your nose as you deliver the dose. Do not let the nozzle come out when pressing the plunger.

Spray only 1 time into 1 nostril.

10

Remove the Device and Keep Your Head Level for 20 Seconds

10.1

Remove the device from your nostril and your finger from your other nostril.

10.2

While keeping your head level and upright, gently breathe in through your nose and out through your mouth for 10 to 20 seconds (see Figure K).

If you feel a drip from your nose, gently sniff so you do not lose any of your dose.

Throwing away (Disposing of) Device

11

Throw Away Used Device

11.1

Throw away the used device into trash (see Figure L)

You have received your full dose, if you have:

✓

Used 1 device

✓

Given 1 spray into 1 nostril

Additional Information

For more information on ZAVZPRET (zavegepant), visit www.zavzpret.com or call 1-800-438-1985.

This Instructions for Use has been approved by the U.S. Food and Drug Administration Approved: 3/2023

LAB-1546-1.0