Patient information: uses, side effects, how to take - Zavzpret
What is ZAVZPRET?
ZAVZPRET is a prescription medicine used in adults for the acute treatment of migraine attacks with or without aura.
ZAVZPRET is not used to prevent migraine attacks.
It is not known if ZAVZPRET is safe and effective in children.
Do not use ZAVZPRET if you are:
- allergic to zavegepant, or any of the ingredients in ZAVZPRET.
See the end of this leaflet for a complete list of ingredients in ZAVZPRET.
Before you use ZAVZPRET, tell your healthcare provider about all of your medical conditions, including if you:
- have high blood pressure.
- have circulation problems in your fingers and toes.
- have kidney problems.
- have liver problems.
are pregnant or plan to become pregnant. It is not known if ZAVZPRET will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known whether ZAVZPRET passes into your breast milk. Talk with your healthcare provider about the best way to feed your baby if you use ZAVZPRET.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How should I use ZAVZPRET?
- Use ZAVZPRET exactly how your healthcare provider tells you to use it.
- See the Instructions for Use for complete information on how to use ZAVZPRET nasal spray.
- ZAVZPRET is given in the nose (nasal) only.
- Each ZAVZPRET only sprays 1 time and cannot be reused. Do not test or prime the nasal spray before use.
- Each dose of ZAVZPRET is provided in an individual pack. Use all of the medicine in 1 pack for a complete dose.
- The recommended dose is 10 mg given as a single spray in one nostril.
- Do not use more than 1 spray (10 mg) of ZAVZPRET nasal spray in a 24-hour period.
- It is not known if it is safe to use more than 8 sprays (doses) of ZAVZPRET in 30 days.
- Avoid using intranasal decongestants with ZAVZPRET. If you have to use an intranasal decongestant, use it at least 1 hour after using ZAVZPRET.
What are the possible side effects of ZAVZPRET?
ZAVZPRET may cause serious side effects including:
Allergic reactions. Allergic reactions, including trouble breathing, hives, and swelling of the face, can happen after you use ZAVZPRET. Call your healthcare provider or get emergency help right away if you have any of the following symptoms, which may be part of an allergic reaction:
- swelling of the face, mouth, tongue, or throat
- trouble breathing
- rash
- hives
- High blood pressure. High blood pressure or worsening of high blood pressure can happen after you use ZAVZPRET. Contact your healthcare provider if you have an increase in blood pressure.
- Raynaud’s phenomenon. A type of circulation problem can worsen or happen after you use ZAVZPRET. Raynaud’s phenomenon can lead to your fingers or toes feeling numb, cool, or painful, or changing color from pale, to blue, to red. Contact your healthcare provider if these symptoms occur.
The most common side effects of ZAVZPRET are:
- unusual taste
- nausea
- nasal discomfort
- vomiting
These are not the only possible side effects of ZAVZPRET.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store ZAVZPRET?
- Store ZAVZPRET in the blister package that it comes in.
- Store ZAVZPRET at room temperature between 68°F to 77°F (20°C to 25°C).
- Do not freeze.
Keep ZAVZPRET and all medicines out of the reach of children.
General information about the safe and effective use of ZAVZPRET:
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ZAVZPRET for a condition for which it was not prescribed. Do not give ZAVZPRET to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about ZAVZPRET that is written for health professionals.
What are the ingredients in ZAVZPRET?
Active ingredients in ZAVZPRET: zavegepant
Inactive ingredients in ZAVZPRET: dextrose, hydrochloric acid, sodium hydroxide, and succinic acid in water for injection.
For more information, go to www.zavzpret.com or call 1-800-438-1985.
LAB-1545-3.0
| This Patient Information has been approved by the US. Food and Drug Administration | 8/2025 |
Instructions for Use
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
Storage Information
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. | |
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| 2 | Remove 1 Blister from the Carton | |
| 2.1 | Remove 1 blister containing a device from the carton (see Figure C). | |
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| 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. | ||
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| 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. | |
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| 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. | |
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| 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. | |
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| 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. | |
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| 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). | |
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| 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. | |
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| 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. | ||
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| Throwing away (Disposing of) Device | ||
| 11 | Throw Away Used Device | |
| 11.1 | Throw away the used device into trash (see Figure L) | |
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You have received your full dose, if you have:
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: 7/2024 LAB-1546-2.0 | ||