Zavegepant Nasal Spray

Zavegepant nasal spray is used to treat the symptoms of migraine headaches (severe, throbbing headaches that sometimes are accompanied by nausea and sensitivity to sound or light). Zavegepant is in a class of medications called calcitonin gene-related peptide receptor antagonists. It works by blocking the action of a certain natural substance in the body that causes migraine headaches. Zavegepant does not prevent migraine attacks or reduce the number of headaches you have.

Zavegepant comes as a solution (liquid) to spray into the nose. It is usually used as a single dose sprayed into one nostril at the first sign of a migraine headache. Do not use more than one dose in a 24-hour period. Your doctor will tell you the maximum number of migraine headaches you should treat with zavegepant nasal spray in a 30-day period. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use zavegepant nasal exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Call your doctor if your headaches do not get better or occur more frequently after using zavegepant nasal spray.

To use the nasal spray, follow these steps:

1. Read all of the manufacturer's instructions for using the nasal spray before you use your first dose.
2. Blow your nose gently.
3. Remove one blister containing one device from the carton. Remove the device from the blister pack. Peel back the tab to open the spray.
4. Check the expiration date printed on the blister and device and do not use the device if the expiration date has passed.
5. Do not prime the nasal spray before using it.
6. Hold the zavegepant nasal spray with your thumb on the bottom of the plunger and two fingers on either side of the nozzle, but be careful not to press the plunger.
7. Use your other hand to block one nostril by pressing firmly on the side of your nose.
8. Put the tip of the sprayer into your other nostril as far as feels comfortable. Keep your head upright and close your mouth. Be careful not to press the plunger or spray the medication in your eyes.
9. Breathe in gently through your nose. At the same time, press the plunger firmly with your thumb.
10. Keep your head level and remove the tip from your nose.
11. Breathe gently in through your nose and out through your mouth for 10 to 20 seconds. Do not breathe in deeply.
12. The sprayer only contains one dose of medication. After you have used it, dispose of it safely, so that is out of the reach of children and pets.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before using zavegepant nasal spray,

• tell your doctor and pharmacist if you are allergic to zavegepant, any other medications, or any of the ingredients in zavegepant nasal spray. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• if you are using nasal decongestants such as oxymetazoline (Afrin, Vicks Sinex, others) or phenylephrine (Neo-Synephrine), take them at least 1 hour after using zavegepant nasal spray.
• tell your doctor if you have or have ever had kidney or liver problems.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using zavegepant nasal spray, call your doctor.

Unless your doctor tells you otherwise, continue your normal diet.

Zavegepant nasal spray may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• change in how things taste or loss of taste
• nasal discomfort
• nausea
• vomiting

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• swelling of the face, throat, or around the mouth or eyes
• difficulty breathing
• hives
• rash
• itching

Zavegepant nasal spray may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Do not freeze.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor.

You should keep a headache diary by writing down when you have headaches and when you use zavegepant nasal spray.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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