Zavzpret®(zavegepant)

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.

Allergic to zavegepant, or any of the ingredients in ZAVZPRET. See the end of this leaflet for a complete list of ingredients in 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). Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

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.

ZAVZPRET may cause serious side effects including: Allergic reactions (trouble breathing, hives, and swelling of the face, mouth, tongue, or throat), High blood pressure or worsening of high blood pressure, Raynaud's phenomenon (fingers or toes feeling numb, cool, or painful, or changing color from pale, to blue, to red). The most common side effects of ZAVZPRET are: unusual taste, nausea, nasal discomfort, vomiting. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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.

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.

Active ingredients in ZAVZPRET: zavegepant. Inactive ingredients in ZAVZPRET: dextrose, hydrochloric acid, sodium hydroxide, and succinic acid in water for injection.