Zavzpret

Zavzpret (zavegepant) is a calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray used for the acute treatment of migraine attacks, with or without aura, in adults. Zavzpret can begin relieving pain as early as 15 minutes, and after 2 hours, Zavzpret is significantly better than a placebo at relieving nausea, sensitivity to light (photophobia), or sensitivity to sound (phonophobia).

Zavzpret is not used to prevent migraine attacks. It is not known if Zavzpret is safe and effective in children.

Zavzpret (zavegepant) received FDA approval on March 9, 2023. There is no generic.

CGRP is a chemical messenger that has a role in causing pain and other symptoms of migraines. Zavzpret is a small-molecule CGRP receptor antagonist that works by blocking the CGRP receptors, which reduces migraine pain and other symptoms of migraine, including nausea and sensitivity to light and sound.

Do not use Zavzpret if you:

• are allergic to the active ingredient, zavegepant, or any of the inactive ingredients. There is a complete list of ingredients at the bottom of the page
• have severe liver disease
• have severe kidney disease (CLcr < 30 mL/min).

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 this medicine passes into your breast milk. Talk with your healthcare provider about the best way to feed your baby.

Common side effects

The most common Zavzpret side effects are:

• unusual taste (dysgeusia)
• feeling sick (nausea)
• nasal discomfort
• vomiting.

Serious side effects

Serious Zavzpret side effects are:

• Allergic reactions. Allergic reactions, including trouble breathing, hives, and swelling of the face, can happen after you use this medicine. 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.

These are not the only possible side effects of this medicine. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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.
• 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 24 hours.
• 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.

How to use the Zavzpret nasal spray

Zavzpret comes as a single-use nasal spray that delivers one dose. Do not test or prime it before use.

• Blow your nose to clear your nostrils.
• Peel open the blister pack and remove the device.
• Hold the device upright with your thumb on the bottom plunger and two fingers on either side of the nozzle, without pressing yet.
• Gently close one nostril with your free hand and insert the nozzle into the other nostril as far as is comfortable.
• Keep your head level and breathe in slowly as you firmly press the plunger to release the spray.
• Remove the device and breathe gently in through your nose and out through your mouth for 10 to 20 seconds.
• Throw the used device away. Each device sprays 1 time only and cannot be reused.

Some medicines can change how Zavzpret works, so tell your healthcare provider and pharmacist about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

• Medicines that can raise the amount of Zavzpret in your body. Some medicines block the transporters (called OATP1B3 and NTCP) that help move zavegepant through the body. Taking them with Zavzpret can raise Zavzpret levels and make side effects more likely. An example is rifampin (an antibiotic used to treat tuberculosis); the immunosuppressant cyclosporine can also affect these transporters. Avoid using these medicines with Zavzpret.
• Medicines that can lower the amount of Zavzpret in your body. Other medicines speed up these same transporters, which can lower Zavzpret levels and may make it work less well. Rifampin taken regularly over time is one example. Avoid using these medicines with Zavzpret.
• Nasal decongestant sprays. Using a nasal decongestant spray around the same time, such as oxymetazoline (Afrin) or phenylephrine, can reduce how much Zavzpret your body absorbs. Avoid using them together. If you have to use a nasal decongestant, use it at least 1 hour after your Zavzpret dose.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

• Store Zavzpret in the blister package that it comes in.
• Store at room temperature between 68°F and 77°F (20°C and 25°C).
• Do not freeze.
• Keep this medicine and all medicines out of the reach of children.

Active ingredient: zavegepant

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

Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10001. For more information, go to www.zavzpret.com or call 1-800-438-1985.