Zavegepant

What is Zavegepant?

• Zavegepant (Zavzpret) is a calcitonin gene-related peptide receptor antagonist.

Zavegepant (2)

Zavegepant

What are the uses of this medicine?

• Zavegepant (Zavzpret), is a prescription medicine used in adults for the acute treatment of migraine attacks with or without aura.

Limitations of use:

• Zavzpret is not used to prevent migraine attacks.

How does this medicine work?

• Zavegepant (Zavzpret), is a highly soluble small molecule calcitonin gene related peptide (CGRP) receptor antagonist, with potential analgesic and immunomodulating activities.
• Upon administration, zavegepant targets, binds to and inhibits the activity of CGRP receptors located on mast cells in the brain.
• This may inhibit neurogenic inflammation caused by trigeminal nerve release of CGRP.
• In addition, by blocking the CGRP receptors located in smooth muscle cells within vessel walls, zavegepant inhibits the pathologic dilation of intracranial arteries.
• Zavegepant, by blocking the CGRP receptors, also suppresses the transmission of pain by inhibiting the central relay of pain signals from the trigeminal nerve to the caudal trigeminal nucleus.
• Altogether, this may relieve migraine.
• As CGRP receptors induce the release of pro-inflammatory mediators, such as interleukin-6 (IL-6), from inflammatory cells, zavegepant may prevent an IL-6-mediated inflammatory response.
• Zavegepant may also inhibit the CGRP-mediated induction of eosinophil migration and the stimulation of beta-integrin-mediated T cell adhesion to fibronectin at the site of inflammation, and may abrogate the CGRP-mediated polarization of the T cell response towards the pro-inflammatory state characterized by Th17 and IL-17.
• This may improve lung inflammation and oxygenation, prevent edema, and further lung injury.
• CGRP, a 37 amino-acid peptide expressed in and released from a subset of polymodal primary sensory neurons of the trigeminal ganglion and nerve fibers projecting to the airways and by pulmonary neuroendocrine cells, plays an important role in pain transmission, inflammation, and neurogenic vasodilatation.
• It is released upon acute lung injury and upregulation of transient receptor potential (TRP) channels.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• allergic to zavegepant, or any of the ingredients in Zavzpret.

What drug interactions can this medicine cause?

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

• vitamins, and herbal supplements.
• Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

Be sure to mention any of the following:

• Avoid use with drugs that inhibit OATP1B3 or NTCP transporters.
• Avoid use with drugs that induce OATP1B3 or NTCP transporters.

• Avoid use of intranasal decongestants; if unavoidable, administer intranasal decongestants at least 1 hour after Zavzpret administration.

Is this medicine FDA approved?

• Zavegepant was approved for medical use in the United States in March 2023.

How should this medicine be used?

Recommended dosage:

• The recommended dose of Zavzpret is 10 mg given as a single spray in one nostril, as needed.
• The maximum dose that may be given in a 24-hour period is 10 mg (one spray).
• The safety of treating more than 8 migraines in a 30-day period has not been established.

Administration:

• 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 dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Nasal spray: 10 mg

This medicine is available in fallowing brand namesː

• Zavzpret

What side effects can this medication cause?

The most common side effects of this medicine include:

• unusual taste
• nausea
• nasal discomfort
• vomiting

Less common, but serious side effects may include:

• Allergic reactions

What special precautions should I follow?

• Hypersensitivity reactions, including facial swelling and urticaria, have occurred in patients treated with Zavzpret in clinical studies. Inform patients about the signs and symptoms of hypersensitivity reactions after administration of Zavzpret. Advise patients to contact their healthcare provider immediately if signs or symptoms of hypersensitivity reactions occur.
• There are no data on the presence of zavegepant or its metabolites in human milk, the effects of zavegepant on the breastfed infant, or the effects of zavegepant on milk production.
• Clinical studies of Zavzpret did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.
• No dosage adjustment of Zavzpret is necessary in patients with mild hepatic impairment. Avoid use of Zavzpret in patients with severe hepatic impairment.
• Avoid use of Zavzpret in patients with CLcr less than 30 mL/min.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• There are no adequate data on the developmental risk associated with the use of Zavzpret in pregnant women.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

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

Who manufactures and distributes this medicine?

Distributed by:

• Pfizer labs
• Division of Pfizer Inc.
• New york, NY

What should I know about storage and disposal of this medication?

• Store Zavzpret at controlled room temperature, 20°C to 25°C (68°F to 77°F); with excursions permitted between 15°C to 30°C (59°F to 86°F).
• Do not freeze.
• Do not test spray, prime, or press the plunger before use.

• Dailymed label info on Zavegepant
• FDA Zavegepant

Zavegepant Resources
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