Section 02 · Monograph

Zavegepant

Reviewed Nov 2026FDA label
ZavzpretGepant · intranasal
Forms
NS: 10mg/spray
Dose
10mg intranasal PRN
MOA
CGRP receptor antagonist

Indications

  • Acute treatment of migraine with or without aura in adultsFDA-labeled
  • Not indicated for the preventive treatment of migraineFDA-labeled

Mechanism of Action

  • Small-molecule calcitonin gene-related peptide (CGRP) receptor antagonist ("gepant") formulated as an intranasal spray
  • Antagonizes CGRP receptors to block neurogenic inflammation and vasodilation implicated in migraine pathophysiology
  • Intranasal delivery provides rapid absorption, enabling faster onset of action than oral gepants — useful for patients with migraine-associated nausea/vomiting limiting oral intake

Full Dosing

Adult / usual

  • Recommended dose: 10 mg administered as a single spray in one nostril, as needed
  • Maximum dose: 10 mg (one spray) in a 24-hour period
  • Safety of treating more than 8 migraine attacks per month has not been established

Renal

  • Renal impairment: no dosage adjustment needed if creatinine clearance ≥30 mL/min; avoid use if CLcr <30 mL/min or in end-stage renal disease

Hepatic

  • Hepatic impairment: no adjustment needed for mild (Child-Pugh A) or moderate (Child-Pugh B) impairment; avoid use in severe impairment (Child-Pugh C)

Contraindications

  • History of hypersensitivity reaction to zavegepant or any component of Zavzpret, including reported cases of anaphylaxis

Drug Interactions

  • No clinically relevant interaction observed with strong CYP3A4 inhibitors (e.g., itraconazole) based on studies conducted
  • OATP1B3/NTCP inhibitors and inducers: avoid concomitant use — can significantly alter zavegepant systemic exposure
  • Intranasal decongestants (e.g., oxymetazoline): avoid concurrent use, or separate administration by at least 1 hour, as they may reduce zavegepant absorption/efficacy

Adverse Effects

  • Taste disorders/dysgeusia (most common, ~18%)
  • Nausea (~4%)
  • Nasal discomfort (~3%)
  • Vomiting (~2%)
  • Hypersensitivity reactions, including anaphylaxis
  • Postmarketing: hypertension (new onset or worsening)
  • Postmarketing: Raynaud's phenomenon

Monitoring Parameters

  • Monitor for hypersensitivity reactions, which can occur even after prior tolerated doses
  • Assess nasal mucosal tolerability with repeated use
  • Monitor frequency of use to avoid medication-overuse headache
  • Assess renal function; avoid use if CLcr <30 mL/min
  • Monitor blood pressure for new-onset or worsening hypertension

Pregnancy & Lactation

  • Pregnancy: No adequate human data on drug-associated risk; animal reproduction studies did not show adverse fetal effects at clinically relevant exposures
  • Lactation: No data on the presence of zavegepant in human milk or its effects on the breastfed infant or milk production
  • Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for zavegepant and any potential adverse effects on the breastfed infant

References

  1. FDA Prescribing Information — Zavzpret (zavegepant)