ZAVEGEPANT SOLN,SPRAY,NASAL

Clinical Criteria Summary

Patient has uncontrolled hypertension
Patient has a history of Raynaud’s phenomenon with ischemia (e.g., digital ulcers, tissue necrosis, or other critical ischemia)
Concurrent therapy with a triptan, ergot, or gepant once zavegepant is initiated

Treatment initiated by or in consultation with a VA/VA Community Care neurologist or locally designated headache expert
Diagnosis of migraine, with or without aura, per the International Classification of Headache Disorders (ICHD-3)
Moderate to severe migraine intensity
Currently receiving preventive therapy for migraine if indicated

Contraindication, intolerance, or lack of response to trial of two different oral gepants for acute migraine treatment at a clinically effective dose
Patient requires a non-oral acute migraine therapy and has contraindication, intolerance, or lack of response to trial of at least two other non-oral acute migraine pharmacotherapies

Discontinue zavegepant if signs or symptoms of Raynaud’s phenomenon develop
Monitor patients with a history of Raynaud’s phenomenon for recurrence and worsening, and inform them of this possibility
Locally designated headache expert must perform a comprehensive headache assessment including evaluation for medication overuse headache, other secondary headache types, adherence to prior headache therapies, and features requiring urgent/emergent evaluation; review headache history for triggers, effective preventive treatment, and nonpharmacologic interventions
Scheduled blood pressure check required 2–4 weeks after initiation of therapy

Vascular contraindications to triptans and ergots include ischemic coronary artery disease, previous stroke or transient ischemic attack, peripheral vascular disease, or ischemic bowel disease; other contraindications may be drug interaction related (e.g., concurrent use of a MAO inhibitor)
If using a combination of a calcitonin gene related peptide (CGRP)-targeted monoclonal antibody for preventative therapy and zavegepant for abortive therapy, patient must be evaluated and counseled on risks of concomitant therapy
Safety evidence of concomitant CGRP acting agents is limited; patients may be prone to CGRP-related adverse events (vasodilation, GI motor-stimulation, prosecretory effects); consider alternative therapies for patients at high risk for ischemic events or severe constipation

• History of hypersensitivity to zavegepant or any of its components
• Hypersensitivity reactions including facial swelling and urticaria (occurred in less than 1% of patients in clinical trials)

• Avoid administration with inhibitors or inducers of the organic anion transporting polypeptide 1B3 (OATP1B3) or sodium taurocholate co-transporting polypeptide (NTCP) (e.g., rifampin, pretomanid, trofinetide, voclosporin)
• Concurrent intranasal decongestant use may decrease absorption; if needed, administer intranasal decongestant at least 1 hour after zavegepant administration

• Hepatic Impairment: Avoid in severe (Child-Pugh Class C) impairment
• Renal Impairment: Avoid in CrCl less than 30 mL/min
• Pregnancy and Lactation: No data on developmental risk or presence in human milk; no adverse developmental effects observed in animal studies

• May be used as an alternative for patients requiring a non-oral option (e.g., vomiting during migraine, severe nausea that swallowing pills aggravates)
• May be used as an alternative for patients experiencing intolerance or therapeutic failure with other acute migraine intranasal spray medications (e.g., triptans, ergots) who require maintaining a non-oral route
• No evidence to support off-label use in acute cluster headache treatment