ZAVZPRET (zavegepant hydrochloride)

AbsorptionPeak plasma concentration of zavegepant was observed at approximately 30 minutes after a single 10 mg dose of the nasal spray. After nasal spray administration of zavegepant, the absolute bioavailability is approximately 5%. Zavegepant given as a single dose of the nasal spray displays slightly less than dose-proportional pharmacokinetics up to 40 mg (approximately 4 times the recommended dosage of 10 mg). Following once daily dosing of ZAVZPRET for 14 days there was no evidence of za...

The efficacy of ZAVZPRET for the acute treatment of migraine with or without aura in adults was demonstrated in two randomized, double-blind, placebo-controlled trials (Study 1 and Study 2). In both studies, patients were instructed to treat a migraine of moderate to severe headache pain intensity. Rescue medication (i.e., NSAIDs, acetaminophen, and/or an antiemetic) was allowed 2 hours after the initial treatment. Other forms of rescue medication such as triptans were not allowed within 48 hours of initial treatment. In Study 1 and Study 2, 13.4% and 13.6% of patients were taking preventive m...

The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling:

• Hypersensitivity Reactions [see Warnings and Precautions (5.1) ]
• Hypertension [see Warnings and Precautions (5.2) ]
• Raynaud’s Phenomenon [see Warnings and Precautions (5.3) ] Most common adverse reactions (at least 2% of patients treated with ZAVZPRET and greater than placebo) were taste disorders, nausea, nasal discomfort, and vomiting. ( 6.1 ) To report SUSPECTED ADVE...

ZAVZPRET is contraindicated in patients with a history of hypersensitivity reaction to zavegepant or any of the components of ZAVZPRET. Reactions have included anaphylaxis [see Warnings and Precautions (5.1) ] . Patients with a history of hypersensitivity reaction to zavegepant or to any of the components of ZAVZPRET. ( 4 )

• Hypersensitivity Reactions: If a serious hypersensitivity reaction occurs, discontinue ZAVZPRET and initiate appropriate therapy. Hypersensitivity reactions including anaphylaxis, facial swelling, and urticaria, have occurred with ZAVZPRET. ( 5.1 )
• Hypertension: New-onset or worsening of pre-existing hypertension may occur. ( 5.2 )
• Raynaud’s Phenomenon: New-onset or worsening of pre-existing Raynaud’s phenomenon may occur. ( 5.3 ) 5.1 Hypersensitivity Reactions Serious hypersensitivity rea...

7 DRUG INTERACTIONS

• Avoid use with drugs that inhibit OATP1B3 or NTCP transporters. ( 7.1 )
• Avoid use with drugs that induce OATP1B3 or NTCP transporters. ( 7.2 )
• Avoid use of intranasal decongestants; if unavoidable, administer intranasal decongestants at least 1 hour after ZAVZPRET administration. ( 7.3 ) 7.1 OATP1B3 or NTCP Inhibitors Concomitant administration of ZAVZPRET with inhibitors...