HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use ZAVZPRET safely and effectively. See full prescribing information for ZAVZPRET. ZAVZPRET™ (zavegepant) nasal spray Initial U.S. Approval: 2023 INDICATIONS AND USAGEDOSAGE AND ADMINISTRATIONDOSAGE FORMS AND STRENGTHSNasal spray: 10 mg (3) CONTRAINDICATIONSPatients with a history of hypersensitivity reaction to zavegepant or to any of the components of ZAVZPRET. (4) WARNINGS AND PRECAUTIONSHypersensitivity Reactions: If a serious hypersensitivity reaction occurs, discontinue ZAVZPRET and initiate appropriate therapy. Hypersensitivity Reactions including facial swelling and urticaria have occurred with ZAVZPRET. (5.1) ADVERSE REACTIONSMost 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 ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. DRUG INTERACTIONSUSE IN SPECIFIC POPULATIONSSee 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Revised: 3/2023 |
HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use ZAVZPRET safely and effectively. See full prescribing information for ZAVZPRET. ZAVZPRET™ (zavegepant) nasal spray Initial U.S. Approval: 2023 INDICATIONS AND USAGEDOSAGE AND ADMINISTRATIONDOSAGE FORMS AND STRENGTHSNasal spray: 10 mg (3) CONTRAINDICATIONSPatients with a history of hypersensitivity reaction to zavegepant or to any of the components of ZAVZPRET. (4) WARNINGS AND PRECAUTIONSHypersensitivity Reactions: If a serious hypersensitivity reaction occurs, discontinue ZAVZPRET and initiate appropriate therapy. Hypersensitivity Reactions including facial swelling and urticaria have occurred with ZAVZPRET. (5.1) ADVERSE REACTIONSMost 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 ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. DRUG INTERACTIONSUSE IN SPECIFIC POPULATIONSSee 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Revised: 3/2023 |
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